BioVaxys Technology Corp. (BIOV.CN) (LMNFG.PK)

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BIOVAXYS BEGINS TOXICITY STUDY AHEAD OF COVIDTH IND SUBMISSION

Vancouver, BC – September 28, 2021 —  BioVaxys Technology Corp. (CSE: BIOV) (FRA:5LB) (OTCQB:BVAXF) (“BioVaxys” or “Company”), announced today that it has started its planned in vivo animal toxicology study of CoviDTH in parallel with the preparation of an IND submission.  Under the terms of a March 2021 agreement, global contract research organization (“CRO”) Inotiv, Inc. (“Inotiv”) is evaluating the safety, tolerability, and toxicity of the purified recombinant SARS-CoV-2 s-protein that is a principal constituent of CoviDTH in an intradermal research model, which will include a battery of clinical pathology, immunology, and histopathology evaluations.  The Inotiv study will be utilizing purified recombinant SARS-CoV-2 s-protein recently produced by BioVaxys bioproduction partner, WuXi Biologics.

 

Headquartered in West Lafayette, Indiana, Inotiv (NASDAQ: NOTV; market capitalization: $795M) provides contract research services to emerging pharmaceutical companies and some of the world’s leading drug development companies and medical research organizations.

 

In its July 2021 Written Response to BioVaxys on the Company’s request for a Pre-IND Type B review of CoviDTH as a diagnostic for evaluating T-cell immune response to SARS-CoV-2, the US Food and Drug Administration (“FDA”) indicated that animal toxicity studies for CoviDTH were not required and that the Company could start its clinical development program with a combined Phase I/II study.    Although the animal tox study is discretionary, it will not interfere with the IND timing and BioVaxys believes it may provide useful data when the study is completed next month.

 

CoviDTH™ is the world’s first and only low cost, disposable, point-of-care diagnostic tool that screens for a T-cell response to SARS-CoV-2 in vaccinated patients, or those exposed to SARS-CoV-2.  Recent published clinical studies1,2 have validated the use of the delayed type hypersensitivity (DTH) cutaneous test behind CoviDTH as a feasible and safe in vivo method to assess cellular immune responses in both natural and vaccinated SARS-CoV-2 exposed individuals and also that the DTH response is highly durable and persists for at least one year after COVID-19 exposure or vaccine administration3.

 

BioVaxys President and Chief Operating Officer Ken Kovan stated, “Based on the millions of people who have received COVID-19 vaccines that are based on in vivo cellular expression of SARS-CoV-2 s-spike protein, as well as the human DTH studies, we are confident that the toxicology study with Inotiv of the s-protein will likewise confirm the safety profile of CoviDTH.”

 

 

For greater certainty, BioVaxys is not making any express or implied claims that it has the ability to treat the SAR-CoV-2 virus at this time.

 

  1. The Beauty of Simplicity: Delayed-Type Hypersensitivity Reaction to Measure Cellular Immune Responses in RNA-SARS-Cov-2 Vaccinated Individuals. Barrios Y, Franco A, Sánchez-Machín I, Poza-Guedes P, González-Pérez R, Matheu V.Vaccines (Basel). 2021 Jun 1;9(6):575. doi: 10.3390/vaccines9060575.
  2. A Novel Application of Delayed-Type Hypersensitivity Reaction to Measure Cellular Immune Response in SARS-CoV-2 Exposed Individuals. Barrios Y, Franco A, Sanchez-Machin I, Poza-Guedes P, Gonzalez-Perez R, Matheu V.Clin Immunol. 2021 May;226:108730. doi: 10.1016/j.clim.2021.108730. Epub 2021 Apr 16.
  3. Long term follow-up of in vivo cellular immune response to SARS-CoV-2 using delayed-type hypersensitivity cutaneous test. Barrios Y, Sánchez-Machín I, Matheu V. Eur J Immunol 2021 51,S1, 338. Abstract P-0814 doi: 10.1002/eji.202170200

 

About BioVaxys Technology Corp.

 

Based in Vancouver, BioVaxys Technology Corp. (www.biovaxys.com) is a British Columbia-registered, clinical stage biotechnology company that is developing viral and oncology vaccine platforms, as well as immuno-diagnostics.  The Company is advancing a SARS-CoV-2 vaccine based on its haptenized viral protein technology, and is planning a clinical trial of its haptenized autologous cell vaccine used in combination with anti-PD1 and anti-PDL-1 checkpoint inhibitors that will initially be developed for Stage III/Stage IV ovarian cancer. Also in development is CoviDTH®, a diagnostic for evaluating the presence or absence of a T cell immune response to SARS-CoV-2, the virus that causes COVID-19. BioVaxys has two issued US patents and two patent applications related to its cancer vaccine, and pending patent applications for its SARS-CoV-2 (Covid-19) vaccine and diagnostic technologies. BioVaxys common shares are listed on the CSE under the stock symbol “BIOV” and trade on the Frankfurt Bourse (FRA: 5LB) and in the US (OTCQB: BVAXF).

 

ON BEHALF OF THE BOARD

Signed “James Passin”

James Passin, CEO

+1 646 452 7054

 

Media Contacts BioVaxys Technology Corp.

Gina Cestari, Senior VP

6 Degrees Public Relations

+1 917 797 7904

gcestari@6degreespr.com

  

Cautionary Statements Regarding Forward Looking Information 

 

This press release includes certain “forward-looking information” and “forward-looking statements” (collectively “forward-looking statements”) within the meaning of applicable Canadian and United States securities legislation including the United States Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, included herein, without limitation, statements relating the future operating or financial performance of the Company, are forward looking statements. Forward-looking statements are frequently, but not always, identified by words such as “expects”, “anticipates”, “believes”, “intends”, “estimates”, “potential”, “possible”, and similar expressions, or statements that events, conditions, or results “will”, “may”, “could”, or “should” occur or be achieved. Forward-looking statements in this news release relate to, among other things, completion of the murine model study, regulatory approval for a Phase I study of its BVX-0320 Vaccine Candidate in humans and the overall development of BioVaxys’ vaccines, including any haptenized SARS-Cov-2 protein vaccine. There can be no assurance that such statements will prove to be accurate, and actual results and future events could differ materially from those expressed or implied in such forward-looking statements. 

 

These forward-looking statements reflect the beliefs, opinions and projections on the date the statements are made and are based upon a number of assumptions and estimates, primarily the assumption that BioVaxys will be successful in developing and testing vaccines, that, while considered reasonable by the Company, are inherently subject to significant business, economic, competitive, political and social uncertainties and contingencies including, primarily but without limitation, the risk that BioVaxys’ vaccines will not prove to be effective and/ or will not receive the required regulatory approvals. With regards to BioVaxys’ business, there are a number of risks that could affect the development of its biotechnology products, including, without limitation, the need for additional capital to fund clinical trials, its lack of operating history, uncertainty about whether its products will complete the long, complex and expensive clinical trial and regulatory approval process for approval of new drugs necessary for marketing approval, uncertainty about whether its autologous cell vaccine immunotherapy can be developed to produce safe and effective products and, if so, whether its vaccine products will be commercially accepted and profitable, the expenses, delays and uncertainties and complications typically encountered by development stage biopharmaceutical businesses, financial and development obligations under license arrangements in order to protect its rights to its products and technologies, obtaining and protecting new intellectual property rights and avoiding infringement to third parties and their dependence on manufacturing by third parties.

 

The Company does not assume any obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law.

 

SOURCE:  BioVaxys Technology Corp.

 

BIOVAXYS PREPARES FOR GROUND-BREAKING STUDY ON REDUCED ACE2 BINDING CAPABILITIES OF HAPTEN-MODIFIED SARS-COV-2 PROTEINS

POTENTIAL FOR SUPERIOR TOLERABILITY TO MRNA AND ADENOVIRUS VECTOR VACCINES 

 

PRODUCTION AGREEMENT SIGNED WITH MILLIPORE-SIGMA FOR SARS-COV-2 VACCINE SUPPLY

 

Vancouver, BC – September 23, 2021 —  BioVaxys Technology Corp. (CSE: BIOV, FRA:5LB, OTCQB:BVAXF) (“BioVaxys” or “Company”), announced today that it has initiated what could be a scientifically groundbreaking study on the reduced ACE2 binding capabilities of the hapten-modified spike protein that is the foundation of BVX-0320, the Company’s SARS-CoV-2 vaccine.

 

Many SARS-CoV-2-infected patients develop pneumonia that may lead to acute respiratory distress, with some patients developing cardiac symptoms and cardiovascular injury.

 

In their peer-reviewed research paper “SARS-CoV-2 binds platelet ACE2 to enhance thrombosis in COVID-19,” published in the Journal of Hematological Oncology, S. Zhang et.al. (1) conclude that the Receptor Binding Domain (RBD) of the SARS-CoV-2 spike protein binds to the ACE2 receptor and that this binding of SARS-CoV-2 to ACE2 prevents the enzyme from converting angiotensin II, potentiating pulmonary and cardiovascular issues.  Currently available vaccines, whether comprise either recombinant full-length or partial Spike protein can result in rare, but life-threatening side effects, such as abnormal blood clotting or myocarditis. These toxicities may be caused by unwanted binding of the vaccine spike protein to ACE2 receptors in the heart or platelet factor 4. The Biovaxys vaccine for Covid-19, BVX-0320, comprises a portion of the spike protein that is modified by the hapten, dinitrophenyl (DNP).  Biovaxys believes that the haptenized spike protein has much diminished ability to bind to ACE2, which would result in much diminished vaccine toxicity.

 

David Berd, MD, Chief Medical Officer of Biovaxys, explained that “Biovaxys will compare the binding of haptenized spike protein with the non-haptenized. The results could provide evidence that our vaccine has lowered potential for some of the observed serious vaccine side effects.”

 

James Passin, BioVaxys CEO, stated, “Haptenization, as a method to inhibit the ACE2-binding ability of the s-spike protein, while increasing its immunogenicity, may prove to play a critical role in global Covid-19 vaccine development and deployment strategies, as public health authorities consider options for repeated seasonal vaccine boosters in the context of reported, albeit rare, adverse effects and apparent waning immunity.”

 

This week BioVaxys entered into an agreement with Millipore-Sigma (“Millipore”) a global Contract Development and Manufacturing Research Organization (“CDMO”), to manufacture a supply of GLP-grade BVX-0320, the Company’s SARS-CoV-2 vaccine candidate for the study.  Millipore produced similar yields of BVX-0320 last summer for the Company’s animal immune response studies, but will now be incorporating in the manufacturing the recently produced purified recombinant s-protein produced by BioVaxys bioproduction partner, WuXi Biologics. Millipore is a subsidiary of Merck KGaA (Deutsche Bourse: MRCG), one of the largest pharmaceutical companies in the world, with a market capitalization of US$102 billion.

 

BioVaxys is currently finalizing arrangements with a major US academic research institution who will be collaborating with the Company on the study.

 

For greater certainty, BioVaxys is not making any express or implied claims that it has the ability to treat the SAR-CoV-2 virus at this time.

 

J Hematol Oncol 2020 Sep 4;13(1):120

 

About BioVaxys Technology Corp.

 

Based in Vancouver, BioVaxys Technology Corp. (www.biovaxys.com) is a British Columbia-registered, clinical stage biotechnology company that is developing viral and oncology vaccine platforms, as well as immuno-diagnostics.  The Company is advancing a SARS-CoV-2 vaccine based on its haptenized viral protein technology, and is planning a clinical trial of its haptenized autologous cell vaccine used in combination with anti-PD1 and anti-PDL-1 checkpoint inhibitors that will initially be developed for Stage III/Stage IV ovarian cancer. Also in development is CoviDTH®, a diagnostic for evaluating the presence or absence of a T cell immune response to SARS-CoV-2, the virus that causes COVID-19. BioVaxys has two issued US patents and two patent applications related to its cancer vaccine, and pending patent applications for its SARS-CoV-2 (Covid-19) vaccine and diagnostic technologies. BioVaxys common shares are listed on the CSE under the stock symbol “BIOV” and trade on the Frankfurt Bourse (FRA: 5LB) and in the US (OTCQB: BVAXF).

 

ON BEHALF OF THE BOARD

Signed “James Passin”

James Passin, CEO

+1 646 452 7054

 

Media Contacts BioVaxys Technology Corp.

Gina Cestari, Senior VP

6 Degrees Public Relations

+1 917 797 7904

gcestari@6degreespr.com

 

Cautionary Statements Regarding Forward Looking Information 

 

This press release includes certain “forward-looking information” and “forward-looking statements” (collectively “forward-looking statements”) within the meaning of applicable Canadian and United States securities legislation including the United States Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, included herein, without limitation, statements relating the future operating or financial performance of the Company, are forward looking statements. Forward-looking statements are frequently, but not always, identified by words such as “expects”, “anticipates”, “believes”, “intends”, “estimates”, “potential”, “possible”, and similar expressions, or statements that events, conditions, or results “will”, “may”, “could”, or “should” occur or be achieved. Forward-looking statements in this news release relate to, among other things, completion of the murine model study, regulatory approval for a Phase I study of its BVX-0320 Vaccine Candidate in humans and the overall development of BioVaxys’ vaccines, including any haptenized SARS-Cov-2 protein vaccine. There can be no assurance that such statements will prove to be accurate, and actual results and future events could differ materially from those expressed or implied in such forward-looking statements. 

 

These forward-looking statements reflect the beliefs, opinions and projections on the date the statements are made and are based upon a number of assumptions and estimates, primarily the assumption that BioVaxys will be successful in developing and testing vaccines, that, while considered reasonable by the Company, are inherently subject to significant business, economic, competitive, political and social uncertainties and contingencies including, primarily but without limitation, the risk that BioVaxys’ vaccines will not prove to be effective and/ or will not receive the required regulatory approvals. With regards to BioVaxys’ business, there are a number of risks that could affect the development of its biotechnology products, including, without limitation, the need for additional capital to fund clinical trials, its lack of operating history, uncertainty about whether its products will complete the long, complex and expensive clinical trial and regulatory approval process for approval of new drugs necessary for marketing approval, uncertainty about whether its autologous cell vaccine immunotherapy can be developed to produce safe and effective products and, if so, whether its vaccine products will be commercially accepted and profitable, the expenses, delays and uncertainties and complications typically encountered by development stage biopharmaceutical businesses, financial and development obligations under license arrangements in order to protect its rights to its products and technologies, obtaining and protecting new intellectual property rights and avoiding infringement to third parties and their dependence on manufacturing by third parties.

 

The Company does not assume any obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law.

 

SOURCE:  BioVaxys Technology Corp.

BIOVAXYS CANCER VACCINE MANUFACTURING PARTNER BIO ELPIDA REACHES BIOPRODUCTION MILESTONE

Vancouver, BC – September 17, 2021 – BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) (OTCQB: BVAXF) (“BioVaxys”), announced today that cancer vaccine manufacturing partner Bio Elpida in Lyon, France, has reached major milestones in the development of the bioproduction process for BVX-0918A, BioVaxys’ ovarian cancer vaccine and is beginning the next phase of manufacturing process development.

 

Bio Elpida has completed the technology process transfer with BioVaxys and started the development phase using a Quality by Design (“QbD”) approach which includes establishing the control methods and manufacturing process development. In parallel, as Bio Elpida further prepares for GMP manufacturing of BVX-0918A, the preparation of the new manufacturing facility is ongoing and on schedule. The next step is the vaccine process validation using donated tumor samples obtained following surgical excision from ovarian cancer patients.

 

Bio Elpida President Gilles Devillers says that “This major step is essentially a ‘dry-run’ for manufacturing the vaccine and preparation for GMP production.  Although there is significant know-how required to produce a GLP process that has been contributed by both BioVaxys and Bio Elpida, production of GMP-grade vaccine is about validation, proving sterility, quality control, etc., which must all be extremely well documented for regulatory authorities.”

 

BVX-0918A is headed for a planned Phase I clinical trial in Spain early next year with BioVaxys’ EU commercial partner Procare Health Iberia.

 

BioVaxys President and Chief Operating Officer Ken Kovan stated, “Today’s news represents a significant manufacturing milestone for BioVaxys and follows on the back of the news earlier this week that our CDMO partner WuXi Biologics has completed the synthesis of recombinant SARS-CoV-2 s-protein for our BVX-0320 and CoviDTH programs, further demonstrating the outstanding strength of our bioproduction partners while serving as a testimony to the operational and executional capacity of BioVaxys.”

 

About BioVaxys Technology Corp.

 

Based in Vancouver, BioVaxys Technology Corp. (www.biovaxys.com) is a British Columbia-registered, clinical stage biotechnology company that is developing viral and oncology vaccine platforms, as well as immuno-diagnostics.  The Company is advancing a SARS-CoV-2 vaccine based on its haptenized viral protein technology, and is planning a clinical trial of its haptenized autologous cell vaccine used in combination with anti-PD1 and anti-PDL-1 checkpoint inhibitors that will initially be developed for Stage III/Stage IV ovarian cancer. Also in development is CoviDTH®, a diagnostic for evaluating the presence or absence of a T cell immune response to SARS-CoV-2, the virus that causes COVID-19. BioVaxys has two issued US patents and two patent applications related to its cancer vaccine, and pending patent applications for its SARS-CoV-2 (Covid-19) vaccine and diagnostic technologies. BioVaxys common shares are listed on the CSE under the stock symbol “BIOV” and trade on the Frankfurt Bourse (FRA: 5LB) and in the US (OTCQB: BVAXF).

 

ON BEHALF OF THE BOARD

Signed “James Passin”

James Passin, CEO

+1 646 452 7054

Media Contacts BioVaxys Technology Corp.

