Coherent Biopharma Ltd, a specialist in bispecific-ligand drug conjugates (Bi-XDCs) with operations in Suzhou, China, has been granted fast-track status by the US Food and Drug Administration (FDA) for its investigational drug CBP-1008. This drug is indicated for the treatment of platinum-resistant ovarian clear cell carcinoma (OCCC), a particularly aggressive form of ovarian cancer that accounts for approximately 10% of epithelial ovarian cancer cases.
CBP-1008, which targets the FR α and TRPV6 receptors overexpressed on tumor cell membranes, is a first-of-its-kind Bi-XDC product developed on Coherent Bio’s proprietary technology platform. In Phase I/II clinical trials, CBP-1008 has demonstrated promising efficacy and a favorable safety profile. The drug is currently undergoing a Phase I study in patients with solid tumors, including breast cancer and non-small cell lung cancer (NSCLC), in the US and Australia. The FDA’s fast-track designation for CBP-1008 is based on the drug’s potential to address the urgent unmet need for effective treatments in platinum-resistant OCCC, where current treatment options are limited, and survival rates post-recurrence are significantly lower compared to other ovarian cancer subtypes.
As of March 12, 2024, the confirmed objective response rate (ORR) for CBP-1008 reached 31.3%, a substantial improvement over historical data for OCCC (ORR<8%), with a median duration of remission (mDOR) of 7.2 months. These results, along with the drug’s significant efficacy demonstrated in a Phase III study in platinum-resistant ovarian cancer (PROC) patients who had previously received 1-3 lines of treatment at the recommended phase III dose (RP3D), underscore the potential impact of CBP-1008 on improving outcomes for patients with this challenging disease.- Flcube.com