Coherent Biopharma (CBP) revealed Phase Ia clinical study results of the CBP-1008 in a poster presentation at the 2021 ASCO Annual Meeting. CBP-1008 is a first-in-class bi-specific ligand drug conjugate based on CBP’s proprietary Bi-Engaging ligand-mediated Selective Targeting (BESTTM) platform.
This FIH study (NCT 04740398) was led by renowned experts in the cancer research, Prof. SHEN Lin from Peking University Cancer Hospital and Prof. HU Xichun from Fudan University Cancer Hospital.
Preliminary study results in patients with advanced malignant solid tumors having FRα and/or TRPV6 receptor expression were unveiled in a meeting poster (Poster #3077). This is an open-label, multi-center FIH study to explore safety, tolerability, pharmacokinetics, and antitumor activity of CBP-1008 as a single agent in in subjects with advanced malignant solid tumors. Results in this Phase Ia trial demonstrated that CBP-1008 was safe and well tolerated, and had clear efficacy signal in patients having expression of targeted receptors.
By February 9, 2021 (ASCO data submission period), this study enrolled 18 subjects with advanced malignant solid tumors, and having failed previous cancer standard treatments. Results showed that overall safety and adverse events of CBP-1008 is predictable, controllable, and manageable. No unexpected adverse events were observed in the study and no drug-related mortality occurred. Clear relationship between drug antitumor activities and expressions FRα and/or TRPV6 receptors were seen from the preliminary results.
The most recent data from ongoing Phase Ib study in patients with expressions FRα and/or TRPV6 receptors and failed multiple-line of cancer treatments further demonstrated the antitumor activity of CBP-1008, and significant reduction of target lesions was confirmed.
According to Ms. Annie Teng, Chief Medical Officer (CMO) at Coherent Biopharma, “We are very excited to see the good safety and tolerability, as well as the efficacy signs of CBP-1008 in this study. This efficacy shows the great antitumor potential of CBP-1008 in subjects with expressions of target receptors. With the progress of the study, we expect to see the clinical benefits of CBP-1008 for more patients. CBP is committed to the innovation and breakthrough of tumor treatment. In addition to CBP-1008, we have initiated the phase I clinical study of CBP-1018, and quickly advance clinical development of other pipeline products”