[Edaily Reporter Minji Son ] #

Celltrion has secured Fast Track designation from the U.S. Food and Drug Administration (FDA) for three new antibody-drug conjugate (ADC) drug candidates that have entered the clinical trial phase.

On the 13th, Celltrion announced that its ADC-based anticancer drug candidate “CT-P73” has been designated for Fast Track consideration by the U.S. FDA. The indicated use is recurrent or metastatic cervical cancer in patients with a history of platinum-based chemotherapy (PBC).

Consequently, all three ADC drug candidates currently undergoing Phase 1 clinical trials at Celltrion—CT-P70, CT-P71, and CT-P73—have now been granted Fast Track designation. CT-P70 targets c-MET, CT-P71 targets Nectin-4, and CT-P73 targets tissue factor, respectively.

The Fast Track program is a system designed to expedite the development and review of treatments for serious diseases where existing therapies are unlikely to be effective or where there is a high unmet medical need. Designation under Fast Track allows companies to receive more proactive support from the FDA regarding clinical trial design and the formulation of approval strategies. Additionally, if certain requirements are met, companies can utilize “rolling review,” which allows them to submit prepared data in stages for review, and they will have expanded opportunities for future consideration for priority review and accelerated approval.

Celltrion explained that with all three of its ADC candidates that have entered the clinical phase designated for Fast Track, the company is now able to pursue development and approval strategies for each candidate more efficiently based on close consultation with the FDA. Going forward, the company expects to have a broader range of options for commercialization strategies by pipeline. This includes comprehensively evaluating clinical data and market potential to select candidates for in-house development and direct commercialization, as well as those for early monetization—such as through technology transfer (license-out)—to generate royalty payments and milestone payments.

CT-P73 targets a tissue factor that is overexpressed in various solid tumors, including cervical cancer. Celltrion explained that in preclinical studies, CT-P73 demonstrated antitumor efficacy comparable to or superior to that of the existing treatment, tisotumab vedotin, while also showing improved safety.

Of the three ADCs currently in Phase 1 clinical trials, two candidate compounds are scheduled to complete Part 1 of Phase 1 by the end of this year, with topline results to be announced sequentially starting in the first half of next year. The company also plans to rapidly proceed to Part 2 for dose optimization. In particular, “CT-P70,” which is progressing the fastest, aims to enter Part 2 in March of next year.

Meanwhile, Celltrion also plans to apply for FDA Fast Track designation for CT-P72, a multi-antibody-based candidate, by the end of this year. Following ADCs, the company intends to expand its new drug pipeline to include multi-antibodies and other therapies, and strengthen the foundation for mid- to long-term growth in the new drug sector by linking achievements at each development stage with commercialization strategies.

A Celltrion official stated, “With all three ADC candidates currently in clinical trials designated for Fast Track, we have laid the groundwork to enhance development efficiency through closer consultation with the FDA.” The official added, “Going forward, we will carefully evaluate clinical data and market potential to strategically select between in-house development and commercialization or technology transfer for each candidate, thereby simultaneously increasing the long-term growth value of our new drugs and the potential for early monetization.”