FDA Fast Tracks Coherent Biopharma's CBP-101

In a recent development, Coherent Biopharma announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to its investigational drug, CBP-1019, intended for the treatment of recurrent endometrial cancer (EC) following at least one line of platinum-based systemic therapy. This marks a significant achievement for the company, as it is the second such designation they have received. The first was for CBP-1008, targeted at platinum-resistant ovarian clear cell carcinoma, highlighting Coherent’s innovative capabilities in developing therapeutic solutions for advanced conditions.

Fast Track Designation is designed to accelerate the development and review process of drugs aimed at serious conditions with unmet medical needs, thereby speeding up their availability to patients. This designation allows for earlier and more frequent communication between the FDA and the drug developers, which can facilitate smoother regulatory processes. Additionally, drugs under this designation may qualify for Accelerated Approval and Priority Review, contingent on meeting certain criteria.

CBP-1019 is a unique drug developed using Coherent’s proprietary Bi-XDC technology platform. It is a bi-specific ligand drug conjugate that targets two receptors: the Folate Receptor (FRα) and the Transient Receptor Potential Vanilloid Subfamily Member 6 receptor (TRPV6), known as an Oncochannel. These receptors are widely and often highly expressed in various cancers, including those of a gynecological and gastrointestinal nature. The drug carries a payload of DX-8951 derivative, a topoisomerase I inhibitor. Early Phase I/II trials have shown its potential in treating advanced solid malignancies, including recurrent endometrial, colorectal, and pancreatic cancers.

The CBP-1019-101 study is a global Phase I/II clinical trial conducted across several centers in the U.S. and China. It is designed to assess the safety, tolerability, and preliminary efficacy of CBP-1019 in patients with advanced solid tumors. By October 31, 2024, a total of 61 patients had been enrolled and treated with CBP-1019 at different dose levels. The drug displayed a favorable safety profile, with no cases of interstitial lung disease, stomatitis, or ocular toxicity, which are common adverse events linked with TOPOi-based antibody-drug conjugates.

Among the participants, ten advanced/metastatic EC patients had undergone previous platinum-based chemotherapy and showed visceral metastases. The study demonstrated that CBP-1019 was effective irrespective of the patients' FRα/TRPV6 expression status. Particularly, at a dosage of 3.0 mg/kg, which is the potential recommended Phase II dose, 7 out of 9 evaluable patients experienced an objective response rate of 42.9% and a disease control rate of 100%. As of the data cutoff date, the median duration of response and progression-free survival had not been reached, and all patients were still receiving treatment.

Endometrial cancer, a serious health threat for women, has limited treatment options and a poor prognosis, particularly in advanced stages, where the 5-year survival rate drops to just 17%. The introduction of CBP-1019 promises a groundbreaking therapeutic option for these patients. The FDA’s Fast Track Designation for this drug is a pivotal step in addressing this critical medical need and providing new treatment options worldwide.

Coherent Biopharma, a clinical-stage biotechnology company, focuses on developing bispecific-targeting ligand drug conjugates. Their leading assets, including CBP-1008 and CBP-1018, have shown promising results in clinical trials. With CBP-1019, Coherent aims to deliver more effective treatments for patients with advanced/metastatic EC, underscoring their commitment to advancing therapeutic innovations.