H3 Biomedicine Files IND for Oncology Drug Candidate

FDA has accepted from H3 Biomedicine an IND application to begin Phase 1 clinical trials for its lead oncology drug candidate H3B-8800. The oral and selective small molecule modulator of splicing factor 3b subunit 1 is being developed as an anticancer therapeutic agent for treating select hematologic malignancies. “Mutations in the spliceosome are a hallmark of various hematological malignancies, and the results from our initial pre-clinical studies targeting these through splice modulation with H3B-8800 are encouraging,” the company says.

In pre-clinical studies, H3B-8800 showed “dose dependent modulation of canonical and aberrant splicing when dosed orally at tolerated doses,” H3 says. “More importantly, oral administration of H3B-8800 demonstrated preferential antitumor activity in several pre-clinical xenograft models carrying spliceosome mutations.”