Celltrion said on the 4th that "CT-P70," an Antibody-Drug Conjugate (ADC)-based anticancer drug candidate the company is developing, has been designated for Fast Track by the U.S. Food and Drug Administration (FDA).
The FDA's Fast Track is a program that allows expedited consultations between developers and the FDA throughout the clinical development cycle for treatments for serious diseases for which existing therapies are not sufficiently effective.
Once designated, developers can benefit from ◇ securing continuous communication channels with the FDA ◇ consultations on clinical trial design and development strategies ◇ an expanded possibility of Priority Review and Accelerated Approval ◇ Rolling Review. It offers institutional advantages that can significantly shorten the timeline to approval.
A Celltrion official said, "The Fast Track designation of CT-P70 is official confirmation from the FDA that Celltrion's new drug has the potential to be a new treatment that addresses unmet medical needs."
CT-P70 is an ADC anticancer drug candidate called an "anti-cancer cell guided missile."
ADCs are next-generation anticancer technologies that selectively attack only cancer cells while minimizing damage to normal cells. The core components are an antibody that seeks out cancer cells, a drug (payload) that kills cancer cells, and the linker that connects the two. When the antibody binds to an antigen on the surface of a cancer cell, the drug is delivered into the cell and precisely destroys the cancer.
CT-P70 targets patients with metastatic non-squamous non-small cell lung cancer (non-squamous NSCLC) who express cMET (cell growth factor receptor) and have a history of prior systemic therapy. Celltrion said it received Investigational New Drug (IND) approval from the FDA in Mar. and is currently administering the drug to patients in a phase 1 trial.
The FDA is said to have granted the Fast Track designation after comprehensively evaluating that the target patient group is a high-risk group with limited treatment effects under existing methods and the potential of CT-P70's early development data.
Celltrion plans to sequentially apply for Fast Track for follow-up pipeline candidates based on ADCs and multi-specific antibodies, including CT-P71, CT-P72, and CT-P73.
By the end of this year, the company aims to advance a total of four candidates, including CT-P70, into clinical stages and expand the new drug pipeline to 20 candidates, including more than 10 in clinical stages, by 2027.
To that end, Celltrion is securing platform technologies across a wide range of fields, including ADCs and multi-specific antibodies, by collaborating with various corporations in addition to its in-house development capabilities. The company said, "Our strategy is to strengthen technological competitiveness by securing high scalability across antibody-chemical conjugation methods and formulation types."
A Celltrion official said, "Using this designation as a springboard, we plan to continue applying for Fast Track for new drugs under development, including follow-up ADCs and multi-specific antibodies," adding, "We will accelerate development so that we can provide new treatment options to patients more quickly."