05 Mar 2025: Celltrion receives FDA Phase 1 IND approval for next-generation ADC Drug ‘CT-P70’
Celltrion received FDA approval for an Investigational New Drug (IND) application for its antibody-drug conjugate (ADC) cancer treatment, CT-P70
CT-P70 targets the cMET receptor, which promotes tumor growth, and is being developed for solid tumors such as lung, colorectal, and gastroesophageal cancers
The company plans to begin patient administration this year through a global Phase 1 trial to evaluate safety, maximum tolerated dose, pharmacokinetics, and efficacy
The drug features a novel payload, PBX-7016, designed for higher safety, reduced toxicity, and improved tumor penetration
By 2026, the company targets the launch of two ADC and two multi-antibody drugs, with additional candidates planned through 2028, totaling 13 drugs