Celltrion(068270)'s three antibody-drug conjugate (ADC) drug candidates under development have all received fast track designation from the U.S. Food and Drug Administration (FDA). The company plans to accelerate development by strengthening consultations with the FDA in the early clinical stages, while pursuing both in-house development and technology export depending on each candidate's clinical performance.
Celltrion said on the 13th that its ADC drug candidate "CT-P73" has been designated for the FDA fast track. With this, all three ADC candidates currently in phase 1 trials—CT-P70, CT-P71, and CT-P73—have been designated for the fast track.
The fast track is a program that facilitates the development and review of treatments for serious diseases where existing therapies are unlikely to be effective or where there is high unmet medical need. It allows close consultation with the FDA during development and, if requirements are met, the use of tools such as rolling review, which permits submitting sections of the application on a rolling basis.
Called a guided missile that targets cancer cells, ADC is a therapeutic technology that delivers a drug (payload) only to specific cancer cells by linking it to an antibody with a linker.
CT-P73 is an ADC candidate targeting tissue factor. It is being developed for patients with recurrent or metastatic cervical cancer who have a history of platinum-based chemotherapy. Celltrion said that in preclinical studies, it confirmed antitumor efficacy that was similar or superior and improved safety compared with the existing therapy tisotumab vedotin.
Based on clinical data from CT-P70, which targets c-MET, CT-P71, which targets Nectin-4, and CT-P73, which targets tissue factor, the company plans to set a commercialization strategy for each candidate.
A Celltrion official said, "With all three clinical-stage ADC candidates designated for the fast track, we have laid the groundwork to improve development efficiency through close consultation with the FDA," and added, "Based on clinical data and marketability, we will strategically choose between in-house development and commercialization and technology transfer for each candidate to raise both long-term growth value and the potential for early monetization."
The company plans to complete part 1 of phase 1 for two ADC candidates within this year and sequentially disclose key results from the first half of next year. It will then enter part 2 for dose optimization. CT-P70, which has the fastest development pace, is targeting entry into part 2 in Mar. next year. The company also said it plans to apply within this year for FDA fast track designation for the multispecific antibody drug candidate "CT-P72," following ADCs.