Nanjing Leads Biolabs Co., Ltd.

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

Joe Jimenez’s Aditum Bio, an investment firm that builds companies around in-licensed assets, is going after one of the hottest new areas for its latest startup. The Oakland, CA-based firm is setting up Oblenio Bio with a license to a tri-specific T cell engager from Nanjing, China-based Leads Biolabs, the companies said Thursday morning. Leads will get $35 million upfront and in near-term payments, up to $579 million in biobucks as well as royalties and an equity stake in Oblenio. Aditum and Oblenio could hand over all of that in exchange for the exclusive option to develop, manufacture and commercialize LBL-051 worldwide. Aditum, which is currently raising a $400 million third fund , will back Oblenio and work with Leads to “rapidly bring” the TCE into human trials, the companies said. The T cell engager goes after CD19, BCMA and CD3. Oblenio is one of multiple companies now attempting to take T cell engagers into autoimmune diseases after they’ve been proven out in oncology. Ken Song’s new company Candid Therapeutics recently raised $370 million and in-licensed two T cell engagers from China. Big pharmas are also signing TCE deals for either autoimmune or oncology aspirations. Autoimmune diseases were one of the areas of interest that Jimenez highlighted in an interview with Endpoints News last fall. “Autoimmune is the new oncology in terms of pharma interest,” said Jimenez, who is a former CEO of Novartis. Aditum has created about a dozen companies so far. Eli Lilly bought Aditum’s obesity startup Versanis Bio for up to $1.9 billion last year after the company salvaged a muscle-preserving drug from Novartis.