FDA Grants Fast Track Designation to Cothera Bioscience’s PC-002

On October 23th the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Cothera Bioscience’s clinical program PC-002

Cothera Bioscience, a pioneering biotech company focused on developing clinical-stage therapeutics for challenging oncology targets, has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its lead candidate, PC-002. The designation will allow Cothera Bioscience to engage in more frequent interactions with the FDA, ensuring that the PC-002 program remains on track toward potential approval.

“This Fast Track designation is a significant milestone for Cothera Bioscience and reflects   the potential of PC-002 targeting Myc driven cancers. We are committed to advancing innovative treatments that can make a difference in patients’ lives.” – said Alex Wu, Ph.D., CEO of Cothera Bioscience

PC-002 is particularly aimed at treating Myc-driven cancers, including relapsed or refractory Burkitt Lymphoma, a condition with limited treatment options and significant unmet medical needs. The Fast Track designation underscores the potential of PC-002 to provide a new therapeutic avenue for patients suffering from this aggressive form of lymphoma. This first-in-class small molecule inhibitor targets deubiquitinase (DUB) enzymes, specifically inducing degradation of the Myc protein and inhibiting survivin at clinically relevant concentrations.

Fast Track Designation and Its Benefits for Drug Development

The Fast Track designation is a program established by the U.S. Food and Drug Administration (FDA) to facilitate the development and expedite the review of drugs intended to treat serious conditions and fill unmet medical needs.

A drug that receives Fast Track designation from the U.S. Food and Drug Administration (FDA) is eligible for several significant advantages aimed at expediting its development and review process. These benefits include:

– Increased Interaction with the FDA: Companies can have more frequent meetings with the FDA to discuss the drug’s development plan, ensuring that appropriate data is collected to support drug approval.

– Enhanced Written Communication: The FDA provides more frequent written communication regarding the design of proposed clinical trials and the use of biomarkers, helping to clarify expectations and requirements.

– Eligibility for Accelerated Approval and Priority Review: If relevant criteria are met, drugs with Fast Track designation may qualify for Accelerated Approval and Priority Review, which can significantly shorten the time to market.

– Rolling Review: This allows drug companies to submit completed sections of their Biologics License Application (BLA) or New Drug Application (NDA) for review by the FDA as they become available, rather than waiting until the entire application is completed. This can lead to a more efficient review process.

These advantages are particularly beneficial for drugs targeting serious conditions with high unmet medical needs, facilitating a faster path to approval and ultimately improving patient access to potentially life-saving therapies.

Cothera Bioscience

Cothera Bioscience is a clinical-stage biotech company focused on developing therapeutics for previously undruggable oncology targets that address high unmet medical needs. Leveraging a clinically validated translational platform, the company exploits synthetic lethality and protein degradation pathways to develop innovative cancer treatments.

“The designation accelerates our efforts to deliver a potentially groundbreaking therapy to patients suffering from one of the most aggressive forms of hematologic malignancies. 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.” –  Hagop Youssoufian, M.D., Head of Medical Science at Cothera Bioscience and Adjunct Professor of Medicine at Brown University.

Founded by key members from Crown Bioscience, a leading contract research organization in translational oncology, Cothera combines extensive expertise with entrepreneurial leadership from Silicon Valley.

Leadership Team

Alex Wu, Ph.D./MBA: Chairman & CEO
Yiyou Chen, Ph.D.: Scientific Founder
Vernon Jiang, Ph.D.: Executive Vice President
Felix Lin: Head, Greater China

Cothera Bioscience’s commitment to addressing high unmet medical needs through innovative therapies positions it as a leader in the oncology field, with PC-002 representing a significant step forward in cancer treatment strategies. The company looks forward to advancing this promising candidate through clinical development and ultimately improving outcomes for patients with Myc-driven malignancies.

“The FDA’s Fast Track designation underscores the urgent need for new treatments in this therapeutic area. We are excited to work closely with the FDA to bring PC-002 to patients as swiftly as possible.” – Vernon Jiang, Ph.D., Executive Vice President of Cothera Bioscience.

Hagop Youssoufian:

“Happy to share the news that the FDA granted Fast Track Designation for SepB, a small molecule degrader of MYC and inhibitor of survivin. The designation underscores the unmet need in Burkitt Lymphoma, a highly aggressive and lethal form of non-Hodgkin lymphoma. This is a meaningful achievement for Cothera Bioscience in its mission to serve cancer patients.”