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Product Development

COVID-19 Quick Takes: FDA expands remdesivir EUA; plus Warp Speed, Abbott, Moderna-Japan, CanSino-Canada, BeiGene-Singlomics, Sinovac, UNC, Daiichi, Laurent

Aug 29, 2020 | 1:54 AM GMT

Remdesivir authorized for mild patients
FDA expanded an emergency use authorization for remdesivir to include all patients hospitalized with COVID-19. The antiviral from Gilead Sciences Inc. (NASDAQ:GILD) had previously been limited to patients with blood oxygen saturation <94% on room air, requiring supplemental oxygen, mechanical ventilation or extracorporeal membrane oxygenation (ECMO).

Warp Speed clarifies vaccine timeline, year-end expectations
HHS’s Deputy Chief of Staff for Policy Paul Mango provided an update on Operation Warp Speed’s vaccine development timeline at a media briefing Friday. A pair of Phase III trials for vaccines from BioNTech SE (NASDAQ:BNTX) and Pfizer Inc. (NYSE:PFE), and from Moderna Inc. (NASDAQ:MRNA), have each enrolled more than half the total 30,000 volunteers, and two more vaccines are expected to start Phase III testing by mid-September. Mango also clarified that Warp Speed’s stated goal of having 300 million vaccine doses by year-end referred to the manufacturing of those doses, not their authorization, which he estimated could come between October and December, depending on Phase III data. The Data Safety and Monitoring Board overseeing the trials will review safety and efficacy data after 150-175 infection events have occurred, Mango said (see “Trump Administration Lays out Path to 300M COVID-19 Doses”).

Abbott to supply U.S. with 150M rapid antigen tests
HHS and the U.S. Department of Defense closed a $760 million contract with Abbott Laboratories (NYSE:ABT) for 150 million of its 15-minute point-of-care COVID-19 antigen tests, which received an EUA from FDA on Wednesday. Abbott expects to ship tens of millions of the BinaxNOW COVID-19 tests next month, and 50 million tests a month beginning in October. Antigen tests are considered a key technology for asymptomatic screening (see “FDA Authorizes Test from Abbott”; “Asymptomatic Testing Pushes Forward”).

Moderna nears supply deal with Japan
Moderna said Friday it is in talks with the Japanese government to provide 40 million doses of COVID-19 vaccine mRNA-1273. Under the tentative agreement, the biotech would supply the vaccine and Takeda Pharmaceutical Co. Ltd. (Tokyo:4502; NYSE:TAK) would be responsible for distribution starting 1H21, pending approval. Japan also has supply agreements for vaccines from BioNTech and Pfizer, as well as Novavax Inc. (NASDAQ:NVAX).

CanSino vaccine won’t be tested in Canada
Canada’s National Research Council told BioCentury it will no longer be running a Phase I trial of a COVID-19 vaccine from CanSino Biologics Inc. (HKEX:6185; Shanghai:688185) because Chinese customs did not approve shipment of the doses. “It is evident this specific opportunity is over and the NRC is focusing its team and facilities on other partners and COVID-19 priorities,” the agency said. It is prioritizing development of vaccines from VBI Vaccines Inc. (NASDAQ:VBIV) and the University of Saskatchewan.

BeiGene, Singlomics deal on antiviral antibodies
BeiGene Ltd. (NASDAQ:BGNE; HKEX:6160) has gained exclusive rights outside greater China from Singlomics Biopharmaceuticals Co. Ltd. to develop, manufacture and commercialize COVID-19 neutralizing antibodies including DXP-593 and DXP-604. Singlomics will receive an undisclosed upfront payment and is eligible for undisclosed milestones, plus royalties. Enrollment in an Australian Phase I trial and in an international Phase I/II study is slated to begin in September and by early October, respectively.

China grants EUAs to Chinese COVID-19 vaccines
An inactivated SARS-CoV-2 vaccine from Sinovac Biotech Ltd. (NASDAQ:SVA) was approved by China's National Medical Products Administration (NMPA) in July for emergency use, according to Reuters, which cited an unnamed person familiar with the matter. Sinovac could not be reached for comment. If true, it would be the second COVID-19 vaccine available in the country before the completion of Phase III testing.  The state-affiliated publication Global Times reported Sunday that China has been offering citizens a COVID-19 vaccine from Sinopharm since July 22.

Modeling COVID-19 disease, treatment with mouse-adapted SARS-CoV-2
A team led by Ralph Baric at University of North Carolina at Chapel Hill showed that Peginterferon Lambda-1a from Eiger BioPharmaceuticals Inc. (NASDAQ:EIGR) could be effective against COVID-19 using a mouse model produced by creating a mouse-adapted strain of SARS-CoV-2.

The scientists described the SARS-CoV-2 strain in a Nature paper published Thursday. Wild-type mice infected with the mouse-adapted SARS-CoV-2 strain had more clinically relevant COVID-19 phenotypes than human ACE2-expressing mice infected with wild-type SARS-CoV-2. They also showed that mouse-adapted SARS-CoV-2 led to more severe disease in old vs. young mice.

In an aged mouse model of COVID-19, prophylactic or therapeutic administration of Eiger’s pegylated IFNƛ product reduced replication of mouse-adapted SARS-CoV-2 in the lungs and pulmonary dysfunction. The treatment, which is in Phase II testing to treat COVID-19, also blocked viral replication in the lungs of young mice.

Daiichi vaccine selected for Japan initiative
Daiichi Sankyo Co. Ltd. (Tokyo:4568) said it was selected for Japan’s “Emergent Initiative to Build Production Capacity for COVID-19 Vaccines.” The biopharma expects to bring mRNA vaccine DS-5670 to the clinic around March.

Laurent to start 200-patient antiviral study
Laurent Pharmaceuticals Inc. was cleared Thursday to start a placebo-controlled, Phase II trial of LAU-7b to treat patients hospitalized with COVID-19. The inflammation-controlling antiviral is an oral formulation of fenretinide, a synthetic retinoid derivative.

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