Palm Beach, FL – September 14, 2021 – FinancialNewsMedia.com News Commentary – All across the globe, innumerable scientists are looking to beat COVID-19… the two main paths are to find better vaccines and to utilize better treatments. As with most viruses, developing COVID-19 treatments has been difficult, but several drugs have shown strong enough efficacy to gain regulatory support. Historically, one of the best ways to control viruses is through vaccines, and experts believe the vaccines emerging will significantly lower the need for COVID-19 treatments by 2023 and beyond. Nevertheless, treatments are in high demand currently and are likely to remain so through 2021 and into 2022. Currently, several drugs are used to treat COVID-19, but most have limitations in efficacy and timing of use relative to the disease progression. A report published by Morningstar forecasts that over $10 billion in sales potential for newly authorized treatments, led by antibody treatments. “Despite significant sales potential in 2021, the uncertain market duration prevents significant impact on our discounted cash flow-based fair value estimates. That said, several biopharma companies with COVID-19 treatments (Gilead, Roche, Glaxo, and Merck) look undervalued, based on strong potential for their core businesses. As global cases of COVID-19 rise internationally, we expect the need for treatments to spike in 2021. However, following heavy vaccination in 2021 and 2022, we expect a relatively quick decline in treatment demand. As a result, the fastest treatments to the market with the most supply will likely gain a short-term windfall of sales. By 2022, we expect sales to fall roughly 75%, followed by another steep decline in 2023.” Active biotech companies in the market this week include BioVaxys Technology Corp. (OTCQB: BVAXF) (CSE: BIOV), Sorrento Therapeutics, Inc. (NASDAQ: SRNE), BioNTech SE (NASDAQ: BNTX), CytoDyn Inc. (OTCQB: CYDY), Novavax, Inc. (NASDAQ: NVAX).
The Morningstar article continued: “Overall, we see the highest sales potential for antibody treatments for mild to moderate COVID-19 patients at more than $6 billion in total 2021 antibody treatment sales, with Eli Lilly and Regeneron (partnered with Roche) leading the class. Additionally, while further strains of COVID-19 could emerge, we believe both vaccines and treatments will still be effective. Despite early challenges with the utilization of the antibody treatments for COVID-19, we expect increased use in 2021, followed by a decline in 2022 as vaccines reduce the incidence rate of COVID-19. Hospitalizations are likely to continue at a high level in 2021 with the increase in severe COVID-19 patients, and antibody treatments hold the potential to reduce the need for hospitalization for COVID-19 patients if used early enough in the disease progression, which could ease the strain on the limited number of intensive care beds.”
BioVaxys Technology Corp. (OTCQB: BVAXF) (CSE: BIOV.CNQ) BREAKING NEWS: BIOVAXYS BIOPRODUCTION PARTNER WUXI BIOLOGICS COMPLETES SYNTHESIS OF RECOMBINANT SARS-COV-2 S-PROTEINS FOR BVX-0320 AND CoviDTH PROGRAMS – BioVaxys Technology Corp. (“BioVaxys”) announced today that global CDMO partner WuXi Biologics, has completed the synthesis of recombinant SARS-CoV-2 s-protein for BVX-0320, the company’s COVID-19 vaccine candidate, and CoviDTH, its immunodiagnostic product. Both are headed for clinical trials, with BioVaxys having begun preparing an IND submission to the US Food and Drug Administration (“FDA”) for a combined Phase I/II clinical study of CoviDTH as a diagnostic for evaluating T-cell immune response to SARS-CoV-2.
Under the terms of the March 11th, 2021 agreement, WuXi Biologics synthesized high yields of fully characterized, SARS-CoV-2 s-protein for BioVaxys’ Good Laboratory Practice (GLP) preclinical safety study of its CoviDTH which will begin this month. In its official Written Response in July to the Company’s request for a Pre-IND Type B review of CoviDTH, the FDA has indicated that BioVaxys’ planned animal toxicity study is discretionary and not required for IND submission. However, the Company is continuing with this study of CoviDTH as it does not interfere with the IND submission and may in fact provide useful data.
