Cothera Bioscience has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its clinical program PC-002 for the treatment of relapsed or refractory Burkitt Lymphoma. PC-002 is a first-in-class deubiquitinase (DUB) inhibitor designed to induce Myc degradation and inhibit survivin at clinically relevant concentrations.
The Fast Track program is intended to accelerate the development and review of drugs that treat serious conditions and address unmet medical needs. This designation will allow Cothera Bioscience to have more frequent interactions with the FDA, potentially speeding up the path to approval for PC-002.
Mechanism of Action
PC-002 is Cothera Bioscience’s lead candidate targeting Myc-driven cancers. As a small molecule inhibitor of the DUB family enzymes, PC-002 works by inducing Myc degradation. Myc is a key protein involved in cell growth and proliferation, and its dysregulation is implicated in various cancers, including Burkitt Lymphoma.
Management Commentary
"This Fast Track designation is a significant milestone for Cothera Bioscience and reflects the potential of PC-002 targeting Myc driven cancers," said Alex Wu, Ph.D., CEO of Cothera Bioscience. Vernon Jiang, Ph.D., Executive Vice President of Cothera Bioscience, added, "The FDA's Fast Track designation underscores the urgent need for new treatments in this therapeutic area."
Hagop Youssoufian, M.D., Head of Medical Science at Cothera Bioscience, noted, "The designation accelerates our efforts to deliver a potentially groundbreaking therapy to patients suffering from one of the most aggressive forms of hematologic malignancies."
Upcoming Data Presentation
Cothera Bioscience will present updated Phase 2 clinical results from the clinical trial PC002-01 at the 2024 American Society of Hematology (ASH) annual meeting in San Diego, CA. The presentation, titled "Study of PC-002 (Sepantronium Bromide), a First-in-Class Inhibitor of Deubiquitinases (DUBs) Targeting Myc Degradation in Relapsed/Refractory c-Myc Rearranged High-Grade B Cell Lymphoma (HGBCL): Updated Phase 2 Results," will be part of Session 627: Aggressive Lymphomas: Pharmacologic Therapies, Poster II.
The presentation is scheduled for Sunday, December 8, 2024, from 6:00 PM to 8:00 PM at the San Diego Convention Center, Halls G-H. The publication number is 3120.
