FDA accept Biomedicine IND application to begin Phase 1 clinical trials for H3B-8800
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.
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“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.
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“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.”