Palm Beach, FL – February 2, 2021 – Recent reports of ongoing testing regarding the length of time that the initially approved vaccines for COVID-19 will give the patients for immunity after having been inoculated with the vaccine. Early in the covid-19 pandemic it was unclear whether and how individuals and populations would develop protective and enduring immunity against SARS-CoV-2, either after infection or vaccination. Initial focus was on defining virus neutralizing antibodies from B cells after infection. Early reports indicated that such antibodies decline substantially over less than six months, raising questions about how long protective immunity might last following infection. T cells are also known to be important in protecting against many viral infections through processes known as cellular immunity. Defining the roles of T cells in covid-19 became a central focus for investigation. An ongoing study in the UK, report that both memory T cell and B cell responses specific to SARS-CoV-2 have now been found up to six months after infection. Similar T and B cell responses might be expected following vaccination, and may account for the good efficacy suggested by interim results from the three most advanced vaccine candidates. All three vaccines—two mRNA vaccines (Pfizer-BioNTech and Moderna) and a DNA vaccine (Oxford-AstraZeneca)—encode genetic information, enabling the body to produce a viral antigen (the spike protein) that stimulates an immune response. In phase I and II trials, all three vaccines induced neutralizing antibodies to the spike protein and also cellular immune responses. Interim data from phase III trials suggest all three vaccines protect against symptomatic infection with SARS-CoV-2. 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), Dynavax Technologies Corporation (NASDAQ: DVAX), Novavax, Inc. (NASDAQ: NVAX).
“These studies and others. offer strong evidence that T cell immune responses are sustained, even in the face of declining or undetectable antibodies, implying that some immunity persists. It is possible, but as yet unconfirmed, that immunity might last even longer, as T cell responses to SARS-CoV-1 and MERS-CoV have been found several years after infection.” The study concluded: “High vaccine uptake will be critical to achieving individual and population immunity. Equitable global access to effective vaccines is also essential. Open debate and public education campaigns will be required to build trust and counter vaccine hesitancy and effective pharmacovigilance will be needed to monitor long term safety. Continued research and development will be needed to stay ahead of potentially consequential viral mutations, which could have negative consequences for covid-19 vaccines.”
BioVaxys Technology Corp. (OTCPK: LMNGF) (CSE: BIOV.CNQ) BREAKING NEWS: BIOVAXYS SARS-CoV-2 VACCINE CANDIDATE BVX-0320 STIMULATES NEUTRALIZING ANTIBODIES TO LIVE COVID-19 VIRUS – BioVaxys Technology Corp. (“BioVaxys”) 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. 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:
INOVIO (NASDAQ: INO) 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.
Dynavax Technologies Corporation (NASDAQ: DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, recently announced Valneva SE has informed it that the UK Government exercised its option to order an additional 40 million doses of Valneva’s SARS-CoV-2 adjuvanted vaccine candidate, VLA2001. This option exercise triggers the reservation of additional quantities of Dynavax’s advanced adjuvant CgP 1018 to support production of 40 million doses of Valneva’s SARS-CoV-2 adjuvanted vaccine candidate, VLA2001. In connection with its contract with the UK Government, Valneva has now reserved for delivery in 2021 CpG 1018 in quantities sufficient to support production of 100 million doses of VLA2001.
Novavax, Inc. (NASDAQ: NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, recently announced that NVX-CoV2373, its protein-based COVID-19 vaccine candidate, met the primary endpoint, with a vaccine efficacy of 89.3%, in its Phase 3 clinical trial conducted in the United Kingdom (UK). The study assessed efficacy during a period with high transmission and with a new UK variant strain of the virus emerging and circulating widely. It was conducted in partnership with the UK Government’s Vaccines Taskforce. Novavax also announced successful results of its Phase 2b study conducted in South Africa.
“With today’s results from our UK Phase 3 and South Africa Phase 2b clinical trials, we have now reported data on our COVID-19 vaccine from Phase 1, 2 and 3 trials involving over 20,000 participants. In addition, our PREVENT-19 US and Mexico clinical trial has randomized over 16,000 participants toward our enrollment goal of 30,000. NVX-CoV2373 is the first vaccine to demonstrate not only high clinical efficacy against COVID-19 but also significant clinical efficacy against both the rapidly emerging UK and South Africa variants,” said Stanley C. Erck, President and Chief Executive Officer, Novavax. “NVX-CoV2373 has the potential to play an important role in solving this global public health crisis. We look forward to continuing to work with our partners, collaborators, investigators and regulators around the world to make the vaccine available as quickly as possible.”
Sorrento Therapeutics, Inc. (NASDAQ: SRNE) recently announced additional positive 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.
On January 26, 2021, Sorrento announced the first three enrolled ICU COVID-19 patients were discharged from the hospital within a week of starting COVI-MSC infusions and a fourth patient just started the COVI-MSC treatment last Monday, January 25, 2021. The fourth patient who had been in the hospital for more than 2 weeks and required intubation and mechanical ventilation with worsening pulmonary compromise received 3 infusions of COVI-MSC and improved so rapidly that he was able to be discharged the evening after his 3rd infusion on January 29, 2021. No infusion related safety events were reported. Dr. Eyad Almasri, Associate Professor of Medicine, Pulmonary, Critical Care and Sleep Medicine at UCSF Fresno, is the principal investigator in this ongoing study.
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