Nikita Sachdev
Luna PR
info@lunapr.io

 

Cautionary Statements Regarding Forward Looking Information 

 

This press release includes certain “forward-looking information” and “forward-looking statements” (collectively “forward-looking statements”) within the meaning of applicable Canadian and United States securities legislation including the United States Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, included herein, without limitation, statements relating the future operating or financial performance of the Company, are forward looking statements. Forward-looking statements are frequently, but not always, identified by words such as “expects”, “anticipates”, “believes”, “intends”, “estimates”, “potential”, “possible”, and similar expressions, or statements that events, conditions, or results “will”, “may”, “could”, or “should” occur or be achieved. Forward-looking statements in this news release relate to, among other things, completion of the murine model study, regulatory approval for a Phase I study of its BVX-0320 Vaccine Candidate in humans and the overall development of BioVaxys’ vaccines, including any haptenized SARS-Cov-2 protein vaccine. There can be no assurance that such statements will prove to be accurate, and actual results and future events could differ materially from those expressed or implied in such forward-looking statements. 

 

These forward-looking statements reflect the beliefs, opinions and projections on the date the statements are made and are based upon a number of assumptions and estimates, primarily the assumption that BioVaxys will be successful in developing and testing vaccines, that, while considered reasonable by the Company, are inherently subject to significant business, economic, competitive, political and social uncertainties and contingencies including, primarily but without limitation, the risk that BioVayxs’ vaccines will not prove to be effective and/ or will not receive the required regulatory approvals. With regards to BioVaxys’ business, there are a number of risks that could affect the development of its biotechnology products, including, without limitation, the need for additional capital to fund clinical trials, its lack of operating history, uncertainty about whether its products will complete the long, complex and expensive clinical trial and regulatory approval process for approval of new drugs necessary for marketing approval, uncertainty about whether its autologous cell vaccine immunotherapy can be developed to produce safe and effective products and, if so, whether its vaccine products will be commercially accepted and profitable, the expenses, delays and uncertainties and complications typically encountered by development stage biopharmaceutical businesses, financial and development obligations under license arrangements in order to protect its rights to its products and technologies, obtaining and protecting new intellectual property rights and avoiding infringement to third parties and their dependence on manufacturing by third parties.

 

The Company does not assume any obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law.

 

Source:  BioVaxys Technology Corp.

BIOVAXYS BIOPRODUCTION PARTNER WUXI BIOLOGICS COMPLETES SYNTHESIS OF RECOMBINANT SARS-COV-2 S-PROTEINS FOR BVX-0320 AND CoviDTH PROGRAMS

Vancouver, BC –  September 14h, 2021 – BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) (OTCQB: BVAXF) (“BioVaxys”), announced today that global CDMO partner WuXi Biologics, has completed the synthesis of recombinant SARS-CoV-2 s-protein for BVX-0320, the company’s COVID-19 vaccine candidate, and CoviDTH, its immunodiagnostic product.  Both are headed for clinical trials, with BioVaxys having begun preparing an IND submission to the US Food and Drug Administration (“FDA”) for a combined Phase I/II clinical study of CoviDTH as a diagnostic for evaluating T-cell immune response to SARS-CoV-2.

 

Under the terms of the March 11th, 2021 agreement, WuXi Biologics synthesized high yields of fully characterized, SARS-CoV-2 s-protein for BioVaxys’ Good Laboratory Practice (GLP) preclinical safety study of its CoviDTH which will begin this month.  In its official Written Response in July to the Company’s request for a Pre-IND Type B review of CoviDTH, the FDA has indicated that BioVaxys’ planned animal toxicity study is discretionary and not required for IND submission.  However, the Company is continuing with this study of CoviDTH as it does not interfere with the IND submission and may in fact provide useful data.

 

BioVaxys President & Chief Operating Officer Kenneth Kovan commented that “The production of the recombinant s-protein using WuXi Biologics’ proprietary cell expression system is a significant milestone for Biovaxys, as we not only have a high production yield of protein, but also now have the ability and know-how to produce protein in large scale with the level of purity, consistency and protein characterization required by the FDA for our clinical studies and commercial-scale yields.”

 

For greater certainty, BioVaxys is not making any express or implied claims that it has the ability to treat the SAR-CoV-2 virus at this time.

 

About BioVaxys Technology Corp.

 

Based in Vancouver, BioVaxys Technology Corp. (www.biovaxys.com) is a British Columbia-registered, clinical stage biotechnology company that is developing viral and oncology vaccine platforms, as well as immuno-diagnostics.  The Company is advancing a SARS-CoV-2 vaccine based on its haptenized viral protein technology, and is planning a clinical trial of its haptenized autologous cell vaccine used in combination with anti-PD1 and anti-PDL-1 checkpoint inhibitors that will initially be developed for Stage III/Stage IV ovarian cancer. Also in development is CoviDTH®, a diagnostic for evaluating the presence or absence of a T cell immune response to SARS-CoV-2, the virus that causes COVID-19. BioVaxys has two issued US patents and two patent applications related to its cancer vaccine, and pending patent applications for its SARS-CoV-2 (Covid-19) vaccine and diagnostic technologies. BioVaxys common shares are listed on the CSE under the stock symbol “BIOV” and trade on the Frankfurt Bourse (FRA: 5LB) and in the US (OTCQB: BVAXF).

 

ON BEHALF OF THE BOARD

Signed “James Passin”

James Passin, CEO

+1 646 452 7054

Media Contacts BioVaxys Technology Corp.

Nikita Sachdev
Luna PR
info@lunapr.io

 

Cautionary Statements Regarding Forward Looking Information 

 

This press release includes certain “forward-looking information” and “forward-looking statements” (collectively “forward-looking statements”) within the meaning of applicable Canadian and United States securities legislation including the United States Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, included herein, without limitation, statements relating the future operating or financial performance of the Company, are forward looking statements. Forward-looking statements are frequently, but not always, identified by words such as “expects”, “anticipates”, “believes”, “intends”, “estimates”, “potential”, “possible”, and similar expressions, or statements that events, conditions, or results “will”, “may”, “could”, or “should” occur or be achieved. Forward-looking statements in this news release relate to, among other things, completion of the murine model study, regulatory approval for a Phase I study of its BVX-0320 Vaccine Candidate in humans and the overall development of BioVaxys’ vaccines, including any haptenized SARS-Cov-2 protein vaccine. There can be no assurance that such statements will prove to be accurate, and actual results and future events could differ materially from those expressed or implied in such forward-looking statements. 

 

These forward-looking statements reflect the beliefs, opinions and projections on the date the statements are made and are based upon a number of assumptions and estimates, primarily the assumption that BioVaxys will be successful in developing and testing vaccines, that, while considered reasonable by the Company, are inherently subject to significant business, economic, competitive, political and social uncertainties and contingencies including, primarily but without limitation, the risk that BioVayxs’ vaccines will not prove to be effective and/ or will not receive the required regulatory approvals. With regards to BioVaxys’ business, there are a number of risks that could affect the development of its biotechnology products, including, without limitation, the need for additional capital to fund clinical trials, its lack of operating history, uncertainty about whether its products will complete the long, complex and expensive clinical trial and regulatory approval process for approval of new drugs necessary for marketing approval, uncertainty about whether its autologous cell vaccine immunotherapy can be developed to produce safe and effective products and, if so, whether its vaccine products will be commercially accepted and profitable, the expenses, delays and uncertainties and complications typically encountered by development stage biopharmaceutical businesses, financial and development obligations under license arrangements in order to protect its rights to its products and technologies, obtaining and protecting new intellectual property rights and avoiding infringement to third parties and their dependence on manufacturing by third parties.

 

The Company does not assume any obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law.

 

SOURCE:  BioVaxys Technology Corp.

 

FURTHER STUDY IN HUMANS SHOWS THAT THE DTH RESPONSE, THE BASIS FOR CoviDTH, IS HIGHLY DURABLE AND PERSISTS FOR AT LEAST ONE YEAR AFTER COVID-19 EXPOSURE OR VACCINE ADMINISTRATION

Vancouver, British Columbia and San Cristóbal de  La Laguna, Tenerife, Spain – September 8,  2021 –   BioVaxys Technology Corp. (CSE: BIOV) (FRA:5LB) (OTCQB:BVAXF) (“BioVaxys” or “the Company”) is pleased to announce that the Scientific Advisor for its CoviDTH program, Yvelise Barrios, MD, PhD, and Clinical Immunologist at Hospital Universitario de Canarias, Tenerife, Spain, has been invited to present her new clinical study entitled LONG TERM FOLLOW-UP OF IN VIVO CELLULAR IMMUNE RESPONSE TO SARS-CoV-2 USING DELAYED-TYPE HYPERSENSITIVITY CUTANEOUS TEST 1  at the  6th European Congress of Immunology (“ECI”) held September 1-4, 2021.  ECI is one of the most highly-regarded international conferences in the field of basic and clinical immunology.

 

Dr. Barrios is a leading expert in the clinical use of delayed type hypersensitivity (“DTH”), the mechanism behind CoviDTH, the Company’s disposable point-of-care diagnostic tool that screens for a T-cell response to SARS-CoV-2 in vaccinated patients or those exposed to SARS-CoV-2.  Her collaborators were Inmaculada Sanchez Machín MD, PhD, and Victor Matheu, MD, PhD, Allergology Department and Grupo de Expertos Inmunodeficiencias, Hospital Universitario de Canarias, Tenerife.

 

Their study shows that the DTH response, which is the basis for CoviDTH, in individuals who had recovered from Covid-19 is highly durable, persisting for at least one year after viral exposure in these preliminary data. They conclude that the DTH test can be used as a routine diagnostic method to monitor the T cell-mediated response to SARS-CoV-2.

 

Two recovered patients were tested for DTH at 6 and 12 months after infection.  The DTH responses were as follows:  Subject A: 6 months=41mm, 12 months=35mm; Subject B: 6 months=14mm, 12 months=30mm.  These are considered very large responses, compared, for example, to the DTH responses of people with a history of tuberculosis. These results pointed out that natural, acquired immunity in these two patients is still very clearly present after one year of follow-up and that the DTH is a very simple and easy to interpret test to answer questions about durability of cellular immune responses in COVID19.

 

In June 2021, Dr Barrios and her colleagues had previous human studies of DTH published in the medical research journals Vaccines2 and Clinical Immunology3, which validated the use of the CoviDTH approach of a delayed type hypersensitivity (DTH) cutaneous test as a feasible and safe  in vivo method to assess cellular immune responses in both natural and vaccinated SARS-CoV-2 exposed individuals.

 

There is significant evidence that an antibody-mediated and T cell-mediated immune response is required for protection against SARS-CoV-24,5 and that T cell-mediated immunity is a more reliable correlate of vaccine protection than antibody titers in seniors6, strongly supporting the need for a determination of T cell response in COVID-19 vaccine design and population screening.

 

Kenneth Kovan, President and Chief Operating Officer of BioVaxys, stated, “These human studies conducted by Dr. Barrios give us significant confidence in CoviDTH, especially as we now are preparing our IND for the planned US combined Phase I/II study.”

 

Dr. Barrios is a specialist in Clinical Immunology at Hospital Universitario de Canarias, with a clinical focus on histocompatibility, autoimmune diseases and allergy, and is senior Immunology consultant for primary immunodeficiency diseases.  Her lab is the Reference Laboratory for kidney transplantation of the Canary Islands Province in Spain.  Dr. Barrios received her medical degree at La Laguna University, Tenerife, Spain and conducted her Clinical Immunology Residency at Puerta de Hierro Hospital. She received her PhD on Active Immunotherapy in B-cell Tumors, from Universidad Autonoma, Madrid, and did her post-doctoral in phage display expression of antibody fragments in Immunotechnology at Lund University in Sweden.

 

For greater certainty, BioVaxys is not making any express or implied claims that it has the ability to treat the SAR-CoV-2 virus at this time.

 

[1] Long term follow-up of in vivo cellular immune response to SARS-CoV-2 using delayed-type hypersensitivity cutaneous test. Barrios Y, Sánchez-Machín I, Matheu V. Eur J Immunol 2021 51,S1, 338. Abstract P-0814 doi: 10.1002/eji.202170200

 

[2] The Beauty of Simplicity: Delayed-Type Hypersensitivity Reaction to Measure Cellular Immune Responses in RNA-SARS-Cov-2 Vaccinated Individuals.

Barrios Y, Franco A, Sánchez-Machín I, Poza-Guedes P, González-Pérez R, Matheu V.Vaccines (Basel). 2021 Jun 1;9(6):575. doi: 10.3390/vaccines9060575.

 

[3] A Novel Application of Delayed-Type Hypersensitivity Reaction to Measure Cellular Immune Response in SARS-CoV-2 Exposed Individuals. Barrios Y, Franco A, Sanchez-Machin I, Poza-Guedes P, Gonzalez-Perez R, Matheu V.Clin Immunol. 2021 May;226:108730. doi: 10.1016/j.clim.2021.108730. Epub 2021 Apr 16.

 

[4] Sariol, A.; Perlman, S. Lessons for COVID-19 Immunity from Other Coronavirus Infections. J. Immun. 53, 248–263

 

[5] Tay, M.Z.; Poh, C.M.; Rénia, L.; Macary, P.A.; Ng, L.F.P. The trinity of COVID-19: Immunity, inflammation and intervention. Nat. Rev. Immunol. 2020,20, 363–374.

 

[6] Haq, K.; E McElhaney, J. Immunosenescence: Influenza vaccination and the elderly. Curr. Opin. Immunol. 29, 38–42

 

About BioVaxys Technology Corp.

 

Based in Vancouver, BioVaxys Technology Corp. (www.biovaxys.com) is a British Columbia-registered, clinical stage biotechnology company that is developing viral and oncology vaccine platforms, as well as immuno-diagnostics.  The Company is advancing a SARS-CoV-2 vaccine based on its haptenized viral protein technology, and is planning a clinical trial of its haptenized autologous cell vaccine used in combination with anti-PD1 and anti-PDL-1 checkpoint inhibitors that will initially be developed for Stage III/Stage IV ovarian cancer. Also in development is CoviDTH®, a diagnostic for evaluating the presence or absence of a T cell immune response to SARS-CoV-2, the virus that causes COVID-19. BioVaxys has two issued US patents and two patent applications related to its cancer vaccine, and pending patent applications for its SARS-CoV-2 (Covid-19) vaccine and diagnostic technologies. BioVaxys common shares are listed on the CSE under the stock symbol “BIOV” and trade on the Frankfurt Bourse (FRA: 5LB) and in the US (OTCQB: BVAXF).

 

ON BEHALF OF THE BOARD

Signed “James Passin”

James Passin, CEO

+1 646 452 7054

Media Contacts BioVaxys Technology Corp.

Nikita Sashdev
Luna PR
info@lunapr.io

 

Cautionary Statements Regarding Forward Looking Information 

 

This press release includes certain “forward-looking information” and “forward-looking statements” (collectively “forward-looking statements”) within the meaning of applicable Canadian and United States securities legislation including the United States Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, included herein, without limitation, statements relating the future operating or financial performance of the Company, are forward looking statements. Forward-looking statements are frequently, but not always, identified by words such as “expects”, “anticipates”, “believes”, “intends”, “estimates”, “potential”, “possible”, and similar expressions, or statements that events, conditions, or results “will”, “may”, “could”, or “should” occur or be achieved. Forward-looking statements in this news release relate to, among other things, completion of the murine model study, regulatory approval for a Phase I study of its BVX-0320 Vaccine Candidate in humans and the overall development of BioVaxys’ vaccines, including any haptenized SARS-Cov-2 protein vaccine. There can be no assurance that such statements will prove to be accurate, and actual results and future events could differ materially from those expressed or implied in such forward-looking statements. 

 

These forward-looking statements reflect the beliefs, opinions and projections on the date the statements are made and are based upon a number of assumptions and estimates, primarily the assumption that BioVaxys will be successful in developing and testing vaccines, that, while considered reasonable by the Company, are inherently subject to significant business, economic, competitive, political and social uncertainties and contingencies including, primarily but without limitation, the risk that BioVayxs’ vaccines will not prove to be effective and/ or will not receive the required regulatory approvals. With regards to BioVaxys’ business, there are a number of risks that could affect the development of its biotechnology products, including, without limitation, the need for additional capital to fund clinical trials, its lack of operating history, uncertainty about whether its products will complete the long, complex and expensive clinical trial and regulatory approval process for approval of new drugs necessary for marketing approval, uncertainty about whether its autologous cell vaccine immunotherapy can be developed to produce safe and effective products and, if so, whether its vaccine products will be commercially accepted and profitable, the expenses, delays and uncertainties and complications typically encountered by development stage biopharmaceutical businesses, financial and development obligations under license arrangements in order to protect its rights to its products and technologies, obtaining and protecting new intellectual property rights and avoiding infringement to third parties and their dependence on manufacturing by third parties.

 

The Company does not assume any obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law.

 

SOURCE:  BioVaxys Technology Corp.

FDA PROVIDES NECESSARY GUIDANCE FOR BIOVAXYS TO BEGIN PREPARATION OF IND FOR PHASE I/II CLINICAL TRIALS OF CoviDTH

Vancouver, BC – July 22, 2021 – BioVaxys Technology Corp. (CSE: BIOV) (FRA:5LB) (OTCQB: BVAXF) (“BioVaxys”), is pleased to announce today that the US Food and Drug Administration (“FDA”) has provided its official Written Response to the Company’s request for a Pre-IND Type B review of CoviDTH as a diagnostic for evaluating T-cell immune response to SARS-CoV-2.

 

The FDA found the Chemistry, Manufacturing and Controls, and other elements of the clinical development program proposed by BioVaxys to be acceptable and provided guidance and feedback supportive of BioVaxys’ clinical development plans for CoviDTH.  In addition, the FDA indicated that animal toxicity studies for CoviDTH were not required and that the Company could start its clinical development program with a combined Phase I/II study.     Based on this feedback, BioVaxys will begin preparation of an IND application to support a Phase I/II safety, dosing, and efficacy study.

 

BioVaxys submitted a Pre-Investigational New Drug (“IND”) meeting request and briefing package with the FDA’s Center for Biologics Evaluation and Research (CBER) for CoviDTH earlier this year. The Pre-IND review is a critical step in the US regulatory approval process, as it affords an opportunity for study sponsor companies to seek clarification from the FDA on clinical trials design, clinical materials manufacturing, quality controls, etc.

