● The preliminary clinical results showed that CBP-1008 has manageable safety profile. Evident antitumor activity was observed in patients with high FRα or TRPV6 receptor expression, especially in platinum-resistant OC cohort
● CB-1008’s safety and efficacy are proved to be encouraging in Phase Ib dose expansion study
● The company plans to initiate pivotal phase II study in 2022 H2
2022 American Society of Clinical Oncology (ASCO) annual meeting was held in Chicago from 3rd to 7th June local time. It provides a forum to explore and discuss the important issues and ongoing controversies in cancer care across a variety of disease sites, treatment approaches, and disciplines. The theme for this year’s meeting “Advancing Equitable Cancer Care Through Innovation” signifies the need to discover novel solutions that fundamentally improve the lives of all those struck by cancer, leading toward a future of equity in cancer care.
CBP-1008, a first-in-class bi-specific ligand drug conjugate targeting FRα and TRPV6, was selected as abstract oral presentation at ASCO 2022. The leading principal investigator of CBP-1008 clinical trial is Professor Shen Lin from Peking University Cancer Hospital.
Video of MD Lingying Wu’s oral presentaion on 2022 ASCO
Lingying Wu, MD from Cancer Hospital Chinese Academy of Medical Sciences, one of the CBP-1008 investigators, gave the oral presentation at ASCO 2022 titled “A Phase Ia/Ib Study of CBP-1008, a Bi-specific Ligand Drug Conjugate, in Patients with Advanced Solid Tumors” on 7th June, with preliminary CBP-1008 clinical data.
As clinical data shown, in Phase Ia dose escalation study（from 0.015 mg/kg to 0.18 mg/kg）, DLTs were observed in 3 patients （0.12, 0.15, 0.18 mg/kg respectively）,and currently MTD has not yet reached. Majority of adverse events were mild to moderate （few ≥3 grade）, AEs such as fever are 1-2 grades, which are predictable, manageable, and preventable. Grade 3 or higher TEAEs are neutropenia and decreased white blood cell count which are related to the cytotoxic payload MMAE, normally occurs as dose increasing.
By the cut-off date on 28th Feb, 2022, phase 1b clinical study data are shown as follows：
●Among 139 enrolled patients, 104 were efficacy-evaluable patients.91 patients were treated with ≥ 0.15 mg/kg dose levels, and 49 of them were Platinum-Resistant Ovarian Cancer ( PROC）patients.
● Among 49 PROC patients (FRα ≥ 5%, prior therapy regimens ≥ 3), treatment effect was observed with 9 Partial Response (PR) cases, 18.4% ORR and 21 Stable Disease (SD), 61.2% DCR. This result has already exceeded the current therapy for PROC patients
● The PROC patients with ≥ 25% FRα expression and prior therapy regimens ≤ 3, ORR arrived at 40% (4/10 PR)
Dr. Baohua Robert Huang
Coherent Biopharma Founder & CEO
“CBP-1008 is a first-in-class bi-specific ligand drug conjugate targeting FRα and TRPV6 carrying monomethyl auristatin E (MMAE) as payload. It possesses several desired physiochemical characteristics such as small molecular size, unambiguous molecular form and structure, straightforward chemical synthesis with better quality control. Coherent Biopharma focuses on its proprietary bi-targeting XDC technology R&D and commercialization, the bi-targeting XDC technology of CBP has the potential to overcome the undruggability obstacle of a variety of molecules with high bioactivity, thus to Drug the Undruggable, and pioneer a new pathway of drug development. The preliminary results showed that CBP-1008 has well-tolerated and manageable safety profile. Antitumor activity was observed in patients with FRα or TRPV6 receptor expression, especially in platinum-resistant OC cohort. Looking forward to the upcoming phase 2 pivotal study in platinum-resistant OC, we have confidence that CBP-1008 has the potential to be breakthrough therapy for platinum-resistant OC.”