Celltrion submits IND for CT-P70 to the U.S. FDA
Accelerating global clinical development of next-generation anticancer drugs
Celltrion announced on the 3rd that it has submitted an Investigational New Drug application (IND) to the U.S. Food and Drug Administration (FDA) to initiate a global Phase 1 clinical trial for its antibody-drug conjugate (ADC) anticancer drug candidate, 'CT-P70.'
Celltrion plans to accelerate next-generation drug development starting with the CT-P70 IND application. The company aims to submit a total of four INDs this year, including three ADC drug candidates and one multi-antibody drug candidate.
CT-P70 is an ADC anticancer therapeutic under development targeting various solid tumors such as non-small cell lung cancer, colorectal cancer, and gastric cancer. It targets 'cMET (cellular growth factor receptor),' which is activated in cancer cells and promotes tumor growth. Celltrion plans to commence the global Phase 1 clinical trial with the first patient dosing targeted for mid-year.
CT-P70 has previously demonstrated excellent tumor suppression effects in multiple solid tumor models, including lung, colorectal, and gastric cancers, through preclinical studies such as in vitro and animal experiments. Compared to competitor cMET-targeting ADCs, CT-P70 has shown superior efficacy even in tumors with low cMET expression, suggesting potential effectiveness across a broad patient population.
Additionally, CT-P70 has reportedly confirmed a higher Therapeutic Index, which comprehensively evaluates efficacy and safety, surpassing competing pipelines currently in clinical development.
Celltrion applied a newly co-developed payload, 'PBX-7016,' through open innovation to CT-P70. PBX-7016 is a platform technology that secures superior efficacy and safety compared to existing technologies. It is expected to have advantages such as excellent tumor penetration due to its low toxicity and high dosing capability.
Starting with CT-P70, Celltrion plans to submit a total of four INDs this year for CT-P71, CT-P72, and CT-P73, sequentially entering clinical development stages for its next-generation drug pipeline. Following this, development is planned for a total of 13 new drug candidates, including two ADC drugs and two multi-antibody drugs in 2026, three ADC drugs in 2027, and one ADC drug and one multi-antibody drug in 2028.
A Celltrion representative stated, "Shortly after presenting our vision to become a global new drug development company at last month’s JPM Conference in the U.S., we swiftly submitted our first global clinical IND, accelerating the expansion of our new drug portfolio. We will continue to develop innovative therapeutics to provide new treatment benefits to patients and strive to establish ourselves as a global new drug company."
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