 

“With the guidance we received from this FDA review, BioVaxys is now able to begin preparing its IND,” stated BioVaxys President and Chief Operating Officer Ken Kovan.  He adds “Although the FDA has indicated that our planned animal tox study is discretionary, we will likely continue with the animal tox study of CoviDTH as it does not interfere with the development time frame and may in fact provide useful data.”

 

James Passin, BioVaxys CEO, stated, “We are pleased to advance CoviDTH towards clinical trials, as we believe that mass screening for T cell immunity to Covid-19 will represent a critical tool for public health authorities to address the continued pandemic, as Covid variants continue to circulate and major governments in the southern hemisphere enact new lockdown policies.”

  

About BioVaxys Technology Corp.

 

Based in Vancouver, BioVaxys Technology Corp. is a British Columbia-registered, early stage biotechnology company that is developing viral and oncology vaccine platforms, as well as immuno-diagnostics.  The Company is advancing a SARS-CoV-2 vaccine based on its haptenized viral protein technology, and is planning a clinical trial of its haptenized autologous cell vaccine used in combination with anti-PD1 and anti-PDL-1 checkpoint inhibitors that will initially be developed for ovarian cancer. Also in development is a diagnostic for evaluating the presence or absence of a T cell immune response to SARS-CoV-2, the virus that causes COVID-19. BioVaxys has two issued US patents and two patent applications related to its cancer vaccine, and pending patent applications for its SARS-CoV-2 (Covid-19) vaccine and diagnostic technologies. BioVaxys common shares are listed on the CSE under the stock symbol “BIOV” and trades on the Frankfurt Bourse (FRA: 5LB) and in the US (OTCQB: BVAXF).

 

ON BEHALF OF THE BOARD

Signed “James Passin”

James Passin, CEO

+1 646 452 7054

 

Media Contacts BioVaxys Technology Corp.

Nikita Sachdev
Luna PR
info@lunapr.io

 

Cautionary Statements Regarding Forward Looking Information

 

This press release includes certain “forward-looking information” and “forward-looking statements” (collectively “forward-looking statements”) within the meaning of applicable Canadian and United States securities legislation including the United States Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, included herein, without limitation, statements relating the future operating or financial performance of the Company, are forward looking statements. Forward-looking statements are frequently, but not always, identified by words such as “expects”, “anticipates”, “believes”, “intends”, “estimates”, “potential”, “possible”, and similar expressions, or statements that events, conditions, or results “will”, “may”, “could”, or “should” occur or be achieved. Forward-looking statements in this news release relate to, among other things, completion of the Private Placement, the use of proceeds of the Private Placement and the overall development of BioVaxys’ vaccines and diagnostic technologies. There can be no assurance that such statements will prove to be accurate, and actual results and future events could differ materially from those expressed or implied in such forward-looking statements.

 

These forward-looking statements reflect the beliefs, opinions and projections on the date the statements are made and are based upon a number of assumptions and estimates, primarily the assumption that BioVaxys will be successful in locating suitable purchasers for Private Placement and in developing and testing vaccines and diagnostic tools, that, while considered reasonable by the Company, are inherently subject to significant business, economic, competitive, political and social uncertainties and contingencies including, primarily but without limitation, the risk that BioVaxys’ vaccines and diagnostic tools will not prove to be effective and/ or will not receive the required regulatory approvals. With regards to BioVaxys’ business, there are a number of risks that could affect the development of its biotechnology products, including, without limitation, the need for additional capital to fund clinical trials, its lack of operating history, uncertainty about whether its products will complete the long, complex and expensive clinical trial and regulatory approval process for approval of new drugs necessary for marketing approval, uncertainty about whether its autologous cell vaccine immunotherapy can be developed to produce safe and effective products and, if so, whether its vaccine products will be commercially accepted and profitable, the expenses, delays and uncertainties and complications typically encountered by development stage biopharmaceutical businesses, financial and development obligations under license arrangements in order to protect its rights to its products and technologies, obtaining and protecting new intellectual property rights and avoiding infringement to third parties and their dependence on manufacturing by third parties.

 

The Company does not assume any obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law.

 

SOURCE:  BioVaxys Technology Corp.

 

BIOVAXYS ANNOUNCES APPOINTMENT OF POLICY ADVISOR

Vancouver, BC – May 20, 2021 —  BioVaxys Technology Corp. (CSE: BIOV) (FRA:5LB) (OTCQB:BVAXF) (“BioVaxys”), a biotechnology company that is advancing viral and oncology vaccine platforms as well as immuno-diagnostic products, today announced the appointment of Adam Coutts, PhD, as Policy Advisor.

 

Dr. Coutts is a Senior Research Fellow at Magdalene CollegeUniversity of Cambridge and a Research Associate in the Department of Sociology, University of Cambridge.  Dr. Coutts’ research focuses on the social and political determinants of health looking at how non-health sector public policies affect the health and wellbeing of vulnerable groups and how government interventions can be used to help them. Dr. Coutts holds a PhD from the Department of SociologyUniversity of Cambridge and has held post-doctoral fellowships at Cambridge, and the Department of Politics and International Relations, University of Oxford, Nuffield College.  Dr. Coutts is also a research associate at the Centre for Business Research, Cambridge

 

James Passin, BioVaxys CEO, stated, “We are honored to onboard Dr. Coutts as a Policy Advisor to BioVaxys. Dr. Coutts’ expertise and experience in public health policy, bringing together academic, policy decision makers and multilateral agencies with those working on- the-ground to deliver healthcare, will prove critical as BioVaxys advances CoviDTH, a novel skin test for T cell immunity to Covid-19, through regulatory and commercial development. We believe that CoviDTH can offer a transformative approach to public health policy in low-income contexts especially in humanitarian and conflict settings, where resources and access are limited. This approach provides a tool to help governments optimize the distribution and targeting of vaccines which will accelerate the lifting of restrictions and lockdown policies.”

 

Dr. Coutts stated, “CoviDTH provides a low-cost and reliable solution to help mitigate the impacts of the pandemic in fragile and humanitarian settings where health systems are already severely strained, and funds and access are challenging. To end the pandemic, everyone, everywhere need the protection of affordable and effective products like CoviDTH.”

 

About BioVaxys Technology Corp.

 

Based in Vancouver, BioVaxys Technology Corp. is a British Columbia-registered, early stage biotechnology company that is developing viral and oncology vaccine platforms, as well as immuno-diagnostics.  The Company is advancing a SARS-CoV-2 vaccine based on its haptenized viral protein technology and is progressing a clinical trial of its haptenized autologous cell vaccine used in combination with anti-PD1 and anti-PDL-1 checkpoint inhibitors that will initially be developed for ovarian cancer. Also in development is a diagnostic for evaluating the presence or absence of a T cell immune response to SARS-CoV-2, the virus that causes Covid-19. BioVaxys has two issued US patents and multiple pending patents related to its cancer vaccine, and pending patent applications for its SARS-CoV-2 (Covid-19) vaccine and diagnostic technologies. BioVaxys common shares are listed on the CSE under the stock symbol “BIOV” and trade on the Frankfurt Bourse (FRA: 5LB) and US OTC: BVAXF.

 

ON BEHALF OF THE BOARD

Signed “James Passin”

James Passin, CEO

+1 646 452 7054

 

Media Contacts

Nikita Sachdev

Luna PR

info@lunapr.io

 

Cautionary Statements Regarding Forward Looking Information

This press release includes certain “forward-looking information” and “forward-looking statements” (collectively “forward-looking statements”) within the meaning of applicable Canadian and United States securities legislation including the United States Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, included herein, without limitation, statements relating the future operating or financial performance of the Company, are forward looking statements. Forward-looking statements are frequently, but not always, identified by words such as “expects”, “anticipates”, “believes”, “intends”, “estimates”, “potential”, “possible”, and similar expressions, or statements that events, conditions, or results “will”, “may”, “could”, or “should” occur or be achieved. Forward-looking statements in this news release relate to, among other things, completion of the murine model study, regulatory approval for a Phase I study of its BVX-0320 Vaccine Candidate in humans and the overall development of BioVaxys’ vaccines, including any haptenized SARS-Cov-2 protein vaccine. There can be no assurance that such statements will prove to be accurate, and actual results and future events could differ materially from those expressed or implied in such forward-looking statements.

 

These forward-looking statements reflect the beliefs, opinions and projections on the date the statements are made and are based upon a number of assumptions and estimates, primarily the assumption that BioVaxys will be successful in developing and testing vaccines, that, while considered reasonable by the Company, are inherently subject to significant business, economic, competitive, political and social uncertainties and contingencies including, primarily but without limitation, the risk that BioVayxs’ vaccines will not prove to be effective and/ or will not receive the required regulatory approvals. With regards to BioVaxys’ business, there are a number of risks that could affect the development of its biotechnology products, including, without limitation, the need for additional capital to fund clinical trials, its lack of operating history, uncertainty about whether its products will complete the long, complex and expensive clinical trial and regulatory approval process for approval of new drugs necessary for marketing approval, uncertainty about whether its autologous cell vaccine immunotherapy can be developed to produce safe and effective products and, if so, whether its vaccine products will be commercially accepted and profitable, the expenses, delays and uncertainties and complications typically encountered by development stage biopharmaceutical businesses, financial and development obligations under license arrangements in order to protect its rights to its products and technologies, obtaining and protecting new intellectual property rights and avoiding infringement to third parties and their dependence on manufacturing by third parties.

 

The Company does not assume any obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law.

 

SOURCE:  BioVaxys Technology Corp.

BIOVAXYS AND BIOELPIDA SIGN DEFINITIVE EXCLUSIVE AGREEMENT TO BEGIN OVARIAN CANCER VACCINE BIOPRODUCTION

Vancouver, BC – May 3, 2021 —  BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) (OTC: BVAXF) (“BioVaxys” or “Company”) announced today that it has signed the definitive exclusive bioproduction agreement (“Agreement”) with BioElpida S.A.S. (“BioElpida”) of Lyon, France, to begin the clinical-grade bioproduction and aseptic packaging for BXV-0918A, BioVaxys’ vaccine candidate for Stage III/Stage IV ovarian cancer.  BioVaxys and BioElpida executed a Term Sheet in February outlining the commercial relationship, with todays definitive Agreement focusing on the GMP facility build-out in Lyon, and technical aspects of the bioproduction protocol such as process design and validation, quality control and quality assurance steps, batch test runs, stability testing, and aseptic fill.  BioVaxys expects to be able to prepare its regulatory submission for a EU Phase I study of BVX-0918A in Stage III/Stage IV ovarian cancer near the end of this year, with vaccine supply for the planned clinical study available early May 2022.

 

BioElpida is a biotechnology contract development and manufacturing company (“CDMO”) which applies single-use bioprocessing for development and manufacturing of biological and cell-based products.  BioElpida’s expertise extends from R&D to pharmaceutical manufacturing and release of clinical batches, and intermediate steps such as process development, feasibility studies, analytical method validation, as well as aseptic fill & finish and other bioproduction services. BioElpida’s facility is certified for clinical bioproduction by France’s National Security Agency of Medicines and Health Products (ANSM).

 

“Early on we made the decision to seek a bioproduction partner with the ability to quickly move from smaller-yield GMP-grade clinical study supplies to large-scale manufacturing if our clinical trials prove successful and EU regulatory approval is granted,” said Kenneth Kovan, Co-Founder, President and Chief Operating Officer of BioVaxys.  “BioElpida’s technical experience and previous work on early generations of our cancer vaccine platform will be a significant advantage in our efforts to provide hope to those suffering from advanced ovarian cancer.”

 

BioVaxys is collaborating on the ovarian cancer vaccine clinical program with Spanish biopharma company ProCare Health Iberia S.A.S., which plans to submit a Clinical Trial Application (“CTA”) for BVX-0918A to the European Medicines Agency (“EMEA”) later this year for a compassionate use approval in Stage III & Stage IV ovarian cancer.    ProCare Health will have marketing rights to BVX-0918A in the EU and UK, whereas BioVaxys will market its ovarian cancer vaccine in North America and Rest of World.

 

Globally, there remain significant unmet therapeutic needs for ovarian cancer treatment. Worldwide, over 300,000 women are diagnosed with ovarian cancer each year (World Cancer Research Fund, 2020), with ovarian cancer the leading cause of death from gynecologic malignancy in the United States (American Cancer Society Facts & Figures 2020). An estimated 21,750 new cases of ovarian cancer were expected in the US in 2020 with 13,940 deaths (National Cancer Institute, Surveillance and Epidemiology Program, 2020). The majority of women with Stage III or Stage IV cancer will ultimately have recurrent disease resistant to chemotherapy. Patients who have relapsed after platinum-based chemotherapy have limited life expectancy even with multiple salvage regimens. This large group of non-responders to first line therapy, or those who relapse after first line therapy, are the initial target market for BioVaxys.

 

The global ovarian cancer drugs market was valued US$1.2B in 2017 and is expected to reach US$4.6B by 2026, at a CAGR of 18.29 % (www.medgadget.com/2020/11/ovarian-cancer-drugs-2020-global-market-to-reach-us-4-6-bn-and-growing-at-cagr-of-18-29-by-2026.html).

 

About BioVaxys Technology Corp.

 

Based in Vancouver, BioVaxys Technology Corp. is a British Columbia-registered, early stage biotechnology company that is developing viral and oncology vaccine platforms, as well as immuno-diagnostics.  The Company is advancing a SARS-CoV-2 vaccine based on its haptenized viral protein technology, and is planning a clinical trial of its haptenized autologous cell vaccine used in combination with anti-PD1 and anti-PDL-1 checkpoint inhibitors that will initially be developed for ovarian cancer. Also in development is a diagnostic for evaluating the presence or absence of a T cell immune response to SARS-CoV-2, the virus that causes COVID-19. BioVaxys has two issued US patents and two patent applications related to its cancer vaccine, and pending patent applications for its SARS-CoV-2 (Covid-19) vaccine and diagnostic technologies. BioVaxys common shares are listed on the CSE under the stock symbol “BIOV” and trades on the Frankfurt Bourse (FRA: 5LB) and in the US (OTC: BVAXF).

 

ON BEHALF OF THE BOARD

Signed “James Passin”

James Passin, CEO

+1 646 452 7054

 

Media Contacts BioVaxys Technology Corp.

Nikita Sachdev
Luna PR
info@lunapr.io

 

Cautionary Statements Regarding Forward Looking Information

 

This press release includes certain “forward-looking information” and “forward-looking statements” (collectively “forward-looking statements”) within the meaning of applicable Canadian and United States securities legislation including the United States Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, included herein, without limitation, statements relating the future operating or financial performance of the Company, are forward looking statements. Forward-looking statements are frequently, but not always, identified by words such as “expects”, “anticipates”, “believes”, “intends”, “estimates”, “potential”, “possible”, and similar expressions, or statements that events, conditions, or results “will”, “may”, “could”, or “should” occur or be achieved. Forward-looking statements in this news release relate to, among other things, completion of the murine model study, regulatory approval for a Phase I study of its BVX-0320 Vaccine Candidate in humans and the overall development of BioVaxys’ vaccines, including any haptenized SARS-Cov-2 protein vaccine. There can be no assurance that such statements will prove to be accurate, and actual results and future events could differ materially from those expressed or implied in such forward-looking statements.

 

These forward-looking statements reflect the beliefs, opinions and projections on the date the statements are made and are based upon a number of assumptions and estimates, primarily the assumption that BioVaxys will be successful in developing and testing vaccines, that, while considered reasonable by the Company, are inherently subject to significant business, economic, competitive, political and social uncertainties and contingencies including, primarily but without limitation, the risk that BioVayxs’ vaccines will not prove to be effective and/ or will not receive the required regulatory approvals. With regards to BioVaxys’ business, there are a number of risks that could affect the development of its biotechnology products, including, without limitation, the need for additional capital to fund clinical trials, its lack of operating history, uncertainty about whether its products will complete the long, complex and expensive clinical trial and regulatory approval process for approval of new drugs necessary for marketing approval, uncertainty about whether its autologous cell vaccine immunotherapy can be developed to produce safe and effective products and, if so, whether its vaccine products will be commercially accepted and profitable, the expenses, delays and uncertainties and complications typically encountered by development stage biopharmaceutical businesses, financial and development obligations under license arrangements in order to protect its rights to its products and technologies, obtaining and protecting new intellectual property rights and avoiding infringement to third parties and their dependence on manufacturing by third parties.

 

The Company does not assume any obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law.

 

SOURCE:  BioVaxys Technology Corp.

BIOVAXYS EXPANDS INTELLECTUAL PROPERTY PORTFOLIO

PATENT FILING TO ADDRESS EMERGING SARS-COV-2 VARIANTS NATIONAL PHASE FILINGS FOR CANCER VACCINE

 

Vancouver, BC – March 24, 2021 —  BioVaxys Technology Corp. (CSE: BIOV, FRA:5LB, OTC:LMNGF) (“BioVaxys” or “the Company”), the world leader in haptenized antigen vaccines for antiviral and cancer applications, announced today that it is expanding its intellectual property portfolio with the filing of an international patent application through the Patent Cooperation Treaty (“PCT”) for its haptenized viral antigen vaccine platform, including new claims for a multivalent version of BVX-0320, its SARS-CoV-2 vaccine candidate. The planned multivalent version of the BioVaxys vaccine is a combination of the haptenized spike protein subunits from each newly emerging, highly transmissible, SARS-CoV-2 variants, including United Kingdom (B.1.1.7 lineage), South Africa (B.1.351 lineage), and Brazil (P.1 lineage), that are of high concern to worldwide governments, healthcare practitioners, and infectious disease researchers.

 

The provisional patent application covering the Company’s haptenized viral antigen vaccine platform was filed with the US Patent and Trademark Office (“USPTO”) last year and has now been converted to an International PCT Application, which is a patent treaty with more than 150 member countries. The PCT makes it possible to seek patent protection for an invention simultaneously in a large number of countries by filing a single “international” patent application instead of filing several separate national or regional patent applications.

