Business
Immunome Reports Fourth Quarter and Full Year 2021 Financial Results
- Immunome Receives Safe-to-Proceed Notification from U.S. FDA for IMM-BCP-01 Investigational New Drug Application - - Immunome Continues to Progress
About this update from Immunome, Inc.
[{"type":"text","content":"\n- Immunome Receives Safe-to-Proceed Notification from U.S. FDA for IMM-BCP-01 Investigational New Drug Application -\n\n- Immunome Continues to Progress IMM-BCP-01 Towards Phase 1b Clinical Trial -\n\n- Ongoing Progress on Oncology Pipeline, Including Lead Program Targeting IL-38, a Novel Innate Immunome Checkpoint -\n\n EXTON, Pa.--(BUSINESS WIRE)--\nImmunome, Inc. (Nasdaq: IMNM), a biopharmaceutical company that utilizes its human memory B cell platform to discover and develop first-in-class antibody therapeutics, today reported financial results for the fourth quarter ended December 31, 2021 and provided a corporate update.\n\n“There remains a clear need for safe and efficacious antibody treatments against COVID-19, especially those less susceptible to mutational drift. We believe our three-antibody cocktail, IMM-BCP-01, has strong potential to address that unmet need. We are pleased the FDA has given us a safe-to-proceed notification and lifted the clinical hold for our Investigational New Drug (IND) application,” stated Purnanand Sarma, Ph.D., President and CEO of Immunome.\n\n“Additionally, we continue to progress IMM-ONC-01, our novel, IL-38-targeting innate immune checkpoint inhibitor, towards an IND submission in the second half of 2022,” Sarma continued. “Our preclinical work is ongoing, and we have analyzed IL-38 expression across nearly 60 tumor subtypes and we have confirmed a high frequency of expression in difficult to treat cancers, such as head and neck squamous cell carcinoma, gastroesophageal squamous carcinoma, and squamous lung carcinoma.”\n\nFourth Quarter and Subsequent Highlights\n\n\nDemonstrated In Vitro Efficacy of IMM-BCP-01 Against SARS-CoV-2 Omicron Variant in Live Virus Testing. In February 2022, Immunome announced that IMM-BCP-01 demonstrated effective neutralization of the Omicron variant of COVID-19 in in vitro testing. The combination of two antibodies in Immunome’s antibody cocktail, IMM20253/IMM20184, demonstrated neutralization of the Omicron variant within 3.5-fold potency compared to a preclinical version of sotrovimab in a head-to-head test using live virus samples. Additionally, IMM20253 exhibited a novel mechanism of action not reported in any other EUA antibodies by promoting a proteolytic cleavage of the portion of the spike protein needed for ACE2 binding.\n\n\n\nIMM-BCP-01 IND App...