Celltrion said on the 23rd that all three antibody-drug conjugate (ADC)-based anticancer drug candidates have entered the patient dosing stage.
The candidates currently in dosing are CT-P70, CT-P71, and CT-P73. All three received clearance for phase 1 investigational new drug (IND) trials from the U.S. Food and Drug Administration (FDA) last year. After trial initiation procedures, CT-P70 and CT-P71 began patient dosing in the second half of last year, and CT-P73 began in the first quarter of this year.
These ADC candidates confirmed differentiated mechanisms of action and safety in preclinical studies. The company plans to evaluate dose-dependent safety and pharmacokinetic characteristics in phase 1.
Development is also underway for the multispecific antibody drug candidate CT-P72. It is currently in patient recruitment through trial sites and could begin first patient dosing as early as next month.
The target diseases by candidate are as follows: ▲CT-P70 (Non-small cell lung cancer (NSCLC), colorectal cancer, gastroesophageal cancer) ▲CT-P71 (urothelial carcinoma, breast cancer, prostate cancer) ▲CT-P73 (cervical cancer, head and neck cancer, colorectal cancer, endometrial cancer) ▲CT-P72 (bladder cancer, breast cancer, colorectal cancer, endometrial cancer, gastric cancer).
Celltrion is pursuing a strategy to seek priority review (fast track) for key candidates. CT-P70 was designated for FDA fast track in December last year, and CT-P71 received the designation this month. The company plans to file for CT-P72 and CT-P73 within the year.
Fast track is a program to support the development of therapies for serious conditions, allowing expedited consultations between the developer and the FDA. Once designated, rolling review is available, enabling documents to be submitted as they are ready for review, which can shorten the review period.
A Celltrion official said, "All three ADC candidates have entered the patient dosing stage, and the multispecific antibody pipeline has also entered patient recruitment, putting new drug development on track," adding, "First-quarter results are scheduled to be released in early to mid next month."