AbClon announced on the 16th that the interim results of its Phase 2 clinical trial of CAR-T (Chimeric Antigen Receptor T-cell) therapy 'Nespe-cel (AT101)' will be presented at the European Hematology Association (EHA) annual meeting. Professor Deok-Hyeon Yoon of Asan Medical Center in Seoul, the principal investigator of the Phase 2 trial, will be the corresponding author. A total of seven institutions participating in the ongoing Phase 2 trial, including Asan Medical Center, Ulsan University Hospital, Ajou University Hospital, Dong-A University Hospital, Seoul National University Hospital, Samsung Medical Center, and Yeouido St. Mary's Hospital, are listed as authors.

EHA, which will be held in Milan, Italy from June 12th to 15th, is considered one of the two most prestigious academic conferences in the field of hematologic malignancies, along with the American Society of Hematology (ASH).

Nespe-cel,  a next-generation anti-CD19 CAR-T therapy, is currently undergoing a Phase 2 clinical trial in South Korea for patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL). Unlike existing CAR-T therapies, Nespe-cel  utilizes AbClon's proprietary humanized antibody h1218, targeting the membrane-proximal region of the CD19 antigen, which results in rapid binding and dissociation kinetics.

The abstract being released presents the results of a multi-center Phase 2 trial evaluating the efficacy and safety of Nespe-cel. The analysis included 32 evaluable patients out of 35 who received Nespe-cel. The objective response rate (ORR), which signifies the reduction of cancer lesions beyond a predefined criterion, was 94%, and the complete response rate (CRR), indicating the disappearance of all lesions, was 63%. These results are remarkable when compared to the Phase 2 trial outcomes of existing treatments such as Kymriah (ORR 50%, CRR 32%) and Yescarta (ORR 72%, CRR 51%).

This presentation reflects the evaluation by clinical investigators, and the presentation at the conference will also include the latest treatment efficacy and safety data obtained since the abstract submission.

An AbClon official stated, "Based on its very high ORR, Nespe-cel  is expected to demonstrate potent anti-tumor effects even in high-risk patient groups who have not responded to existing CAR-T therapies." They added, "The correlation between 'Flying Kiss,' Nespe-cel's unique mechanism of action published in an international journal, and pharmacokinetic (PK) markers supports its therapeutic efficacy."

The official commented, "The ongoing Phase 2 trial is also evaluating long-term survival rates and strategies for managing side effects. Based on the results of the independent data monitoring committee, which are expected soon, we plan to apply for Breakthrough Therapy designation to the Ministry of Food and Drug Safety in early July to expedite the marketing authorization process."

Separately, the latest Phase 2 results and the progress of the Phase 3 trial of AC101 (Henlius code name HLX22), which AbClon licensed out to Henlius, will also be presented at the American Society of Clinical Oncology (ASCO) annual meeting held in Chicago, USA, from May 30th to June 3rd.