AbClon announced on the 1st that it has received the interim topline results from the Phase 2 clinical trial of its next-generation anti-CD19 Chimeric Antigen Receptor T-cell (CAR-T) therapy, Nespe-cel (AT101).

The topline results, received from the independent Data Monitoring Committee (IDMC), represent the independent evaluation of Nespe-cel's anticancer treatment efficacy. The company stated that the results are a significant milestone achievement, proving AbClon's competitiveness in the global CAR-T therapy market.

In the interim analysis of the Phase 2 clinical trial, Nespe-cel achieved an objective response rate (ORR) of 94% and a complete response rate (CRR) of 68%. These values demonstrate superior anticancer efficacy compared to globally approved therapies like Kymriah and Yescarta. Unlike typical independent evaluations, which often yield lower results than investigator’s assessments, Nespe-cel 's independent evaluation on image data were consistent with investigator readings, further clearly proving its efficacy.

Based on the tumor evaluation and safety analysis results, the IDMC assessed that Nespe-cel met the criteria for statistical superiority and showed excellent drug efficacy. Adverse events of special interest (AESI), such as cytokine release syndrome (CRS) and neurotoxicity, commonly observed side effects in CAR-T therapies, occurred within the expected timeframe and were deemed manageable, indicating positive safety results.

An AbClon official stated, "Based on the IDMC's comments, we plan to apply for expedited review designation in the near future and enter into the accelerated drug approval process for advanced biopharmaceuticals." They added, "We will continue to continue the Phase 2 clinical trial to prove not only short-term treatment effects but also long-term survival effects, faithfully implementing the IDMC's recommendations."

Unlike existing CAR-T therapies, Nespe-cel incorporates an antibody developed with AbClon's proprietary NEST technology. Its unique mechanism of action and excellent pharmacokinetic properties have shown a significant correlation with blood cancer treatment efficacy, which was published in the prestigious international academic journal Molecular Cancer.

AbClon believes these interim topline results mark a pivotal moment for Nespe-cel to establish itself as a globally competitive CAR-T therapy.