undifferentiated large cell lung cancer

SOUTH SAN FRANCISCO, Calif.--( BUSINESS WIRE )--Abdera Therapeutics Inc., a clinical-stage biopharmaceutical company leveraging its advanced antibody engineering ROVEr™ platform to design and develop tunable precision radiopharmaceuticals for cancer, today announced that Lori Lyons-Williams, president and chief executive officer, will present at the 43rd Annual J.P. Morgan Healthcare Conference on Monday, January 13, 2025 at 10:30 a.m. PT in San Francisco, CA. Ms. Lyons will detail the company’s progress including the recently initiated first-in-human Phase 1 clinical trial evaluating ABD-147 for the treatment of small cell lung cancer (SCLC) and large cell neuroendocrine carcinoma (LCNEC). The company also plans to share, for the first time publicly, preclinical data for ABD-320, which is currently in IND-enabling studies, and provide an update on expanded radiotherapeutic capabilities. About ABD-147 ABD-147 is a targeted radiopharmaceutical biologic therapy designed to deliver Actinium-225 ( 225 Ac), a highly potent alpha-emitting radioisotope, to solid tumors expressing delta-like ligand 3 (DLL3) with high affinity. DLL3 is a protein in the Notch pathway that is critical for the development and regulation of neuroendocrine versus epithelial cell differentiation in the lungs. In certain high grade neuroendocrine carcinomas including SCLC, DLL3 is upregulated and specifically expressed on the cell surface in more than 80% of cases. In contrast, DLL3 is absent or very rarely expressed on the surface of nonmalignant cells. Given the high specificity of DLL3 expression on cancer cells and the distinct mechanism of action, DLL3 represents a compelling target for treating SCLC and other DLL3+ solid tumors with targeted radiotherapy. The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ABD-147 for the treatment of patients with extensive stage small cell lung cancer (ES-SCLC) who have progressed on or after platinum-based chemotherapy and Orphan Drug Designation to ABD-147 for the treatment of neuroendocrine carcinoma. ABD-147 is currently being evaluated in a first-in-human Phase 1 clinical trial in patients with SCLC or LCNEC who have previously received platinum-based therapy. About ABD-320 ABD-320 is a targeted radiopharmaceutical biologic therapy designed to deliver Actinium-225 ( 225 Ac) to solid tumors expressing an undisclosed target that is widely prevalent and linked to poor outcomes in several different cancer types. ABD-320 was developed leveraging Abdera’s ROVEr™ platform and is custom-engineered to achieve an ideal balance of tumor uptake and retention while avoiding systemic radiotoxicities. ABD-320 represents the first therapy in development to address its undisclosed target. About Abdera Abdera Therapeutics is a clinical-stage biopharmaceutical company leveraging antibody engineering to design and develop new precision radiopharmaceuticals for cancer. Abdera’s R adio O ptimized V ector E nginee r ing (ROVEr™) proprietary platform enables the company to engineer potential best-in-class therapies for both clinically validated and novel targets that deliver potent radioisotopes capable of emitting alpha or beta particles to selectively destroy cancer cells. Abdera’s lead program, ABD-147, is a next-generation precision radiopharmaceutical biologic therapy designed to deliver Actinium-225 ( 225 Ac) to solid tumors expressing delta-like ligand 3 (DLL3) for the treatment of small cell lung cancer (SCLC) and large cell neuroendocrine carcinoma (LCNEC). Headquartered in South San Francisco, CA, Abdera also has offices in Vancouver, British Columbia, Canada. To learn more, please visit www.abderatx.com and follow us on LinkedIn and X .

