October 10, 2024 — Coherent Biopharma (“Coherent”) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to CBP-1008 for Injection (CBP-1008) for the treatment of platinum-resistant ovarian clear cell carcinoma (OCCC).
Dr. Robert Huang, Founder and CEO of Coherent, said:
“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.”
About Fast Track Designation
Fast Track Designation is designed to facilitate the development and expedite the review of drugs to that treat serious conditions and fulfill an unmet medical need, enabling these treatments to reach patients earlier. Clinical programs with Fast Track designation can benefit from early and frequent communication with the FDA throughout the regulatory review process. These clinical programs 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) (a Oncochannel), both broadly expressed in many cancers. In phase I&II clinical trials, CBP-1008 has demonstrated very encouraging efficacy and favorable safety profile in ovarian cancer (OC) patients
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. In particular, no significant ocular disorders and peripheral neuropathy, often associated with ADCs with MMAE payload were observed. CBP-1008 has also shown remarkable efficacy in patients with platinum-resistant OCCC. 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 addition, CBP-1008 has demonstrated excellent efficacy in PROC with prior 1-3L of treatments at the RP3D of 0.15 mg/kg. In the target population with high-grade serous ovarian cancer (HGSOC), the ORR and DCR reached 50.0% and 85.7%, respectively.
About OCCC
OC 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. The successful development of CBP-1008 is expected to offer a breakthrough therapeutic option for patients with platinum-resistant OCCC, addressing a critical need for more effective treatments in this area.
Coherent will accelerate the clinical development of CBP-1008to bring this innovative drug to market as soon as possible, and further expanding its indications to benefit more OC patients.
About Coherent Biopharma
Coherent Biopharma is a clinical-stage biotechnology company developing bispecific-targeting ligand drug conjugates (Bi-XDC). CBP-1008, the leading asset targeting patients with low to high Folate Receptor alpha has demonstrated impressive efficacy and safety profile with over 350 patients treated. CBP-1018, targeting PSMA has also shown a superior profile in Phase II studies with over 150 patients treated, with 7 months of mPFS for 3rd line mCRPC patients. Finally, its next-gen drug, CBP-1019 has shown incredible safety and efficacy advantages compared to ADCs with TOPI inhibitors. In addition, PROTACs and Radio Pharm Therapy (RPT) are among the company’s early pipelines.