Coherent Biopharma has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to CBP-1008 for Injection for the treatment of platinum-resistant ovarian clear cell carcinoma (OCCC). This designation aims to accelerate the development and review process of this promising therapeutic agent.
Significance of Fast Track Designation
The Fast Track Designation is designed to facilitate the development and expedite the review of drugs that treat serious conditions and fulfill an unmet medical need. This designation allows for early and frequent communication with the FDA throughout the regulatory review process. Clinical programs with Fast Track designation may also be eligible to apply for Accelerated Approval and Priority Review if relevant criteria are met.
About CBP-1008
CBP-1008 is a first-in-class Bi-specific ligand drug conjugate developed using Coherent’s proprietary Bi-XDC technology platform. The drug targets Folate Receptor (FRα) and Transient Receptor Potential Vanilloid Subfamily Member 6 receptor (TRPV6), both broadly expressed in many cancers. In phase I & II clinical trials, CBP-1008 has demonstrated encouraging efficacy and a favorable safety profile in ovarian cancer (OC) patients.
Clinical Trial Data
More than 315 patients with malignant solid tumors have been enrolled in CBP-1008 trials, including 227 OC patients. CBP-1008 was well tolerated, and adverse events were mostly mild to moderate. Notably, no significant ocular disorders and peripheral neuropathy, often associated with ADCs with MMAE payload, were observed. As of March 12, 2024, the confirmed objective response rate (ORR) reached 31.3% and the median duration of response (mDOR) reached 7.2 months in patients with platinum-resistant OCCC. In the target population with high-grade serous ovarian cancer (HGSOC), the ORR and DCR reached 50.0% and 85.7%, respectively.
The Unmet Need in OCCC
Ovarian cancer is a highly life-threatening gynecological malignancy, with a five-year survival rate of less than 30% for advanced-stage patients. OCCC accounts for approximately 10% of epithelial ovarian cancers (EOC) and has unique molecular characteristics with a poorer prognosis. The survival rate for recurrent OCCC patients is significantly lower than that of patients with serous ovarian cancer, and there are no approved drugs specifically for OCCC. This presents significant treatment challenges and an unmet medical need for OCCC patients.
Company Statement
"The FTD granted by the FDA is a strong acknowledgment of our innovation and research achievements. It is not only a milestone for Coherent in advancing novel therapeutics, but could also bring a promising new treatment option for patients with OCCC," said Dr. Robert Huang, Founder and CEO of Coherent Biopharma.
