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# H3 Biomedicine Files IND for Oncology Drug Candidate
- URL: https://www.fdaweb.com/h3-biomedicine-files-ind-for-oncology-drug-candidate/
- Published: 2016-05-11T12:00:00.000Z
- Updated: 2026-09-14T21:01:50.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135646

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.”