 

In developments related to BVX-0918A, its ovarian cancer vaccine, Biovaxys has entered the National Phase with its bihaptenized tumor antigen platform patent application, most recently filed in 2019 as an International PCT Application.  The granting of patents remains under the control of the national or regional patent offices in what is called the “National Phase”. Once filed as a PCT, a patent application owner can start to pursue the grant of its patents directly before the national (or regional) Patent Offices of the countries in which they want to obtain them. Entering the National Phase, BioVaxys is pursuing expanded patent protection to include the major pharmaceutical markets of US, European Union (including the UK and Turkey), Australia, Canada, China, India, Japan, Russia, Brazil, and South Korea.

 

BioVaxys President and Chief Operating Officer Kenneth Kovan states that “Because of the time and expense associated with developing novel products, BioVaxys places considerable importance on obtaining patent protection for new technologies, uses, and processes.  The Company will file patent applications to protect inventions and improvements that are important to the development of our business and with respect to the application of our products and technologies to the treatment of a number of diseases.”

 

For greater certainty, BioVaxys is not making any express or implied claims that it has the ability to treat the SAR-CoV-2 virus at this time.

 

About BioVaxys Technology Corp.

 

Based in Vancouver, BioVaxys Technology Corp. is a British Columbia-registered, early stage biotechnology company that is developing viral and oncology vaccine platforms, as well as immuno-diagnostics.  The Company is advancing a SARS-CoV-2 vaccine based on its haptenized viral protein technology, and is planning a clinical trial of its haptenized autologous cell vaccine used in combination with anti-PD1 and anti-PDL-1 checkpoint inhibitors that will initially be developed for ovarian cancer. Also in development is a diagnostic for evaluating the presence or absence of a T cell immune response to SARS-CoV-2, the virus that causes COVID-19. BioVaxys has two issued US patents and two patent applications related to its cancer vaccine, and pending patent applications for its SARS-CoV-2 (Covid-19) vaccine and diagnostic technologies. BioVaxys common shares are listed on the CSE under the stock symbol “BIOV” and trades on the Frankfurt Bourse (FRA: 5LB) and US OTC: LMNGF.

 

ON BEHALF OF THE BOARD

Signed “James Passin”

James Passin, CEO

+1 646 452 7054

 

Media Contacts BioVaxys Technology Corp.

Nikita Sachdev
Luna PR
info@lunapr.io

 

Cautionary Statements Regarding Forward Looking Information

 

This press release includes certain “forward-looking information” and “forward-looking statements” (collectively “forward-looking statements”) within the meaning of applicable Canadian and United States securities legislation including the United States Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, included herein, without limitation, statements relating the future operating or financial performance of the Company, are forward looking statements. Forward-looking statements are frequently, but not always, identified by words such as “expects”, “anticipates”, “believes”, “intends”, “estimates”, “potential”, “possible”, and similar expressions, or statements that events, conditions, or results “will”, “may”, “could”, or “should” occur or be achieved. Forward-looking statements in this news release relate to, among other things, completion of the murine model study, regulatory approval for a Phase I study of its BVX-0320 Vaccine Candidate in humans and the overall development of BioVaxys’ vaccines, including any haptenized SARS-Cov-2 protein vaccine. There can be no assurance that such statements will prove to be accurate, and actual results and future events could differ materially from those expressed or implied in such forward-looking statements.

 

These forward-looking statements reflect the beliefs, opinions and projections on the date the statements are made and are based upon a number of assumptions and estimates, primarily the assumption that BioVaxys will be successful in developing and testing vaccines, that, while considered reasonable by the Company, are inherently subject to significant business, economic, competitive, political and social uncertainties and contingencies including, primarily but without limitation, the risk that BioVayxs’ vaccines will not prove to be effective and/ or will not receive the required regulatory approvals. With regards to BioVaxys’ business, there are a number of risks that could affect the development of its biotechnology products, including, without limitation, the need for additional capital to fund clinical trials, its lack of operating history, uncertainty about whether its products will complete the long, complex and expensive clinical trial and regulatory approval process for approval of new drugs necessary for marketing approval, uncertainty about whether its autologous cell vaccine immunotherapy can be developed to produce safe and effective products and, if so, whether its vaccine products will be commercially accepted and profitable, the expenses, delays and uncertainties and complications typically encountered by development stage biopharmaceutical businesses, financial and development obligations under license arrangements in order to protect its rights to its products and technologies, obtaining and protecting new intellectual property rights and avoiding infringement to third parties and their dependence on manufacturing by third parties.

 

The Company does not assume any obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law.

 

SOURCE: BioVaxys Technology Corp.

BIOVAXYS ENTERS AGREEMENT WITH INOTIV TO CONDUCT PRECLINICAL TOXICITY STUDIES FOR ITS COVID-T™ IMMUNODIAGNOSTIC PROGRAM

Vancouver, BC –  March 18th, 2021 — BioVaxys Technology Corp. (CSE: BIOV) (FRA:5LB) (OTCPK:LMNGF) (“BioVaxys”), the world leader in haptenized protein vaccines for antiviral and cancer applications, announced today that it has entered into an agreement with Bioanalytical Systems, Inc. d/b/a Inotiv (“Inotiv”), a global Contract Research Organization (“CRO”), to conduct preclinical toxicology studies for its Covid-T™ immunodiagnostic. Headquartered in West Lafayette, IN, Inotiv, provides contract research services and monitoring instruments to emerging pharmaceutical companies and some of the world’s leading drug development companies and medical research organizations.

 

Covid-T™ is a low-cost, easy-to-administer, and accurate tool to test for the presence of T cells against SARS-CoV-2, and to evaluate the effectiveness of any SARS-CoV-2 vaccine candidate in stimulating T cell immunity. Covid-T™ uses Delayed-Type Hypersensitivity (“DTH”), which is known to be a measure of T cell immunity and has been used for many years for other infectious diseases including tuberculosis, fungal diseases, and mumps. The test is performed by placing a small amount of synthesized test material, e.g., SARS-Cov-2 spike protein, intradermally and inspecting the site for mild localized reddening and hardening of the skin ~24 hours later.

Under the terms of the March 15th, 2021, agreement, Inotiv will evaluate the safety, tolerability, and toxicity of purified SARS-CoV-2 s-protein in an intradermal research model, which will include a battery of clinical pathology, immunology, and histopathology evaluations. The fully characterized, Good Laboratory Practice (GLP) grade SARS-CoV-2 s-protein will be synthesized by WuXi Biologics and is a core element of the Covid-T immunodiagnostic. BioVaxys anticipates that the preclinical toxicity study results will be available early summer, with the successful completion of the study a critical step towards the initiation of a pivotal human trial of Covid-T later this year, subject to FDA approval. BioVaxys intends to submit its pre-IND meeting request to the FDA for Covid-T early next month.

 

BioVaxys President and Chief Operating Officer Ken Kovan stated, “Based on previous preclinical studies conducted with BVX-0320, and the fact that our SARS-CoV-2 vaccine candidate likewise incorporates synthetic s-protein, we have high expectations that this detailed toxicology study of the s-protein with Inotiv will confirm the safety profile of the diagnostic and lead to our planned pivotal clinical study later this year.”

 

James Passin, BioVaxys CEO, stated “We are delighted to work with Inotiv, a leading CRO, to complete a toxicity study, further advancing Covid-T, our novel low cost and scalable skin test for T cell immunity to SARS-CoV-2, the virus that causes Covid-19. We believe that Covid-T will help to solve the world’s most pressing public health policy crisis by enabling the rational distribution and allocation of vaccine resources, while preventing unnecessary and wasteful vaccination of people with demonstrable T cell immunity to Covid-19.”

 

For greater certainty, BioVaxys is not making any express or implied claims that it has the ability to treat the SAR-CoV-2 virus at this time.

 

About BioVaxys Technology Corp.

 

Based in Vancouver, BioVaxys Technology Corp. is a British Columbia-registered, early stage biotechnology company that is developing viral and oncology vaccine platforms, as well as immuno-diagnostics. The Company is advancing a SARS-CoV-2 vaccine based on its haptenized viral protein technology, and is planning a clinical trial of its haptenized autologous cell vaccine used in combination with anti-PD1 and anti-PDL-1 checkpoint inhibitors that will initially be developed for ovarian cancer. Also in development is a diagnostic for evaluating the presence or absence of a T cell immune response to SARS-CoV-2, the virus that causes COVID-19. BioVaxys has two issued US patents and two patent applications related to its cancer vaccine, and pending patent applications for its SARS-CoV-2 (Covid-19) vaccine and diagnostic technologies. BioVaxys common shares are listed on the CSE under the stock symbol “BIOV” and trades on the Frankfurt Bourse (FRA: 5LB) and US OTC: LMNGF.

 

ON BEHALF OF THE BOARD
Signed “James Passin”
James Passin, CEO
+1 646 452 7054

 

Media Contacts BioVaxys Technology Corp.
Nikita Sachdev
Luna PR
info@lunapr.io

Cautionary Statements Regarding Forward Looking Information

 

This press release includes certain “forward-looking information” and “forward-looking statements” (collectively “forward-looking statements”) within the meaning of applicable Canadian and United States securities legislation including the United States Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, included herein, without limitation, statements relating the future operating or financial performance of the Company, are forward looking statements. Forward-looking statements are frequently, but not always, identified by words such as “expects”, “anticipates”, “believes”, “intends”, “estimates”, “potential”, “possible”, and similar expressions, or statements that events, conditions, or results “will”, “may”, “could”, or “should” occur or be achieved. Forward-looking statements in this news release relate to, among other things, completion of the murine model study, regulatory approval for a Phase I study of its BVX-0320 Vaccine Candidate in humans and the overall development of BioVaxys’ vaccines, including any haptenized SARS-Cov-2 protein vaccine. There can be no assurance that such statements will prove to be accurate, and actual results and future events could differ materially from those expressed or implied in such forward-looking statements.

 

These forward-looking statements reflect the beliefs, opinions and projections on the date the statements are made and are based upon a number of assumptions and estimates, primarily the assumption that BioVaxys will be successful in developing and testing vaccines, that, while considered reasonable by the Company, are inherently subject to significant business, economic, competitive, political and social uncertainties and contingencies including, primarily but without limitation, the risk that BioVayxs’ vaccines will not prove to be effective and/ or will not receive the required regulatory approvals. With regards to BioVaxys’ business, there are a number of risks that could affect the development of its biotechnology products, including, without limitation, the need for additional capital to fund clinical trials, its lack of operating history, uncertainty about whether its products will complete the long, complex and expensive clinical trial and regulatory approval process for approval of new drugs necessary for marketing approval, uncertainty about whether its autologous cell vaccine immunotherapy can be developed to produce safe and effective products and, if so, whether its vaccine products will be commercially accepted and profitable, the expenses, delays and uncertainties and complications typically encountered by development stage biopharmaceutical businesses, financial and development obligations under license arrangements in order to protect its rights to its products and technologies, obtaining and protecting new intellectual property rights and avoiding infringement to third parties and their dependence on manufacturing by third parties.

 

The Company does not assume any obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law.

 

SOURCE:  BioVaxys Technology Corp

BIOVAXYS ENTERS MAJOR BIOPRODUCTION AGREEMENT WITH WUXI BIOLOGICS (HONG KONG) LTD. TO SYNTHESIZE PROTEINS FOR ITS SARS-COV-2 VACCINE AND COVID-T™ IMMUNODIAGNOSTIC PROGRAMS

Vancouver, British Columbia, March 15th, 2021 —  BioVaxys Technology Corp. (CSE: BIOV, FRA:5LB, OTC:LMNGF) (“BioVaxys”), the world leader in haptenized protein vaccines for antiviral and cancer applications, announced today that it has entered into a major bioproduction agreement with WuXi Biologics Limited (“WuXi”), a leading global Contract Development and Research Organization (“CDMO”) and business unit of Shanghai-based Wuxi AppTec, to produce SARS-CoV-2 s-proteins required by BioVaxys for BVX-0320, its COVID-19 vaccine candidate, and for its Covid-T™ immunodiagnostic program.

 

Under the terms of the March 11th, 2021 agreement, WuXi will synthesize high yields of fully characterized, Good Laboratory Practice (GLP) grade SARS-CoV-2 s-protein for BioVaxys’ preclinical safety study of its COVID-T™ diagnostic this spring. The recombinant s-protein will be constructed and expressed using WuXi Biologics’ proprietary vector, with high yield protein production in a pilot plant bioreactor. By establishing its own source of s-protein, rather than depending upon a bulk commercial supplier, BioVaxys will be able to secure the level of purity, consistency and protein characterization required by the U.S Food and Drug Administration (“the FDA”), as well as the economics of sourcing its own protein supply, facilitating the future production of GMP-grade s-protein for human trials and future commercial-scale production.

 

Synthesized GMP-grade s-protein is used in both BioVaxys’s Covid-T™ immunodiagnostic as well as in BVX-0320, the company’s SARS-CoV-2 candidate vaccine which is also being prepared for a clinical study this year. BioVaxys will submit its pre-IND meeting request to the FDA for Covid-T early next month.

 

BioVaxys President and Chief Operating Officer Ken Kovan stated that “Establishing a bioproduction method for a steady supply of purified and fully characterized s-protein from a validated process will enable us to quickly transition from having the GLP material for the upcoming Covid-T™ animal toxicity study to having a steady source the GMP-grade s-protein for clinical trials later this year. Now that we know the gene sequences, a further major benefit of our relationship with WuXi will be our ability to quickly source the s-protein of newly emerging SARS-CoV-2 variants for use in a planned multi-valent version of BVX-0320 and line extensions of Covid-T™.”

 

James Passin, BioVaxys CEO, stated “We are delighted to execute a definitive agreement with WuXi Biologics, a leading China-based CDMO listed on the Hong Kong Stock Exchange under the symbol 2269, with a market capitalization of USD$45 billion.  The relationship with WuXi positions BioVaxys to accelerate the regulatory and commercial advancement of Covid-T™ and BVX-0320.”

 

For greater certainty, BioVaxys is not making any express or implied claims that it has the ability to treat the SAR-CoV-2 virus at this time.

 

About BioVaxys Technology Corp.

 

Based in Vancouver, BioVaxys Technology Corp. is a British Columbia-registered, early stage biotechnology company that is developing viral and oncology vaccine platforms, as well as immuno-diagnostics.  The Company is advancing a SARS-CoV-2 vaccine based on its haptenized viral protein technology, and is planning a clinical trial of its haptenized autologous cell vaccine used in combination with anti-PD1 and anti-PDL-1 checkpoint inhibitors that will initially be developed for ovarian cancer. Also in development is a diagnostic for evaluating the presence or absence of a T cell immune response to SARS-CoV-2, the virus that causes COVID-19. BioVaxys has two issued US patents and two patent applications related to its cancer vaccine, and pending patent applications for its SARS-CoV-2 (Covid-19) vaccine and diagnostic technologies. BioVaxys common shares are listed on the CSE under the stock symbol “BIOV” and trades on the Frankfurt Bourse (FRA: 5LB) and US OTC: LMNGF.

 

ON BEHALF OF THE BOARD

Signed “James Passin”

James Passin, CEO

+1 646 452 7054

 

Media Contacts BioVaxys Technology Corp.

Nikita Sachdev
Luna PR
info@lunapr.io

  

Cautionary Statements Regarding Forward Looking Information

This press release includes certain “forward-looking information” and “forward-looking statements” (collectively “forward-looking statements”) within the meaning of applicable Canadian and United States securities legislation including the United States Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, included herein, without limitation, statements relating the future operating or financial performance of the Company, are forward looking statements. Forward-looking statements are frequently, but not always, identified by words such as “expects”, “anticipates”, “believes”, “intends”, “estimates”, “potential”, “possible”, and similar expressions, or statements that events, conditions, or results “will”, “may”, “could”, or “should” occur or be achieved. Forward-looking statements in this news release relate to, among other things, completion of the murine model study, regulatory approval for a Phase I study of its BVX-0320 Vaccine Candidate in humans and the overall development of BioVaxys’ vaccines, including any haptenized SARS-Cov-2 protein vaccine. There can be no assurance that such statements will prove to be accurate, and actual results and future events could differ materially from those expressed or implied in such forward-looking statements.

  

These forward-looking statements reflect the beliefs, opinions and projections on the date the statements are made and are based upon a number of assumptions and estimates, primarily the assumption that BioVaxys will be successful in developing and testing vaccines, that, while considered reasonable by the Company, are inherently subject to significant business, economic, competitive, political and social uncertainties and contingencies including, primarily but without limitation, the risk that BioVayxs’ vaccines will not prove to be effective and/ or will not receive the required regulatory approvals. With regards to BioVaxys’ business, there are a number of risks that could affect the development of its biotechnology products, including, without limitation, the need for additional capital to fund clinical trials, its lack of operating history, uncertainty about whether its products will complete the long, complex and expensive clinical trial and regulatory approval process for approval of new drugs necessary for marketing approval, uncertainty about whether its autologous cell vaccine immunotherapy can be developed to produce safe and effective products and, if so, whether its vaccine products will be commercially accepted and profitable, the expenses, delays and uncertainties and complications typically encountered by development stage biopharmaceutical businesses, financial and development obligations under license arrangements in order to protect its rights to its products and technologies, obtaining and protecting new intellectual property rights and avoiding infringement to third parties and their dependence on manufacturing by third parties.

 

The Company does not assume any obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law.

 

SOURCE: BioVaxys Technology Corp.

BIOVAXYS EXPANDING TECHNOLOGY PLATFORM TO ADDRESS EMERGING SARS-COV-2 VARIANTS

BVX-0320 and Covid-T to have capability to address UK, Brazilian and South African Virus Variants

 

Vancouver, BC – March 1, 2021 —  BioVaxys Technology Corp. (OTCPK: LMNGF) (CSE: BIOV.CNQ) (FRA:5LB) (“BioVaxys”), the world leader in haptenized protein vaccines for antiviral and cancer applications, announced today that it is assessing steps to modify BVX-0320 and Covid-T, its SARS-CoV-2 vaccine candidate and T-cell diagnostic, to address the newly emerging variants (the South African, UK, and Brazilian variants) of SARS-CoV-2 that are of high concern to worldwide governments, healthcare practitioners, and infectious disease researchers.

