San Francisco, California, October 23, 2024 — Cothera Bioscience, a leading biotech innovator advancing clinical stage therapeutics for previously undruggable oncology targets with high unmet medical needs, is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its clinical program PC-002, a first-in-class deubiquitinase (DUB) inhibitor that induces Myc degradation as well as inhibits survivin at clinically relevant concentrations. This designation is a testament to the program's potential to address significant unmet medical needs in the treatment of relapsed or refractory Burkitt Lymphoma.
"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. "We are committed to advancing innovative treatments that can make a difference in patients' lives."
The Fast Track program is designed to facilitate the development and expedite the review of drugs that treat serious conditions and fill an unmet medical need. PC-002 is Cothera Bioscience’s lead candidate to treat Myc-driven cancers as a first-in-class small molecule inhibitor of the DUB family enzymes inducing Myc degradation. The designation of Fast Track will enable Cothera Bioscience to have more frequent interactions with the FDA, ensuring the program remains on track towards potential approval.
"The FDA's Fast Track designation underscores the urgent need for new treatments in this therapeutic area," added Vernon Jiang, Ph.D., Executive Vice President of Cothera Bioscience. "We are excited to work closely with the FDA to bring PC-002 to patients as swiftly as possible."
"The designation accelerates our efforts to deliver a potentially groundbreaking therapy to patients suffering from one of the most aggressive forms of hematologic malignancies," noted Hagop Youssoufian, M.D., Head of Medical Science at Cothera Bioscience and Adjunct Professor of Medicine at Brown University. "Cothera will present the latest clinical results from the clinical trial PC002-01 at the 2024 American Society of Hematology annual meeting at San Diego, CA. We look forward to sharing our clinical data and will advance PC-002 through the clinical development process to provide hope to those affected by Burkitt Lymphoma as well as other Myc driven cancers.”
Cothera’s ASH presentation title is “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”
The presentation can be found
in Session 627: Aggressive Lymphomas: Pharmacologic
Therapies. Poster II
Session Date: Sunday, December 8, 2024
Presentation Time: 6:00 PM - 8:00 PM
Location: San Diego Convention Center, Halls G-H
Publication Number: 3120
For further information, please visit https://cotherabio.com/ or email to: bd@cotherabio.com.
