스피드 바카라 announces interim Phase 2 results for CAR-T treatment ‘Nespe-cel’ at EHA, achieving 94% ORR
Achieves superior complete remission rate over existing treatments, plans for expedited processing application to MFDS in July
[by Sung, Jae Jun] 스피드 바카라 announced on May 16 that interim results from the Phase 2 clinical trial of ‘Nespe-cel (development code: AT101),’ a next-generation chimeric antigen receptor T cell (CAR-T) treatment candidate, will be presented at the European Hematology Association (EHA) Congress.
Professor Yoon Dok-hyun of Asan Medical Center will serve as the corresponding author for this presentation. The research was conducted with the participation of seven major hospitals in Korea, including Asan Medical Center, Ulsan University Hospital, and Ajou University Hospital. The EHA congress, one of the two leading academic societies in the field of hematologic oncology alongside the American Society of Hematology (ASH), will be held in Milan, Italy, from June 12 to 15.
Nespe-cel is an anti-CD19 CAR-T therapy candidate for patients with diffuse large B-cell lymphoma (DLBCL), designed to precisely target the membrane-proximal region of the CD19 antigen using 스피드 바카라’s humanized antibody ‘h1218.’ It features a unique mechanism that differentiates it from existing treatments through its rapid binding and dissociation properties.
The abstract for this presentation includes the analysis results of 32 out of 35 patients eligible for efficacy evaluation, reporting an objective response rate (ORR) of 94% and a complete response rate (CRR) of 63%. The company highlighted that these outcomes surpass the 스피드 바카라 2 clinical results of existing treatments, including ‘Kymriah (tisagenlecleucel, ORR 50%, CRR 32%)’ and ‘Yescarta (axicabtagene ciloleucel, ORR 72%, CRR 51%)’.
This figure is based on ‘researcher evaluation,’ and additional safety and efficacy data collected after the abstract submission will also be presented at the congress. “Nespe-cel is expected to demonstrate antitumor effects even in high-risk patients who have not responded to existing CAR-T treatments,” an 스피드 바카라 official said. “This expectation is supported by the correlation between the ‘Flying Kiss’ mechanism of action and pharmacokinetic (PK) indicators published in an international academic journal.”
“In the 스피드 바카라 2 clinical trial, we are also evaluating long-term survival rates and strategies for managing side effects,” the official further commented. “We plan to apply for fast-track designation with the Ministry of Food and Drug Safety in early July to expedite the product approval process.”
Conversely, the Phase 2 clinical trial results and Phase 3 development progress of ‘AC101 (Henlius development code: HLX22),’ a human epidermal growth factor receptor type 2 (HER2) targeting antibody licensed by 스피드 바카라 to China’s Henlius, will be presented at the upcoming American Society of Clinical Oncology (ASCO) annual meeting in Chicago, USA, from May 30 to June 3.