NANJING, China, April 30,
2024 /PRNewswire/ -- Nanjing Leads Biolabs Co.,
Ltd. (hereinafter referred to as "Leads Biolabs") announced that
LBL-024, an anti-PD-L1/4-1BB bispecific antibody independently
developed by Leads Biolabs with global intellectual property rights
has received approval to conduct the single-arm pivotal study for
registration and market authorization from the Center for Drug
Evaluation (CDE) of the National Medical Products Administration
(NMPA). Currently, there are no similar products approved for
marketing domestically or internationally.
LBL-024 is a bispecific antibody composed of anti-programmed
death ligand-1 (PD-L1) and anti-4-1BB (CD137) antibodies. It binds
to PD-L1 with high affinity, blocking the PD-L1/PD-1
immunosuppressive pathway while conditionally activating the 4-1BB
costimulatory pathway in the tumor microenvironment. This
activation of T cells exerts a powerful immune response, resulting
in a stronger antitumor effect than anti-PD-1/PD-L1 monoclonal
antibodies alone.
LBL-024 received IND approvals from both FDA and NMPA on
July 30, 2021 and September 9, 2021 respectively to conduct
phase Ⅰ/Ⅱ clinical research, and has achieved outstanding
results. The clinical study results of LBL-024 monotherapy in
patients with advanced malignant tumors demonstrated good safety
profile and encouraging efficacy signals in the advanced solid
tumors.
The approved Phase IIb pivotal clinical study is led by
Professor Shen Lin from Peking
University Cancer Hospital, and detailed clinical data will be
disclosed during the ASCO Annual Meeting on May 31st to June 4th, 2024. LBL-024 has
First-in-Class potential and is expected to offer an effective
treatment option to patients with advanced solid tumors.
Dr. Charles Cai, Chief Medical
Officer of Leads Biolabs, said " The approval of this pivotal
clinical study is an encouraging news. Based on the current
treatment status and the available safety and efficacy data,
LBL-024 meets the requirements of the drug registration
management measures for 'innovative drugs used to prevent and
treat diseases that seriously endanger life or severely affect the
quality of life, and for which there are no effective prevention or
treatment methods, or there is sufficient evidence to demonstrate
significant clinical advantages compared to existing treatment
methods.' The approval of the single-arm pivotal clinical study by
CDE will help accelerate the marketing process of LBL-024 and bring
more effective treatment options to patients as early as
possible."
Dr. Xiaoqiang Kang, founder,
chairman and CEO of Leads Biolabs, said " We are delighted to see
the positive progress of LBL-024, which has the potential to become
an effective immunotherapy and prove 4-1-BB to be druggable immune
checkpoint target approved for marketing following PD-1/PD-L1,
CTLA-4, and LAG-3. This milestone achievement also reflects our
corporate philosophy of focus on innovation and our determination
to discover and advance First-in-Class products. We have always
been guided by clinical needs in our differentiated approach to
innovation, deploying novel targets while combining some targets
based on a deep understanding of their biological mechanisms and
disease mechanisms to achieve a 1+1>2 effect. The vision of
Leads Biolabs is to become a company that can truly develop
innovative drugs, delivering safe, effective, and accessible new
therapies to patients worldwide. To this end, we will continue to
make full efforts to support the subsequent clinical research of
LBL-024, and look forward to delivering the benefit earlier to
patients around the world. "
About Leads Biolabs
Nanjing Leads Biolabs Co., Ltd. is a clinical-stage
biotechnology company founded in Nanjing by a team of senior U.S.-trained
antibody drug developers. Since 2014, Leads Biolabs has been
dedicated to the discovery and development of novel antibody drugs
with independent intellectual property rights for the treatment of
oncology and other major diseases of high unmet medical needs,
particularly the challenges in cancer immunotherapy. Our extensive
R&D pipeline consist of more than twenty novel tumor
immunotherapy, autoimmunity and ADC molecules based on monoclonal
and bispecific antibody technology platforms. Leads Biolabs is
committed to providing safe, effective, accessible and affordable
new drugs to address the unmet needs of patients around the
world.
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SOURCE LEADS BIOLABS