 

Given the flexibility in BioVaxys’ viral vaccine platform based on haptenizing viral antigens, the Company is exploring the potential for producing a multivalent vaccine, which will be a combination of the haptenized spike proteins subunits from each clinically significant variant. Once the amino acid sequences for the variants are available,  BioVaxys should be able to quickly produce a multivalent vaccine.  BioVaxys is also planning a product line extension of Covid-T, its disposable diagnostic for screening for T cell response to SARS-CoV-2, that would have capability to screen for T-cell responses to SARS-CoV-2 variants.

 

In recent months, highly transmissible SARS-CoV-2 variants – United Kingdom (B.1.1.7 lineage), South Africa (B.1.351 lineage), and Brazil (P.1 lineage) – with mutations in the spike protein have been spreading globally and appear to cause major changes in the way the virus acts, including enhanced transmissibility and possibly increased clinical severity.  Most disconcerting are findings that recently approved Covid-19 vaccines may not work as well against these variants.   In a new study which was published the New England Journal of Medicine, researchers from Pfizer, BioNTech, and the University of Texas Medical Branch examined how well blood taken from people who had received the companies’ vaccine fought off a virus engineered to have the key mutations found in B.1.351. They reported that there was about a two-thirds drop in neutralization power against the variant compared to other forms of the SARS-CoV-2 (NEJM, Neutralizing Activity of BNT162b2-Elicited SerumPreliminary Report February 17, 2021).  These “mutations” have quickly emerged in different geographical regions, such as the UK, South Africa and Brazil, and in some places have outcompeted the existing variants.  Given the nature of viruses and their natural propensity to mutate, it is likely that additional clinically significant variants will emerge.

 

A multivalent vaccine based on haptenized spike proteins of the emerging variants would be expected to have the same level of effectiveness that Biovaxys has demonstrated with its monovalent BVX-0320 vaccine in a mouse model: a 96.4% spike protein-binding antibody response, activation of CD4+ helper T cells and CD8+ killer T cells, and stimulation of T cells that produce the cytokine, gamma interferon.  Helper CD4+ T-cells are memory cells that retain information about the virus, enabling them to respond rapidly after viral exposure.  CD8+ T cells have the capacity to kill cells infected by the virus, thereby stopping viral replication in those cells.

 

Dr. David Berd, Chief Medical Officer of Biovaxys, noted that “hapten modification induces a strong T cell response against the unmodified, native viral protein.  It is likely that T cells induced by the original viral spike protein would also react with the new variants, even though the antibody response is attenuated.”

 

For greater certainty, BioVaxys is not making any express or implied claims that it has the ability to treat the SAR-CoV-2 virus at this time.

 

About BioVaxys Technology Corp.

 

Based in Vancouver, BioVaxys Technology Corp. is a British Columbia-registered, early stage biotechnology company that is developing viral and oncology vaccine platforms, as well as immuno-diagnostics.  The Company is advancing a SARS-CoV-2 vaccine based on its haptenized viral protein technology, and is planning a clinical trial of its haptenized autologous cell vaccine used in combination with anti-PD1 and anti-PDL-1 checkpoint inhibitors that will initially be developed for ovarian cancer. Also in development is a diagnostic for evaluating the presence or absence of a T cell immune response to SARS-CoV-2, the virus that causes COVID-19. BioVaxys has two issued US patents and two patent applications related to its cancer vaccine, and pending patent applications for its SARS-CoV-2 (Covid-19) vaccine and diagnostic technologies. BioVaxys common shares are listed on the CSE under the stock symbol “BIOV” and trades on the Frankfurt Bourse (FRA: 5LB) and US OTC: LMNGF.

 

ON BEHALF OF THE BOARD

Signed “James Passin”

James Passin, CEO

+1 646 452 7054

 

Media Contacts BioVaxys Technology Corp.

Nikita Sashdev
Luna PR
info@lunapr.io

 

Cautionary Statements Regarding Forward Looking Information

 

This press release includes certain “forward-looking information” and “forward-looking statements” (collectively “forward-looking statements”) within the meaning of applicable Canadian and United States securities legislation including the United States Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, included herein, without limitation, statements relating the future operating or financial performance of the Company, are forward looking statements. Forward-looking statements are frequently, but not always, identified by words such as “expects”, “anticipates”, “believes”, “intends”, “estimates”, “potential”, “possible”, and similar expressions, or statements that events, conditions, or results “will”, “may”, “could”, or “should” occur or be achieved. Forward-looking statements in this news release relate to, among other things, completion of the murine model study, regulatory approval for a Phase I study of its BVX-0320 Vaccine Candidate in humans and the overall development of BioVaxys’ vaccines, including any haptenized SARS-Cov-2 protein vaccine. There can be no assurance that such statements will prove to be accurate, and actual results and future events could differ materially from those expressed or implied in such forward-looking statements.

 

These forward-looking statements reflect the beliefs, opinions and projections on the date the statements are made and are based upon a number of assumptions and estimates, primarily the assumption that BioVaxys will be successful in developing and testing vaccines, that, while considered reasonable by the Company, are inherently subject to significant business, economic, competitive, political and social uncertainties and contingencies including, primarily but without limitation, the risk that BioVayxs’ vaccines will not prove to be effective and/ or will not receive the required regulatory approvals. With regards to BioVaxys’ business, there are a number of risks that could affect the development of its biotechnology products, including, without limitation, the need for additional capital to fund clinical trials, its lack of operating history, uncertainty about whether its products will complete the long, complex and expensive clinical trial and regulatory approval process for approval of new drugs necessary for marketing approval, uncertainty about whether its autologous cell vaccine immunotherapy can be developed to produce safe and effective products and, if so, whether its vaccine products will be commercially accepted and profitable, the expenses, delays and uncertainties and complications typically encountered by development stage biopharmaceutical businesses, financial and development obligations under license arrangements in order to protect its rights to its products and technologies, obtaining and protecting new intellectual property rights and avoiding infringement to third parties and their dependence on manufacturing by third parties.

 

The Company does not assume any obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law.

 

Source:  BioVaxys Technology Corp.

BioVaxys and BioElpida Sign Term Sheet for Clinical Grade BVX-0918a Bio-Production

Significant Advancement Towards Launch of Phase 1 Ovarian Cancer Vaccine Trial

 

Vancouver, British Columbia, February 18th, 2021 — BioVaxys Technology Corp. (CSE: BIOV, FRA:5LB, OTC:LMNGF) (“BioVaxys” or “Company”) announced today that it has signed a Term Sheet (“Term Sheet”) with BioElpida S.A.S. (“BioElpida”) of Lyon, France, to collaborate on the build-out for the clinical-grade manufacturing process and aseptic packaging for BXV-0918A, BioVaxys’ vaccine for Stage III/Stage IV ovarian cancer.  Completion of the GMP-grade bioproduction process development is planned for later this year, with the EU Phase I/II clinical trial slated for early 2022, pending European Medicines Agency (“EMEA”) approval.

 

BioElpida is a biotechnology contract development and manufacturing company (“CDMO”) which applies single-use bioprocessing for development and manufacturing of biological and cell-based products.  BioElpida’s expertise extends from R&D to pharmaceutical manufacturing and release of clinical batches, and intermediate steps such as process development, feasibility studies, analytical method validation, as well as aseptic fill & finish and other bioproduction services.  BioElpida’s facility is certified for clinical bioproduction by France’s National Security Agency of Medicines and Health Products (ANSM).

 

The two companies are working towards the execution of a definitive agreement by the end of this March.  Completion of the GMP-grade bioproduction process development is planned for later this year, with the EU Phase I/II clinical trial slated for early 2022, pending European Medicines Agency (“EMEA”) approval.

 

Kenneth Kovan, President and Chief Operating Officer of BioVaxys, stated that “In addition to its bioproduction expertise, the BioElpida team is intimately familiar with our haptenized protein approach, having previously been involved in the process development for the clinical supply of the ‘first generation’ haptenized tumor cell vaccines.”

 

BioVaxys recently announced that it is collaborating on the ovarian cancer vaccine clinical program with Spanish biopharma company ProCare Health Iberia S.A.S., which plans to submit a Clinical Trial Application (“CTA”) for BVX-0918A to the European Medicines Agency (“EMEA”) later this year for a compassionate use approval in Stage III & Stage IV ovarian cancer.    ProCare Health will have marketing rights to BVX-0918A in the EU and UK, whereas BioVaxys will market its ovarian cancer vaccine in North America and Rest of World.

 

Globally, there remain significant unmet therapeutic needs for ovarian cancer treatment. Worldwide, over 300,000 women are diagnosed with ovarian cancer each year (World Cancer Research Fund, 2020), with ovarian cancer the leading cause of death from gynecologic malignancy in the United States (American Cancer Society Facts & Figures 2020). An estimated 21,750 new cases of ovarian cancer were expected in the US in 2020 with 13,940 deaths (National Cancer Institute, Surveillance and Epidemiology Program, 2020). The majority of women with Stage III or Stage IV cancer will ultimately have recurrent disease resistant to chemotherapy. Patients who have relapsed after platinum-based chemotherapy have limited life expectancy even with multiple salvage regimens. This large group of non-responders to, or those who relapse after, first line therapy are the initial target market for BioVaxys.

 

The global ovarian cancer drugs market was valued US$1.2B in 2017 and is expected to reach US$4.6B by 2026, at a CAGR of 18.29 % (www.medgadget.com/2020/11/ovarian-cancer-drugs-2020-global-market-to-reach-us-4-6-bn-and-growing-at-cagr-of-18-29-by-2026.html).

 

About BioVaxys Technology Corp.

 

Based in Vancouver, BioVaxys Technology Corp. is a British Columbia-registered, early stage biotechnology company that is developing viral and oncology vaccine platforms, as well as immuno-diagnostics.  The Company is advancing a SARS-CoV-2 vaccine based on its haptenized viral protein technology, and is planning a clinical trial of its haptenized autologous cell vaccine used in combination with anti-PD1 and anti-PDL-1 checkpoint inhibitors that will initially be developed for ovarian cancer. Also in development is a diagnostic for evaluating the presence or absence of a T cell immune response to SARS-CoV-2, the virus that causes COVID-19. BioVaxys has two issued US patents and two patent applications related to its cancer vaccine, and pending patent applications for its SARS-CoV-2 (Covid-19) vaccine and diagnostic technologies. BioVaxys common shares are listed on the CSE under the stock symbol “BIOV” and trade on the Frankfurt Bourse (FRA: 5LB) and US OTC: LMNGF.

 

ON BEHALF OF THE BOARD

 

Signed “James Passin”

James Passin, CEO

+1 646 452 7054

 

Media Contacts

Nikita Sashdev

Luna PR

info@lunapr.io

 

Cautionary Statements Regarding Forward Looking Information

 

This press release includes certain “forward-looking information” and “forward-looking statements” (collectively “forward-looking statements”) within the meaning of applicable Canadian and United States securities legislation including the United States Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, included herein, without limitation, statements relating the future operating or financial performance of the Company, are forward looking statements. Forward-looking statements are frequently, but not always, identified by words such as “expects”, “anticipates”, “believes”, “intends”, “estimates”, “potential”, “possible”, and similar expressions, or statements that events, conditions, or results “will”, “may”, “could”, or “should” occur or be achieved. Forward-looking statements in this news release relate to, among other things, completion of the murine model study, regulatory approval for a Phase I study of its BVX-0320 Vaccine Candidate in humans and the overall development of BioVaxys’ vaccines, including any haptenized SARS-Cov-2 protein vaccine. There can be no assurance that such statements will prove to be accurate, and actual results and future events could differ materially from those expressed or implied in such forward-looking statements.

 

These forward-looking statements reflect the beliefs, opinions and projections on the date the statements are made and are based upon a number of assumptions and estimates, primarily the assumption that BioVaxys will be successful in developing and testing vaccines, that, while considered reasonable by the Company, are inherently subject to significant business, economic, competitive, political and social uncertainties and contingencies including, primarily but without limitation, the risk that BioVayxs’ vaccines will not prove to be effective and/ or will not receive the required regulatory approvals. With regards to BioVaxys’ business, there are a number of risks that could affect the development of its biotechnology products, including, without limitation, the need for additional capital to fund clinical trials, its lack of operating history, uncertainty about whether its products will complete the long, complex and expensive clinical trial and regulatory approval process for approval of new drugs necessary for marketing approval, uncertainty about whether its autologous cell vaccine immunotherapy can be developed to produce safe and effective products and, if so, whether its vaccine products will be commercially accepted and profitable, the expenses, delays and uncertainties and complications typically encountered by development stage biopharmaceutical businesses, financial and development obligations under license arrangements in order to protect its rights to its products and technologies, obtaining and protecting new intellectual property rights and avoiding infringement to third parties and their dependence on manufacturing by third parties.

 

The Company does not assume any obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law.

 

SOURCE: BioVaxys Technology Corp.

BioVaxys and Procare Health Announce Broad CO-Development, JOINT Commercialization and Marketing Collaboration for Cancer and Viral Vaccines

USD$900,000 In-Kind Investment by Procare Health into Phase I Clinical Study for BVX-0918A in the EU 

 

Co-Development of Vaccines for Cervical Cancer and HPV 

 

Right of First Refusal for US Marketing of Papilocare™

 

Vancouver, BC and Barcelona, Spain – February 10th, 2021 —  BioVaxys Technology Corp. (CSE: BIOV) (FRA:5LB) (OTCPK:LMNGF) (“BioVaxys”), the world leader in haptenized protein vaccines for antiviral and cancer applications, and Procare Health Iberia, S.L., of Barcelona, Spain (“Procare Health”), a leading privately-held European pharmaceutical company, announced today that they have entered into a broad collaboration for the co-development, joint commercialization, and marketing of BioVaxys vaccines for ovarian cancer, cervical cancer, and human papilloma virus (“HPV”), and the right of first refusal for marketing by BioVaxys in the United States of Procare Health’s vaginal gel product, Papilocare™, the world’s first and only product to prevent and treat HPV-dependent cervical lesions.  Left untreated, HPV infection generally leads to cervical cancer (World Health Organization, HPV and Cervical Cancer, 11 November 2020). Formed in 2012 as a spin-out from Procter & Gamble Pharmaceuticals, Procare Health is a market leader in the women’s health field in the European Union (“EU”), with marketed products including Papilocare™, Libicare™, Palomacare™, Idracare™, Pronolis HD™ and Ovosicare™.

 

Under the terms of the agreement, which was executed on February 9th, 2021, the companies will jointly conduct a Phase I Clinical Study of BVX-0918A in Spain, BioVaxys’ autologous haptenized protein vaccine for late-stage ovarian cancer.   BioVaxys will be responsible for the core technology and vaccine production, with Procare Health overseeing and making an in-kind investment in the clinical program and regulatory planning, CRO management, patient/clinical center recruitment, marketing, and opinion leader management. Both companies have agreed to equally share costs associated with engaging a European clinical research organization (“CRO”) to conduct the study.   In return, Procare Health will have exclusive rights to market and distribute BVX-0918A in the European Union (“EU”), and the United Kingdom.  Clinical data from the Spanish Phase I study will be used by BioVaxys to support its planned IND for BVX-0918A in the US next year, as well as for all other global markets.   The two companies will be working out any remaining details by end of 2Q21.

 

BioVaxys President and Chief Operating Officer Ken Kovan said “This co-development gives BioVaxys access to Procare Health’s clinical development and regulatory expertise in the EU, and to  its marketing & sales presence in Europe.” Kovan added that “Procare Health has an established portfolio of marketed brands that is focused heavily on the women’s health and gynecological oncology markets.  As we anticipate that these will be the primary users of our ovarian cancer vaccine, the relationship with Procare Health will give access to key gynecological oncology opinion leaders for patient access, clinical trial recruitment, and a relationship that post-approval will drive vaccine sales.  Having a strong EU opinion leader network will also be invaluable for our planned US launch of the vaccine.”

 

The collaboration with BioVaxys will help Procare Health fuel its product offerings in the gynecological oncology field.   Yann Gaslain, CEO of Procare Health stated, “We are thrilled to start working the collaboration with BioVaxys as it brings a new hope in the field of gynecological cancer. We have been working for 8 years in the area of cervical cancer and HPV, investigating to understand how the immune response of the host could be stimulated to help defend versus HPV infection and persistency, and we believe that the new haptenized cell platform technology can bring a valid answer to this unmet therapeutical need, mainly when high grade lesions of the cervix or even cervical carcinoma have been characterized. The promising vaccine technology platform of BioVaxys will likely help bringing response in ovarian and cervical cancer¨

 

In Phase I and Phase II clinical studies previously conducted by BioVaxys, co-founder and Chief Medical Officer, Dr. David Berd, using an earlier generation of the BioVaxys cancer vaccine on nearly 500 patients with melanoma or ovarian cancer, the haptenized cell platform showed significant clinical promise. BioVaxys has developed its vaccine technology platforms based on the established immunological concept that modifying proteins with simple chemicals called haptens makes them more visible to the immune system. The process of haptenization “teaches” a patient’s immune system to recognize and make target proteins more ‘visible’ as foreign, thereby stimulating an immune response.

 

Javier Cortés, MD, Specialist in Gynecology and Cytology for the international Academy of Cytology (Chicago, USA), member of the Spanish association against Cancer (AECC) and of the European Cervical Cancer Association (ECCA) stated, “I believe that the planned clinical trial in Phase I is of a very high interest based on my experience in oncology for more than 30 years. The immunotherapy is a line of treatment with very active investigation and promising early results in some cancers (lungs, melanoma and ovarian). That is why, every single line of investigation well based and with consistent criteria of quality in the design of the investigation should be very well received and encouraged.”

