U.S. testing of coronavirus vaccine, therapeutic begin

NIH is kicking off the first U.S. clinical trials for COVID-19 with an adaptive trial of remdesivir, an antiviral therapeutic, and a Phase I trial of Moderna’s vaccine candidate. Separately Tuesday, FDA Commissioner Stephen Hahn took to Twitter to debunk media reports referencing a list of 150 drugs at risk for shortages due to the COVID-19 outbreak and CDC warned that it was preparing for a potential pandemic.

The Trump administration has asked Congress for $1.8 billion in additional funding to address the outbreak (see “White House Requests $2.5B”).

NIH’s National Institute of Allergy and Infectious Diseases (NIAID) is running the Phase II trial of remdesivir from Gilead Sciences Inc. (NASDAQ:GILD).

The study, which is being conducted at the University of Nebraska Medical Center, will initially compare the nucleotide analog with placebo, but an interim monitoring system will allow for the introduction of new arms. If one therapy proves efficacious, it will then become the control arm.

The first patient has been enrolled in the trial -- a repatriated patient from the Diamond Princess cruise ship, which was quarantined off Yokohama, Japan, when ongoing transmission was identified on the ship. The trial will enroll up to 394 patients, according to ClinicalTrials.gov.

The U.S. government flew back 329 citizens from the cruise ship last week. Of the 13 people repatriated and transported to the National Quarantine Unit at UNMC, CDC has confirmed that 11 are infected with COVID-19. CDC said Tuesday there have been 53 cases of infection in the U.S.

NIAID Director Anthony Fauci said at an HHS press briefing Tuesday that an identical remdesivir trial is being started in Japan with other patients from the cruise ship. The trial’s design is the same as a pair of Chinese remdesivir trials, which are being conducted by Gilead’s partner, the China-Japan Friendship Hospital in Beijing (see “Gilead Ramping up Remdesivir Production”).

In a separate press briefing Tuesday, WHO Assistant-Director Bruce Aylward said a Chinese remdesivir trial is recruiting slowly because of competition from other agents that are being studied. He called for prioritization of the Gilead therapy because it is the “most promising” agent.

While there are several dozen agents being evaluated in clinical trials for COVID-19, in vitro data for remdesivir have thus far supported the WHO’s prioritization of the therapy (see “Preclinical Potencies of Clinical COVID-19 Candidates”).

From zero to vaccine in 42 days

A Phase I trial for Moderna’s COVID-19 vaccine, which is also being run by NIAID, is slated to start March 6, according to ClinicalTrials.gov. The trial, which will enroll 45 healthy volunteers to receive mRNA-1273, is being conducted at the Kaiser Permanente Washington Health Research Institute in Seattle.

After announcing late Monday that it has shipped the first batch of mRNA-1273, Moderna Inc. (NASDAQ:MRNA) gained $5.17 (28%) to $23.76 Tuesday, adding about $1.9 billion in market cap.

mRNA-1273 is an RNA-based vaccine encoding the SARS-CoV-2 spike protein.

Kizzmekia Corbett, the scientific lead of the coronavirus team at NIAID’s vaccine research center, told BioCentury, “We wanted to target 100 days after sequence release as part of a proof-of-concept towards pandemic preparedness.”

The team was able to achieve its goal in less than half that time. The first clinical batch of mRNA-1273 was ready 42 days after the SARS-CoV-2 sequence was released, Moderna said.

The gains by Moderna’s stock came in stark contrast to biotech and broader indexes. The Dow Jones Industrial Index fell 879 points, or 3.2%, while the NASDAQ Composite slid 2.8%. The NASDAQ Biotechnology Index (NBI) was off 2.3%, and the NYSE Arca Biotechnology Index (BTK) fell 3%. Major indexes began the day with gains only to fall after the CDC’s warning. It was the second straight day of steep declines (see “Biopharma Stocks Tumble as Drug Supply Chain Risk Mounts”).

CDC, FDA

CDC said in a report published Tuesday that community mitigation measures, like school and meeting cancellations, might be critical to avert widespread COVID-19 transmission.

“We expect we will see community spread in this country,” Nancy Messonnier, director of CDC’s National Center for Immunization and Respiratory Diseases, said during a Tuesday press conference. “It’s not so much a question of if this will happen anymore, but rather more a question of exactly when this will happen and how many people in this country will have severe illness.”

Hahn’s comments on social media came after an Axios report said Monday that about 150 therapies are on a list of drugs at risk for shortages compiled by FDA. At the time, CDER declined to comment to BioCentury on the existence of the list, but Hahn tweeted late Tuesday that reports on the list are incorrect and that “no firms are reporting drug shortages due to #COVID19, including the approximately 20 drug products that are solely sourced from China.”

Further analysis of the coronavirus crisis can be found at https://www.biocentury.com/coronavirus. The COVID-19 content is free to all who visit the site.

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