FinancialNewsMedia.com News Commentary More than 100 companies have rushed into vaccine development against COVID-19 as the U.S. government pushes for a vaccine rollout at "warp speed" -- possibly by the end of the year -- but the bar set for an effective, long-lasting vaccine is far too low and may prove dangerous, according to Marc Hellerstein of the University of California, Berkeley. Most vaccine developers are shooting for a robust antibody response to neutralize the virus and are focusing on a single protein, called the spike protein, as the immunizing antigen. Yet, compelling evidence shows that both of these approaches are problematic, said Hellerstein, a UC Berkeley professor of nutritional sciences and toxicology, in an article in Berkley News. It said: "A better strategy is to take a lesson from one of the world's best vaccines, the 82-year-old yellow fever vaccine, which stimulates a long-lasting, protective T-cell response. T-cells are immune cells that surveil the body continuously for decades, ready to react quickly if the yellow fever virus is detected again. "We know what really good vaccines look like for viral infections," Hellerstein said. "While we are doing phase 2 trials, we need to look at the detailed response of T-cells, not just antibodies, and correlate these responses with who does well or not over the next several months. Then, I think, we will have a good sense of the laboratory features of vaccines that work. If we do that, we should be able to pick good ones." Active biotech companies in the market this week include BioVaxys Technology Corp. (OTCQB: BVAXF) (CSE: BIOV), Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), Moderna, Inc. (NASDAQ: MRNA), Sorrento Therapeutics, Inc. (NASDAQ: SRNE), Pfizer Inc. (NYSE: PFE).
It continued: "Using a technique Hellerstein's laboratory developed and perfected over the past 20 years that assesses the lifespan of T-cells, it is now possible to tell within three or four months whether a specific vaccine will provide long-lasting cells and durable T-cell-mediated protection. Hellerstein points out that antibodies are not the primary protective response to infection by coronaviruses, the family of viruses that includes SARS-CoV-2. Indeed, high antibody levels to these viruses are associated with worse disease symptoms, and antibodies to coronaviruses, including SARS-CoV-2, don't appear to last very long... strong T-cell levels in SARS and MERS patients correlated with better outcomes. The same has also played out, so far, in COVID-19 patients. A strong antibody response correlates with more severe clinical disease in COVID-19, while a strong T-cell response is correlated with less severe disease. And antibodies have been short-lived, compared to virus-reactive T-cells in recovered SARS patients," Hellerstein said.
BioVaxys Technology Corp. (OTCQB: BVAXF) (CSE: BIOV.CNQ) BREAKING NEWS: BIOVAXYS BEGINS TOXICITY STUDY AHEAD OF COVIDTH IND SUBMISSION - BioVaxys Technology Corp. ("BioVaxys") announced today that it has started its planned in vivo animal toxicology study of CoviDTH in parallel with the preparation of an IND submission. Under the terms of a March 2021 agreement, global contract research organization ("CRO") Inotiv, Inc. ("Inotiv") is evaluating the safety, tolerability, and toxicity of the purified recombinant SARS-CoV-2 s-protein that is a principal constituent of CoviDTH in an intradermal research model, which will include a battery of clinical pathology, immunology, and histopathology evaluations. The Inotiv study will be utilizing purified recombinant SARS-CoV-2 s-protein recently produced by BioVaxys bioproduction partner, WuXi Biologics.
Headquartered in West Lafayette, Indiana, Inotiv (NASDAQ: NOTV); market capitalization: $795M) provides contract research services to emerging pharmaceutical companies and some of the world's leading drug development companies and medical research organizations.
In its July 2021 Written Response to BioVaxys on the Company's request for a Pre-IND Type B review of CoviDTH as a diagnostic for evaluating T-cell immune response to SARS-CoV-2, the US Food and Drug Administration ("FDA") indicated that animal toxicity studies for CoviDTH were not required and that the Company could start its clinical development program with a combined Phase I/II study. Although the animal tox study is discretionary, it will not interfere with the IND timing and BioVaxys believes it may provide useful data when the study is completed next month.
