While COVID-19 Drags On, Biotechs Introduce New Treatments & Vaccines to Combat Subvariants

FinancialNewsMedia.com News Commentary

PALM BEACH, Fla., Nov. 16, 2022 /PRNewswire/ -- The COVID-19 pandemic has devastated the world and impacted millions of people… as a result, the demand for the creation of therapeutic treatments has increased due to the pandemic outbreak. The pandemic outbreak has surged the need for the development of therapeutic solutions for treating it.   COVID-19 can be treated using a range of drugs such as antivirals, monoclonal antibodies, and kinase inhibitors. The increasing investment by key players in the market serves as one of the major driving factors for the growth of the COVID-19 oral medicine market during the forecast period. For instance, in June 2022, Pfizer Inc. announced to strengthen its commitment to US manufacturing with a US$ 120 million investment at its Kalamazoo, Michigan, facility, enabling US-based production in support of its COVID-19 oral treatment. A report from Market Study Report said that: "The global COVID-19 oral medicine market is expected to grow at a CAGR of around 10.5% during the forecast period of 2022-2028. The COVID-19 outbreak has caused havoc globally and affected millions of individuals…. The demand for the creation of therapeutic treatments has increased due to the pandemic outbreak. Citing an instance, Pfizer Inc. stated in June 2022 that it will increase its commitment to US manufacturing by investing USD 120 million at its Kalamazoo, Michigan, facility, allowing US-based manufacturing in support of its COVID-19 oral treatment, PAXLOVIDTM."  Active biotech and pharma companies in the markets this week include BIOXYTRAN, INC. (OTCQB: BIXT), Novavax, Inc. (NASDAQ: NVAX), Pfizer Inc. (NYSE: PFE), Moderna, Inc., (NASDAQ: MRNA), INOVIO (NASDAQ: INO).

Indeed, there are numerous clinical trials by both the largest and smaller R&D companies worldwide. The NIH website, ClinicalTrials.gov shows that in the U.S. alone there are 150 Vaccine Studies and an even higher number of Drug Studies at 661.  The report, discussing collaborations among a number of R&D firms, added: "Aside from that, strategic alliances between major corporations and increased R&D endeavors are assisting in the growth of the corporate environment… The rising investment by prominent players is one of the primary factors driving the expansion of global COVID-19 oral medicine market. The leading players in global COVID-19 oral medicine industry are increasing the competitive landscape... These major players (are) concentrating on a variety of growth tactics such as alliances, collaborations, geographic expansion, product launches…" with companies of all sizes in order to maintain and increase their resultant revenue share… which should certainly increase the Global COVID-19 Oral Medicine Market.

BIOXYTRAN, INC. (OTCQB: BIXT) BREAKING NEWS:  Bioxytran Releases Positive Top-line Results from Phase 2 Trial of Galectin Antagonist on COVID-19 Patients in medRxiv Pre-print - BIOXYTRAN, INC. (the "Company"), a clinical stage biotechnology company developing oral drugs to treat COVID-19 and other viral diseases, announced positive topline safety and efficacy results of its randomized, placebo-controlled Phase 2 clinical trial in 34 patients with mild-to-moderate COVID-19. During the 7 days of treatment, an orally administered Galectin Antagonist in the form of a chewable tablet was administered 8 times per day on an hourly basis. The endpoint was a statistically significant reduction in viral load measured by the number of patients reaching a below threshold PCR value (Ct value ≥ 29) by day 7. The trial met its endpoint with a 100% response rate by day 7 versus 6% in placebo, which was statistically significant (p-value = .001). Our analysis also revealed an 88% response rate by day 3, which was statistically significant (p-value = .001). There were no drug-related serious adverse events (SAE's) in the patient population or viral rebounds by day 14 in the patient population. The positive data from this clinical trial provided the rationale of dosing and protocol design for study in an upcoming phase 2/3 registrational trial. 

The full text of the preprint is located at the following link.
https://www.medrxiv.org/content/10.1101/2022.11.09.22282151v1

Nuclear Magnetic Resonance ("NMR") testing was used to elucidate the Mechanism of Action of the specific Galectin Antagonist.  Tests concluded that ProLectin-M ("PL-M") binds relatively strongly to galectin-3 with micromolar affinity down to 2µM. While the Galectin Antagonist does indeed bind to the S1 Spike Protein, the study showed that it could bind in 2 different orientations with galectin-3. The NMR binding data indicate that 5 molecules of galectin-3 are required to saturate one spike protein. These findings on the mechanism of action supported the decisions on dosing, duration, and ingestion. The results showed PL-M's inhibition of galectin-3 and the blockade of the N-Terminal Domain of the S-1 subunit.    

