FDA Grants Fast Track to Coherent Biopharma's CBP-1019

Coherent Biopharma, a company based in Suzhou, China, has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to its drug candidate CBP-1019 for Injection. This designation is specifically for the treatment of recurrent endometrial cancer (EC) in patients who have previously undergone at least one line of platinum-based systemic therapy. The CEO of Coherent, Dr. Robert Huang, expressed that this is the second instance where Coherent has received such a designation, following the FTD of CBP-1008 for treating platinum-resistant ovarian clear cell carcinoma in 2024.

The Fast Track Designation is an FDA program designed to facilitate the development and expedite the review of drugs aimed at serious conditions that meet significant unmet medical needs. This program allows for more frequent communication between the company and the FDA, potentially accelerating the drug’s availability to patients. Additionally, this designation can lead to eligibility for Accelerated Approval and Priority Review if certain criteria are fulfilled.

CBP-1019 is a bispecific ligand drug conjugate created through Coherent’s proprietary Bi-XDC technology platform. It targets both the Folate Receptor (FRα) and Transient Receptor Potential Vanilloid Subfamily Member 6 receptor (TRPV6), which are frequently overexpressed in various cancers, including gynecological and gastrointestinal malignancies. The drug utilizes a DX-8951 derivative, a topoisomerase I inhibitor, as its active component. Phase I/II trials have shown promising results, indicating CBP-1019’s potential effectiveness in treating advanced solid tumors, such as recurrent endometrial, colorectal, and pancreatic cancers.

The CBP-1019-101 study is an ongoing global, multicenter, open-label Phase I/II clinical trial conducted in the U.S. and China. It aims to assess the safety, tolerability, and preliminary efficacy of CBP-1019 in patients with advanced solid tumors. As of October 31, 2024, the study had enrolled 61 patients who received the drug intravenously every two weeks in 4-week cycles. CBP-1019 has demonstrated a favorable safety profile, with no significant adverse events such as interstitial lung disease, stomatitis, or ocular toxicity, which are commonly associated with topoisomerase I inhibitor-based antibody-drug conjugates.

In the subset of 10 patients with advanced or metastatic endometrial cancer, all of whom had previously undergone at least one line of platinum-based chemotherapy, the drug showed impressive results. At a dose of 3.0 mg/kg, 7 out of the 9 evaluable patients achieved an objective response rate of 42.9%, with a disease control rate of 100%. The study has not yet determined the median duration of response or progression-free survival, as all patients were still receiving treatment at the last data cutoff.

Endometrial cancer represents a significant health concern for women, with a 5-year survival rate of only 17% for those with advanced stages of the disease. The Limited treatment options and poor prognosis emphasize the urgent need for new therapies. The FDA’s Fast Track Designation for CBP-1019 is a crucial milestone in addressing these unmet needs on a global scale. Coherent Biopharma is dedicated to advancing the clinical development of CBP-1019 and aims to deliver more effective treatment options for patients facing this challenging condition.

Coherent Biopharma is a clinical-stage biotechnology company focused on developing bispecific-targeting ligand drug conjugates. Its other notable projects include CBP-1008 and CBP-1018, which have shown efficacy in treating various cancer types. The company is also exploring advanced technologies like cellular targeted PROTACs and Radiopharmaceutical Therapy as part of its early-stage research pipeline.