GEn1E Lifesciences, Inc.

Former CEO of NPS Pharma brings strong biotech expertise to further accelerate GEn1E’s development and commercialization of dual signal modulators as novel precision therapies PALO ALTO, Calif., Dec. 11, 2024 (GLOBE NEWSWIRE) -- GEn1E Lifesciences (GEn1E), a clinical-stage, Phase 2 company, focused on accelerating novel therapies for inflammatory and rare diseases using machine learning, is pleased to announce the appointment of François Nader, MD, MBA as chair of its Board of Directors, effective immediately. "We are thrilled to welcome François to GEn1E’s Board of Directors as Chair," said Ritu Lal, PhD, CEO and Co-founder of GEn1E Lifesciences. "François’ deep expertise in biopharmaceutical innovation, strategic leadership, and rare diseases aligns perfectly with our mission to develop novel therapies for patients suffering from inflammatory and rare diseases. His transformational guidance will be invaluable as we continue to accelerate our pipeline to bring precision therapies to patients in need." "We are entering a pivotal time for treating inflammatory and rare diseases, and I'm excited to support GEn1E as it pioneers innovative therapies that could redefine patient care," said Dr. Nader. "I look forward to collaborating with Ritu and the GEn1E team to fully harness the potential of precision signal modulators and to accelerate the company's pipeline in addressing devastating diseases for patients." Dr. Nader currently serves as an Independent Board Director at Moderna and Ring Therapeutics, and Senior Advisor at Blackstone Life Sciences. Dr. Nader is the Chairman of BioLink.org and serves on the Board of Trustees for the Lebanese American University. Dr. Nader brings 30+ years of experience in the life sciences industry, including a highly successful tenure at NPS Pharmaceuticals as President and CEO where he led the company through a period of remarkable growth and achievement, culminating in its acquisition by Shire Pharmaceuticals for $5.2 billion. Formerly, François served as a chair or director of the Board of several public and private companies including chairman for Acceleron Pharma (acquired by Merck for $11.5B), and member of the Board for Alexion Pharmaceuticals (acquired by AstraZeneca for $39B) and Baxalta (acquired by Shire for $32B). Dr. Nader earned his French Doctorate in Medicine from St. Joseph University (Lebanon) and his Physician Executive MBA from the University of Tennessee. About GEn1E Lifesciences: GEn1E Lifesciences is a clinical-stage, Phase 2 company accelerating novel, dual signal modulator precision therapies for rare and inflammatory diseases. GEn1E Lifesciences is based in Palo Alto, California, with a laboratory in Mountain View, California. GEn1E has developed a well-differentiated "Platform-in-a-Mechanism" drug development model that uses AI which spans the entire end-to-end drug development cycle. The company has accelerated several milestones to build a portfolio of 21+ novel Dual Signal Modulators across two targets, which are actively being developed as first-in-class therapies for rare and inflammatory diseases with lead compound in Phase 2 currently enrolling patients in the US. For more information on GEn1E, visit www.gen1e.com and follow GEn1E on LinkedIn. Contacts:PR: info@gen1elifesci.comPartnering: partnering@gen1elifesci.comWeb: http://www.gen1e.com A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/30ec883f-2e8f-4aae-833c-40edef90287a

