Shanghai-based biotech GenFleet Therapeutics announced that its CDK9 inhibitor, SLS009 (GFH009), has received fast-track and orphan drug designation (ODD) statuses from the U.S. FDA. These designations highlight the drug’s potential as a treatment for recurrent or refractory peripheral T-cell lymphoma (PTCL) and recurrent or refractory acute myeloid leukemia (AML).
In April 2022, U.S.-based biopharma SELLAS Life Sciences Group Inc. (NASDAQ: SLS) secured all therapeutic and diagnostic rights to GFH009 outside the Greater China market through a licensing agreement valued at $150 million. Currently, GFH009 is in Phase II clinical trials for both PTCL and AML in the U.S. and China, having shown promising safety and efficacy results in earlier Phase I and II studies.- Flcube.com
