Palm Beach, FL – January 28, 2021 – According to the National Institutes of Health (NIH), the tide in the global fight against COVID-19, the disease caused by the SARS-CoV-2 virus, may soon begin to turn. Last month, three pharmaceutical companies announced promising results from vaccine trials. Countries around the world are now poised to begin the largest mass vaccination campaigns since the 1950s. Researchers led by Dr. Dan Barouch of Beth Israel Deaconess Medical Center used monkeys to look at levels of antibodies and immune cells required to prevent reinfection with the virus. NIH said some questions remain about what types and amounts of immune system components are needed to produce long-term immunity against SARS-CoV-2. This information would be valuable both for tracking the effectiveness of vaccines and designing new ones in the future. It said that This finding suggests that T cells are needed for long-term protection from the virus. “Antibodies alone can protect, including at relatively low levels, but T cells are also helpful if antibody levels are insufficient,” Barouch says. “Such knowledge will be important in the development of next generation vaccines, antibody-based therapeutics, and public health strategies for COVID-19.” Active biotech companies in the Covid-19 developments this week include Sorrento Therapeutics, Inc. (NASDAQ: SRNE), BioVaxys Technology Corp. (OTCPK: LMNGF) (CSE: BIOV), INOVIO (NASDAQ: INO), CytoDyn Inc. (OTCQB: CYDY), Novavax, Inc. (NASDAQ: NVAX).
BMJ. Com reported on a similar test but humans were the patients here, to find out how long the T Cells last after an infection. The results were that Robust cellular immunity persists for at least for six months after even mild or asymptomatic SARS-CoV-2 infection, research has shown. The study of 100 people showed that all had a cellular immune response against SARS-CoV-2 six months after infection although the size of response was 50% higher in those who had experienced symptomatic disease. There has been concern that the cellular immune response following covid-19 infection may not be sustained. “This data is reassuring,” lead study author Paul Moss, from the University of Birmingham, told a Science Media Centre briefing on 2 November. “However, it does not mean that people cannot be re-infected. We need to have much larger population studies to show that.” Moss also added that the findings “can’t be taken as confirmation that an ‘immunity passport’ would be feasible.”
BioVaxys Technology Corp. (OTCPK: LMNGF) (CSE: BIOV.CNQ) BREAKING NEWS: COVID-T™ CLINICAL DEVELOPMENT PROGRAM INITIATED REGULATORY ADVISORY GROUP ENGAGED – BioVaxys Technology Corp. (“BioVaxys”) 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…. Read this full release and more news for BioVaxys Technology at: https://www.financialnewsmedia.com/news-biov/
Other recent developments in the biotech industry include:
Sorrento Therapeutics, Inc. (NASDAQ: SRNE) recently announced positive preliminary results from its Phase 1b study of human allogeneic adipose-derived mesenchymal stem cells (COVI-MSC™) for patients suffering from COVID-19-induced acute respiratory distress (ARD) or acute respiratory distress syndrome (ARDS). This ongoing study (PSC-CP-004) is a single arm, non-randomized Phase 1b study of the safety and preliminary efficacy of COVI-MSCs administered every other day for three infusions for a total of 1 x 106 cells/kg. The primary objective is to evaluate the safety of intravenous infusion of allogeneic adipose MSC cells in patients with COVID-19-induced ARD or ARDS. The secondary objective is to evaluate efficacy outcome variables to give guidance regarding the risk/benefit ratio in patients with COVID-19 respiratory distress.
The first three patients enrolled tolerated treatment well and improved rapidly. Each of the three patients was discharged from the hospital within a week of starting the patient’s COVI-MSC infusions and two patients were discharged on the day of their last infusion. One of the patients had been in the hospital for three weeks, unable to be weaned from significant oxygen support, and another patient with uncontrolled diabetes had been discharged previously but had to be readmitted due to recurrent ARD. Each of the infusions were well-tolerated and no patient reported any infusion-related adverse events. A fourth patient is currently at the beginning of a course of treatment, with no safety issues following the patient’s first infusion. Additional enrollment continues.
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, and Advaccine Biopharmaceuticals Suzhou Co., Ltd. (“Advaccine”), an emerging biotech company with next-generation technology in vaccines, both preventive and therapeutic, recently announced that they have entered into a collaboration and license agreement for COVID-19 DNA vaccine candidate INO-4800.
Under the collaboration and license agreement, Advaccine will have the exclusive right to develop, manufacture and commercialize INO-4800 within Greater China, inclusive of Mainland China, Hong Kong, Macao, and Taiwan. Advaccine will license its plasmid manufacturing process for use with INO-4800 and other INOVIO pipeline product candidates to INOVIO with the right to sublicense to INOVIO’s manufacturing partners. Additionally, Advaccine will provide its clinical data to INOVIO in support of INOVIO’s global INO-4800 regulatory filings and INOVIO will provide its INO-4800 clinical data for Advaccine to incorporate into its marketing applications in Greater China. Advaccine will make to INOVIO an upfront payment of $3.0 million as well as pay an aggregate of $108.0 million upon the achievement of specified development and sales-based milestones for INO-4800 in Greater China. INOVIO will be entitled to receive a royalty equal to a high single-digit percentage of annual net sales in each region within Greater China.
CytoDyn Inc. (OTCQB: CYDY), a late-stage biotechnology company developing Vyrologix™ (leronlimab-PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced this month a research manuscript submitted by Nicholas J. Agresti, M.D. has been accepted for publication in the Journal of Translational Autoimmunity. Dr. Agresti’s research findings were based on four critically ill COVID-19 patients treated with leronlimab under eIND.
The manuscript Ms. No. JTAUTO-D-20-00043R1 is entitled “Disruption of CCR5 Signaling to Treat COVID-19-Associated Cytokine Storm: Case Series of Four Critically Ill Patients Treated with Leronlimab.”
Nicholas J. Agresti, M.D., stated, “We are very thankful with the clinical outcomes for these patients and are honored by the acceptance of our research for publication. We hope this work will continue to advance research to understand how to effectively mitigate the effects of COVID-19.”
Novavax, Inc. (NASDAQ: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, recently announced that it has finalized an agreement with the Government of Canada to supply up to 76 million doses of NVX-CoV2373, the company’s recombinant protein-based COVID-19 vaccine. Canada has committed to purchase 52 million doses of the vaccine with the option for up to an additional 24 million doses. NVX-CoV2373 is currently in Phase 3 clinical development for the prevention of COVID-19.
“We thank the Government of Canada for their confidence in our program and ongoing partnership in the regulatory review and delivery of a safe, effective COVID-19 vaccine for the citizens of Canada,” said John J. Trizzino, Chief Commercial Officer and Chief Business Officer, Novavax. “Novavax is proud to play our part in working tirelessly together with governments, scientists, regulators and others in the global effort to put an end to the pandemic.”
The company expects to supply NVX-CoV2373 to Canada beginning as early as the second quarter of 2021, following authorization by Canada’s regulatory agency.
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