Data Raising Hopes for a Pandemic Treatment in 2020
The race is on for a treatment to stop the pandemic in its tracks. While there are no proven treatments to speak of just yet, late-stage trials are taking place, with some showing a good deal of progress. Moderna, for example, just announced a $472 million commitment from the U.S. government to develop a vaccine. According to SVB Leerink analysts, that commitment will be used to fund a Phase 3 trial for Moderna’s vaccine, which is “set to begin immediately,” as quoted by MarketWatch. The US FDA even just “fast tracked” a vaccine in development with Pfizer and BIoNTech. “The FDA’s decision to grant these two COVID-19 vaccine candidates Fast Track designation signifies an important milestone in the efforts to develop a safe and effective vaccine against SARS-CoV-2,” said Peter Honig, Senior Vice President, Global Regulatory Affairs, Pfizer. The University of Oxford and AstraZeneca are also in phase three trials. Some of the top companies to watch as they race to treat the virus include Revive Therapeutics (CSE:RVV)(OTC:RVVTF), Gilead Sciences Inc. (NASDAQ:GILD), Novavax Inc. (NASDAQ:NVAX), Moderna Inc. (NASDAQ:MRNA), and GlaxoSmithKline PLC (NYSE:GSK).
Revive Therapeutics Ltd. (CSE:RVV)(OTC:RVVTF) BREAKING NEWS: Revive Therapeutics Ltd., a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, has been moving forward aggressively on its studies of Bucillamine, as a potential treatment for the virus. CORP UPDATE
In late April 2020, the US FDA recommended that the Company proceed directly into a Phase 3 confirmatory clinical trial (“Phase 3 study”) to evaluate Bucillamine for the treatment of patients with mild-moderate COVID-19 due to the SARS-CoV-2 infection. By late June 2020, Revive submitted its Investigational New Drug (IND) application to the U.S. FDA for a Phase 3 confirmatory study for Bucillamine as a potential treatment in COVID-19.
On July 31st, the company announced that the U.S. FDA approved the company’s randomized, double-blind, placebo-controlled confirmatory Phase 3 clinical trial protocol to evaluate the safety and efficacy of Bucillamine in patients with mild-moderate COVID-19. “The FDA approval of the Phase 3 study to evaluate Bucillamine in the treatment of patients with mild-moderate COVID-19 is a tremendous milestone for Revive and I am very proud of the dedication of our team and partners to bring forward a potential new treatment option for patients with a confirmed diagnosis of COVID-19 globally,” said Michael Frank, Revive’s Chief Executive Officer. “We thank the FDA for recognizing the importance of this Phase 3 study and we are now focused on executing on our plans for initiating the clinical trial in an expeditious manner.”
Other related developments from around the markets include:
Gilead Sciences Inc. (NASDAQ:GILD) announced that the company’s Board of Directors has declared a cash dividend of $0.68 per share of common stock for the third quarter of 2020. The dividend is payable on September 29, 2020, to stockholders of record at the close of business on September 15, 2020. Future dividends will be subject to Board approval.
Novavax Inc. (NASDAQ:NVAX) late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, and FUJIFILM Diosynth Biotechnologies (FDB), a world leading contract development and manufacturing organization (CDMO) for biologics, viral vaccines and gene therapies, announced today an agreement to manufacture bulk drug substance for NVX-CoV2373, Novavax’ COVID-19 vaccine candidate. FDB’s site in Morrisville, North Carolina has begun production of the first batch of NVX-CoV2373. This arrangement falls under Novavax’ recent $1.6 billion award by the federal government as part of Operation Warp Speed (OWS), a U.S. government program that aims to begin delivering millions of doses of a safe, effective vaccine for COVID-19 to the U.S. population. The OWS funding is being used by Novavax to complete late-stage clinical development, including a pivotal Phase 3 clinical trial; establish large-scale manufacturing; and deliver 100 million doses of NVX‑CoV2373 beginning as early as late 2020. NVX-CoV2373 consists of a stable, prefusion protein made using Novavax’ proprietary nanoparticle technology and includes Novavax’ proprietary Matrix‑M™ adjuvant. The batches produced at the FDB site in North Carolina will be utilized in a future pivotal Phase 3 clinical trial of up to 30,000 subjects which is expected to begin in the fall of 2020 and which will determine the safety and efficacy of NVX-CoV2373.
Moderna Inc. (NASDAQ:MRNA), a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, announced a preclinical study evaluating mRNA-1273, its vaccine candidate against COVID-19, was published in The New England Journal of Medicine. The study showed a two-dose vaccination schedule of mRNA-1273 led to a robust immune response and protection against SARS-CoV-2 infection in the upper and lower airways in non-human primates, without evidence of vaccine-associated enhanced respiratory disease (VAERD). In the study, immunogenicity and protective efficacy were assessed after a two-dose vaccination schedule of 10 or 100 µg doses of mRNA-1273 or control given four weeks apart (n=24; 8 per group). Four weeks after the second vaccination, animals were challenged with high doses of SARS-CoV-2 through intranasal and intratracheal routes.
GlaxoSmithKline PLC (NYSE:GSK) and Sanofi announced a collaborative effort with the U.S. government to accelerate the development and manufacturing of a COVID-19 recombinant protein-based vaccine. The vaccine candidate, developed by Sanofi in partnership with GSK, is based on the recombinant protein technology used by Sanofi to produce an influenza vaccine, and GSK’s established pandemic adjuvant technology. Collaborating with the U.S. Department of Health and Human Services (HHS) and Department of Defense will help fund the development activities and secure scale-up of Sanofi’s and GSK’s manufacturing capabilities in the United States for the recombinant protein-based, adjuvanted vaccine, resulting in a significant increase in capacity. The U.S. government will provide up to $2.1 billion, more than half of which is to support further development of the vaccine, including clinical trials, with the remainder used for manufacturing scale up and delivery of an initial 100 million doses of the vaccine. Sanofi will receive the majority of the U.S. government funding. The U.S. government has a further option for the supply of an additional 500 million doses longer term. This helps the U.S. government’s Operation Warp Speed goals of providing millions of doses of a safe and effective COVID-19 vaccine.
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