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
pro over 350 patients treated. CBP-1018, targeting PSMA has also shown
a superior pro 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.
