FDA Grants Fast Track Designation to Coherent Biopharma's CBP-1019 for Recurrent Endometrial Cancer

The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to Coherent Biopharma's CBP-1019 for the treatment of recurrent endometrial cancer (EC) after at least one line of platinum-based systemic therapy. This development marks a significant milestone in addressing the unmet medical needs of patients with advanced or metastatic EC.

Breakthrough in Endometrial Cancer Treatment

CBP-1019, a Bi-specific ligand drug conjugate developed using Coherent's proprietary Bi-XDC technology platform, targets Folate Receptor (FRα) and Transient Receptor Potential Vanilloid Subfamily Member 6 receptor (TRPV6). The drug carries DX-8951 derivative, a topoisomerase I inhibitor (TOPOi) as payload, and has shown promising results in early Phase I/II trials for advanced solid malignancies, including recurrent endometrial, colorectal, and pancreatic cancers.

Dr. Robert Huang, Founder and CEO of Coherent, commented on the FDA's decision: "This represents the second FTD granted to Coherent Biopharma, following the designation of CBP-1008 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."

Clinical Trial Results and Safety Profile

The CBP-1019-101 study, a global, multicenter, open-label Phase I/II clinical trial conducted in the U.S. and China, has demonstrated encouraging results. 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.

Key findings from the trial include:

• 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).
• At the 3.0 mg/kg dose level (potential recommended Phase II dose), 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, with all patients remaining on treatment as of the data cutoff date.

Addressing an Unmet Medical Need

Endometrial cancer is a serious gynecological malignancy with limited treatment options for advanced-stage patients. Approximately 15% of EC patients are diagnosed at an advanced stage, resulting in a 5-year survival rate of only 17%. The development of CBP-1019 offers a potential breakthrough therapeutic option for these patients.

The FDA's Fast Track Designation for CBP-1019 is expected to facilitate the development and expedite the review of this promising treatment, potentially allowing it to reach patients earlier. Coherent Biopharma remains committed to advancing the clinical development of CBP-1019 and delivering more effective treatment options for patients with advanced/metastatic EC on a global scale.