Terns Pharmaceuticals Secures Orphan Drug Designation for TERN-701 in Chronic Myeloid Leukemia Treatment
Monday, March 11, 2024
Terns Pharmaceuticals, Inc. (NASDAQ: TERN), a clinical-stage biopharmaceutical company specializing in the development of small-molecule treatments for severe diseases like oncology and obesity, has announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to TERN-701 for the treatment of chronic myeloid leukemia (CML). TERN-701, an allosteric BCR-ABL tyrosine kinase inhibitor (TKI) developed internally by the company, is currently undergoing Phase 1 clinical trials, with interim data from initial dose escalation cohorts expected in the latter part of 2024.
According to Dr. Emil Kuriakose, Chief Medical Officer at Terns, "CML is a serious form of leukemia that requires long-term treatment. Allosteric TKIs represent a new class of inhibitors known for their high selectivity and significant improvements in clinical efficacy, safety, and tolerability compared to traditional active-site TKIs. The FDA's Orphan Drug Designation for TERN-701 reflects recognition of the unmet needs of individuals living with CML and Terns' commitment to developing innovative treatment options."
The FDA grants Orphan Drug Designation to investigational treatments targeting rare medical conditions affecting fewer than 200,000 individuals in the United States. This designation provides several benefits to drug developers, including support in the drug development process, tax credits for clinical expenses, exemptions from certain FDA fees, and seven years of market exclusivity following approval.
Source: globenewswire.com
