BioAegis Therapeutics, Inc.

Feb. 27, 2024 -- BioAegis Therapeutics, a pioneering biotech company at the forefront of innovative therapies for inflammatory diseases, is pleased to announce site recruitment for BTI-203, a Phase 2 study of recombinant human gelsolin (rhu-pGSN) for the treatment of Acute Respiratory Distress Syndrome (ARDS) (NCT05947955). The study, A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Adjunctive Recombinant Human Plasma Gelsolin With Standard of Care for Moderate-to-Severe ARDS Due to Pneumonia or Other Infections is being conducted under a contract with BARDA’s Division of Research, Innovation, and Ventures (DRIVe), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services. Approximately 80 sites in the US, Canada, UK and the EU, including Belgium, France, Italy, Germany, Netherlands, Spain and others will conduct the study. Enrollment is targeted for 600 subjects. The planned primary outcomes are all-cause mortality at Day 28 between treatment groups and incidence, causality, and severity of SAEs in rhu-pGSN vs placebo treatment. ARDS is a condition that can develop as a severe complication of sepsis, trauma, pneumonia or other infectious diseases, resulting in life-threatening lung injury with fluid leakage into the lungs. Breathing becomes difficult and patients require oxygen, mechanical ventilation and extensive critical care resources, placing a significant burden on the healthcare system. Even with aggressive medical management, a substantial number of patients do not survive, and those who do may suffer from long-term complications, including impaired lung function and reduced quality of life. In the U.S. alone, ARDS affects over 700,000 patients per year or roughly 10% of all ICU admissions. The mortality rate for ARDS is approximately 40%. The lack of effective therapies to treat ARDS and its associated high mortality driven by excess inflammation underscores the urgent need for an innovative therapy in this field. Plasma gelsolin holds immense promise as a therapeutic intervention for ARDS due to its multifaceted mechanism of action. Gelsolin has demonstrated the ability to: Modulate the activation of the NLRP3 inflammasome and generation of IL-1β-containing microparticles Facilitate uptake and killing of microbial pathogens by innate immune cells Bind to and remove harmful inflammatory mediators Regulate macrophage phenotype to modulate inflammation Gelsolin is a naturally occurring human protein found in the bloodstream, which is depleted by counteracting the inflammatory process. Supplementation with the recombinant gelsolin protein holds promise to address the overzealous inflammatory response associated with ARDS. "ARDS is significant source of mortality as well as a drain on healthcare resources across the globe. We are committed to reaching our goal of saving lives by addressing the challenges of this complex disease," stated Susan Levinson, Ph.D., Chief Executive Officer of BioAegis. This project has been supported in whole or in part with federal funds from the U.S. Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority, under contract number 75A50123C00067. BioAegis Therapeutics Inc. is a NJ-based clinical-stage, private company whose mission is to capitalize on a key component of the body’s innate immune system, plasma gelsolin, to prevent adverse outcomes in diseases driven by inflammation and infection. BioAegis’ platform is built upon the recombinant form of plasma gelsolin, a highly conserved abundant human protein in healthy individuals. Its role is to keep inflammation localized to the site of injury and to boost the body’s ability to clear pathogens. Normal levels of pGSN are depleted by diverse inflammatory conditions. Restoring gelsolin levels with the human recombinant form, rhu-pGSN, helps immune cells fight infection and controls inflammation so it does not spread and cause organ damage. Rhu-pGSN is a non-antibiotic, host-directed, non-immunosuppressive treatment for inflammation due to both infectious and non-infectious causes. BioAegis has the exclusive license to broad, worldwide intellectual property through Harvard-Brigham and Women’s Hospital. It holds over 40 patents issued for coverage of inflammatory disease, infection, renal failure, and neurologic disease. BioAegis will also have US biologics exclusivity and has recently filed new IP in areas of unmet need. The content above comes from the network. if any infringement, please contact us to modify.

