Immunome's COVID-19 antibody cocktail back on track for phase 1 after FDA lifts hold

Immunome’s antibody cocktail COVID-19 treatment is free from an FDA hold, two months after the pause was first placed. 

In January, the FDA told the company to slow its roll and requested more information on the preparation and administration of IMM-BCP-01 at clinical sites. Immunome can now move forward with human trials after providing the agency with a "comprehensive report" with the requested information, according to a Friday press release

Last month, Immunome reported that in vitro studies showed its treatment remained effective against the highly transmissible omicron variant, outperforming a preclinical version of GlaxoSmithKline’s authorized monoclonal antibody sotrovimab. With phase 1 trials now back on the horizon, the company has an ambitious timeline of presenting top line data in the first half of this year. 

Immunome’s treatment is a three-antibody cocktail that targets three different parts of the spike protein on the coronavirus in an effort to elicit a more durable immune response. The company is using the same platform and mechanism in oncology to target IL-38, a cytokine that it believes operates as an immune checkpoint. 

In February 2021, Immunome was awarded $13.3 million from the Department of Defense to develop a biosynthetic convalescent plasma treatment that could be scaled up. At the time, the department noted that while the grant was intended to address COVID-19, “the technology’s potential to also treat or protect service members from other future biological threats they may face makes it a particularly worthwhile DOD investment.”

But it’s been tough sledding as of late for fed-backed COVID-19 treatments, particularly in NIH’s ACTIV-2 trial. At the beginning of March, SAB Therapeutics' antibody treatment was axed after the trial recorded too few Omicron-related hospitalizations and deaths. A day later, Synairgen’s arm of the same trial was paused while the NIH adjusted the study design.