Accelerating as a New Drug Developer
Follow-up IND Applications Also Underway
Celltrion announced on the 5th that it has obtained approval from the U.S. Food and Drug Administration (FDA) for the Investigational New Drug (IND) application to proceed with Phase 1 clinical trials of its antibody-drug conjugate (ADC)-based anticancer drug candidate, 'CT-P70.'
CT-P70 is an ADC anticancer drug candidate targeting 'cMET (cellular growth factor receptor),' which is activated in cancer cells and promotes tumor growth. It is being developed for patients with solid tumors such as non-small cell lung cancer, colorectal cancer, and gastroesophageal cancer.
Celltrion plans to begin patient dosing within this year. In the global Phase 1 clinical trial, the safety and maximum tolerated dose (MTD) will be confirmed through stepwise dose escalation in cancer patients, and pharmacokinetics, immunogenicity, and preliminary efficacy will be comprehensively evaluated.
In preclinical studies including in vitro and animal experiments, CT-P70 demonstrated excellent tumor suppression effects in multiple solid tumor models, including lung cancer, colorectal cancer, and gastric cancer. Additionally, it showed a higher therapeutic index compared to competing pipelines currently in clinical trials.
Based on its therapeutic efficacy and safety, Celltrion believes CT-P70 will enable treatment of a broad patient population in the future and plans to accelerate its development as a best-in-class drug with the most outstanding competitiveness among therapies with the same mechanism of action.
CT-P70 incorporates a new payload drug, 'PBX-7016,' co-developed through open innovation. PBX-7016 is a platform technology that ensures superior safety compared to existing technologies and is expected to enhance tumor penetration effects through low toxicity and high dosing capacity.
A Celltrion representative stated, "Having confirmed the therapeutic efficacy and safety of CT-P70 in preclinical studies, we will focus our development capabilities on the remaining global clinical procedures to rapidly secure the next-generation anticancer drug. Starting with this IND approval, we will proceed swiftly with subsequent INDs within the year to demonstrate our drug development capabilities and lay the foundation for becoming a global new drug company."
Meanwhile, starting with the IND approval for CT-P70, Celltrion plans to sequentially submit a total of four INDs this year, including CT-P71, CT-P72, and CT-P73, to actively advance clinical trials for its next-generation drug pipeline. The company aims to develop 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.
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