NANJING, China, Oct. 9, 2024
/PRNewswire/ -- Nanjing Leads Biolabs Co., Ltd. ("Leads Biolabs")
announced that Center for Drug Evaluation (CDE) of National Medical
Products Administration (NMPA) has granted Breakthrough Therapy
Designation to LBL-024, an anti-PD-L1/4-1BB bispecific antibody
independently developed by Leads Biolabs with global intellectual
property rights, for the treatment of the patients with advanced
extrapulmonary neuroendocrine carcinoma (EP-NEC) who have
progressed after receiving two or more lines of chemotherapy. The
Breakthrough Therapy Designation awarded to LBL-024 stems from its
remarkable clinical efficacy and safety profile in patients with
advanced EP-NEC who failed in second-line and above chemotherapy.
The current clinical data demonstrate that LBL-024 monotherapy has
more than doubled both the Objective Response Rate (ORR) and
Overall Survival (OS) compared to existing treatments for this
disease.
Breakthrough Therapy refers to innovative or improved drugs that
treat life-threatening conditions or significantly impact quality
of life, where no effective treatment exist, or there is sufficient
evidence that the therapy offers clear advantages over existing
treatment options. In July 2012, the
U.S. Food and Drug Administration (FDA) pioneered the "Breakthrough
Therapy" review process, complementing fast track, accelerated
approval, and priority review mechanisms. By accelerating the
approval process and fostering closer collaboration, Breakthrough
Therapy Designation facilitates faster development and market
access for drugs with significant clinical potential. Historically,
FDA data suggests that Breakthrough Therapy Designation can reduce
time-to-market by approximately 2.5 years on average.
In July 2020, CDE officially
introduced the Breakthrough Therapy Designation concept in
China. Products granted
Breakthrough Therapy Designation status will receive closer
guidance and various forms of support to ensure that patients are
provided with new treatment options as soon as possible.
Dr. Charles Cai, Chief Medical
Officer of Leads Biolabs, said "According to historical data from the China
Drug Review Annual Report, only a
few products are eligible for Breakthrough Therapy
Designation, and even fewer have been approved. The designation for
LBL-024 is another proof of the robust R&D capabilities of
Leads Biolabs, and it is also a major victory for Leads Biolabs'
insistence on focusing on the first-in-class product R&D
strategy for the global market. Leads Biolabs will vigorously
pursue the global clinical development of LBL-024, with the
anticipation of offering more effective treatment options for
patients with EP-NEC at the earliest opportunity."
Dr. Xiaoqiang Kang, founder,
chairman and CEO of Leads Biolabs, said "The Breakthrough Therapy granted by the CDE
prioritizes candidates that demonstrate exceptional clinical data,
differentiated targets, and therapies with a high degree of
efficacy certainty. This Designation represents the highest
threshold and most prestigious qualification within China's pharmaceutical regulatory system,
functioning as a crucial benchmark for uncovering valuable new drug
projects. Leads Biolabs has consistently embraced differentiated
innovation, and we eagerly anticipate the timely market
introduction of LBL-024 as a novel immunotherapy, following the groundbreaking
successes of anti-PD-1/PD-L1,
CTLA-4, and LAG-3."
About LBL-024
LBL-024 is a tetravalent bispecific antibody that simultaneously
targets PD-L1 and 4-1BB, serving dual functions: blocking the
immunosuppressive PD-1/PD-L1 pathway, and selectively
co-stimulating 4-1BB in the tumor microenvironment to enhance
immune responses. The dual functions of LBL-024—lifting PD-1/PD-L1
immune inhibition and intensifying 4-1BB modulated T cell
activation—synergistically enhance the anti-tumor immune
response.
About EP-NEC
Neuroendocrine carcinoma (NEC) is a class of poorly
differentiated, high-grade neuroendocrine neoplasms (NENs), which
originate in the diffuse neuroendocrine cell system and can occur
in many different sites. NEC can be categorized into pulmonary NEC
and EP-NEC. EP-NEC exhibits similar highly aggressive and
metastatic characteristics to small cell lung cancer (SCLC). Most
patients are diagnosed at a later stage or already have distant
metastases, resulting in rapid disease progression and a poor
prognosis.
Currently, the primary first-line treatment for advanced EP-NEC
involves platinum-based chemotherapy, achieving an overall response
rate (ORR) of approximately 30% to 50%, with a median overall
survival (mOS) of only approximately one year. Treatment options
for advanced EP-NEC are limited, and there are no standard
treatment strategies for patients who progress beyond second-line
chemotherapy. These underscore the urgency to develop novel
therapeutic approaches.
About Leads Biolabs
Nanjing Leads Biolabs Co., Ltd is a clinical-stage biotechnology
company dedicated to the discovery, development, and
commercialization of innovative therapies to address underserved
medical needs in oncology, autoimmune, and other severe diseases
both in China and globally.
Backboned by our proprietary technology platforms and robust drug
development capabilities, we have curated a rationally designed and
differentiated pipeline of 12 innovative drug candidates, six have
successfully progressed into the clinical stage. 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