CoviDTH(TM) is the world's first and only low cost, disposable, point-of-care diagnostic tool that screens for a T-cell response to SARS-CoV-2 in vaccinated patients, or those exposed to SARS-CoV-2. Recent published clinical studies have validated the use of the delayed type hypersensitivity (DTH) cutaneous test behind CoviDTH as a feasible and safe in vivo method to assess cellular immune responses in both natural and vaccinated SARS-CoV-2 exposed individuals and also that the DTH response is highly durable and persists for at least one year after COVID-19 exposure or vaccine administration.
BioVaxys President and Chief Operating Officer Ken Kovan stated, "Based on the millions of people who have received COVID-19 vaccines that are based on in vivo cellular expression of SARS-CoV-2 s-spike protein, as well as the human DTH studies, we are confident that the toxicology study with Inotiv of the s-protein will likewise confirm the safety profile of CoviDTH." CONTINUED... Read this full release and more news for BioVaxys Technology at: https://www.financialnewsmedia.com/news-biov/
Other recent covid-19 developments in the biotech industry include:
Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company, recently provided an update on its development programs in oncology and infectious disease for mupadolimab (formerly CPI-006), a humanized monoclonal antibody directed against CD73 with a proposed dual mechanism of activating B cells to generate immune responses to viruses and tumor antigens, and inhibiting the production of immunosuppressive adenosine in the tumor micro environment.
Corvus is developing mupadolimab as a therapeutic for oncology indications and for infectious disease, starting with COVID-19. Today the Company announced results from its Phase 3 clinical trial of mupadolimab for COVID-19, which have been published online at medRxiv.org. The results, which cover 40 patients that were enrolled in the trial prior to its voluntary discontinuation, suggest improvement in the primary and key secondary endpoints in patients treated with single doses of mupadolimab at 2mg/kg and 1mg/kg compared to placebo. No drug related adverse events were reported in the trial.
Moderna, Inc. (NASDAQ: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, recently announced a supply agreement with the government of Peru for 20 million doses of Moderna's COVID-19 vaccine to begin delivery in the first quarter of 2022. The COVID-19 Vaccine Moderna is not currently approved for use in Peru, and the Company will work with regulators to pursue necessary approvals prior to distribution.
"We appreciate the support from the government of Peru with this supply agreement for doses of the Moderna COVID-19 vaccine," said Corinne Le Goff, Pharm.D., M.B.A, Chief Commercial Officer of Moderna. "We are committed to making our vaccine available around the world as we seek to address the pandemic with our COVID-19 vaccine."
Sorrento Therapeutics, Inc. (NASDAQ: SRNE), a clinical and commercial stage biopharmaceutical company developing new therapies to treat cancer, pain (non-opioid treatments), autoimmune disease and COVID-19, recently announced impressive results from an independent study conducted under real-world field conditions by INMEGEN (The Institute of National Genomics Medicine, Mexico).
Key highlights included, the for the population tested with COVISTIX(TM) (n=783), sensitivity and specificity were 81% (CI95% 76.0-85.0) and 96.0% (CI95% 94.0-98.0), respectively. In contrast, the sensitivity of the Panbio comparator test (n=2202) was measured at 62% (CI95%: 58.0-64.0%) and specificity at 99.0% (CI95%: 0.99-1.00).
Pfizer Inc. (NYSE: PFE) recently announced the start of the Phase 2/3 EPIC-PEP (Evaluation of Protease Inhibition for COVID-19 in Post-Exposure Prophylaxis) study to evaluate the investigational novel oral antiviral candidate PF-07321332, co-administered with a low dose of ritonavir, for the prevention of COVID-19 infection. This Phase 2/3 trial is part of a global clinical research program and is enrolling individuals who are at least 18 years old and live in the same household as an individual with a confirmed symptomatic SARS-CoV-2 infection.
"With the continued impact of COVID-19 around the world, we believe that tackling the virus will require effective treatments for people who contract, or have been exposed to, the virus, complementing the impact that vaccines have had in helping quell infections. If successful, we believe this therapy could help stop the virus early - before it has had a chance to replicate extensively - potentially preventing symptomatic disease in those who have been exposed and inhibiting the onset of infection in others," said Mikael Dolsten, MD, PhD., Chief Scientific Officer and President, Worldwide Research, Development and Medical of Pfizer. "Given the continued emergence and evolution of SARS-CoV-2 variants and their immense impact, we continue to work diligently to develop and study new ways that our investigational oral antiviral candidate could potentially lower the impact of COVID-19, not only on patients' lives, but also the lives of their families and household members."
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