Nanjing Leads Biolabs Co., Ltd.

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

Today, a brief rundown of news from AstraZeneca, Amgen and Jazz Pharmaceuticals, as well as updates from Geron, Gilead Sciences and Avid Bioservices that you may have missed.AstraZeneca and Amgens drug Tezspire reduced nasal congestion and the size of nasal polyps versus placebo in a Phase 3 trial involving people with a form of chronic rhinosinusitis, the companies said Friday. The results, which AstraZeneca and Amgen plan to present at an upcoming medical meeting, could help the two partners expand approval of Tezspire, which is currently cleared for asthma in the U.S. and five dozen other countries. Tezspire could also compete in the future with depemokimab, a drug from GSK that recently succeeded in two Phase 3 studies of people with the same condition. Ned PagliaruloJazz Pharmaceuticals plans to, in the first half of next year, start an early-stage study evaluating an experimental treatment for narcolepsy. Researchers recently tested the drug, called JZP441, in a different Phase 1 clinical trial, but Jazz paused the experiment due to reports of visual disturbances and cardiovascular effects. The drug is designed to target “orexins,“ a class of proteins that regulate important brain activity like wakefulness, arousal, hunger and even mood. On an earnings call Wednesday, Jazz's head of research and development, Robert Iannone, told investors that the new study will not only help the company decide whether to advance JZP441, but also “inform our backup programs. Jacob BellGeron has secured $250 million in funding, and potentially as much as $375 million overall, through agreements with Royalty Pharma and funds managed by Pharmakon Advisors. In the first deal, Geron has sold tiered royalty rights on U.S. net sales of Rytelo, its newly approved drug for anemia in people with myelofibrosis, in exchange for $125 million. The company also secured a 5-year senior secured term loan of up to $250 million from the Pharmakon-associated funds, half of which it has already drawn. Some of the funds have been used to repay loans Geron owed to Hercules Capital and Silicon Valley Bank. The rest will help Geron launch Rytelo and complete further testing of the drug. Ned PagliaruloVenture firm Aditum Bio and China-based Leads Biolabs have formed a new company to develop a tri-specific T cell engager for autoimmune diseases. The new company, dubbed Oblenio Bio, will launch with an exclusive option to develop the drug globally, in exchange for paying Leads $35 million in upfront and near-term fees. Leads will also take an equity stake in Oblenio, the 13th company spun out by Aditum. Ned PagliaruloGilead Sciences will no longer develop its antibody-drug conjugate Trodelvy in second-line non-small cell lung cancer, CEO Daniel ODay told investors Wednesday on an earnings call. The decision followed discussions with regulators after negative results from a lung cancer study earlier this year. As a result, Gilead will take a $1.8 billion write down in the value it ascribes to its in-process R&D. The company continues to develop Trodelvy, which is currently approved for certain kinds of breast tumors, in first-line lung cancer. Ned PagliaruloContract drugmaker Avid Bioservices will be taken private by GHO Capital Partners and Ampersand Capital Partners in a deal worth roughly $1.1 billion. The two investors will pay $12.50 per Avid share, a nearly 14% premium on the stocks closing price Wednesday. The deal comes the same week Ampersand paid $70 million in cash to buy a Nektar Therapeutics drug factory, and follows a pattern of contract development and manufacturing organizations being taken private in recent years. Ned Pagliarulo '

Leads Biolabs grants Oblenio Bio an exclusive option to license LBL-051, a first-in-class CD19xBCMAxCD3 tri-specific T-cell engager antibody OAKLAND, Calif. and NANJING, China, Nov. 7, 2024 /PRNewswire/ -- Aditum Bio and Leads Biolabs today announced the formation of Oblenio Bio, which is being formed in conjunction with an exclusive option and license agreement to develop LBL-051, a first-in-class CD19xBCMAxCD3 tri-specific T-cell engager antibody for autoimmune diseases. Aditum Bio will fund Oblenio Bio and the parties will collaborate to rapidly bring LBL-051 into clinical studies. Recent clinical data from CD19 and BCMA targeted therapies have demonstrated compelling efficacy in difficult-to-treat autoimmune diseases. Despite these promising results, there is a continued unmet need for increased efficacy and durability. By targeting both CD19 and BCMA, LBL-051 has the potential to deliver stronger and more durable responses by depleting a broader range of pathological B-cell populations across a wide spectrum of antibody-mediated autoimmune diseases. LBL-051 is a novel tri-specific T-cell engager developed using the LeadsBody™ Platform. Each target binding domain CD19, BCMA, and CD3- has been engineered with the intent of enhancing safety while optimizing efficacy by finely tuning the relative potency of each domain. Under the terms of the agreement, Leads Biolabs will grant Oblenio an exclusive option to develop, manufacture, and commercialize LBL-051 worldwide. Leads Biolabs is eligible to receive up to $35 million in upfront and near-term payments, $579 million in development, regulatory, and commercialization milestone payments, as well as royalties on sales. Additionally, Leads Biolabs is entitled to receive an equity stake in Oblenio Bio. "By targeting both CD19 and BCMA in autoimmune disorders, LBL-051 has the potential to achieve a complete immune reset and superior efficacy and durability, compared to single targeting of either CD19 or BCMA alone", said Joe Jimenez, Co-Founder and Managing Director of Aditum Bio. Dr. Xiaoqiang Kang, Founder, Chairman and CEO of Leads Biolabs added, "LBL-051 offers a differentiated approach to treating certain autoimmune conditions and has the potential to be a Pipeline in a Product. We are pleased to establish this partnership with the high caliber team at Aditum to bring this innovative therapy to patients around the world". Oblenio Bio is the thirteenth company launched by Aditum Bio, whose mission is to give large patient populations access to important medicines. To speed these drugs to market, Aditum Bio fosters an incubator model, focusing on the translational phase of drug development. The "spin out" model enables a nimble, start-up platform with a dedicated team of managers supported by Aditum's in-house team of development professionals. About Aditum Bio Aditum Bio is a biotech venture firm committed to improving health by accelerating drug development in disease areas with high unmet need where medical innovation can have a significant impact. Aditum Bio in-licenses promising drug candidates and spins out individual companies dedicated to bringing each candidate through early clinical trials. For more information, please visit . About Leads Biolabs Founded in 2014, Nanjing Leads Biolabs Co., Ltd. is a clinical-stage biotechnology company based in Nanjing, China, with operations extending to the U.S. Our focus is to discover and develop innovative therapies that address significant unmet medical needs in oncology, autoimmune diseases, metabolic disorders, and other serious conditions. Our robust R&D pipeline includes over twenty novel candidates across various modalities, including monoclonal antibodies, multi-specific antibodies, T cell engagers, and antibody-drug conjugates (ADCs). For more information, please visit SOURCE Aditum Bio WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED