Nanjing Leads Biolabs Co., Ltd.

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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NANJING, China, June 17, 2024 /PRNewswire/ -- At the recent European League Against Rheumatism (EULAR) Congress in Vienna, Austria, Nanjing Leads Biolabs Co., Ltd. (Leads Biolabs) delivered an oral presentation on its highly innovative therapeutic candidate LBL-047. LBL-047 is a first-in-class, long-acting TACI/BDCA2 bispecific antibody fusion protein. LBL-047 is composed of a Transmembrane Activator and a Calcium Modulator and Cyclophilin Ligand Interactor (TACI) domain fused to an antibody targeting Blood Dendritic Cell Antigen 2 (BDCA2). The bispecific antibody is further modified with the YTE mutation on the Fc region to prolong the half-life in circulation, thereby, enabling less frequent dosing, and improved patient compliance. LBL-047 has demonstrated excellent activity and pharmacokinetic properties in multiple preclinical experiments. Significantly inhibit INF-α release Robust depletion of pDCs in vitro and in vivo Superior inhibition of B cell and plasma cell function in vitro and in vivo compared to marketed TACI fusion protein Significantly alleviated clinical symptoms and inhibited B cell and plasma cell function in EAE mouse model (MS model) Excellent PK profile and markedly reduced IgM, IgA, IgG in cynomolgus monkey for up to six weeks These results indicate that LBL-047 can simultaneously inhibit B cell function and deplete interferon-secreting pDCs, thereby attenuating autoimmune activity. This innovative research offers new possibilities for treating a wide range of autoimmune related diseases, including Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE), Lupus Nephritis (LN), Sjogren's Syndrome, and Myasthenia Gravis. Engineered to significantly prolong the dosing interval, LBL-047 presents an optimal product profile for subsequent clinical and commercial development. Huang Xiao, Vice President of Discovery Research at Leads Biolabs, said: "EULAR is a highly anticipated event in the fields of rheumatology and immunology. We are honored to be featured in this prestigious gathering of over 18,000 experts and scholars from more than 130 countries to share the exciting data we have generated. LBL-047, independently developed and fully owned by Leads Biolabs, represents a significant achievement arising from our differentiated innovation strategy. Its unique design is based on our profound understanding of autoimmune diseases and target mechanisms, integrating extensive antibody engineering technologies and optimization efforts. We are very pleased with the results we have seen in preclinical studies. Leads Biolabs is dedicated to our corporate philosophy of 'care for life, focus on innovation, and win-win cooperation,' and is committed to providing safer and more effective treatment options for patients. Currently, LBL-047 is in the preclinical research stage, and we will continue to efficiently promote the development of this drug candidate to bring effective treatments to patients with autoimmune diseases as soon as possible." About LBL-047 B cells and pDCs play a crucial and synergistic role in the pathogenesis of many autoimmune diseases. Inhibiting the function of B cells and pDCs is a potential therapeutic strategy for treating various autoimmune diseases. LBL-047 is a long-acting TACI/anti- BDCA2 bispecific fusion protein, obtained by fusing an engineered TACI domain with a defucosylated anti-BDCA2 humanized monoclonal antibody. TACI is the natural high-affinity receptor for B cell activation factor of the tumor necrosis factor family (BAFF) and a proliferation-inducing ligand (APRIL), which are key cytokines that promote B cell and plasma cell survival, maturation, and function. Engineered TACI domain can be used to trap BAFF and APRIL, inhibiting B-cell function. BDCA2 is specifically expressed on pDCs and BDCA2 agonist antibody can suppress the IFNs release. Additionally, anti-BDCA2 antibodies can directly eliminate pDCs through mechanisms such as ADCC, inhibiting pDC-mediated immune responses. The defucosylated anti-BDCA2 antibody has stronger ADCC activity, and the introduction of YTE mutation in the Fc region further prolongs the half-life of the antibody. Preclinical studies have demonstrated that LBL-047 can potently inhibit the functions of B cells and pDCs simultaneously, and possesses excellent pharmacokinetic properties, indicating broad clinical applications and market prospects in the treatment of various autoimmune diseases. 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.

NANJING, China, June 2, 2024 /PRNewswire/ -- The annual meeting of the American Society of Clinical Oncology (ASCO) commenced on May 31st, Showcasing groundbreaking cancer research from around the world. According to official information, over 7,000 abstracts were submitted this year. After rigorous evaluation by Scientific Program Committee and ASCO Leadership, LBL-024, a bispecific antibody independently developed by Leads Biolabs with global intellectual property rights, was selected for an oral presentation. Today, Dr. Panpan Zhang, the investigator of LBL-024, presented the outstanding clinical data during the Clinical Science Symposium-Building Novel Antibody-Based Approaches in Gastrointestinal Cancers. This is a phase I/II first in human, open-label, multicenter, dose escalation/expansion study that evaluates the safety and efficacy of LBL-024 monotherapy in patients with advanced malignant tumors and neuroendocrine carcinoma. The study results demonstrated good safety profile and very promising antitumor effects as a monotherapy in patients with advanced malignant tumors, particularly extrapulmonary neuroendocrine carcinomas (EP-NEC) patients who failed at least one line of chemotherapy. EP-NEC is a rare disease that typically occurs in the stomach, intestines, and pancreas. Most patients are diagnosed at a later stage when the cancer has already metastasized to other areas in the body. By then, the disease has progressed rapidly and the prognosis is extremely poor. No drug has been approved by the Regulatory Agencies for this lethal malignancy so far and the recommended treatment options for the advanced EP-NEC are very limited, especially for those who progress beyond first-line platinum-based chemotherapy. These underscore the urgency to develop novel therapeutic approaches. According to results in the oral presentation, LBL-024 monotherapy showed good safety profile, especially mild liver toxicity in advanced solid tumors. The severity of AEs was mostly grade 1-2, no unexpected AEs were observed. At the dose of 15 mg/kg, ORR was 37.5% and DCR was 50.0% in 2nd line EP-NEC, and robust anti-tumor activities were observed in wide therapeutic dose range (0.8-15mg/kg) in EP-NEC. Median follow-up was 8.5 months, Median DoR was 5.3 months, mOS was not reached, 6-months OS rate of the overall, 2nd line, and ≥3rd line were 61.7%, 72.7% and 52.0%，respectively. 54.5% ORR in 22 patients with PD-L1 negative expression (CPS<1) were observed, which indicate patients can benefit from treatment with LBL-024 regardless of PD-L1 expression in tumor tissue. The promising efficacy data of the LBL-024 monotherapy support continued development of LBL-024 in patients with EP-NEC. A single-arm pivotal study of LBL-024 monotherapy in EP-NEC was approved on April 30, 2024, which will help accelerate the listing process of LBL-024 (Click to view details). Currently, there are no 4-1BB-targeting drugs available both domestically and internationally. LBL-024 has First-in-Class potential and is expected to become the first approved standard treatment for EP-NEC after progression on second-line therapy, offering a more effective treatment option and providing hope for survival to patients with advanced EP-NEC. Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, said "ASCO has very strict selection criteria, and abstracts selected for oral presentation must be among the most representative studies in the field of cancer that are significant for patient treatment. Leads Biolabs adopted a differentiated, innovative, and efficient development strategy in the clinical development of LBL-024. In patients with advanced malignant tumors, particularly EP-NEC patients who failed at least one line of chemotherapy, LBL-024 has demonstrated good safety and strong efficacy signals and was recently approved to conduct an accelerated development of single-arm pivotal clinical study by China Regulatory Authority, CDE." Dr. Xiaoqiang Kang, founder, chairman and CEO of Leads Biolabs, said" Leads Biolabs has always been committed to differentiated innovation, encompassing the development of new targets, the design of drug molecules, and clinical development strategies. From the very beginning of the project, we evaluate whether our technology and products are scientifically sound, whether they can overcome obstacles and challenges of current products, and whether they can bring better therapeutic benefits. It is this persistence that ensures our products have potential advantages, enabling them to stand out from numerous competitors. These innovative achievements, in turn, have verified the feasibility of our R&D strategy. In the future, Leads Biolabs will continue to focus on unmet medical need, persist in innovation, and look forward to innovative drugs with clinical value bringing benefits to patients as soon as possible." About LBL-024 LBL-024 is a uniquely designed bispecific antibody composed of an anti-Programmed Cell Death Ligand-1 (PD-L1) and an anti-4-1BB (CD137) antibody. It binds to PD-L1 with high affinity, blocks the immunosuppressive pathway of tumor cells by targeting PD-L1 and effectively localizes 4-1BB co-stimulation to the tumor microenvironment. This activation of T cells exerts a powerful immune response, resulting in a potentially stronger antitumor effect than anti-PD-1/PD-L1 monoclonal antibodies alone. 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. Contact [email protected] SOURCE Leads Biolabs