 

Leveraging the recent proven ability of its haptenized viral antigen vaccine platform in stimulating both a 96.4% positive immune response and powerful ‘memory’ T-cell activation against SARS-CoV-2, BioVaxys will use the platform’s flexibility to swap in viral antigens for Human Papilloma Virus (“HPV”), with the intent to develop a treatment for adults who are already infected with HPV.  There are vaccines to protect against getting HPV, but none to treat someone who already has HPV.  BioVaxys and Procare Health will split costs for feasibility, proof-of-concept, and preclinical development for a HPV viral vaccine, as well as a cervical cancer vaccine based on the BioVaxys cancer vaccine platform.  In return, Procare Health will have an exclusive right in the EU and UK for a HPV and/or cervical cancer vaccine, with BioVaxys retaining rights to North America and Rest of World.   Development milestones, go/no-go decisions, and other details will be finalized in 2Q2021.

 

In a major step toward transitioning to a revenue-generating company, BioVaxys has agreed to have a right of first refusal to market and distribute Papilocare™ in the US.

 

In Procare Health’s PALOMA Phase IIb clinical trial, Papilocare™ showed consistent and significant efficacy in normalizing cervical cytology at 3 months and at 6 months in the total study population with 50% to 70% of High-Risk HPV clearance at 6 months in six different international studies and more than 600 patients. HPV infection causes 528,000 cases of cervical cancer and 266,000 cervical cancer deaths each year.1  Papilocare™ has a CE mark valid for the entire EU, and is currently marketed as a Class IIa medical device in Spain, France, Portugal, Italy, Belgium, Luxembourg, Lithuania, Latvia, Poland, Czech Republic, Hungary, Bulgaria, and Romania.  Once the FDA regulatory pathway has been determined for the US, BioVaxys will have a detailed plan in place by 3Q21 to build an appropriate capability to market and support the brand in the US, with BioVaxys providing the funding for such efforts.

 

James Passin, CEO of BioVaxys, stated, “We are honored to partner with Procare Health, a market leader in gynecological oncology and women’s health in the EU; this transformative collaboration leverages all of the innovative work of Dr. David Berd in the field in oncology and novel vaccine development, as well as our recent success with the preclinical development of a viable haptenized viral protein vaccine for Covid-19. We look forward to using our proprietary haptenized vaccine technology to address urgent and large market deficiencies in the area of women’s health and to potentially generate a new and material revenue stream for our company.”

 

For greater certainty, BioVaxys is not making any express or implied claims that it has the ability to treat the SAR-CoV-2 virus at this time.

 

1.WHO. https://www.who.int/news-room/fact-sheets/detail/sexually-transmitted-infections-(stis)

 

About BioVaxys Technology Corp.

 

Based in Vancouver, BioVaxys Technology Corp. is a British Columbia-registered, early stage biotechnology company that is developing viral and oncology vaccine platforms, as well as immuno-diagnostics.  The Company is advancing a SARS-CoV-2 vaccine based on its haptenized viral protein technology, and is planning a clinical trial of its haptenized autologous cell vaccine used in combination with anti-PD1 and anti-PDL-1 checkpoint inhibitors that will initially be developed for ovarian cancer. Also in development is a diagnostic for evaluating the presence or absence of a T cell immune response to SARS-CoV-2, the virus that causes COVID-19. BioVaxys has two issued US patents and two patent applications related to its cancer vaccine, and pending patent applications for its SARS-CoV-2 (Covid-19) vaccine and diagnostic technologies. BioVaxys common shares are listed on the CSE under the stock symbol “BIOV” and trades on the Frankfurt Bourse (FRA: 5LB) and US OTC: LMNGF.

 

About Procare Health

 

Procare Health is a multi-national EU biotechnology company based in Barcelona (Spain) founded in 2012 as a result of the spin-off of executives and employees of Procter & Gamble Pharmaceuticals that is focused primarily to bring innovative solutions in women´s health, with a special interest into unmet therapeutical needs. Procare Health invests every year circa 25% of its investments budget into R&D, fundamental research on Cervix (“cervix on a chip” research project) and clinical trials in order bring clinical evidence of its main products in the market. Procare Health develops, investigates and commercializes its own products into more than 50 countries in the world with main focus in EU and in women´s genital tract diseases (HPV, cervical lesions, vaginal infections, vaginal dryness, and fertility). Procare Health vision is to become a women´s health leader in Europe.

 

ON BEHALF OF THE BOARD

Signed “James Passin”

James Passin, CEO

+1 646 452 7054

 

Media Contacts BioVaxys Technology Corp.

Nikita Sashdev
Luna PR
info@lunapr.io

 

Signed “Yann Gaslain”

Yann Gaslain, CEO

Gaslain.y@procarehealth.com

 

Media Contacts Procare Health

 

Irene de la Casa

+34 91 577 92 72

irene.delacasa@evercom.es

 

Cautionary Statements Regarding Forward Looking Information

 

This press release includes certain “forward-looking information” and “forward-looking statements” (collectively “forward-looking statements”) within the meaning of applicable Canadian and United States securities legislation including the United States Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, included herein, without limitation, statements relating the future operating or financial performance of the Company, are forward looking statements. Forward-looking statements are frequently, but not always, identified by words such as “expects”, “anticipates”, “believes”, “intends”, “estimates”, “potential”, “possible”, and similar expressions, or statements that events, conditions, or results “will”, “may”, “could”, or “should” occur or be achieved. Forward-looking statements in this news release relate to, among other things, completion of the murine model study, regulatory approval for a Phase I study of its BVX-0320 Vaccine Candidate in humans and the overall development of BioVaxys’ vaccines, including any haptenized SARS-Cov-2 protein vaccine. There can be no assurance that such statements will prove to be accurate, and actual results and future events could differ materially from those expressed or implied in such forward-looking statements.

 

These forward-looking statements reflect the beliefs, opinions and projections on the date the statements are made and are based upon a number of assumptions and estimates, primarily the assumption that BioVaxys will be successful in developing and testing vaccines, that, while considered reasonable by the Company, are inherently subject to significant business, economic, competitive, political and social uncertainties and contingencies including, primarily but without limitation, the risk that BioVayxs’ vaccines will not prove to be effective and/ or will not receive the required regulatory approvals. With regards to BioVaxys’ business, there are a number of risks that could affect the development of its biotechnology products, including, without limitation, the need for additional capital to fund clinical trials, its lack of operating history, uncertainty about whether its products will complete the long, complex and expensive clinical trial and regulatory approval process for approval of new drugs necessary for marketing approval, uncertainty about whether its autologous cell vaccine immunotherapy can be developed to produce safe and effective products and, if so, whether its vaccine products will be commercially accepted and profitable, the expenses, delays and uncertainties and complications typically encountered by development stage biopharmaceutical businesses, financial and development obligations under license arrangements in order to protect its rights to its products and technologies, obtaining and protecting new intellectual property rights and avoiding infringement to third parties and their dependence on manufacturing by third parties.

 

The Company does not assume any obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law.

 

Source:  BioVaxys Technology Corp.

BIOVAXYS SARS-CoV-2 VACCINE CANDIDATE BVX-0320 STIMULATES NEUTRALIZING ANTIBODIES TO LIVE COVID-19 VIRUS

Vancouver, BC – February 2, 2021 —  BioVaxys Technology Corp. (CSE: BIOV) (FRA:5LB) (OTC:LMNGF) (“BioVaxys” or “Company”) is pleased to announce that its Covid-19 vaccine candidate, BVX-0320, elicits a neutralizing antibody response against SARS-CoV-2, as evidenced by further analysis of sera samples from a preclinical animal study (also known as the “murine model study”) of its haptenized viral protein vaccine technology.

 

Under a BioVaxys-sponsored research collaboration with The Ohio State University (“OSU”) Wexner School of Medicine, OSU researchers observed in a pooled sample that BVX-0320 elicited the production of neutralizing antibodies to SARS-CoV-2. It’s worth noting that OSU is one of the few institutions that has the laboratory capability to study live SARS-CoV-2 virus.

 

The findings were obtained from a Plaque Reduction Neutralization Test, where the endpoint is reduction of plaques by 50%, after using available remaining mouse sera from the immune response assay.  Plaques are produced by infection of cultured human cells by a live SARS-CoV-2 virus.

 

BioVaxys President & Chief Operating Officer Ken Kovan says that “Although we’re pleased to see a reduction in plaques as measured by the Plaque Reduction Neutralization Test, it’s our belief that a robust T-cell response is key for eliciting a long-term immune protection.  As its not fully known yet whether the durability of the antibodies induced by SARS-CoV-2 or the antibody titres will protect against reinfection, the induction of SARS-CoV-2-specific memory T-cells and B cells (as opposed to circulating antibodies) is important for long-term protection.”

 

The BioVaxys team recently found in a murine model that BVX-0320, its haptenized SARS-CoV-2 s-spike vaccine, activated CD4+ helper T cells and CD8+ killer T cells that express the activation markers, CD69 and CD25. This result indicates that immunization with BVX-0320 at two different dose levels of 3µg or 10µg stimulated immune system memory ‘helper’ T-cells as well as killer T cells.

 

CD4+ T-cells are crucial in achieving a regulated effective immune response to viral pathogens, and are central to adaptive immune responses. Generated following an immune response, memory ‘helper’ CD4+ T-cells retain information about the virus, which enables them to respond rapidly after viral exposure.  CD8+ T cells have the capacity to kill cells infected by the virus, thereby stopping viral replication in those cells.

 

For greater certainty, BioVaxys is not making any express or implied claims that it has the ability to treat the SAR-CoV-2 virus at this time.

 

About BioVaxys Technology Corp.

 

Based in Vancouver, BioVaxys Technology Corp. is a British Columbia-registered, early stage biotechnology company that is developing viral and oncology vaccine platforms, as well as immuno-diagnostics.  The Company is advancing a SARS-CoV-2 vaccine based on its haptenized viral protein technology, and is planning a clinical trial of its haptenized autologous cell vaccine used in combination with anti-PD1 and anti-PDL-1 checkpoint inhibitors that will initially be developed for ovarian cancer. Also in development is a diagnostic for evaluating the presence or absence of a T cell immune response to SARS-CoV-2, the virus that causes COVID-19. BioVaxys has two issued US patents and two patent applications related to its cancer vaccine, and pending patent applications for its SARS-CoV-2 (Covid-19) vaccine and diagnostic technologies. BioVaxys common shares are listed on the CSE under the stock symbol “BIOV” and trade on the Frankfurt Bourse (FRA: 5LB) and US OTC: LMNGF.

 

ON BEHALF OF THE BOARD

 

Signed “James Passin”

James Passin, CEO

+1 646 452 7054

 

Media Contacts

Nikita Sashdev

Luna PR

info@lunapr.io

 

Cautionary Statements Regarding Forward Looking Information

 

This press release includes certain “forward-looking information” and “forward-looking statements” (collectively “forward-looking statements”) within the meaning of applicable Canadian and United States securities legislation including the United States Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, included herein, without limitation, statements relating the future operating or financial performance of the Company, are forward looking statements. Forward-looking statements are frequently, but not always, identified by words such as “expects”, “anticipates”, “believes”, “intends”, “estimates”, “potential”, “possible”, and similar expressions, or statements that events, conditions, or results “will”, “may”, “could”, or “should” occur or be achieved. Forward-looking statements in this news release relate to, among other things, completion of the murine model study, regulatory approval for a Phase I study of its BVX-0320 Vaccine Candidate in humans and the overall development of BioVaxys’ vaccines, including any haptenized SARS-Cov-2 protein vaccine. There can be no assurance that such statements will prove to be accurate, and actual results and future events could differ materially from those expressed or implied in such forward-looking statements.

 

These forward-looking statements reflect the beliefs, opinions and projections on the date the statements are made and are based upon a number of assumptions and estimates, primarily the assumption that BioVaxys will be successful in developing and testing vaccines, that, while considered reasonable by the Company, are inherently subject to significant business, economic, competitive, political and social uncertainties and contingencies including, primarily but without limitation, the risk that BioVayxs’ vaccines will not prove to be effective and/ or will not receive the required regulatory approvals. With regards to BioVaxys’ business, there are a number of risks that could affect the development of its biotechnology products, including, without limitation, the need for additional capital to fund clinical trials, its lack of operating history, uncertainty about whether its products will complete the long, complex and expensive clinical trial and regulatory approval process for approval of new drugs necessary for marketing approval, uncertainty about whether its autologous cell vaccine immunotherapy can be developed to produce safe and effective products and, if so, whether its vaccine products will be commercially accepted and profitable, the expenses, delays and uncertainties and complications typically encountered by development stage biopharmaceutical businesses, financial and development obligations under license arrangements in order to protect its rights to its products and technologies, obtaining and protecting new intellectual property rights and avoiding infringement to third parties and their dependence on manufacturing by third parties.

 

The Company does not assume any obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law.

 

SOURCE:  BioVaxys Technology Corp.

COVID-T™ CLINICAL DEVELOPMENT PROGRAM INITIATED  REGULATORY ADVISORY GROUP ENGAGED

Vancouver, BC – January 28, 2021 —  BioVaxys Technology Corp. (OTCPK: LMNGF) (CSE: BIOV) (FRA:5LB) (“BioVaxys” or “Company”) is pleased to announce that it has initiated the clinical development program for Covid-T™, the Company’s novel diagnostic platform for detecting T-cell activity. The US Food and Drug Administration (“FDA”) has tentatively agreed to permit that BioVaxys can file for a pre-Emergency Use Authorization (“EUA”) for Covid-T™.   Under an EUA, FDA may allow the use of unapproved medical products, or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain statutory criteria have been met, including that there are no adequate, approved, and available alternatives.

 

Covid-T™ addresses an unmet need for a low-cost, easy-to-administer, and accurate tool to test for the presence of T-cells which may offer lasting protection against SARS-CoV-2.

 

It is believed that detection of T-cells can potentially identify safe and/or at-risk populations. Covid-T™ also provides an ability to evaluate the effectiveness of any SARS-CoV-2 vaccine candidate in stimulating T-cell immunity. Mass availability of Covid-T™ would complement antibody testing and various public health risk mitigation strategies.

 

James Passin, CEO of BioVaxys, stated, “We believe that our low cost, scalable, easy-to-administer test for T cell immunity to SARS-CoV-2 may help solve the urgent global public health crisis of prioritizing the distribution of Covid-19 vaccines; we look forward to rapidly advancing Covid-T™ towards commercialization.”

 

Current methods of measuring T-cell immunity require drawing blood from the test subject, followed by a time-consuming and expensive analysis of the blood sample at laboratories possessing specialized equipment.

 

Covid-T™ is based on the well-established concept of Delayed Type Hypersensitivity (“DTH”), the oldest and most reliable test of human T lymphocyte function. The process involves an intradermal “skin prick” of an immunogenic composition of the SARS-CoV-2 S-protein, where an inflammatory response develops 24-72 hours after skin exposure to the s-spike antigen.

 

BioVaxys anticipates that once clinical testing is complete, Covid-T™ would have the potential for detecting differences in T-cell responses between the original SARS-CoVC-2 virus and the two new strains of SARS-Cov-2 the had originally been identified in the UK and South Africa—B.1.1.7 and 501Y.V2, respectively— but which are spreading worldwide.

 

“Although our vaccine programs are of major importance to us, Covid-T™ is a priority for BioVaxys, especially given the unmet need for such a simple, disposable, and accurate tool to test for the presence of T-cells against SARS-CoV-2,” says BioVaxys President and Chief Operating Officer Ken Kovan.

 

BioVaxys has prepared the clinical development plan for Covid-T™, and engaged global regulatory advisory group Rio Pharmaceutical Services (“RPS”) of Bridgewater, NJ, to provide strategic regulatory guidance, prepare an FDA pre-submission guidance package, recommend regulatory pathway, and support BioVaxys on the registration filing.

 

RPS has provided pharmaceutical and medical-device advisory services across the entire drug, biologic and device development and approval spectrum of the pharmaceutical industry since 2000.  Collectively, the RPS team of pharmaceutical industry executives offers nearly 150 years of experience in providing advice and support services for medical, scientific, clinical-trial and regulatory issues to clients including a majority of Fortune 500 pharmaceutical companies.

 

Since Covid-T™ requires a biological substance to be placed intradermally, a nonclinical study will be needed to establish the risk profile prior to the start of clinical studies.

 

BioVaxys plans to shortly conduct a GLP animal toxicology study, is currently evaluating proposals from Contract Research Organizations (CROs), and is in the process of obtaining the appropriate cell lines, expression systems, and licenses so as to produce its own supply of SARS-CoV-2 s-spike protein.

 

The Company is not making any express or implied claims that its product line has the ability to eliminate, cure, or contain the Covid-19 (or SARS-2 Coronavirus) at this time.

 

About BioVaxys Technology Corp.

 

Based in Vancouver, BioVaxys Technology Corp. is a British Columbia-registered, early stage biotechnology company that is developing viral and oncology vaccine platforms, as well as immuno-diagnostics.  The Company is advancing a SARS-CoV-2 vaccine based on its haptenized viral protein technology, and is planning a clinical trial of its haptenized autologous cell vaccine used in combination with anti-PD1 and anti-PDL-1 checkpoint inhibitors that will initially be developed for ovarian cancer. Also in development is a diagnostic for evaluating the presence or absence of a T cell immune response to SARS-CoV-2, the virus that causes COVID-19. BioVaxys has two issued US patents and two patent applications related to its cancer vaccine, and pending patent applications for its SARS-CoV-2 (Covid-19) vaccine and diagnostic technologies. BioVaxys common shares are listed on the CSE under the stock symbol “BIOV” and trade on the Frankfurt Bourse (FRA: 5LB) and US OTC: LMNGF.

