Suzhou, China, February 21, 2025 — Coherent Biopharma (“Coherent”) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to CBP-1019 for Injection (CBP-1019) for the treatment of recurrent endometrial cancer (EC) after at least one line of platinum-based systemic therapy.
Dr. Robert Huang, Founder and CEO of Coherent, commented:
“This represents the second FTD granted to Coherent Biopharma, following the designation of CBP-1008, another drug derived from Coherent’s proprietary Bi-XDC technology platform, in October 2024 for the treatment of platinum-resistant ovarian clear cell carcinoma. This further underscores the platform's therapeutic potential and highlights the company’s robust innovation capabilities in drug development and offering new therapeutic options for patients with advanced/metastatic EC worldwide.”
About Fast Track Designation
Fast Track Designation is granted to facilitate the development and expedite the review of drugs to that treat serious conditions and fulfill unmet medical needs, enabling these treatments to reach patients earlier. Clinical programs with Fast Track designation can benefit from early and frequent communication with the FDA throughout the regulatory review process. These clinical programs may also be eligible to apply for Accelerated Approval and Priority Review if relevant criteria are met.
About CBP-1019
CBP-1019 is a Bi-specific ligand drug conjugate developed using Coherent’s proprietary Bi-XDC technology platform. The drug targets Folate Receptor (FRα) and Transient Receptor Potential Vanilloid Subfamily Member 6 receptor (TRPV6) (an Oncochannel), both broadly, and often highly expressed in many cancers including gynecological and GI cancers. The drug carries DX-8951 derivative, a topoisomerase I inhibitor (TOPOi) as payload. Promising early Phase I/II results of CBP-1019 demonstrate its therapeutic potential in addressing advanced solid malignancies, including recurrent endometrial, colorectal and pancreatic cancers.
The CBP-1019-101 study is a global, multicenter, open-label Phase I/II clinical trial (conducted in the U.S. and China) designed to evaluate the safety, tolerability, and preliminary efficacy of CBP-1019 in patients with advanced solid tumors. As of October 31, 2024, 61 patients with advanced solid tumors were enrolled and treated with CBP-1019 at various dose levels, administered intravenously every two weeks (Q2W) in 4-week cycles. CBP-1019 demonstrated a favorable safety and tolerability profile, with no observed cases of interstitial lung disease (ILD), stomatitis, or ocular toxicity—typical adverse events associated with TOPOIi-based antibody-drug conjugates (ADCs).
Among the 10 advanced/metastatic EC patients enrolled, all had received at least one prior line of platinum-based systemic chemotherapy and presented with visceral metastases. The study results showed that CBP-1019 exhibited superior efficacy regardless of FRα/TRPV6 expression status. At the 3.0 mg/kg dose level (potential recommended Phase II dose, RP2D), 7 out of 9 evaluable advanced/metastatic EC patients achieved an objective response rate (ORR) of 42.9% and a disease control rate (DCR) of 100%. Median duration of response (DoR) and progression-free survival (PFS) were not yet reached, and all patients remained on treatment as of the data cutoff date.
About advanced/metastatic EC
Endometrial cancer is a serious gynecological malignancy threatening women’s health, with approximately 15% of patients who are in the advanced stage of the disease. Limited treatment options and poor prognosis result in a 5-year survival rate of only 17%, highlighting a significant unmet medical need. The development of CBP-1019 offers a breakthrough therapeutic option for these patients.
The FDA’s Fast Track Designation for CBP-1019 represents a major milestone in addressing unmet medical needs and providing new therapeutic options for patients with advanced/metastatic EC on a global scale. Coherent is committed to advancing the clinical development of CBP-1019 and delivering more effective treatment options for patients.
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. Finally, 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.