"Our sights were set on a statistically significant reduction of viral load by day 7 because we expected that there would be real-world issues that we would be unable to account for in our theories about efficacy. We can say that these trial results exceeded our expectations by orders of magnitude, but the proof of that statement lies in our trial design which should have been hourly instead of daily so that we would have had a more detailed picture of how rapidly the viral load was dropping" said Dr. Alben Sigamani, Bioxytran Medical Advisory Board and lead Author. "Our theories on COVID were proven consistently in vitro, in vivo, and also in the clinic. One of the reasons that COVID-19 has become endemic is the abandonment of protective measures like masks, social distancing, ventilation, testing, and contract tracing which are all designed to limit infectivity.  We believe there is an unmet medical need to control infectivity in a patient population without access to existing COVID-19 antivirals. The enormous loss of worker productivity during this pandemic due to sick days and the increasing infectivity of the variants, has many businesses doing a balancing act by quarantining the sick and then aggressively pushing them to return to the workplace as soon as possible."

"Existing therapies target viral replication which battles on the inside of the cell interfering with replication, our Galectin Antagonist helps keep the fight outside the cell interfering with cellular entry. This novel Mechanism of Action in battling viruses may require little assistance from the immune system, which typically requires a lead time to mount a response. With the creation of this molecule, we contribute to the science of Glycovirology, which is the study of carbohydrates and viruses." CONTINUED… Read this full press release and more news for BIXT at:  https://www.financialnewsmedia.com/news-bixt/  

Other recent developments in the biotech industry of note include

Novavax, Inc. (NASDAQ: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, recently announced that the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (U.K.) has expanded the conditional marketing authorization (CMA)ⁱ for Nuvaxovid™ (NVX-CoV2373) COVID-19 vaccine as a homologous and heterologous booster dose after the primary series of Nuvaxovid (six months) or of an mRNA or adenoviral vector vaccine for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adults aged 18 and older.

"Our protein-based vaccine, developed using an innovative approach to traditional technology, may have a prominent role to play in COVID-19 boosting," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "As we continue to explore best practices for managing COVID-19 long term, we have ongoing trials further exploring Nuvaxovid's immunogenicity as a booster dose. Currently available clinical and preclinical data indicate that our vaccine induces robust immune responses against Omicron variants, including BA.4/5."

Pfizer Inc. (NYSE: PFE) and BioNTech SE (NASDAQ: BNTX) recently announced updated data from a Phase 2/3 clinical trial demonstrating a robust neutralizing immune response one-month after a 30-µg booster dose of the companies' Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine (Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5)). Immune responses against BA.4/BA.5 sublineages were substantially higher for those who received the bivalent vaccine compared to the companies' original COVID-19 vaccine, with a similar safety and tolerability profile between both vaccines. These results reinforce the previously reported early clinical data measured 7 days after a booster dose of the bivalent vaccine, as well as the pre-clinical data, and suggest that a 30-µg booster dose of the Omicron BA.4/BA.5-adapted bivalent vaccine may induce a higher level of protection against the Omicron BA.4 and BA.5 sublineages than the original vaccine.

"As we head into the holiday season, we hope these updated data will encourage people to seek out a COVID-19 bivalent booster as soon as they are eligible in order to maintain high levels of protection against the widely circulating Omicron BA.4 and BA.5 sublineages," said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. "These updated data also provide confidence in the adaptability of our mRNA platform and our ability to rapidly update the vaccine to match the most prevalent strains each season."

Moderna, Inc., (NASDAQ: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, recently announced that both of Moderna's bivalent Omicron-targeting booster candidates (mRNA-1273.214 and mRNA-1273.222) trigger a superior antibody response compared to a booster dose of mRNA-1273, the Company's prototype vaccine, against Omicron (BA.4/BA.5) in Phase 2/3 clinical trials. Both bivalent vaccines also met non-inferiority immunogenicity criteria to the original strain.

"We are pleased to see that both of our bivalent booster vaccine candidates offer superior protection against Omicron BA.4/BA.5 variants compared to our original booster, which is encouraging given COVID-19 remains a leading cause of hospitalization and death globally. In addition, the superior response against Omicron persisted for at least three months after the mRNA-1273.214 booster," said Stéphane Bancel, Moderna's Chief Executive Officer. "Our bivalent boosters also show, in research assays, neutralizing activity against BQ.1.1, an increasingly dominant emerging variant, confirming that updated vaccines have the potential to offer protection as the virus continues to evolve rapidly to escape our immunity."

INOVIO (NASDAQ: INO) recently announced that it has discontinued its internally funded efforts to develop INO-4800 as a COVID-19 heterologous booster vaccine. The decision follows INOVIO's comprehensive review of its portfolio, market conditions, and global demand for COVID-19 vaccines.

Dr. Jacqueline Shea, INOVIO's CEO and President, stated: "We continue to believe that our DNA medicine technology has attributes that could be beneficial to a heterologous COVID-19 booster vaccine. However, our assessment of the current global demand for COVID-19 vaccines, changes in regulatory timelines and requirements, diminishing government financial support, and the overall growing uncertainty related to opportunities for heterologous booster vaccines have resulted in our decision to discontinue internal funding efforts to develop INO-4800 as a heterologous booster vaccine.

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