Appclon Reports 94% ORR in Nespacel Lymphoma Clinical Trial

Appclon announced on May 16 that the interim results of the Phase 2 clinical trial for its CAR-T therapy "Nespacel (AT101)" will be presented at the European Hematology Association (EHA) by Professor Yoon Deokhyun of Asan Medical Center, the principal investigator of the Phase 2 study, as the corresponding author. Seven institutions participating as authors in the Phase 2 trial include 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.

The EHA, which will be held in Milan, Italy from June 12 to 15, is regarded as one of the two most prestigious conferences in the field of hematologic malignancies, alongside the American Society of Hematology (ASH).

Nespacel, a next-generation anti-CD19 CAR-T therapy, is currently undergoing a Phase 2 clinical trial in Korea targeting patients with diffuse large B-cell lymphoma (DLBCL). Unlike existing CAR-T therapies, Nespacel utilizes Appclon's proprietary humanized antibody h1218 to target the region near the cell membrane of the CD19 antigen, resulting in rapid binding and dissociation characteristics.

The abstract contains the results of evaluating the efficacy and safety of Nespacel through the multicenter Phase 2 trial. Of the 35 patients who received Nespacel, 32 patients were eligible for efficacy analysis. The objective response rate (ORR), which indicates a reduction in tumor lesions beyond a predefined threshold, was 94%, and the complete remission rate (CRR), which indicates the disappearance of all lesions, was 63%. These results are superior compared to the Phase 2 results of existing therapies such as Kymriah (ORR 50%, CRR 32%) and Yescarta (ORR 72%, CRR 51%).

These findings are based on assessments by clinical investigators, and the presentation at the conference will also include the most recent data on treatment efficacy and safety collected since the abstract submission.

An Appclon representative stated, "Based on the very high ORR, we expect Nespacel to demonstrate strong antitumor effects even in high-risk patient groups who did not respond to existing CAR-T therapies. The unique mechanism of action of Nespacel, termed 'Flying Kiss,' and its correlation with pharmacokinetic (PK) parameters, as published in international journals, further support its therapeutic efficacy."

The representative added, "The ongoing Phase 2 trial is also evaluating long-term survival rates and strategies for managing side effects. Based on the results from the upcoming Independent Data Monitoring Committee, we plan to apply for Fast Track Designation with the Ministry of Food and Drug Safety in early July this year to expedite the product approval process."

Appclon will also present the latest Phase 2 results and Phase 3 progress of AC101 (Henlius code HLX22), which was licensed to Henlius, at the American Society of Clinical Oncology (ASCO) Annual Meeting to be held in Chicago, USA from May 30 to June 3.