The CV-19 pandemic shows no signs of slowing. To date, there are nearly 21 million cases, with 769,235 deaths. In the U.S., cases are up to 5.25 million. Brazil is up to 3.22 million. India is nearing 2.5 million. Russia is now up to 910,778. Meanwhile, the World Health Organization has warned the situation could get far worse, meaning we need treatment immediately. With the coronavirus showing no signs of cooling, some of the top companies racing to develop treatment, include Revive Therapeutics (CSE:RVV)(OTC:RVVTF), Moderna Inc. (NASDAQ:MRNA), Johnson & Johnson (NYSE:JNJ), Vaxart Inc. (NASDAQ:VXRT), and CytoDyn Inc. (OTC:CYDY).
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, is pleased to announce that it has signed a Memorandum of Understanding with Attwill Medical Solutions Sterilflow, LP to establish AMS as a resource for clinical packaging and distribution for the Company’s Phase 3 clinical trial to evaluate the safety and efficacy of Bucillamine in patients with mild-moderate COVID-19.
“We are pleased to engage in formal discussions with Attwill Medical to assist us in the clinical packaging and distribution for our Phase 3 clinical study in COVID-19, as they have the resources and capabilities to execute on a number of activities that are critical to large-scale clinical studies,” said Michael Frank, CEO of Revive.
Based in Lodi, Wisconsin, AMS is one of the largest contract Lyophilization services facilities in the USA and recently announced a MOU with Vaxart, Inc. affirming the parties’ intent to establish AMS as a resource for lyophilization development and large scale manufacturing including tableting and enteric coating for Vaxart’s oral COVID-19 vaccine. AMS operates an FDA compliant facility with ISO 13485 2016 certification and operates under cGMP and specializes in the lyophilization and related processing of pharmaceutical intermediates, medical devices, nutraceuticals and nutritional ingredients and supplements.
The MOU outlines a proposed scope of work with the intention to form a collaboration between Revive and AMS in the area of clinical packaging. The primary activities that AMS may perform for the Phase 3 clinical study in COVID-19 are analytical and stability studies, clinical supply chain management, storage, distribution and project management.
As AMS is a related party to the Company due to the fact that Bill Jackson, a director of Revive, is an insider of AMS, the MOU is deemed to be a “related party transaction” as defined under Multilateral Instrument 61-101—Protection of Minority Security Holders in Special Transactions (“MI 61-101”). The transaction with AMS is exempt from the formal valuation and minority shareholder approval requirements of MI 61-101 (pursuant to subsections 5.5(a) and 5.7(a)) as the fair market value of the consideration to be paid to AMS will not exceed 25% of the Company’s market capitalization.
Revive would also like to announce that it has commenced the process to have the Company’s common shares upgraded and quoted on the OTCQB® Market exchange in the United States. Commencement of trading through the facilities of the OTCQB® is subject to the fulfilment of the various regulatory requirements and completion of due diligence.
Moving to the OTCQB® in the United States will provide existing shareholders with an additional trading platform to the Canadian Securities Exchange in addition to introducing the Company to a broader range of retail and institutional investors that a U.S. listing provides.
Other related developments from around the markets include:
Moderna Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that the U.S. government has secured 100 million doses of mRNA-1273 as part of the U.S. government’s goal of securing early access to safe and effective COVID-19 vaccines for the American people. Today’s award of up to $1.525 billion is for the manufacturing and delivery of 100 million doses of mRNA-1273 including incentive payments for timely delivery of the product. With the previous award of up to $955 million from BARDA for the development of mRNA-1273 to licensure, today’s announcement brings the U.S. government commitments for early access to mRNA-1273 to up to $2.48 billion. Under the terms of the agreement, the U.S. government, as a part of Operation Warp Speed, will also have the option to purchase up to an additional 400 million doses of mRNA-1273 from Moderna. The U.S. government has announced that consistent with its commitment to free access to COVID-19 vaccines, Americans will receive mRNA-1273 at no cost for the vaccine itself. As is customary with government-purchased vaccines, healthcare professionals could charge for the cost of administering the vaccine.
Johnson & Johnson (NYSE:JNJ) announced its Janssen Pharmaceutical Companies have entered into an agreement with the U.S. government for the large scale domestic manufacturing and delivery in the U.S. of 100 million doses of Janssen’s SARS-CoV-2 investigational vaccine, Ad26.COV2.S, for use in the United States following approval or Emergency Use Authorization by the U.S. Food and Drug Administration (FDA). The Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response, in collaboration with the U.S. Department of Defense, is committing over $1 billion for this agreement. The vaccine will be provided at a global not-for-profit basis for emergency pandemic use. The U.S. government may also purchase an additional 200 million doses of Ad26.COV2.S under a subsequent agreement.
Vaxart Inc. (NASDAQ:VXRT), a clinical-stage biotechnology company developing oral recombinant vaccines that are administered by tablet rather than by injection, today announced that its COVID-19 Investigational New Drug (IND) application has been filed with the US Food and Drug Administration (FDA). “We are very excited to reach this important milestone in advancing our oral COVID-19 vaccine candidate towards the clinic,” said Andrei Floroiu, chief executive officer of Vaxart. “We expect our upcoming Phase I study to generate data that will further differentiate our oral vaccine from injectable vaccines by substantiating the importance of activating both systemic and mucosal immunity in protecting against COVID-19. We believe that this mechanistic benefit combined with the significant advantages of oral administration to the patient while eliminating the need for cold chain distribution, could make our COVID-19 vaccine an ideal candidate for successful mass vaccination campaigns globally.”
CytoDyn Inc. (OTC:CYDY), a late-stage biotechnology company announced the Top-line results from its recently completed, randomized, double-blind, Phase 2 trial for COVID-19 patients with mild-to-moderate symptoms. CytoDyn will submit its Top-line Report for this trial to the U.S. Food and Drug Administration for review later this week. The Top-line Report revealed the following information: Clinical improvement assessed by change in total clinical symptom score:In patients with Total Clinical Symptom Score of ≥ 4 at baseline (higher scores equate to poorer health state): At Day 3, more subjects treated with leronlimab reported improvement in total clinical symptom score compared to the placebo group (90% on leronlimab arm vs. 71% on placebo). The subgroup analysis indicates that among patients with more symptoms at baseline, those who received leronlimab had a greater treatment effect than patients who received the placebo.
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