AbClon, Nespe-cel Lymphoma Clinical Trial Shows 94% ORR... P…
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.
