DUBLIN – Abivax SA has rejected an acquisition offer in order to pursue a phase IIb/III trial of its lead anti-inflammatory drug, ABX-464, in 1,034 COVID-19 patients. The study will get underway in 50 centers in France and in other European countries in the coming weeks. “We are expecting the first patient in at the end of May – at the latest early June,” CEO Hartmut Ehrlich told BioWorld. Participants will be randomized, in a 2-to-1 ratio, to receive a 50-mg, once-daily oral dose of ABX-464 or placebo, on top of standard of care. The primary endpoint will be the absence of high-flow oxygen use, or assisted ventilation, or death, within 28 days.

Allogene shares jump on early new NHL data

Shares of Allogene Therapeutics Inc. leapt 33% higher by midday on news that limited data on a small number of relapsed/refractory non-Hodgkin lymphoma patients showed a combination of the company's anti-CD19 allogeneic CAR T candidate, ALLO-501, and an anti-CD52 monoclonal antibody, ALLO-647, met with an overall response rate of 78%, including three complete responses and four partial responses. No dose-limiting toxicities or graft-vs.-host disease were observed. The news arrived amid a flood of new data to be presented at the upcoming American Society of Clinical Oncology annual meeting. "In our view, this is good initial data but is hard to interpret relative to other CAR T/CD19 approaches given the limited details in the abstract," J.P. Morgan analyst Cory Kasimov wrote.

J&J prostate cancer treatment significantly prolongs survival

New data show Johnson & Johnson’s prostate cancer drug, Erleada (apalutamide), combined with androgen deprivation therapy (ADT), prolonged median overall survival by 14 months and reduced the risk of death by 22% compared to ADT alone. The data come from the final analysis of the company’s phase III SPARTAN study of patients with non-metastatic castration-resistant prostate cancer who were at high risk of developing metastases. The median overall survival rate was 73.9 months for patients receiving treatment with apalutamide in combination with ADT compared to 59.9 months with patients receiving placebo in combination with ADT. The data are a preview of the company’s presentation at the upcoming and virtual American Society of Clinical Oncology conference, which begins May 29.

Bright warns of ‘darkest winter in modern history’

“Our window of opportunity is closing. If we fail to develop a national coordinated response, based in science, I fear the pandemic will get far worse and be prolonged, causing unprecedented illness and fatalities,” Rick Bright, former director of the Biomedical Advanced Research and Development Authority, said today as he testified at a House subcommittee hearing on the U.S. response to COVID-19. In his testimony before the Energy and Commerce Subcommittee on Health, Bright offered no new solutions other than more coordination and better nationwide planning that takes into consideration the critical supplies that are needed for testing and a vaccination program and an equitable distribution of those supplies.

PTO offers priority for pandemic-related patents, but time is of the essence

The U.S. Patent and Trademark Office has opened a priority track for patents related to the COVID-19 pandemic, another signal of federal government intent on overcoming this new plague. However, Scott Marty, a partner with the Atlanta office of Ballard Spahr LLP, told BioWorld that while the program offers some distinct advantages for pandemic-driven patents, inventors should have their filings in good form before entry because any delays incurred by a less-than-airtight application could lead the PTO to boot the application out of the program.

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