Antibody Cocktail Working again after FDA Hold Lifted

Two months after the FDA imposed a hold on Immunome’s Antibody cocktail COVID-19 therapy, the hold has been lifted. The FDA warned the business to slow down and asked more information on how IMM-BCP-01 is prepared and administered at clinical sites in January. According to a Friday press statement, Immunome can now move on with human studies after supplying the agency with a “full report” with the needed details.

In vitro investigations demonstrated Immunome’s therapy was still effective against the highly transmissible omicron type, exceeding a preclinical version of GlaxoSmithKline’s approved monoclonal Antibody sotrovimab. With phase 1 trials resuming, the company has set a goal of providing top line findings in the first part of this year. Immunome’s treatment is a three-Antibody cocktail that aims to elicit a more persistent immune response by targeting three different regions of the coronavirus’s spike protein.

In oncology, the business is targeting IL-38, a cytokine it believes acts as an immunological checkpoint, with the similar platform and approach. Immunome was awarded $13.3 million by the Department of Defense in February 2021 to develop a scaleable biosynthetic convalescent plasma therapy. While the funding was meant to combat COVID-19, the department stated at the time that “the technology’s potential to also treat or protect service members from other future biological dangers they may face makes it a particularly important DOD investment.”

However, fed-backed COVID-19 therapies have had a difficult time recently, particularly in the NIH’s ACTIV-2 trial. SAB Therapeutics’ Antibody treatment was discontinued in early March when the trial found that there were too few Omicron-related hospitalizations and deaths. Synairgen’s arm of the same trial was halted a day later as the NIH tweaked the study design.