LBL-024, a Bispecific Antibody by Leads Biolabs, Receives CDE Breakthrough Therapy Designation for Extrapulmonary Neuroendocrine Carcinoma.

Nanjing, China, Oct. 9, 2024 -- Leads Biolabs Co., Ltd. ("Leads Biolabs") recently revealed that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has provided a Breakthrough Therapy Designation to LBL-024. This anti-PD-L1/4-1BB bispecific antibody, developed solely by Leads Biolabs with international intellectual property rights, is aimed at treating patients with advanced extrapulmonary neuroendocrine carcinoma (EP-NEC) who have not responded to two or more chemotherapy treatments. The designation is a result of the impressive clinical effectiveness and safety profile of LBL-024 in patients with advanced EP-NEC who weren't successful with second-line and subsequent chemotherapy treatments. Present clinical data indicate that LBL-024 monotherapy has more than doubled both the Objective Response Rate (ORR) and Overall Survival (OS) compared to current treatment methods for this condition.

Breakthrough Therapy refers to innovative or improved drugs that treat life-threatening conditions or significantly impact quality of life, particularly in cases where no effective treatment exists or where there is substantial evidence that the therapy provides clear advantages over existing treatments. In July 2012, the U.S. Food and Drug Administration (FDA) initiated the "Breakthrough Therapy" review process, which complements other mechanisms like fast track, accelerated approval, and priority review. This designation accelerates approval processes and encourages closer collaboration to facilitate quicker development and market access for drugs with significant clinical potential. Historical FDA data shows that Breakthrough Therapy Designation can reduce time-to-market by about 2.5 years on average.

In July 2020, the CDE officially introduced the Breakthrough Therapy Designation in China. Products granted this status receive closer guidance and various forms of support to ensure new treatment options are provided to patients as rapidly as possible.

Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, noted, "According to historical data from the China Drug Review Annual Report, only a few products qualify for Breakthrough Therapy Designation, and even fewer are approved. The designation for LBL-024 is a testament to Leads Biolabs' robust R&D capabilities and dedication to focusing on first-in-class product R&D strategies for the global market. Leads Biolabs will actively pursue the global clinical development of LBL-024, with hopes of offering more effective treatment options for EP-NEC patients as soon as possible."

Dr. Xiaoqiang Kang, founder, chairman, and CEO of Leads Biolabs, stated, "The Breakthrough Therapy granted by the CDE prioritizes candidates demonstrating exceptional clinical data, differentiated targets, and therapies with a high degree of efficacy certainty. This Designation is the highest threshold and most prestigious qualification in China's pharmaceutical regulatory system, serving as a crucial benchmark for discovering valuable new drug projects. Leads Biolabs has always embraced differentiated innovation, and we look forward to 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."

LBL-024 is a tetravalent bispecific antibody targeting PD-L1 and 4-1BB. It performs dual functions: blocking the immunosuppressive PD-1/PD-L1 pathway and selectively co-stimulating 4-1BB in the tumor microenvironment to enhance immune responses. These dual functions synergistically boost the anti-tumor immune response by lifting PD-1/PD-L1 immune inhibition and intensifying 4-1BB modulated T cell activation.

Neuroendocrine carcinoma (NEC) is a class of poorly differentiated, high-grade neuroendocrine neoplasms (NENs) originating in the diffuse neuroendocrine cell system and can occur in various sites. NEC is categorized as pulmonary NEC and EP-NEC. EP-NEC exhibits similar aggressive and metastatic characteristics to small cell lung cancer (SCLC). Most patients are diagnosed at a later stage or already have distant metastases, leading to rapid disease progression and poor prognosis.

Currently, the primary first-line treatment for advanced EP-NEC is platinum-based chemotherapy, achieving an ORR of approximately 30% to 50%, with a median overall survival (mOS) of about one year. Treatment options for advanced EP-NEC are limited, and no standard treatment strategies exist for patients progressing beyond second-line chemotherapy, highlighting the need for novel therapeutic approaches.

Nanjing Leads Biolabs Co., Ltd is a clinical-stage biotechnology company focused on discovering, developing, and commercializing innovative therapies for oncology, autoimmune, and other severe diseases globally. Supported by proprietary technology platforms and strong drug development capabilities, Leads Biolabs has created a differentiated pipeline of 12 innovative drug candidates, six of which have entered the clinical stage. Leads Biolabs is committed to providing safe, effective, accessible, and affordable new drugs to meet the unmet needs of patients worldwide.