Optimism Building As Additional COVID-19 Vaccines Are Expected to be Released Globally

Palm Beach, FL – December 21, 2020 – Since the global outbreak that triggered the pandemic, scientists around the world have been working on potential treatments and vaccines for the new coronavirus disease known as COVID-19… and they have been making progress at a rapid pace, perhaps the fastest in history.  Several companies are working on antiviral drugs, some of which are already in use against other illnesses, to treat people who have COVID-19, which could provide the fastest track of all.  Other companies are working on vaccines that could be used as a preventive measure against the disease. Last week, the FDA granted emergency use authorization for a COVID-19 vaccine created by Pfizer-BioNTech. An article in Medical News today added: “The United States is the latest country to join Canada and the United Kingdom in approving a COVID-19 vaccine. Creating a vaccine in under 1 year is no small feat. While the coronavirus pandemic made a new normal of mask-wearing and physical distancing, it also spurred global cooperation for vaccine research and distribution.”    Active biotech companies in the Covid-19 developments this week include Pfizer Inc. (NYSE: PFE), BioVaxys Technology Corp. (OTCPK: LMNGF) (CSE: BIOV), Moderna, Inc. (NASDAQ: MRNA), INOVIO (NASDAQ:INO), Sorrento Therapeutics, Inc. (NASDAQ: SRNE).


The Medical News article continued: “Dr. Eric J. Yager, an associate professor of microbiology at Albany College of Pharmacy and Health Sciences in Albany, NY, told MNT that scientists have been studying coronaviruses for over 50 years. This meant scientists had existing data on the structure, genome, and life cycle of this type of virus. “Early efforts by scientists at Oxford University to create an adenovirus-based vaccine against MERS provided the necessary experimental experience and groundwork to develop an adenovirus vaccine for COVID-19.” Dr. Yager said that thanks to advances in genomic sequencing, researchers successfully uncovered the viral sequence of SARS-CoV-2 in January 2020 — roughly 10 days after the first reported pneumonia cases in Wuhan, China. The ability to fast-track research and clinical trials was a direct result of this worldwide cooperation.”  The article added: “Several countries have started administering the Pfizer/BioNTech COVID-19 vaccine. It is the first mRNA vaccine to be used in humans outside of clinical trials. The other company working on an mRNA COVID-19 vaccine is Moderna, who are collaborating with the NIH. In addition to their accelerated development of vaccines, both companies are pioneers in mRNA technology.”


BioVaxys Technology Corp. (OTCPK: LMNGF) (CSE: BIOV.CNQ) BREAKING NEWSBIOVAXYS VACCINE PLATFORM STIMULATES ROBUST T-CELL RESPONSE AGAINST VIRAL ANTIGENS – BioVaxys Technology Corp. (“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.”  Read this full release and more news for BioVaxys Technology athttps://www.financialnewsmedia.com/news-biov/     


Other recent developments in the biotech industry include:


Moderna, Inc. (NASDAQ: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, recently announced that the European Commission has exercised its option to purchase an additional 80 million doses of mRNA-1273, Moderna’s COVID-19 vaccine candidate, bringing its confirmed order commitment to 160 million doses.


The first deliveries of mRNA-1273 to European countries from Modena’s dedicated European supply chain are expected to commence early in 2021 following regulatory approval by the EMA. These deliveries are subject to receipt of the positive opinion from the European Medicines Agency’s (EMA) scientific committee for human medicines (CHMP) and the European Commission’s Decision regarding the Conditional Marketing Authorisation (CMA) for the vaccine. The CHMP meeting is planned for January 6, 2021.


Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) recently announced that the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted today to recommend the use of the Pfizer-BioNTech COVID-19 vaccine in people 16 years of age and older under the Emergency Use Authorization (EUA) issued by the U.S. Food and Drug Administration (FDA). This ACIP vote follows the December 1, 2020, ACIP recommendation for a Phase 1a rollout where first priority of COVID-19 vaccines is given to health care personnel treating patients, and residents in nursing homes and other long-term care facilities.


“Today’s ACIP recommendation marks a momentous step in this historic journey and the beginning of another, as we work jointly with the U.S. government, other vaccine companies and our many partners to execute the largest mass vaccination program in our nation’s history. Collectively, we aim to vaccinate hundreds of millions of Americans by the end of 2021,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “With vaccinations set to begin this week, I feel a sense of tremendous pride at what we have collectively achieved over the past nine months. I now look forward to the day that this devastating and deadly pandemic is finally behind us.”


INOVIO (NASDAQ:INO), a biotechnology company focused on bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases and cancer, recently announced the company and a team of scientists from The Wistar Institute, AstraZeneca, the University of Pennsylvania, and Indiana University received a $37.6 million grant from the U.S. Defense Advanced Research Projects Agency (DARPA), a research and development agency of the U.S. Department of Defense (DoD) and the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND), to use INOVIO’s innovative DNA-encoded monoclonal antibody (dMAb®) technology to develop anti-SARS-CoV-2-specific dMAbs which could offer versatile capabilities to function as both a therapeutic and preventive treatment for COVID-19.


Dr. J. Joseph Kim, President and CEO of INOVIO, said, “INOVIO’s anti-SARS-CoV-2 dMAbs present a unique complement to our DNA vaccine candidate for COVID-19 prevention, INO-4800, which currently is in the Phase 2 segment of our INNOVATE Phase 2/3 clinical trial with funding from the DoD/JPEO-CBRND, as well as our other candidates in our DNA medicines platform. This public-private partnership allows us to not only broaden the scope and application of our DNA medicines platform across the spectrum of needed COVID-19 treatment modalities, but also to open the door for better patient administration and more cost-effective, scalable production of monoclonal antibody products for other infectious diseases and cancers. We are excited about the potential this funding offers for both situations requiring immediate clinical response and benefit.”


Sorrento Therapeutics, Inc. (NASDAQ: SRNE) recently announced FDA acceptance of its Investigational New Drug (IND) application for its Phase 1 clinical trials for intravenous (IV) STI-2020 (COVI-AMG). The trials will evaluate the safety, pharmacokinetics and efficacy of a single injection of STI-2020 in healthy volunteers and outpatient COVID-19 patients with mild symptoms.


Sorrento previously announced that STI-2020 demonstrated a complete neutralizing effect at a very low dose in preclinical studies and high potency that may potentially enable rapid deployment and availability to patients. Sorrento has initiated cGMP manufacturing to produce up to 100,000 doses in anticipation of a potential EUA.


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