BioVaxys President & Chief Operating Officer Kenneth Kovan commented that “The production of the recombinant s-protein using WuXi Biologics’ proprietary cell expression system is a significant milestone for Biovaxys, as we not only have a high production yield of protein, but also now have the ability and know-how to produce protein in large scale with the level of purity, consistency and protein characterization required by the FDA for our clinical studies and commercial-scale yields.”
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. CONTINUED... 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 the start of enrollment in its Phase 2 efficacy 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) in Brazil. This study (MSC-COV-202BR) is a multi-arm, randomized, placebo-controlled Phase 2 study of the efficacy and safety of three infusions of COVI-MSC administered on varying schedules in the setting of standard of care treatments for COVID-19 in 100 subjects. The primary objective of this study is to evaluate the efficacy of COVI-MSCs in patients with COVID-19-induced ARD or ARDS.
Additionally, Sorrento will soon begin enrollment for two additional Phase 2 studies with COVI-MSC: A parallel Phase 2 placebo-controlled Phase 2 safety study to be conducted across multiple sites in the United States; and A pulmonary long-hauler Phase 2 safety and efficacy study across multiple sites in Brazil.
Pfizer Inc. (PFE) and BioNTech SE (NASDAQ: BNTX) recently announced the initiation of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for the approval of a booster (third) dose of COMIRNATY® (COVID-19 vaccine, mRNA) to prevent COVID-19 in individuals 16 years of age and older. The companies intend to complete submission of the sBLA by the end of this week.
The sBLA includes data from a Phase 3 clinical trial of 306 participants 18-55 years of age who received a booster (third) dose of COMIRNATY, between 4.8 and 8 months after completing the two-dose primary regimen, with a median follow-up time of 2.6 months post booster. The booster (third) dose of COMIRNATY elicited robust neutralizing antibodies to the wild-type strain in participants who were without evidence of SARS-CoV-2 infection through one month post dose three. SARS-CoV-2 50% neutralizing titers (PRNT50) after the third dose were 3.3 times the titers after the second dose. The post dose three neutralizing titers met the prespecified 1.5-fold non-inferiority criterion for success and were statistically superior. Moreover, 99.5% of participants had a four-fold response after the third dose, compared to 98.0% after the second dose. The titers after dose three met the pre-specified 10% non-inferiority margin for the difference in the four-fold seroresponse rates.
CytoDyn Inc. (OTCQB: CYDY) a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, recently announced the treatment of the first patient in its pivotal Phase 3 COVID-19 trial in Brazil for patients with severe symptoms. An interim analysis will be conducted 28 days following the enrollment of 245 patients, which is 40% of the total number of patients to be enrolled in the trial.
As previously announced, this pivotal Phase 3 trial for severe COVID-19 patients is being conducted by Academic Research Organization (“ARO”) Albert Einstein Israelite Hospital. This trial is intended to provide Brazil’s regulatory authority ANVISA (Agência Nacional de Vigilância Sanitária) with the requisite data to consider advancing the availability of leronlimab to Brazilians infected with COVID-19. The trial will be conducted in up to 35 clinical sites with 612 patients who are hospitalized and in need of oxygenation support.
Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, recently announced enrollment of the first participants in a Phase 1/2 study to evaluate the safety and immunogenicity of a combination vaccine using Novavax’ seasonal influenza and COVID-19 vaccines. The clinical trial combines Novavax’ recombinant protein-based NVX-CoV2373 and NanoFlu vaccine candidates and patented saponin-based Matrix-M adjuvant in a single formulation (COVID-NanoFlu Combination Vaccine). Both NVX-CoV2373 and NanoFlu have previously demonstrated strong results as standalone vaccines in Phase 3 clinical trials.
“This study is the first-of-its-kind to evaluate the vaccine’s potential to induce a robust immune response, augmented by our Matrix-M adjuvant, against two life-threatening diseases simultaneously,” said Gregory M. Glenn, M.D., President of Research and Development, Novavax. “The combination of these two vaccines, which have individually delivered outstanding results with favorable safety and tolerability profiles, may lead to greater efficiencies for the healthcare system and achieve high levels of protection against COVID-19 and influenza with a single regimen.”
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