H3 Biomedicine Inc., announced that the U.S. Food and Drug Administration (FDA) accepted the company’s Investigational New Drug (IND) application to begin Phase 1 clinical trials for its lead oncology drug candidate H3B-8800. The compound is an oral and selective small molecule modulator of splicing factor 3b subunit 1 (SF3B1), which is being developed by H3 Biomedicine as an anticancer therapeutic agent for the potential treatment of select hematologic malignancies.
“There is a high unmet need for new medicines to treat patients afflicted with a number of hematologic malignancies, and who have very few treatment options,” said Markus Warmuth, M.D., President and CEO of H3 Biomedicine.
“We are pleased the FDA has accepted H3’s application for the evaluation of H3B-8800 in patients with blood cancers,” said Pete Smith, PhD, Vice President, Drug Discovery Biology for H3 Biomedicine. “H3 is committed to developing medicines like H3B-8800 and looks forward to the evolution of all our pipeline programs.”
