Biopharma Update on the Novel Coronavirus: October 27

News information is not all-inclusive and updates are published once a week on Tuesdays.

FDA Actions

FDA Approval: Last week the FDA approved Veklury (remdesivir) for the treatment of COVID-19 requiring hospitalization in adults and pediatric patients (12 years of age and older).

Diagnostics Update: To-date the FDA has authorized 284 individual EUAs, which include 221 molecular tests, 56 antibody tests and 7 antigen tests.

Testing Therapies, Antivirals and Vaccines

Only a fraction of intravenous antibody treatments will make their way to the lungs of COVID-19 patients, which is where the infection is primarily located. Aridis Chief Executive Officer Vu Truong believes his company has a better solution – an inhaled antibody. Please read more here.

Novavax will present data from an ongoing Phase I/II clinical trial, including new Phase II reactogenicity data from its COVID-19 vaccine candidate. NVX‑CoV2373 on Friday during the CDC’s Advisory Committee on Immunization Practices’ (ACIP) meeting. Novavax anticipates the Phase III portion of its clinical trial to begin in the United States and Mexico by the end of November. The company is currently enrolling patients for the Phase III U.K. portion of the study.

Toronto-based Revive Therapeutics anticipates interim data from its 200 patient Phase III study on the efficacy of bucillamine in patients with mild-moderate COVID-19 by the end of the year. The interim analysis will determine the better-performing dose arm for the remainder of the trial and future complementary studies evaluating it in more severe cases.

Eli Lilly halted a separate study of its LY-COV555 antibody against COVID-19 in hospitalized patients. About two weeks ago an independent Data Monitoring Committee paused enrollment in this trial because of a potential safety issue. The National Institute of Allergy and Infectious Diseases (NIAID), the study sponsor, could not verify the safety issue, but their analysis also indicated there was little likelihood the antibody would help the hospitalized patients.

Days after the U.S. Food and Drug Administration greenlit the restart of AstraZeneca’s Phase III COVID-19 vaccine trial, the U.K.-based company said the preventative medication boosts immune responses in older and younger adults against the novel coronavirus.

Last week shares of Gilead Sciences are jumped in aftermarket trading following full approval for Veklury (remdesivir) as a treatment for COVID-19. The approval marks the first drug approved by the U.S. Food and Drug Administration as a treatment for the novel coronavirus.

Moderna has fully enrolled its late-stage coronavirus disease 2019 (COVID-19) vaccine trial by hitting its target of 30,000 participants. More than one-third of this cohort includes minority participants.

Organizational Actions/Announcements

The Russian Direct Investment Fund has submitted applications to the WHO for prequalification of and accelerated registration for a coronavirus vaccine, Sputnik V.

Histogen and Amerimmune signed a deal to develop and commercialize emricasan for the treatment of COVID-19. The drug is an orally active caspase inhibitor.

Enzo Biochem launched GoTestMeNow, an online platform that allows consumers to directly order physician-authorized laboratory testing, including for COVID-19 molecular and antibody testing, which will be the initial launch. It expects to expand to a broad range of additional tests in the future.

The pharmaceutical supply chain is being pushed to its limit as it prepares to deliver COVID-19 vaccines and therapeutics to the entire world as soon as possible, while continuing to produce and deliver all the usual medications and products. For Catalent Biologics, as a contract development and manufacturing organization (CDMO) with 50 programs ongoing at 40 sites, and with 14,000 employees globally, this means becoming more transparent and collaborative up and down the supply chain, and building out capabilities. Please read more here.

Roche and Atea Pharmaceuticals are partnering to develop, manufacture and distribute AT-527, Atea’s experimental antiviral drug against COVID-19. They expect to launch a Phase III trial of the drug in the first quarter of 2021.

Other Industry News

While pre-license inspections of manufacturing sites are typically done following the acceptance of a Biologics License Application (BLA) filing, due to the public health emergency of COVID-19, the FDA is instead requiring a quality control unit to be established by each manufacturer with detailed report submissions about their manufacturing processes. Please read more here.

Typically, the U.S. Food and Drug Administration (FDA)’s advisory committees meet ahead of a decision on whether to approve a drug or therapy to provide expert recommendations. Last week’s advisory committee meeting held by the Vaccines and Related Biological Products Advisory Committee was a little bit different, as the group held a nine-hour virtual meeting to discuss the COVID-19 vaccine development programs and where to go next. Please read more here.