Celltrion announced on Thursday that all three of its antibody-drug conjugate (ADC) cancer drug candidates have progressed to the patient dosing phase.
The three candidates currently being administered to patients are CT-P70, CT-P71, and CT-P73. All three received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) last year. Following standard clinical trial procedures, CT-P70 and CT-P71 began patient dosing in the latter half of last year, while CT-P73 initiated dosing most recently in the first quarter of this year.
These ADC drug candidates showed promising results in preclinical stages, demonstrating novel mechanisms of action and strong safety profiles. Building on these preclinical findings, Celltrion plans to thoroughly assess dose-dependent safety and pharmacokinetic properties in Phase 1 clinical trials.
In addition to the ADC candidates that have commenced patient dosing, the multi-antibody drug candidate CT-P72 is also making significant progress. CT-P72 has entered the patient recruitment phase at clinical trial sites and is expected to begin patient dosing as early as next month.
The targeted indications for each candidate are as follows: CT-P70 aims to treat non-small cell lung cancer, colorectal cancer, and gastroesophageal cancer; CT-P71 focuses on urothelial carcinoma, breast cancer, and prostate cancer; CT-P73 targets cervical cancer, head and neck cancer, colorectal cancer, and endometrial cancer; and CT-P72 is being developed for bladder cancer, breast cancer, colorectal cancer, endometrial cancer, and gastric cancer.
All four drug candidates address cancer types with significant unmet medical needs. To expedite their path to market, Celltrion has adopted Fast Track Designation as a core strategy. CT-P70 received Fast Track designation from the FDA in December last year, followed by CT-P71 this month. Celltrion intends to submit Fast Track applications for the remaining two candidates (CT-P72 and CT-P73) within the year.
Fast Track designation is a process designed to facilitate the development and expedite the review of drugs that treat serious conditions where there is an unmet medical need. This designation allows for more frequent communication with the FDA throughout the drug development process. Once granted, developers can submit completed sections of their Biologic License Application (BLA) for rolling review, potentially accelerating the approval timeline.
Celltrion aims to leverage its extensive research and development capabilities and global regulatory expertise, honed through its biosimilar business, to maximize the valuation of its novel drug candidates and accelerate its transformation into a global pharmaceutical innovator.
Specifically, Celltrion plans to sequentially release interim results from the four ADC drug candidates currently in Phase 1 clinical trials. This approach will help the company gather crucial early-stage clinical data on efficacy and safety, progressively showcasing the potential of its next-generation drug pipeline.
A Celltrion spokesperson stated that with all the ADC drug candidates now in the patient dosing phase and our multi-antibody pipeline entering patient recruitment, the novel drug development program has hit its stride. The spokesperson added that they’re laying the groundwork for sustainable growth, maintaining a robust global market share for the existing biosimilar products while achieving notable milestones in the next-generation drug pipeline.
The spokesperson further noted that it expects to release the first-quarter financial results in early to mid-May, which will provide concrete indicators of the company’s growth trajectory.