Celltrion is accelerating the development of its novel drugs after all three of its antibody-drug conjugate (ADC) candidates received Fast Track designation from the U.S. Food and Drug Administration.
Celltrion said Aug. 13 that CT-P73, an ADC candidate being developed to treat cervical cancer, had received FDA Fast Track designation. This means all three of the company’s ADC candidates currently in Phase 1 clinical trials — CT-P70, CT-P71 and CT-P73 — have now received the designation.
The FDA Fast Track program is designed to accelerate the development and review of drugs for serious conditions where existing treatments are inadequate or there is a significant unmet medical need. The designation allows developers to work closely with the FDA throughout the development process and, when requirements are met, use tools such as rolling review.
CT-P73 is an ADC targeting tissue factor, which is overexpressed in solid tumors including cervical cancer. It is being developed for patients with recurrent or metastatic cervical cancer who have previously received platinum-based chemotherapy.
Celltrion said preclinical studies confirmed CT-P73’s antitumor activity and safety, with the candidate showing similar or superior antitumor activity and an improved safety profile compared with tisotumab vedotin, an existing treatment.
Celltrion is currently conducting Phase 1 trials of CT-P70, which targets c-MET; CT-P71, which targets nectin-4; and CT-P73, which targets tissue factor.
The company plans to pursue different commercialization strategies for each candidate based on clinical data, market potential and other factors. It plans to independently develop and commercialize candidates with strong competitive potential while seeking early monetization through licensing or other strategic partnerships for candidates where such arrangements are more advantageous.
Two of the three ADC candidates are expected to complete Part 1 of their Phase 1 trials this year, with topline results to be released sequentially starting in the first half of next year. CT-P70, the most advanced of the three, is targeting entry into Part 2 of its Phase 1 trial in March next year.
Following its ADC program, Celltrion also plans to apply for FDA Fast Track designation for its multispecific antibody candidate CT-P72 by the end of this year.
Meanwhile, Celltrion has continued to expand its overseas revenue share by steadily increasing its market share, particularly in Europe, driven by the expansion of its biosimilar portfolio and strengthened direct-sales operations.