COVID-19 roundup: Emergency use of Moderna vaccine could come earlier than expected; plus ASCO goes virtual, Galapagos pauses filgotinib trials and more

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The overarching news was negative for biopharma Tuesday, with a fresh round of companies announcing trial delays. But Moderna offered a rare ray of light, hinting that its vaccine could be available sooner than many expected. On top of that, ASCO joined the list of conferences turning to a digital format.

Moderna Inc. (NASDAQ:MRNA) revealed in an SEC filing that CEO Stéphane Bancel had indicated on March 20 to Goldman Sachs that mRNA-1273 might be available as soon as this fall under emergency use to individuals including healthcare professionals. He has said the vaccine could be commercially available in 12-18 months.

Bancel also confirmed that Moderna is scaling up manufacturing capacity with a goal of producing millions of doses per month.

Moderna, which is co-developing the vaccine with NIH, received early funding for its mRNA technology from the Defense Research Advanced Projects Agency. DARPA has also played a hand in the technologies behind COVID-19 treatment and vaccine candidates from AbCellera Biologics Inc., Inovio Pharmaceuticals Inc. (NASDAQ:INO) and Vir Biotechnology Inc.(NASDAQ:VIR) (see “DARPA’s Gambles Might Have Created the Best Hopes”).

ASCO shifts to virtual format

The American Society of Clinical Oncology announced Tuesday that its annual meeting scheduled for May 29-June 2 will now take place virtually instead of in Chicago. ASCO said its educational program would not take place during that time, and it is evaluating “opportunities for the future.”

ASCO joins more than 20 other conferences that have adjusted their plans; it is the second major cancer meeting to do so. On March 10, the American Association for Cancer Research postponed its April meeting (see “COVID-19: A Guide to Conferences”).

For small biotechs, the consequences of the changes could negatively affect their ability to raise money and find new partners (see “Hidden Consequences of COVID-19”).

Delays for Galapagos
Galapagos N.V. (Euronext:GLPG; NASDAQ:GLPG) CEO Onno van de Stolpe posted a letter Sunday saying that the company is pausing enrollment in clinical trials of filgotinib to protect patients’ safety during the pandemic. Affected studies include the Phase II and III DIVERSITY trials for Crohn’s disease, the Phase III PENGUIN study for psoriatic arthritis and the Phase II MANTA and MANTA-RAy trials to treat uveitis.

The company will also push back the start of a Phase III trial in ankylosing spondylitis to later this year.

Stolpe added that enrollment in the Phase III SELECTION program in ulcerative colitis has already been completed, and the company is still on track for a readout next quarter.

Also announcing delays were Ampio Pharmaceuticals Inc. (NYSE-A:AMPE), which stopped enrolling patients with severe osteoarthritis of the knee in a Phase III trial of Ampion, and BridgeBio Pharma Inc. (NASDAQ:BBIO), which disclosed in an SEC filing delays in patient enrollment for its subsidiaries’ clinical programs.

Development, manufacturing deals

Sorrento Therapeutics Inc. (NASDAQ:SRNE) has gained exclusive rights from Mabpharm Ltd. (HKEX:2181) to develop and commercialize CMAB020 (STI-4920) as a COVID-19 treatment in North America and Europe.

The candidate, which Mabpharm has in cGMP development, is a bispecific ACE-MAB fusion protein. One arm of CMAB020 is a human antibody against the SARS-CoV-2 spike; the other arm comprises truncated ACE2, the host cell receptor for the spike. The two arms bind different epitopes on the spike protein.

Sorrento said the therapy may also be able to prevent the spike from binding BSG. Reported by Fourth Military Medical University scientists, BSG serves as a second host protein that mediates SARS-CoV-2 cell entry upon binding the spike protein (see “Second Receptor Mediating SARS-CoV-2 Infection”).

A Sorrento spokesperson told BioCentury that Mabpharm is eligible for undisclosed royalties.
Separately, Florida-based CDMO Ology Bioservices Inc. announced Tuesday its second Department of Defense contract of the week: $11.9 million to work with Inovio to rapidly manufacture INO-4800 to prevent SARS-CoV-2 infection. The DNA vaccine will be delivered to DoD for clinical trials.

On Monday, Ology won a $14 million DoD contract to develop and manufacture, along with the Vanderbilt University Medical Center, a mAb to treat and prevent COVID-19.

Real-world data

The Observational Health Data Sciences and Informatics (OHDSI) international group, centered at Columbia University, announced plans to evaluate COVID-19 treatments based on real-world data from sources include electronic health records.

The data scientists will conduct retrospective analyses, initially on historical viral infections with COVID-19 data added as it’s generated, to assess the safety and effectiveness of proposed COVID-19 drugs as well as predict patient outcomes.

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