CHENGDU, China, June
20, 2024 /PRNewswire/ -- Keymed Biosciences Inc. (HKEX: 02162)
today announced that Lei Zhang/Renchi Yang's team from the
Institute of Hematology, Chinese Academy of Medical Sciences has
recently published a research paper entitled "A Novel Anti-CD38
Monoclonal Antibody for Treating Immune
Thrombocytopenia" in the New England Journal of
Medicine. This is an investigator-initiated, single-arm,
open-label phase I/II study evaluating the safety
and preliminary efficacy of CM313 in adult patients with primary
ITP.
A total of 22 patients were enrolled in the study, with
one patient dropping out after the first
infusion. The remaining 21 patients completed both the
8-week treatment and 16-week follow-up periods. Results
showed that 95.5% of patients (21/22) achieved a platelet
count of ≥50 × 109/L during the 8-week treatment period,
with a median cumulative response duration of 23 weeks
(interquartile range, 17 to 24). The median time to
first platelet count of ≥50 × 109/L
was 1 week (range: 1-3), and the median time to
first platelet count of ≥30 × 109/L with
a ≥2-fold increase from baseline was 1 week.
Additionally, the durable sustained platelet count
response rate (defined as a platelet count of ≥50 ×
109/L observed six or more times among the final eight
platelet counts) was 63.6% (14/22). Throughout the entire
study, overall response (complete or partial response) was
observed in 21 patients, with 20 patients achieving complete
response. The proportion of patients with bleeding
decreased from 68.2% (15/22) at baseline to 4.8 (1/21) at week
8. Most patients discontinued concomitant medications due
to the restoration of platelet counts to normal or safe levels
with CM313 treatment. In summary, CM313 demonstrated
rapid and sustained efficacy in 95.5% of ITP patients who had
previously received multiple therapies. Safety analyses
showed that CM313 was well-tolerated.
CM313 is a humanized monoclonal antibody targeting CD38 and the
first domestically-developed anti-CD38 antibody with IND approval
by the NMPA in China. Previous
phase I/II studies have demonstrated the favorable safety profile
and encouraging efficacy of CM313 in patients with RRMM and primary
ITP. In addition, the potential use of CM313 in SLE is currently
under clinical development.
About Keymed Biosciences Inc.
Keymed Biosciences Inc. (HKEX: 02162) focuses on the urgent
unmet clinical needs, and is committed to providing high-quality,
affordable, innovative therapies for patients in China and overseas. To accelerate the
efficiency of our research and discovery, the Company has
established a fully-integrated platform encompassing all of the key
functions in the biological drug development which include target
validation, lead molecule discovery and optimization, preclinical
evaluation, process development, translational research, clinical
development and manufacturing. This integrated platform has enabled
us to rapidly and cost-effectively identify, build, expand and
advance our diversified pipeline of innovative and differentiated
antibody-based therapies, including monoclonal antibodies, antibody
drug conjugates (ADCs) and bispecific antibodies.
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content:https://www.prnewswire.co.uk/news-releases/keymed-biosciences-announces-safety-and-efficacy-results-of-cm313-for-primary-immune-thrombocytopenia-published-in-nejm-302177732.html