SAN FRANCISCO/SUZHOU, China, July 18, 2025 — Coherent Biopharma (“Coherent”) announced that the China Center for Drug Evaluation (CDE) has approved the initiation of a Phase III clinical trial for CBP-1008 (Ricorfotide Vedotin , Rico-V) , a small-molecule drug conjugate targeting Folate receptor alpha (FRα) and TRPV6 receptor with MMAE as payload, developed on Coherent's proprietary Bi-XDC technology platform.
Coherent will soon initiate a multicenter, open-labeled, and randomized pivotal phase III clinical study to evaluate the efficacy and safety of Rico-V in patients with epithelial platinum-resistant ovarian cancer (PROC) who have previously received 1-3 lines of systemic anti-tumor treatment.
Rico-V has shown encouraging efficacy as well as favorable safety and tolerability profile in Phase I and Phase II trials enrolled more than 300 patients with malignant solid tumors, including 227 OC patients. In particular, in patients with high-grade serous adenocarcinoma (HGSOC) and clear cell ovarian cancer (OCCC), Rico-V has demonstrated remarkable efficacy for all comers regardless of FRα and TRPV6 expression levels. The objective response rate (ORR), disease control rate (DCR), and especially the overall survival (OS), were substantially better than the historical data of standard PROC treatments. On the safety side, most adverse events (AEs) were mild to moderate, with no ocular toxicity and very minor peripheral neuropathy commonly observed in antibody-drug conjugates (ADCs) with monomethyl auristatin E (MMAE) as the payload.
In addition, with a M.W. of only 3.4 KDa and about 1/50 the size of a typical ADC, Rico-V can be fully chemically synthesized with simple the manufacturing process at a fraction of the cost.
Professor Lingying Wu, Department of Gynecologic
Oncology, Cancer Hospital, Chinese Academy of Medical Sciences, the principal
investigator of Rico-V Phase III clinical trial commented:
As the world's first Bi-XDC drug, Rico-V has shown very favorable safety and
anti-tumor efficacy in platinum-resistant patients previously received 1-3
lines of treatments in the Phase Ib/II clinical study of gynecological tumors
led by us. Moreover, Rico-V is not limited by the folate receptor expression
level and has the potential providing a new treatment option for a wide patient
population with PROC. We look forward to launching the Rico-V Phase III
clinical study soon to bring the benefit of Rico-V to more patients.
Dr. Robert Huang, Founder and CEO of Coherent:
There is still a large unmet medical need in the treatment of
platinum-resistant ovarian cancer. Rico-V's previous clinical data have shown
great therapeutic potential. The CDE's approval for a Phase III clinical trial
is an important milestone in Rico-V's clinical development. It also gives us
great confidence in continuing to pursue more therapeutic indications with our pipeline
products developed on Bi-XDC platform.
About Platinum Resistant Ovarian Cancer (PROC):
Platinum resistant ovarian cancer is a type of ovarian cancer that recurs or progresses within 6 months of completing platinum-based chemotherapy. It is a significant clinical challenge due to limited treatment options and poor prognosis. PROC patients have limited treatment options typically with a median overall survival of 12-15 months. The response rate to chemotherapy in this setting is low, generally 10-15%. Current standard treatment often involves non-platinum chemotherapy, sometimes combined with targeted therapies like bevacizumab. Although multiple FRα ADCs are under development, Elahere is the only approved one for PROC patients with FRα expression level greater than 75%.
About CBP-1008 (Rico-V):
CBP-1008 is the world's first dual-ligand drug conjugate developed based on Coherent's proprietary Bi-XDC technology platform, targeting FRα and TRPV6 receptors expressed on tumor cell membranes. In clinical Phase I/II studies, CBP-1008 showed encouraging efficacy, as well as favorable safety and tolerability. The anticancer efficacy has been verified in patients with platinum-resistant ovarian cancer (PROC), and the Phase III recommended dose (RP3D) has been determined based on safety, pharmacokinetics (PK) and efficacy data. The signals of antitumor activities of CBP-1008 were also observed in patients with advanced solid tumors such as Breast Cancer (BC) and Endometrial Cancer (EC).
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 I/II studies with 120 patients treated, with 8.5 months of median rPFS for all mCRPC patients. Moreover, its next-gen drug, CBP-1019 has shown incredible safety and efficacy advantages compared to ADCs with TOPI inhibitors. Superior efficacy was obtained in advanced/metastatic EC patients irrespective of receptor expression level. In addition, cellular targeted PROTACs and Radiopharmaceutical Therapy (RPT) are among the company’s early pipelines.
