AbClon announced on the 24th that it has applied to the Ministry of Food and Drug Safety (MFDS) for the designation to fast-track processing of its next-generation CAR-T cell therapy, 'Nespe-cel (AT101)', as an advanced biological product.

The application was based on the objective response rate (ORR) and complete response rate (CRR) confirmed in the interim analysis of its Phase 2 clinical trial. Nespe-cel showed an ORR of 94% and a CRR of 68% in the interim results of the Phase 2 clinical trial. These rates are 10 to 40 percentage points higher than the approval cases of global CAR-T cell therapies such as Novartis' Kymriah and Gilead's Yescarta.

The company stated, "The interim results prove AT101’s excellent efficacy even in relapsed/refractory blood cancer groups who did not respond to existing treatments," adding, "This is very significant because most of these patients were in difficult situations with no further treatment options in clinical practices."

Unlike global CAR-T therapies that use existing FMC63-based antibodies, Nespe-cel enhances efficacy and persistence by applying AbClon's independently developed CD19-specific humanized antibody. Furthermore, by optimizing antibody affinity, pharmacokinetic efficiency has also improved. The related research results have been published in the international journal, Molecular Cancer.

The Designation to Fast-Track processing is a system in which the MFDS prioritizes the review of advanced biological products for treatments of severe life-threatening diseases for which there are no existing treatments or there is a significant achievement of medical improvement. If designated, companies receive benefits such as dedicated officials for review, shortened review periods, and partial exemption from clinical trial data, which can dramatically shorten the time until product approval. AbClon aims to obtain domestic product approval in the second half of next year by actively utilizing the customized review and pre-consultation systems.

Overseas commercialization is also accelerating. In Turkey, the biopharmaceutical company TCT is in the process of process development for local commercialization after receiving Nespe-cel technology transfer from AbClon. In Korea, Chong Kun Dang has secured priority for commercialization in Korea and continues its partnership.

Lee Yoon, Director of AbClon's Clinical Research Institute, stated, "Nespe-cel is showing groundbreaking results, presenting a new treatment option for critically ill patients who have failed existing treatments." He added, "Through priority review designation, we will provide treatment opportunities to patients more quickly."

Meanwhile, AbClon is also accelerating the development of a switchable CAR-T (zCAR-T) platform targeting solid tumors for future indication expansion. Through this, the company is pursuing both securing technological leadership in the domestic and international immune cell therapy market and global commercialization.