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

Get Top Rated Stock Alerts Active Traders Depend On

Sign Up Today For FREE News Driven Alerts

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


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/

Disclaimer

FN Media Group LLC (FNMG) owns and operates FinancialNewsMedia.com (FNM) which is a third party publisher that disseminates electronic information through multiple online media channels. FNMG’s intended purposes are to deliver market updates and news alerts issued from private and publicly trading companies as well as providing coverage and increased awareness for companies that issue press to the public via online newswires. FNMG and its affiliated companies are a news dissemination and financial marketing solutions provider and are NOT a registered broker/dealer/analyst/adviser, holds no investment licenses and may NOT sell, offer to sell or offer to buy any security. FNMG’s market updates, news alerts and corporate profiles are NOT a solicitation or recommendation to buy, sell or hold securities. The material in this release is intended to be strictly informational and is NEVER to be construed or interpreted as research material. All readers are strongly urged to perform research and due diligence on their own and consult a licensed financial professional before considering any level of investing in stocks. The companies that are discussed in this release may or may not have approved the statements made in this release. Information in this release is derived from a variety of sources that may or may not include the referenced company’s publicly disseminated information. The accuracy or completeness of the information is not warranted and is only as reliable as the sources from which it was obtained. While this information is believed to be reliable, such reliability cannot be guaranteed. FNMG disclaims any and all liability as to the completeness or accuracy of the information contained and any omissions of material fact in this release. This release may contain technical inaccuracies or typographical errors. It is strongly recommended that any purchase or sale decision be discussed with a financial adviser, or a broker-dealer, or a member of any financial regulatory bodies. Investment in the securities of the companies discussed in this release is highly speculative and carries a high degree of risk. FNMG is not liable for any investment decisions by its readers or subscribers. Investors are cautioned that they may lose all or a portion of their investment when investing in stocks. This release is not without bias, and is considered a conflict of interest if compensation has been received by FNMG for its dissemination. To comply with Section 17(b) of the Securities Act of 1933, FNMG shall always disclose any compensation it has received, or expects to receive in the future, for the dissemination of the information found herein on behalf of one or more of the companies mentioned in this release. For current services performed FNMG has been compensated forty nine hundred dollars for BioVaxys Technology Corp. current news coverage by a non-affiliated third party.  FNMG HOLDS NO SHARES OF BioVaxys Technology Corp.

This release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E the Securities Exchange Act of 1934, as amended and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. “Forward-looking statements” describe future expectations, plans, results, or strategies and are generally preceded by words such as “may”, “future”, “plan” or “planned”, “will” or “should”, “expected,” “anticipates”, “draft”, “eventually” or “projected”. You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, including the risks that actual results may differ materially from those projected in the forward-looking statements as a result of various factors, and other risks identified in a company’s annual report on Form 10-K or 10-KSB and other filings made by such company with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and FNMG undertakes no obligation to update such statements.

Sign Up & Get FREE News Alerts From FNM Today!