Coherent Biopharma Ltd, a Suzhou-based specialist in bispecific-ligand drug conjugates (Bi-XDC), announced that the U.S. Food and Drug Administration (FDA) has granted fast track designation to its lead candidate, CBP-1019, for the treatment of recurrent endometrial cancer in patients who have received prior platinum-based chemotherapy.
FDA Designation and Drug Profile
The fast track status reflects the unmet need for new therapies in advanced endometrial cancer. CBP-1019, developed via Coherent Bio’s proprietary Bi-XDC platform, targets FRα and TRPV6 receptors and delivers monomethyl auristatin E (MMAE) as a cytotoxic payload. The drug is designed to enhance tumor specificity while minimizing off-target effects.
Phase I/II Study Results
In a Phase I/II trial involving 61 patients with advanced solid tumors, CBP-1019 demonstrated favorable safety and tolerability, with no reports of interstitial lung disease, stomatitis, or ocular toxicity. Among 10 patients with advanced/metastatic endometrial cancer, the drug achieved an objective response rate (ORR) of 42.9% and a disease control rate (DCR) of 100% in nine evaluable patients. Median duration of response (DoR) and progression-free survival (PFS) data remain immature, as all patients continue treatment.
Therapeutic Potential
The ongoing study suggests CBP-1019 could address a critical gap in endometrial cancer treatment, particularly for patients who have progressed on standard therapies. The FDA’s fast track designation may accelerate the drug’s development and regulatory review process.-Fineline Info & Tech
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