Oct. 14, 2024 -- GEn1E Lifesciences, a clinical-stage Phase 2 company, and a leading innovator in precision therapies for inflammatory and rare diseases, with a strong partnership with the University of Maryland, Baltimore (UMB), today announced the publication of a landmark study in the prestigious Journal of Pharmacology and Experimental Therapeutics (JPET). The study, titled First-in-Class Mitogen-Activated Protein Kinase p38α: MAPK-Activated Protein Kinase-2 (MK2) Dual Signal Modulator with Anti-inflammatory and Endothelial-Stabilizing Properties, marks a significant advancement of next-generation immunomodulatory therapeutics for treating inflammatory and autoimmune diseases. “Our findings represent a new era in kinase pathways,” said Paul Shapiro, PhD, co-author and professor in the Department of Pharmaceutical Sciences at the University of Maryland School of Pharmacy and its associate dean for research. “We have reasoned that the past clinical failure of previous generation p38 catalytic inhibitors reflects an intrinsic flaw in the strategy of inhibiting kinase activity. So, we utilized an alternative and unique strategy based on the p38 MAPK structure and functions enabling us to modulate critical inflammatory pathways while minimizing off-target effects - a breakthrough that could transform the treatment of inflammatory diseases.” Jeff Hasday, MD, the Dr. Herbert Berger Professor of Medicine and former Head of the Pulmonary and Critical Care Medicine Division at the University of Maryland School of Medicine and the study's co-contributing author, emphasized the clinical relevance of the findings. “GEn-1124 offers a targeted way to destabilize the p38:MK2 complex without blocking p38 catalytic activity or ablating downstream signaling. The result is a rebalancing of downstream pro- and anti- inflammatory signaling, yielding anti-inflammatory, endothelial-stabilizing, and lung-protective effects with therapeutic potential in pulmonary diseases where inflammation and endothelial barrier dysfunction play key roles.” Key Points from the Study: Targeted Modulation: GEn-1124 precisely disrupts the p38α:MK2 complex, maintaining downstream signaling essential for cellular function while selectively inhibiting pro-inflammatory responses. Efficacy in Preclinical Models: GEn-1124 demonstrated remarkable efficacy in preclinical studies, improving survival rates by 4-fold in acute lung injury and 5-fold in influenza-induced pneumonia along with the compound’s potential to halt disease progression. Endothelial-Stabilizing Properties: The compound showed robust barrier-stabilizing effects in human pulmonary artery endothelial cells (hPAEC), a key factor in treating diseases characterized by vascular leakage and inflammation. The breakthrough findings are well-timed, as GEn1E Lifesciences, which has an exclusive, worldwide and all fields license from UMB is enrolling patients for a Phase 2 study for ARDS, a devastating disease costing $25B to the US society. “We’re thrilled to see the immense potential of next generation dual signal modulators unfold in this study,” said Ritu Lal, CEO, Co-founder of GEn1E Lifesciences and adjunct Associate Professor at the University of Maryland School of Pharmacy. “This breakthrough underscores our mission to develop precision therapies for inflammatory diseases and improve outcomes for patients suffering from devastating conditions.” GEn1E Lifesciences is a clinical-stage, Phase 2 company accelerating novel, dual signal modulator precision therapies for rare and inflammatory diseases. GEn1E Lifesciences is based in Palo Alto, California, with a laboratory in Mountain View, California and a strong collaboration with the University of Maryland, Baltimore. GEn1E has developed a well-differentiated “Platform-in-a-Mechanism” model that uses AI to span the entire end-to-end drug development cycle. The company has accelerated several milestones with novel Signal Modulators being actively developed as first-in-class therapies for rare and inflammatory diseases with its lead compound in Phase 2 currently enrolling patients in the US. The content above comes from the network. if any infringement, please contact us to modify.

PALO ALTO, Calif., Oct. 24, 2023 /PRNewswire/ -- GEn1E Lifesciences Inc. has been awarded a contract from the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services to support the development of the company's novel therapy for acute respiratory distress syndrome (ARDS), a devastating respiratory condition with no approved therapies and a 40% mortality rate. The funding is provided via BARDA's Division of Research, Innovation, and Ventures (DRIVe) as part of the Host Directed Therapeutics Program to address a gap in the ability to stratify patients to predict patient outcomes to aid in clinical management. The funding will be used to advance development of the company's ARDS endotyping program called ASPECT, which helps identify ARDS patients with distinct clinical outcomes. This approach will help further accelerate the development of GEn1E's novel, first-in-class, p38a:MK2 Signal Modifier therapy for ARDS, GEn-1124, which is currently enrolling patients in a company-sponsored Phase 2 study (NCT05795465). The clinical heterogeneity of ARDS makes it difficult to understand disease progression and identify appropriate therapeutic options. Developing a pragmatic method for stratifying all ARDS patients, which can be used to identify patient trajectories and improve treatment in the clinical setting can benefit all providers and patients across the U.S. "We thank BARDA for their support and look forward to advancing the development of GEn1E's first-in-class therapy for use in ARDS patients," stated Dr. Ritu Lal, CEO of GEn1E Lifesciences. "Heterogeneous populations and non-personalized treatment of ARDS patients is at the core of disease progression and poor clinical outcomes. Using AI and 'omics' data enables us to better define, diagnose and predict ARDS endophenotypes that can be used to target patients who will benefit from our therapy. Through this partnership with BARDA, we can change the trajectory of ARDS and help patients who do not have any options." This project has been supported in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract number 75A50123C00063. ABOUT GEN1E LIFESCIENCES: GEn1E Lifesciences is a Clinical-Stage Phase 2 Techbio company accelerating novel and first-in-class immunomodulatory therapies for rare and inflammatory diseases. GEn1E Lifesciences is based in Palo Alto, California, with a laboratory in Mountain View, California. GEn1E has created a well-differentiated "Platform-in-a-Mechanism" drug development model that uses artificial intelligence and machine learning (AI/ML) which spans the entire end-to-end drug development cycle. By using its integrated AI platform called RIDGE, the company has accelerated several significant milestones to build a portfolio of 21+ novel Signal Modifiers across two clinically valuable targets, which are actively being developed as first-in-class therapies for rare and inflammatory diseases with no treatments and hurtful health economics for patients and payors. For more information on GEn1E, visit and follow GEn1E on LinkedIn. SOURCE GEn1E Lifesciences Inc.