Celltrion has taken its first step as a new drug developer.
Celltrion announced on the 5th that it has received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) to initiate a Phase 1 clinical trial for CT-P70, an antibody-drug conjugate (ADC)-based oncology candidate.
CT-P70 is an ADC designed to target cMET (cellular growth factor receptor), which is activated in cancer cells and promotes tumor growth. In preclinical studies, including in vitro and animal models, CT-P70 demonstrated tumor-suppressing effects across multiple solid tumor models, including lung, colorectal, and gastric cancers. The therapy is currently being developed for non-small cell lung cancer, colorectal cancer, and gastroesophageal cancer patients.
CT-P70 incorporates PBX-7016, a novel payload co-developed through open innovation. PBX-7016 is expected to enhance tumor penetration by allowing for higher dosing with reduced toxicity.
Celltrion previously announced at the J.P. Morgan Healthcare Conference in January that it would accelerate next-generation drug development. At the time, the company revealed plans to sequentially initiate clinical trials for four novel drug candidates in 2024 and submit a total of 13 IND applications by 2028. Additionally, it aims to commercialize its first novel drug by 2029 and generate 40% of its revenue from innovative drugs by 2030. With IND clearance for CT-P70, Celltrion has successfully cleared the first regulatory hurdle in its new drug development process.
This year, Celltrion plans to evaluate CT-P70’s safety profile, maximum tolerated dose (MTD), pharmacokinetics, immunogenicity, and preliminary efficacy in global Phase 1 clinical trials involving cancer patients.
The company believes CT-P70 has the potential to be widely applicable based on its efficacy and safety profile. It aims to develop the therapy as a best-in-class (BIC) ADC, accelerating the development process to maximize its competitive edge.
Starting with CT-P70, Celltrion plans to sequentially submit IND applications for CT-P71, CT-P72, and CT-P73 this year, marking the full-scale initiation of its next-generation drug pipeline. By 2026, Celltrion aims to develop two ADC therapies and two multi-specific antibodies, followed by three ADC therapies in 2027 and one ADC therapy along with one multi-specific antibody in 2028, totaling 13 novel drug candidates.
A Celltrion representative stated, “Since we have confirmed the therapeutic potential and safety of CT-P70 in preclinical studies, we will now focus our R&D capabilities on expediting the remaining global clinical trials. We will also push forward with additional IND applications within this year to solidify our expertise in new drug development and establish ourselves as a global biopharmaceutical innovator.”
