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The Trump administration is expanding collaboration with AstraZeneca (AZN -1.7%), via a deal between the company and the Dept. of Health and Human Services and Dept. of Defense on the company’s COVID-19 antibody cocktail.
The deal covers late-stage development and large-scale manufacturing of AZD7442, a cocktail of two monoclonal antibodies that “may help treat or prevent infection” of the SARS-CoV-2 virus.
An effective monoclonal antibody (especially a long-lasting one delivered in intramuscular injection) is particularly useful in groups including those with compromised immune function, those over 80, and those undergoing medical treatments that preclude receiving a COVID-19 vaccine.
If the FDA authorizes use of AZD7442 for prevention of SARS-CoV-2, as outlined in agency guidance, the federal government will distribute the doses at no cost,” the government says. “As is customary with government-purchased medical products, healthcare professionals could charge for the cost of administering the product.
Agencies in the two departments collaborated to provide $486M to AstraZeneca for two Phase 3 clinical trials and related development. One trial will evaluate safety and efficacy to prevent infection for up to 12 months in about 5,000 volunteers. Another will evaluate whether AZD744 can help prevent infection in those who have come in contact with someone with COVID-19 in a post-exposure prophylaxis setting, using about 1,100 volunteers.
The company estimates 100,000 doses could be available for the high-risk population by December.
Moderna’s (NASDAQ:MRNA) vaccine candidate against COVID-19, mRNA-1273, is now eligible for submission of an application for a European Union Marketing Authorization under the European Medicine Agency’s centralized procedure.
The submission follows positive results from a preclinical viral challenge study and the positive interim analysis of the Phase 1 study of mRNA-1273 in healthy adults (ages 18-55 years) and older adults (ages 56-70 and 71+) published in the New England Journal of Medicine.
“We are committed to developing a safe and effective vaccine following the guidance of regulatory agencies and we will continue our ongoing dialogue with the EMA,” said the company. “Moderna is scaling up global manufacturing to be able to deliver approximately 500M doses per year and possibly up to 1B doses per year, beginning in 2021.”
In Europe, the firm is working with its strategic manufacturing partners, Lonza (OTCPK:LZAGY) of Switzerland and ROVI of Spain, for manufacturing and fill-finish outside of the U.S.
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Gilead Sciences (NASDAQ:GILD) announces that the required waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 with respect to its cash tender offer for Immunomedics, expired on October 13, 2020.
On September 25, 2020, both the companies filed the Premerger Notification and Report Forms required under the HSR Act.
Unless extended, the offer and withdrawal rights will expire on October 22.
BioVaxys Technology (OTC:LMNGF) has reported interim data from preclinical clinical studies of its SARS-CoV-2 vaccine candidate, BXV-0320.
The study showed that after five weeks of BVX-0320 in the murine animal model, no side effects were observed.
The company anticipates taking further steps to pursue regulatory approval for a Phase I study of BVX-0320.
BioVaxys’s product pipeline includes BVX-0918A, an IND-stage haptenized cancer cell vaccine for late stage ovarian cancer.
Vaxart (VXRT -5.2%) has announced topline results from preclinical studies evaluating oral COVID-19 vaccine candidate, demonstrating that all hamster models that received two oral doses of COVID-19 vaccine candidate were protected against systemic weight loss, as well as lung weight gain, which is a key indicator of lung damage due to infection
The study evaluated Vaxart’s recombinant adenoviral vaccine, and data demonstrated that all unvaccinated animals lost at least 8% of their body weight, and all showed evidence of lung disease as measured by relative weight gain in the lungs. Hamsters receiving one oral dose had partial protection.