NANJING, China, Nov. 22, 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 the company with global intellectual property rights for the treatment of neuroendocrine cancer, has obtained Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA). This marks another significant milestone following the Breakthrough Therapy Designation granted to LBL-024 by the Center for Drug Evaluation (CDE) of National Medical Products Administration (NMPA) in China. Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, said "LBL-024 obtained Breakthrough Therapy Designation from CDE in October this year for the treatment of advanced extrapulmonary neuroendocrine cancer. Our clinical data to date has been very encouraging, suggesting that LBL-024 could meaningfully improve outcomes of patients living with this devastating disease. The grant of ODD from FDA further underscores the exceptional potential of LBL-024 to address a critical gap in this therapeutic area. These policy supports for obtaining Orphan Drug qualification will greatly expedite the commercialization of LBL-024, potentially changing the treatment landscape for patients with advanced neuroendocrine cancer who currently have few therapeutic options." Dr. Xiaoqiang Kang, founder, chairman and CEO of Leads Biolabs, said "The receipt of ODD for LBL-024 from FDA represents a pivotal milestone in our global strategy. This designation not only enables LBL-024 to receive additional policy support and resource allocation during its development, accelerating its path to market and positioning it as a potential first-in-class therapeutic antibody targeting 4-1BB worldwide, but also provides us with greater market opportunities and avenues for growth on a global scale." 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. 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. Sponsored by Leads Biolabs, led by Professor Shen Lin from Beijing Cancer Hospital with participation of multiple clinical trial centers, 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. Based on the current treatment status and the available safety and efficacy data, LBL-024 has entered into a single-arm pivotal trial for extrapulmonary neuroendocrine carcinomas in July 2024 and stands as the globally first 4-1BB-targetd drug candidates to have reached pivotal stage, according to Frost & Sullivan. About Neuroendocrine Cancer Neuroendocrine carcinoma (NEC) is a class of poorly differentiated, high-grade neuroendocrine neoplasms (NEN), which originate in the diffuse neuroendocrine cell system and may occur in many different sites. Its molecular characteristics are significantly different from those of neuroendocrine tumors (NET). NEC can be divided into pulmonary NEC and extrapulmonary NEC, among which pulmonary NEC includes small cell lung cancer (SCLC) and pulmonary large cell neuroendocrine carcinoma (p-LCNEC). According to previous data collected, the number of new cases of SCLC is about 98,193, p-LCNEC is about 19,639, and extrapulmonary NECs is about 9,820 in the United States every year. As a result, there are an estimated 127,652 new cases of NECs in the United States each year, meeting the FDA's definition of a rare disease. Symptoms of NEC can vary depending on the type of tumor, its location in the body and the hormone released. The survival rate of NEC varies according to the type of cancer and whether it spreads. Specifically, the 5-year survival rate of pulmonary NECs is 5.6%, digestive tract NECs is 13.1%, and other primary NECs are 26.0%. Due to the limited effective treatment options available for patients, the overall survival rate of NEC is low, and more effective new treatment options are urgently needed. About Orphan Drug Designation Orphan drugs are medications used for the prevention, treatment, and diagnosis of rare diseases. According to the Orphan Drug Act of the United States, Orphan Drug Designation is established to encourage the development of drugs for treating rare diseases. It provides a series of incentives for new drug development, including but not limited to: (1) tax credits for clinical trial expenses; (2) specific guidance from FDA on all stages of clinical research; (3) exemption of the application fee for new drug registration; and (4) 7 years of market exclusivity after listing. 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. For more information, please visit: SOURCE Leads Biolabs WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

The biologic therapy is created to deliver the radioisotope 225Ac to tumours expressing the DLL3 protein. Credit: Kateryna Kon/Shutterstock. The US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to Abdera Therapeutics’ ABD-147, a treatment aimed at neuroendocrine carcinoma. The biologic therapy is created to deliver the radioisotope Actinium-225 (225Ac) to tumours expressing the DLL3 protein. This protein is found on the neuroendocrine tumours’ surface but is rarely expressed on the normal cells or tissues’ surface. The ODD status is expected to provide Abdera with benefits including tax credits, user fee exemptions and a potential seven years of market exclusivity post-approval. The company is set to commence a first-in-human Phase I clinical trial of ABD-147 in 2024. See Also: FDA grants ODD to Abdera’s neuroendocrine carcinoma treatment NImmune and BioTherapeutics partner on precision medicine development The trial will involve patients with small cell lung cancer (SCLC) or large cell neuroendocrine carcinoma (LCNEC) who have previously undergone platinum-based therapy. ABD-147’s targeted approach utilises Actinium-225, a potent alpha-emitting radioisotope, to selectively attack solid tumours expressing the delta-like ligand 3 (DLL3) with high affinity. Abdera Therapeutics chief medical officer Philippe Bishop stated: “Neuroendocrine carcinomas, including SCLC and LCNEC, are aggressive and challenging to treat effectively with current systemic therapies. “By delivering a potent radioisotope to neuroendocrine tumours expressing DLL3 with custom-engineered PK properties, we believe ABD-147 has the potential to become a best-in-class DLL3-targeting treatment for aggressive neuroendocrine tumours. “Along with FDA recently granting fast track designation to ABD-147 for the treatment of patients with extensive stage small cell lung cancer (ES-SCLC) who have progressed on or after platinum-based chemotherapy, this orphan drug designation for neuroendocrine carcinoma further underscores the potential of ABD 147 development to offer a significant advantage beyond approved drugs.” This content was updated on 25 January 2024