CBP Announces FDA IND Approval for CBP-1019 for Clinical Trial

The third Bi-Ligand-Drug conjugate CBP-1019 of Coherent Biopharma was granted the FDA’s clinical implied licenseon January 18, 2023. On the same day, Coherent Biopharma formally submitted IND application to CDE, and simultaneously completed the application both in China and the U.S.

After the approval of the clinical trial, Coherent Biopharma will carry out An Open-Label, Non-randomized, Multinational, Multi-center Phase I/Ⅱ Study Evaluating the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Bi-Ligand-Drug Conjugate CBP-1019 in Patients with Advanced Solid Tumors both in China and the U.S. The main purpose of phase I study is to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of CBP-1019 in patients with advanced tumors. Phase II main research objective: To evaluate the objective response rate (ORR) of CBP-1019 in patients with various advanced tumors. Patients with advanced tumors include advanced lung cancer, advanced pancreatic cancer, advanced gastrointestinal cancer, advanced colorectal cancer and etc.

About CBP-1019

CBP-1019 is a dual-ligand drug conjugate exclusively developed based on biological technology platform BESTTM by Coherent Biopharma. CBP-1019 has shown significant anti-tumor activity and good safety profile in preclinical studies. The preclinical pharmacodynamic evaluation was carried out by subcutaneous transplantation of CBP-1019 double-receptor high expression PDX tumor model in nude mice. In the three PDX tumor models including ovarian cancer, pancreatic cancer and esophageal cancer, they all showed significant tumor inhibition effect and dose correlation, and the animal weight almost did not drop, showing good safety. The results of preclinical studies show that CBP-1019 has been further improved in the improvement of plasma stability, efficiency and safety of drug enrichment, and the therapy window has been continuously widened, which is expected to obtain better clinical performance in a variety of malignant tumors.

Up to now, three dual-ligand conjugated drugs of Coherent Biopharma have been entering into clinical stage. In the near future, more drugs with different targets and payloads in pipeline will be accelerated, and the active exploration of more combo drugs is another key strategy.