GEn1E Lifesciences, Inc.

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.

GEn1E plans to use the novel discovery, which is licensed from University of Maryland, Baltimore, to develop therapies for pulmonary, oncology and muscle degenerative diseases BALTIMORE and PALO ALTO, Calif., July 26, 2022 /PRNewswire/ -- GEn1E Lifesciences, a next-generation multitarget techbio company developing novel and targeted immunomodulators, has secured an exclusive, worldwide, all-fields license from the University of Maryland, Baltimore (UMB) for patented next-generation Extracellular Signal-Regulated Kinase 1/2 (ERK1/2) immunomodulators. The Company plans to use the newly licensed compounds to advance its portfolio of novel immunomodulators for rare and inflammatory diseases for patients with unmet needs in the areas of pulmonary, oncology and muscle degenerative diseases. ERK1/2 is part of the mitogen-activated protein kinase (MAPK) family, an essential signaling pathway that plays a key role in several basic cellular processes, including proliferation and differentiation. Given the ubiquity of the ERK cascade in cellular processes, it shares the pathogenesis of several pulmonary, oncology, and muscle degeneration diseases. ERK1/2's multiple mechanisms-of-action make it an ideal platform candidate. "Our ERK1/2 research has unlocked new approaches to selectively inhibit enzyme functions involved in disease, which is different from the current ERK1/2 inhibitors that block all enzyme functions and often result in unwanted toxicities and side effects," said Paul Shapiro, PhD, professor of pharmaceutical sciences at the University of Maryland School of Pharmacy and inventor of the technology. "Our discovery of compounds that target unique substrate binding pockets provides an opportunity to develop novel function-selective kinase therapies that will treat the disease and cause fewer side effects." The new license builds on the strong working relationship between GEn1E and UMB. In 2019, GEn1E licensed a technology from UMB for developing next-generation p38 immunomodulators. That agreement is bearing fruit today with a lead compound in the clinic and several more novel compounds being accelerated in the pipeline. "With the addition of ERK1/2 as a new target, the scope of diseases for which we can point our powerful AI-based 'Platform in a Mechanism' model expands greatly," said Ritu Lal, PhD, CEO of GEn1E. "The University of Maryland, Baltimore has produced stellar technologies that have the potential to create long-lasting impacts for patients, many of whom are devastated without effective therapies. A proud UMB alum myself, I am thrilled to continue growing a close working relationship with the University." The power of GEn1E's platform is evident in the progress the Company has made since graduating from Y Combinator in late 2019. The Company's lead compound is in clinical stage and GEn1E scientists have developed more than 21 novel next-generation immunomodulators—all using only seed funding. GEn1E has demonstrated an unprecedentedly fast pace and efficiency in drug development using it's AI platform. "We are delighted to license additional assets to GEn1E Lifesciences and continue to develop our strong working relationship," said Phil Robilotto, DO, MBA, associate vice president of technology transfer at UMB and director of UM Ventures. "GEn1E's application of machine learning to accelerate the process of drug development is very exciting and we are thrilled to see the unmet needs of novel and next-generation therapies being fulfilled." ABOUT THE UNIVERSITY OF MARYLAND, BALTIMORE: The University of Maryland, Baltimore is commercializing breakthrough therapies, diagnostics and devices, fueling the creation of innovative start-up companies, and attracting industry leaders and entrepreneurs to its thriving campus. Founded in 1807 as the first public medical school in the nation, the University is a fast-growing biomedical research center with nationally ranked professional schools of dentistry, law, medicine, nursing, pharmacy, social work, an interdisciplinary graduate school as well as a 14 acre bio-medical research park. ABOUT GEN1E LIFESCIENCES: GEn1E Lifesciences is a clinical-stage, techbio company accelerating novel, next-generation immunomodulatory therapies for rare and inflammatory diseases. GEn1E has created a differentiated "platform in a mechanism" model that uses machine learning across the entire end-to-end drug development cycle. The company has validated its platform through several significant milestones including a portfolio of 21+ novel immunomodulators and a clinical-stage purpose-built therapy for acute respiratory distress syndrome (ARDS), a devastating respiratory condition with no approved therapeutic treatments and a ~40% mortality rate. GEn1E Lifesciences is based in Palo Alto, CA, with a laboratory in Mountain View, CA. For more information on GEn1E, visit and follow GEn1E on LinkedIn. SOURCE University of Maryland Ventures; GEn1E Lifesciences