 

ON BEHALF OF THE BOARD

Signed “James Passin”

James Passin, CEO

+1 646 452 7054

 

Media Contacts

Nikita Sashdev

Luna PR

info@lunapr.io

 

Cautionary Statements Regarding Forward Looking Information

 

This press release includes certain “forward-looking information” and “forward-looking statements” (collectively “forward-looking statements”) within the meaning of applicable Canadian and United States securities legislation including the United States Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, included herein, without limitation, statements relating the future operating or financial performance of the Company, are forward looking statements. Forward-looking statements are frequently, but not always, identified by words such as “expects”, “anticipates”, “believes”, “intends”, “estimates”, “potential”, “possible”, and similar expressions, or statements that events, conditions, or results “will”, “may”, “could”, or “should” occur or be achieved. Forward-looking statements in this news release relate to, among other things, completion of the murine model study, regulatory approval for a Phase I study of its BVX-0320 Vaccine Candidate in humans and the overall development of BioVaxys’ vaccines, including any haptenized SARS-Cov-2 protein vaccine. There can be no assurance that such statements will prove to be accurate, and actual results and future events could differ materially from those expressed or implied in such forward-looking statements.

 

These forward-looking statements reflect the beliefs, opinions and projections on the date the statements are made and are based upon a number of assumptions and estimates, primarily the assumption that BioVaxys will be successful in developing and testing vaccines, that, while considered reasonable by the Company, are inherently subject to significant business, economic, competitive, political and social uncertainties and contingencies including, primarily but without limitation, the risk that BioVayxs’ vaccines will not prove to be effective and/ or will not receive the required regulatory approvals. With regards to BioVaxys’ business, there are a number of risks that could affect the development of its biotechnology products, including, without limitation, the need for additional capital to fund clinical trials, its lack of operating history, uncertainty about whether its products will complete the long, complex and expensive clinical trial and regulatory approval process for approval of new drugs necessary for marketing approval, uncertainty about whether its autologous cell vaccine immunotherapy can be developed to produce safe and effective products and, if so, whether its vaccine products will be commercially accepted and profitable, the expenses, delays and uncertainties and complications typically encountered by development stage biopharmaceutical businesses, financial and development obligations under license arrangements in order to protect its rights to its products and technologies, obtaining and protecting new intellectual property rights and avoiding infringement to third parties and their dependence on manufacturing by third parties.

 

The Company does not assume any obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law.

 

source:  BioVaxys Technology Corp.

BioVaxys Announces Initiation of Cancer Vaccine EU Clinical Program, Completion of BVX-0320 Preclinical Program and Vaccine Platform Expansion

Vancouver, BC –  January 25, 2021 – BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) (OTC: LMNGF) (“BioVaxys” or “Company”) is pleased to provide a corporate update on recent advancements of its vaccine platforms, viral diagnostic and corporate objectives for 2021. BioVaxys is pleased to announce that it has commenced the clinical development program for BVX-0918A, its haptenized tumor antigen vaccine for ovarian cancer. The Company plans to seek a compassionate use approval in the European Union (“EU”) for Stage III & Stage IV ovarian cancer, followed by submitting an IND in the US. BioVaxys is in discussions with its designated Contract Manufacturing Organization (“CMO”) and anticipates the execution of a manufacturing contract in 1Q21. The Company plans to submit its Clinical Trial Application (“CTA”) for BVX-0918A with the European Medicines Agency (“EMEA”) later this year.

 

There are significant unmet therapeutic needs for ovarian cancer treatment. Over 240,000 women are currently diagnosed with ovarian cancer worldwide, and over 140,200 succumbed to the disease. Ovarian cancer is the leading cause of death from gynecologic malignancy in the United States. An estimated 21,750 new cases of ovarian cancer are expected in the United States in 2020 with 13,940 deaths. The case-to-fatality ratio is nearly three times that of breast cancer and makes ovarian cancer the deadliest gynecologic malignancy in developed countries. Like other cancers, the stage of disease is inversely proportional to survival. The 5-year relative survival rate in all stages of the disease is approximately 45%. However, ovarian cancer is usually asymptomatic in the early stages (Stage I and Stage II), and therefore about 80% of patients are diagnosed with advanced stage disease (stages III and IV). The 5-year survival rate for stage III and IV patients is approximately 29%.[1]

 

BioVaxys has developed its vaccine technology platforms based on the established immunological concept that modifying tumor or viral antigens with simple chemicals called haptens makes them more visible to the immune system. The process of haptenization “teaches” a patient’s immune system to recognize and make target proteins more ‘visible’ as foreign, thereby stimulating an immune response. In Phase I and Phase II clinical studies previously conducted by BioVaxys, co-founder and Chief Medical Officer, David Berd MD, using an earlier generation of the BioVaxys cancer vaccine on nearly 500 patients with melanoma or ovarian cancer, the haptenized cell platform showed significant clinical promise. BioVaxys Founder, President & Chief Operating Officer Ken Kovan says: “The autologous approach may have advantages over other approaches, such as those involving a search for specific antigens. Because autologous tumor cells by definition have the patient’s unique set of antigens already on them, the challenge is to increase the immune system’s ability to recognize the ovarian tumor cells as foreign, breaking the “self-tolerance”. A way to achieve this is by the use of a hapten, which is the foundation for the BioVaxys’ haptenized protein vaccine platform.”

 

BioVaxys intends to develop its vaccine together with a “checkpoint inhibitor” that reduces or decreases the cellular function of an immune checkpoint gene or gene product. Checkpoint inhibitors are a type of drug that blocks proteins called ‘checkpoints’ that are made by some types of immune system cells, such as T cells and some cancer cells. These checkpoints help keep immune responses from being too strong, but also can sometimes keep T cells from killing cancer cells. When these checkpoints are blocked, T cells can more effectively kill cancer cells. BioVaxys’ focus is on combinations of immune checkpoint inhibitors with its haptenized tumor antigen vaccine—primarily anti-CTLA4, anti-PD1, or PDL1 checkpoint antibodies—for treatment of ovarian cancer and other solid tumors. BioVaxys’ rationale is that there is (1) a persistent unmet clinical need because the majority of ovarian cancer patients do not benefit from anti-checkpoint monotherapy; (2) evidence that not all patients make immune responses to their tumors; (3) evidence that immune responses to autologous tumor antigens can be induced by patient-specific vaccines; and (4) clinical evidence from the pre-checkpoint era that suggests survival can be positively impacted by such patient-specific vaccines.

 

BioVaxys also recently completed its preclinical program for its SARS-CoV-2 vaccine candidate, BVX-0320, which included those studies suggested by the U.S. Department of Health and Human Services, Food and Drug Administration (“FDA”) Center for Biologics Evaluation and Research “(CBER”) in their published guidance on Development and Licensure of Vaccines to Prevent COVID-19.

 

Source: (1) American Cancer Society, Cancer facts and figures; (2) Cannistra SA. Cancer of the Ovary. N Engl J Med 2004 Dec 9;351(24):2519-29; and (3) McGuire WP, Hoskins WJ, Brady MF, Kucera PR, Partridge EE, Look KY, et al. Cyclophosphamide and cisplatin compared with paclitaxel and cisplatin in patients with stage III and stage IV ovarian cancer. N Engl J Med 1996;334(1):1-6.

 

The FDA’s non-binding Guidance is intended to assist in the clinical development and licensure of vaccines for the prevention of COVID-19, and reflect the Agency’s current thinking on the issue.  Conducted by Charles River Laboratories, Inc. under contract with BioVaxys, the preclinical program which began in September 2020 evaluated the anti-virus immune response elicited by BVX-0320 in a controlled murine model by measuring the development of antibodies to the protein that binds the virus to human cells. Following two injections of BVX-0320 together with the immunological adjuvant, QS21, to 28 mice at four dosage levels, 96.4% developed positive antibody responses detected at week 6. The BioVaxys team also found that its haptenized SARS-CoV-2 s-spike vaccine activated CD4+ helper T-cells and CD8+ killer T-cells that express the activation markers, CD69 and CD25. This result indicates that immunization with BVX-0320 at two different dose levels of 3µg or 10µg stimulated immune system memory ‘helper’ T-cells as well as killer T-cells. CD4+ T-cells are crucial in achieving a regulated effective immune response to viral pathogens, and are central to adaptive immune responses. Generated following an immune response, memory ‘helper’ CD4+ T-cells retain information about the virus, which enables them to respond rapidly after viral exposure. CD8+ T-cells have the capacity to kill cells infected by the virus, thereby stopping viral replication in those cells.

 

Under a BioVaxys-sponsored research collaboration with The Ohio State University (“OSU”) Wexner School of Medicine, the OSU researchers used the available remaining mouse sera from the immune response assay to conduct a Plaque Reduction Neutralization Test, where the endpoint is reduction of plaques by 50%, where it was observed in a pooled sample that BVX-0320 elicited the production of neutralizing antibodies to SARS-CoV-2. Plaques are produced by infection of cultured human cells by a live SARS-CoV-2 virus. OSU is one of the few institutions that has the laboratory capability to study live SARS-CoV-2 virus.

 

Recently, two new strains of SARS-Cov-2 have been identified in the UK and South Africa – B.1.1.7 and 501Y.V2, respectively. Both strains exhibit a number of mutations, some of them in the spike protein. The mutation of most concern, found in both new strains, is the one in spike protein position 501, one of the key contact points in the receptor binding domain. Experimental data suggest that this mutation, called 501Y, can increase binding of the virus to human cells through the ACE2 receptor. This change could result in more rapid transmission of the virus between individuals and thus more rapid spread of Covid-19. There is also concern that the recent approved vaccines may not be completely effective against these new strains.

 

The BioVaxys haptenization strategy constitutes a platform technology in that it is adaptable to almost any virus-derived protein. The haptenization of viral proteins imparts BioVaxys with the flexibility of a ‘cassette-type’ approach not possible with other vaccines, where they can “swap in” the appropriate viral antigen(s) for haptenization and the creation of a new vaccine, potentially allowing for faster development timelines relative to other vaccine approaches.

 

BioVaxys proposes to respond to these potentially dangerous events by modifying its Covid-19 vaccine, BVX-0320. The original version contained the S1 subunit of the spike protein that was dominant in viral isolates at the beginning of the pandemic. A new SARS-CoV-2 vaccine candidate, BVX-0121, is under internal evaluation which would include modifications to address the emerging strains. This would a bivalent or trivalent vaccine containing the original S1 plus the S1 from one or both of the UK and South African strains. The manufacturing process would be similar to that of BVX-0320. BioVaxys plans to collaborate with a pharma partner and jointly seek government funding for the Phase II program.

 

BioVaxys’ Covid-19 diagnostic, Covid-T™, has the potential of detecting differences in T cells responses between the original virus and the two new strains. Current methods of measuring T cell immunity require the drawing of blood from the test subject and a time-consuming and expensive analysis of the blood sample at laboratories possessing specialized equipment. What is needed is a simple, low-cost, easy-to-administer, and accurate tool to test for the presence of T cells against SARS-CoV-2 to identify safe and at-risk populations. Covid-T™ provides a low-cost, easy-to-administer, and accurate tool to test for the presence of T cells against SARS-CoV-2, and to evaluate the effectiveness of any SARS-CoV-2 vaccine candidate in stimulating T cell immunity.  Mass availability of this low cost and easy-to-administer T cell immunity diagnostic would complement antibody testing and various public health risk mitigation strategies.

 

Subjects would be simultaneously tested for delayed-type hypersensitivity to all three S1 variants. The size of the DTH reactions is compared for each subject. The Company has engaged a global regulatory advisory group, is contracting with an FDA-approved Contract Development and Manufacturing Organization (CDMO) for a cell line, expression system and cloning expertise to source GMP-grade s-1 protein, and is preparing an FDA pre-submission guidance package with delivery to the FDA anticipated shortly. A non-GMP animal toxicity study is scheduled for this March, followed by the proposed Phase I study this summer.

 

For greater certainty, BioVaxys is not making any express or implied claims that it has the ability to treat the SAR-CoV-2 virus at this time.

 

About BioVaxys Technology Corp.

 

Based in Vancouver, BioVaxys Technology Corp. is a British Columbia-registered, early stage biotechnology company that is developing viral and oncology vaccine platforms, as well as immuno-diagnostics. The Company is advancing a SARS-CoV-2 vaccine based on its haptenized viral protein technology, and is planning a clinical trial of its haptenized autologous cell vaccine used in combination with anti-PD1 and anti-PDL-1 checkpoint inhibitors that will initially be developed for ovarian cancer. Also in development is a diagnostic for evaluating the presence or absence of a T cell immune response to SARS-CoV-2, the virus that causes COVID-19. BioVaxys has two issued US patents and two patent applications related to its cancer vaccine, and pending patent applications for its SARS-CoV-2 (Covid-19) vaccine and diagnostic technologies. BioVaxys common shares are listed on the CSE under the stock symbol “BIOV” and trade on the Frankfurt Bourse (FRA: 5LB) and US OTC: LMNGF.

 

ON BEHALF OF THE BOARD
Signed “James Passin”
James Passin, CEO
+1 646 452 7054

 

Cautionary Statements Regarding Forward Looking Information

 

This press release includes certain “forward-looking information” and “forward-looking statements” (collectively “forward-looking statements”) within the meaning of applicable Canadian and United States securities legislation including the United States Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, included herein, without limitation, statements relating the future operating or financial performance of the Company, are forward looking statements. Forward-looking statements are frequently, but not always, identified by words such as “expects”, “anticipates”, “believes”, “intends”, “estimates”, “potential”, “possible”, and similar expressions, or statements that events, conditions, or results “will”, “may”, “could”, or “should” occur or be achieved. Forward-looking statements in this news release relate to, among other things, completion of the murine model study, regulatory approval for a Phase I study of its BVX-0320 Vaccine Candidate in humans and the overall development of BioVaxys’ vaccines, including any haptenized SARS-Cov-2 protein vaccine. There can be no assurance that such statements will prove to be accurate, and actual results and future events could differ materially from those expressed or implied in such forward-looking statements.

 

These forward-looking statements reflect the beliefs, opinions and projections on the date the statements are made and are based upon a number of assumptions and estimates, primarily the assumption that BioVaxys will be successful in developing and testing vaccines, that, while considered reasonable by the Company, are inherently subject to significant business, economic, competitive, political and social uncertainties and contingencies including, primarily but without limitation, the risk that BioVayxs’ vaccines will not prove to be effective and/ or will not receive the required regulatory approvals. With regards to BioVaxys’ business, there are a number of risks that could affect the development of its biotechnology products, including, without limitation, the need for additional capital to fund clinical trials, its lack of operating history, uncertainty about whether its products will complete the long, complex and expensive clinical trial and regulatory approval process for approval of new drugs necessary for marketing approval, uncertainty about whether its autologous cell vaccine immunotherapy can be developed to produce safe and effective products and, if so, whether its vaccine products will be commercially accepted and profitable, the expenses, delays and uncertainties and complications typically encountered by development stage biopharmaceutical businesses, financial and development obligations under license arrangements in order to protect its rights to its products and technologies, obtaining and protecting new intellectual property rights and avoiding infringement to third parties and their dependence on manufacturing by third parties.

 

The Company does not assume any obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law.

 

James Passin, CEO
+1 646 452 7054

 

Media Contacts
Nikita Sashdev
Luna PR
info@lunapr.io

 

Source: BioVaxys Technology Corp.

BIOVAXYS VACCINE PLATFORM STIMULATES ROBUST T-CELL RESPONSE AGAINST VIRAL ANTIGENS

BVX-0320 Activates immune system Memory ‘helper ’ CD4+ and killer CD8+ T-cells against SARS-CoV-2

  

PotentIal for longer-term viral protection

 

Vancouver, BC –  December 21, 2020 —  BioVaxys Technology Corp. (CSE: BIOV, FRA:5LB, OTC:LMNGF) (“BioVaxys”) announced today that further analysis of the data from a preclinical animal study (also known as the “murine model study”) of its haptenized viral protein vaccine technology show that BVX-0320, its Covid-19 vaccine candidate based on the Company’s haptenized viral protein platform, elicits a robust T-cell response against SARS-CoV-2.

 

Using a technique called flow cytometry, the BioVaxys team found that its haptenized SARS-CoV-2 s-spike vaccine activated CD4+ helper T cells and CD8+ killer T cells that express the activation markers, CD69 and CD25.  This result indicates that immunization with BVX-0320 at two different dose levels of 3µg or 10µg stimulated immune system memory ‘helper’ T-cells as well as killer T cells.  CD4+ T-cells are crucial in achieving a regulated effective immune response to viral pathogens, and are central to adaptive immune responses. Generated following an immune response, memory ‘helper’ CD4+ T-cells retain information about the virus, which enables them to respond rapidly after viral exposure.  CD8+ T cells have the capacity to kill cells infected by the virus, thereby stopping viral replication in those cells.

 

BioVaxys Co-Founder, President and Chief Operating Officer Kenneth Kovan says “This is an exciting development not only in the COVID-19 vaccine field, but potentially for other viral vaccines.  Post-vaccination generation of antibodies is no doubt critical and garners much attention. However, antibody levels can quickly become undetectable after just a few months, leading to the conclusion that anti-viral immunity has waned.”  He goes on to say that “a robust CD4 and CD8 T-cell response, such as that we are seeing, has potential to confer much longer protection.”

 

Recent data from the preclinical study, which began in September 2020 and was conducted by leading independent contract research organization (“CRO”) Charles River Laboratories, Inc. under contract with BioVaxys, evaluated the anti-virus immune response elicited by BVX-0320 in a controlled murine model by measuring the development of antibodies to the protein that binds the virus to human cells.  Following two injections of BVX-0320 together with the immunological adjuvant, QS21, to 28 mice at four dosage levels, 96.4% developed positive antibody responses detected at week 6.  Co-founder and Chief Medical Officer David Berd, MD, says that “Stimulating a 96.4% antibody response is an excellent development, but we believe that activation of T-cells is even more important. A post-SARS2 infection T cell response appears to be a defining characteristic following recovery in COVID-19 patients.  Seeing activation of CD4 and CD8 T-cells differentiates our approach from some other COVID-19 vaccines.”   Dr. Berd adds that “a duration of immunity that cannot be guaranteed past a few months is really not useful protection.  Activation of a T-cell response may be the critical determinant for effective long-term protection.”

 

A separate study sponsored by BioVaxys is underway at The Ohio State University Wexner Medical Center, where the mouse sera (collected from the test animals) is being tested for the ability to inactivate live SARS-Cov-2 virus. Results are anticipated later this month.

 

James Passin, the CEO of BioVaxys, stated, “The outstanding results from the Murine Model Study of BVX-0320, including robust T cell and antibody results and an excellent safety and manufacturing profile, evidences the value of our haptenized viral protein vaccine technology platform and should support ongoing discussions with potential pharmaceutical partners. We are excited to continue to leverage this scientific momentum, as well as to continue advancing our novel Covid-19 T-cell diagnostic, a low cost and scalable tool which may assist public health authorities in the distribution of scarce vaccine resources, as it should not be a priority to immunize individuals presenting T cell immunity to SARS-CoV-2.”

 

BioVaxys’s product pipeline includes BVX-0918A, an IND-stage haptenized cancer cell vaccine for treating late-stage ovarian cancer.  In Phase I and Phase II clinical studies previously conducted by BioVaxys, co-founder and Chief Medical Officer, Dr. David Berd, using an earlier generation of the BioVaxys cancer vaccine on nearly 500 patients with melanoma or ovarian cancer, the haptenized cell platform showed significant clinical promise.

 

BioVaxys has developed its vaccine technology platforms based on the established immunological concept that modifying proteins with simple chemicals called haptens makes them more visible to the immune system. The process of haptenization “teaches” a patient’s immune system to recognize and make target proteins more ‘visible’ as foreign, thereby stimulating an immune response.

 

For greater certainty, BioVaxys is not making any express or implied claims that it has the ability to treat the SAR-CoV-2 virus at this time.

 

David Berd, M.D. the Chief Medical Officer of BioVaxys, has reviewed and approved the scientific disclosure contained in this press release. Dr. Berd is a medical oncologist with a lifelong record of clinical research in medical oncology and cancer immunotherapy. Dr. Berd received his BS from Pennsylvania State University and his MD from Jefferson Medical College of Thomas Jefferson University.

 

About BioVaxys Technology Corp.

 

Based in Vancouver, BioVaxys Technology Corp. is a British Columbia-registered, early stage biotechnology company that is developing viral and oncology vaccine platforms, as well as immuno-diagnostics.  The Company is advancing a SARS-CoV-2 vaccine based on its haptenized viral protein technology, and is planning a clinical trial of its haptenized autologous cell vaccine used in combination with anti-PD1 and anti-PDL-1 checkpoint inhibitors that will initially be developed for ovarian cancer. Also in development is a diagnostic for evaluating the presence or absence of a T cell immune response to SARS-CoV-2, the virus that causes COVID-19. BioVaxys has two issued US patents and two patent applications related to its cancer vaccine, and pending patent applications for its SARS-CoV-2 (Covid-19) vaccine and diagnostic technologies. BioVaxys common shares are listed on the CSE under the stock symbol “BIOV” and trade on the Frankfurt Bourse (FRA: 5LB) and US OTC: LMNGF.

 

ON BEHALF OF THE BOARD

Signed “James Passin”

James Passin, CEO

+1 646 452 7054

 

Media Contacts

Andrea Vuturo

+1 508 301 3774

biovaxys@dittopr.co

 

Cautionary Statements Regarding Forward Looking Information

 

This press release includes certain “forward-looking information” and “forward-looking statements” (collectively “forward-looking statements”) within the meaning of applicable Canadian and United States securities legislation including the United States Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, included herein, without limitation, statements relating the future operating or financial performance of the Company, are forward looking statements. Forward-looking statements are frequently, but not always, identified by words such as “expects”, “anticipates”, “believes”, “intends”, “estimates”, “potential”, “possible”, and similar expressions, or statements that events, conditions, or results “will”, “may”, “could”, or “should” occur or be achieved. Forward-looking statements in this news release relate to, among other things, completion of the murine model study, regulatory approval for a Phase I study of its BVX-0320 Vaccine Candidate in humans and the overall development of BioVaxys’ vaccines, including any haptenized SARS-Cov-2 protein vaccine. There can be no assurance that such statements will prove to be accurate, and actual results and future events could differ materially from those expressed or implied in such forward-looking statements.

 

These forward-looking statements reflect the beliefs, opinions and projections on the date the statements are made and are based upon a number of assumptions and estimates, primarily the assumption that BioVaxys will be successful in developing and testing vaccines, that, while considered reasonable by the Company, are inherently subject to significant business, economic, competitive, political and social uncertainties and contingencies including, primarily but without limitation, the risk that BioVayxs’ vaccines will not prove to be effective and/ or will not receive the required regulatory approvals. With regards to BioVaxys’ business, there are a number of risks that could affect the development of its biotechnology products, including, without limitation, the need for additional capital to fund clinical trials, its lack of operating history, uncertainty about whether its products will complete the long, complex and expensive clinical trial and regulatory approval process for approval of new drugs necessary for marketing approval, uncertainty about whether its autologous cell vaccine immunotherapy can be developed to produce safe and effective products and, if so, whether its vaccine products will be commercially accepted and profitable, the expenses, delays and uncertainties and complications typically encountered by development stage biopharmaceutical businesses, financial and development obligations under license arrangements in order to protect its rights to its products and technologies, obtaining and protecting new intellectual property rights and avoiding infringement to third parties and their dependence on manufacturing by third parties.

 

The Company does not assume any obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law.

 

Source:  BioVaxys Technology Corp.

BioVaxys Provides Viral Vaccine Platform Program Update

Vancouver, BC – November 30, 2020 – BioVaxys Technology Corp. (CSE: BIOV) (OTCPK: LMNGF) (FSE: 5LB) (“BioVaxys” or “the Company”) is pleased to announce that it has received further data from its successfully completed murine model study demonstrating that immunizing mice with two doses of BVX-0320, its COVID-19 vaccine candidate, induced high levels of antibodies against the S1 fragment of the SARS-CoV-2 spike protein associated with inhibition of the binding of the virus to cells of the respiratory tract. BioVaxys scientists also observed a clear dose-response, with lower levels of antibodies induced by the two lowest doses tested of 0.3ug and 1ug (median titers 1:59 and 1:124, respectively), and with significantly higher antibody levels with the two highest doses tested of 3ug and 10ug (median titers 1:4800 and 1:9430, respectively). No toxicity was noted in mice at any dose level.

 

Dr. David Berd, the Chief Medical Officer of BioVaxys, stated, “Antibody titer is the usual way of measuring the amount of an antibody in the blood or a mouse or a human subject. It is determined by serially diluting a serum sample to reach the point where antibody is no longer detectable. An antibody titer of 1:9430 means that the serum sample could be diluted up to 9000-fold and still retain biologic activity. In human subjects who had recovered from Covid-19, antibody titers were between 1:100 and 1:1000.”

 

The preclinical study (also known as the “murine model study”), which began in September 2020 and was conducted by leading independent contract research organization Charles River Laboratories, Inc. under contract with BioVaxys, evaluated the anti-virus immune response elicited by BVX-0320 in a controlled murine model by measuring the development of antibodies to the protein that binds the virus to human cells. Previous results from the preclinical study show that BVX-0320 elicits a 96.4% positive immune response against the SARS-CoV-2 s-spike protein in a formulation not requiring an extraordinary cold-chain; the titer analysis confirms that 100% of vaccinated mice in all but the lowest dose group had a positive immune response against the SARS-CoV-2 s-spike protein.

 

BioVaxys has developed its vaccine technology platforms based on the established immunological concept that modifying proteins with simple chemicals called haptens makes them more visible to the immune system. The process of haptenization “teaches” a patient’s immune system to recognize and make target proteins more ‘visible’ as foreign, thereby stimulating an immune response. The haptenization of viral proteins imparts BioVaxys with the flexibility of a ‘cassette-type’ approach not possible with other vaccines, where they can “drop in” or “swap” the appropriate viral antigen(s) for haptenization and the creation of a new vaccine, potentially allowing for faster development timelines relative to other vaccine approaches.

 

Kenneth Kovan, co-founder, President & Chief Operating Officer of BioVaxys, says that, “The 100% efficacy seen across higher dose levels in the animal study, safety profile, dose-response, and formulation present a very promising emerging profile for BVX-0320. The preclinical data also supports our corporate strategy of expanding this haptenized viral protein vaccine platform across a range of viral diseases, which we are actively pursuing. Our approach is generating interest as it appears to be ideally suited for quickly addressing emerging viruses.”

 

The Company is in preliminary discussions with third parties on potential collaborations under which BioVaxys would create new vaccines for a range of viral diseases based on haptenizing different viral proteins. BioVaxys co-founder and CEO James Passin stated that, “The results from our Covid-19 vaccine study are highly encouraging and support our view on the scientific and commercial merits of our haptenized viral protein vaccine technology platform; we hope to leverage these encouraging results to accelerate ongoing partnership discussions.”

 

Data from additional analysis by BioVaxys is imminent, including the measurement of post-vaccination T-cell response. This consists of stimulating T-cells obtained from the same mice with viral peptides and measuring the degree of T-cell activation using the established analytical method of flow cytometry and the production of cytokines, including IL-2 and gamma interferon.

 

In a separate study under BioVaxys’ collaboration with The Ohio State University Wexner Medical Center, the mouse sera collected from the test animals will be tested for ability to inactivate live SARS-Cov-2 virus. Results are anticipated in the coming weeks.

 

The Company is not making any express or implied claims that its product has the ability to eliminate, cure or contain the Covid-19 (or SARS-2 Coronavirus) at this time.

 

About BioVaxys Technology Corp.

 

Based in Vancouver, BioVaxys Technology Corp., a British Columbia-registered biotechnology company, is a world leader in haptenized protein vaccines that is developing viral and oncology vaccine platforms as well as immuno-diagnostics. The Company is advancing a SARS-CoV-2 vaccine based on its haptenized viral protein technology, and is planning a clinical trial of its haptenized autologous cell vaccine used in combination with anti-PD1 and anti-PDL-1 checkpoint inhibitors that will initially be developed for ovarian cancer. Also in development is a diagnostic for evaluating the presence or absence of a T-cell immune response to SARS-CoV-2, the virus that causes COVID-19. BioVaxys has two issued US patents and two patent applications related to its cancer vaccine, and pending patent applications for its SARS-CoV-2 (Covid-19) vaccine and diagnostic technologies. BioVaxys common shares trade on the CSE under the stock symbol “BIOV” and are listed on the Frankfurt Bourse (FSE: 5LB).

 

ON BEHALF OF THE BOARD

 

Signed “James Passin”
James Passin, CEO
+1 646 452 7054

 

Media Contacts

 

Andrea Vuturo
+1 508 301 3774
biovaxys@dittopr.co

 

Cautionary Statements Regarding Forward Looking Information

 

This press release includes certain “forward-looking information” and “forward-looking statements” (collectively “forward-looking statements”) within the meaning of applicable Canadian and United States securities legislation including the United States Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, included herein, without limitation, statements relating the future operating or financial performance of the Company, are forward looking statements. Forward-looking statements are frequently, but not always, identified by words such as “expects”, “anticipates”, “believes”, “intends”, “estimates”, “potential”, “possible”, and similar expressions, or statements that events, conditions, or results “will”, “may”, “could”, or “should” occur or be achieved. Forward-looking statements in this news release relate to, among other things, completion of the murine model study, regulatory approval for a Phase I study of its BVX-0320 Vaccine Candidate in humans and the overall development of BioVaxys’ vaccines, including any haptenized SARS-Cov-2 protein vaccine. There can be no assurance that such statements will prove to be accurate, and actual results and future events could differ materially from those expressed or implied in such forward-looking statements.

 

These forward-looking statements reflect the beliefs, opinions and projections on the date the statements are made and are based upon a number of assumptions and estimates, primarily the assumption that BioVaxys will be successful in developing and testing vaccines, that, while considered reasonable by the Company, are inherently subject to significant business, economic, competitive, political and social uncertainties and contingencies including, primarily but without limitation, the risk that BioVayxs’ vaccines will not prove to be effective and/ or will not receive the required regulatory approvals. With regards to BioVaxys’ business, there are a number of risks that could affect the development of its biotechnology products, including, without limitation, the need for additional capital to fund clinical trials, its lack of operating history, uncertainty about whether its products will complete the long, complex and expensive clinical trial and regulatory approval process for approval of new drugs necessary for marketing approval, uncertainty about whether its autologous cell vaccine immunotherapy can be developed to produce safe and effective products and, if so, whether its vaccine products will be commercially accepted and profitable, the expenses, delays and uncertainties and complications typically encountered by development stage biopharmaceutical businesses, financial and development obligations under license arrangements in order to protect its rights to its products and technologies, obtaining and protecting new intellectual property rights and avoiding infringement to third parties and their dependence on manufacturing by third parties.

 

The Company does not assume any obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law.

 

Source:  BioVaxys Technology Corp.

About BioVaxys Technology

Sed ut perspiciatis unde omnis iste natus error

BioVaxys is a clinical-stage biopharma developing antiviral & anticancer vaccine platforms. The Company is evaluating a potential SARS-CoV-2 vaccine based on its haptenized viral protein technology, and advancing a compassionate use trial in the EU to evaluate its haptenized cell vaccine for late-stage ovarian cancer.

 

SARS-CoV-2 Vaccine

Ovarian Cancer Vaccine

T-Cell Antigen Discovery Program

In addition to our haptenized cell vaccines for ovarian cancer and other tumor types, we are exploring ways we can leverage our technology platform in the field of Adoptive Immunotherapy, which is also of significant interest in the immune-oncology market. Adoptive Immunotherapy is where T-cells are collected from a patient and grown in the laboratory. This increases the number of T-cells that are able to kill cancer cells.

Our ovarian cancer clinical studies and manufacturing protocol will provide us with the unique ability to collect T-cells from patients, both pre- and post- vaccine administration. BioVaxys’ objective is to use T-cells made responsive to it’s vaccines to identify new antigens that can be synthesized and explored, as they may prove useful as diagnostic agents or as new, chemically-defined, patient-specific vaccines. These novel antigens may be distinct for each patient, or present across all tumor cells. BioVaxys intends to explore partnerships with CAR T/TCR cell therapy companies to identify novel cancer antigens eliciting a T-cell response, which will develop extensive new intellectual property for BioVaxys.

Our Intellectual Property

>> Exclusive license from Thomas Jefferson University for patents related to haptenized cancer vaccines

Thomas Jefferson University

>> Three patent applications based on internal discoveries for a bihaptenized cancer vaccine platform in combination with checkpoint inhibitors

>> Patent application based on internal discoveries related to a haptenized viral antigen vaccines platform.

Haptenization is based on proven science, a well-understood mechanism of action, and extensive clinical data, with evidence that it can be used to treat multiple viral infections and any resectable solid tumor.

Inducing Targeted T-Cell and Antibody Response 

The BioVaxys vaccine platform is based on the concept of haptenization. This idea has a long history, beginning with the work of the immunologist and Nobel laureate Dr. Karl Landsteiner,

Simply put, the process of haptenization “teaches” a patient’s immune system to recognize and make target proteins more ‘visible’ as foreign, thereby stimulating a more intense immune response. We now understand that T-cells (or T-lymphocytes, which are white blood cells that are crucial in tumor rejection) react against the haptenized material and that the T-cells also then react against the unmodified target protein. At BioVaxys, we believe that tumor and viral antigens, which are proteins, are similarly affected by haptenization which stimulates a T-cell mediated immune response.

Preclinical SARS-CoV-2 Vaccine Development

BVX-0320: Our lead vaccine candidate in preclinical development for SARS-CoV-2.

BVX-0320 is a haptenized s-Spike protein of SARS-CoV-2 which is a critical protein on the surface of the virus that is required for the virus’ ability to bind to and enter human cells. The S protein is immunogenic and antibodies against it neutralized the virus.

Studies have demonstrated that patients recovering from SARS-CoV-2 infection carried helper T-cells that recognized the SARS-CoV-2 S-spike protein, and virus-specific killer T-cells were detected in 70% of the test subjects. As haptenized proteins are known to induce potent T cell responses, we believe the BioVaxys approach could have an advantage over other developing SARS-Cov-2 vaccines. Furthermore, our clinical experience with haptenization and safety data from prior clinical development of haptenized vaccines may prove advantageous from a regulatory perspective and lead to an accelerated development process.

Besides having no observed toxicity in multiple clinical trials, haptenization is based on proven science, a well-understood mechanism of action, and extensive clinical data, with evidence that it can be used to treat multiple viral infections and any resectable solid tumor.

Bi-Haptenized Ovarian Cancer Tumor Cell Vaccine

BVX-0918A: Our lead haptenized tumor cell vaccine for ovarian cancer.

BioVaxys’s cancer vaccines are created by extracting a patient’s own (e.g. ‘autologous’) cancer cells, chemically treating them with a hapten, and re-injecting them into the patient to induce an immune response to proteins which are otherwise not immunogenic. Haptenization is a well-known and well-studied immunotherapeutic approach in cancer treatment, and has been clinically evaluated in both regional and disseminated metastatic tumors. A first generation single-hapten vaccine achieved positive immunological and clinical results in Phase I/II trials. At BioVaxys, we have enhanced this first generation approach to now utilize two haptens (“bi-haptenization”) which we believe will yield superior results.

Single haptenization only modifies hydrophilic amino acids on antigenic proteins, but utilizing two different haptens modifies both both hydrophilic and hydrophobic amino acids on these target proteins, making the protein more foreign to the immune system with modification of additional amino acids. A greater number of T cells is activated by the addition of another hapten (i.e., more modified amino acids) so the number of T cells potentially reactive to the unmodified protein increases.

Further, we plan to combine the use of our vaccine with anti-CTLA4 and anti-PDA checkpoint antibodies. The rationale is that these reagents on their own are powerful augmenters of cellular immune response; We believe our vaccine changes the tumor environment to make them more susceptible to checkpoint mAbs (induction of TILs & activation markers), and we expect a synergistic response from the combination.

SOURCE:  https://biovaxys.com/

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