Partnership supports execution of a large phase 2 global study to evaluate efficacy and safety of recombinant human plasma gelsolin (rhu-pGSN) for moderate-to-severe ARDS. NORTH BRUNSWICK, N.J., Oct. 16, 2023 (GLOBE NEWSWIRE) -- BioAegis Therapeutics, a pioneering biotech company at the forefront of innovative therapies for inflammatory diseases, is pleased to announce a second partnership with 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. This partnership comes with the award of a $20 million contract from BARDA’s Division of Research, Innovation, and Ventures (DRIVe), to advance gelsolin, a master regulator of the innate immune system, for the treatment of Acute Respiratory Distress Syndrome (ARDS). This significant injection of funding accelerates BioAegis’ ARDS program and the execution of its strategy to transform the treatment of inflammatory diseases. Effectively Treating ARDS will Reduce Society’s Vulnerability to Global PandemicsAcute Respiratory Distress Syndrome (ARDS) is a condition that can develop as a severe complication of pneumonia, sepsis, or trauma resulting in life-threatening lung injury with fluid leakage into the lungs. Breathing becomes difficult and patients require oxygen, mechanical ventilation and extensive critical care resources, placing a significant burden on the healthcare system. Even with aggressive medical management, a substantial number of patients do not survive, and those who do may suffer from long-term complications, including impaired lung function and reduced quality of life. In the US alone, ARDS affects over 700,000 patients per year or roughly 10% of all ICU admissions. The mortality rate for ARDS is approximately 40%. The lack of effective therapies to treat ARDS and its associated high mortality driven by excess inflammation underscores the urgent need for an innovative therapy in this field. Plasma Gelsolin: A Multitasking Protein for a Complex Condition Plasma gelsolin holds immense promise as a therapeutic intervention for ARDS due to its multifaceted mechanism of action. Gelsolin has demonstrated the ability to: Modulate the activation of the NLRP3 inflammasome and generation of IL-1β-containing microparticlesFacilitate uptake and killing of microbial pathogens by innate immune cellsBind to and remove harmful inflammatory mediatorsRegulate macrophage phenotype to modulate inflammation Gelsolin is a naturally occurring human protein found in the bloodstream, which is depleted by counteracting the inflammatory process. Supplementation with the recombinant gelsolin protein holds promise to address the overzealous inflammatory response associated with ARDS. "We are delighted that BARDA DRIVe has chosen to continue our partnership with this shared goal of addressing the challenges of ARDS by bringing plasma gelsolin therapy to patients," stated Susan Levinson, Ph.D., Chief Executive Officer of BioAegis. This project has been supported in whole or in part with federal funds from the U.S. Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract number 75A50123C00067. About BioAegisBioAegis Therapeutics Inc. is a NJ-based clinical-stage, private company whose mission is to capitalize on a key component of the body’s innate immune system, plasma gelsolin, to prevent adverse outcomes in diseases driven by inflammation and infection. BioAegis’ platform is built upon the recombinant form of plasma gelsolin, a highly conserved abundant human protein in healthy individuals. Its role is to keep inflammation localized to the site of injury and to boost the body’s ability to clear pathogens. Normal levels of pGSN are depleted by diverse inflammatory conditions. Restoring gelsolin levels with the human recombinant form, rhu-pGSN, helps immune cells fight infection and controls inflammation so it does not spread and cause organ damage. Rhu-pGSN is a non-antibiotic, host-directed, non-immunosuppressive treatment for inflammation due to both infectious and non-infectious causes. BioAegis has the exclusive license to broad, worldwide intellectual property through Harvard-Brigham and Women’s Hospital. It holds over 40 patents issued for coverage of inflammatory disease, infection, renal failure, and neurologic disease. BioAegis will also have US biologics exclusivity and has recently filed new IP in areas of unmet need. Investor Inquiries:Steven Cordovano203-952-6373scordovano@bioaegistx.com Media Inquiries:Christine Laganaclagana@bioaegistx.com This press release contains express or implied forward-looking statements, which are based on current expectations of management. These statements relate to, among other things, our expectations regarding management’s plans, objectives, and strategies. These statements are neither promises nor guarantees but are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. BioAegis assumes no obligation to update any forward-looking statements appearing in this press release in the event of changing circumstances or otherwise, and such statements are current only as of the date they are made.

NORTH BRUNSWICK, N.J., May 10, 2023 (GLOBE NEWSWIRE) --BioAegis Therapeutics Inc., a clinical-stage company developing novel therapies for inflammatory diseases through a portfolio built around plasma gelsolin (pGSN), a highly conserved and abundant endogenous human immune regulatory protein, announces that it will host a free webinar on the expanding spectrum of auto- and hyper- inflammatory diseases on Tuesday, May 23, 2023 at 2:00 pm Eastern Time. The webinar, Below the Eyes of the Hippopotamus: The Expanding Spectrum of Auto- and Hyper- Inflammatory Diseases will delve beneath the surface of this rapidly growing field of auto-inflammatory and hyper-inflammatory diseases. It will explore what we know and will need to know moving forward, in particular: How these diseases of the innate immune system are identified and categorized, and the danger of the cytokine storm. The major scientific breakthrough in identifying genes responsible for autoinflammatory diseases and related genotypes. Key biomarkers for autoinflammatory diseases and new targets for treatments, like the NLRP3 inflammasome. A live Q&A discussion with key opinion leader, David Fajgenbaum, MD, will follow the presentation. Please click here to register. The webinar will feature Lester Kobzik, MD, Chief Medical Officer, Cellecta, Inc., Mark J. DiNubile, MD, FIDSA, Chief Medical Officer, BioAegis Therapeutics, and David Fajgenbaum, MD, MBA, MSc, co-Founder & President of the Castleman Disease Collaborative Network. Speaker Biographies Lester Kobzik, MD is a professor emeritus of Pathology at the Harvard Medical School and the Harvard T. H. Chan School of Public Health. His research interests center on lung disease and how the lung defends itself against inhaled toxic and infectious challenges. His work has characterized scavenger receptors on lung macrophages and how they function to remove potentially harmful if inhaled particulates and bacteria. He is also actively engaged in studies of infectious agents, including use of functional genomic screening to identify novel pathways and therapeutic leads. He has authored over 300 research publications in the area of lung pathobiology and has served on numerous grant and scientific review panels for the NIH, EPA and other research organizations. Dr. Kobzik received his undergraduate degree and medical degree from Tufts University. He completed residency training in anatomic pathology at the Brigham and Women’s Hospital, then joined the faculty there and at the Harvard Medical and Public Health Schools. Dr. Kobzik currently serves as Chief Scientific Advisor for BioAegis Therapeutics. Mark J. DiNubile, MD, FIDSA is a board-certified physician in Internal Medicine and the subspecialty of Infectious Diseases and Fellow of the Infectious Disease Society of America (FIDSA). Prior to joining BioAegis in 2017, Dr. DiNubile spent 16 years at Merck & Co., Inc. where he was primarily focused on the therapeutic areas of Infectious Diseases and Vaccines. He has extensively published on a diverse spectrum of medical and scientific topics. Dr. DiNubile graduated from the University of Pennsylvania summa cum laude and Yale School of Medicine, followed by internship and residency at the Hospital of the University of Pennsylvania. As a fellow at Harvard Medical School, he completed his clinical infectious diseases requirements at Brigham & Women’s Hospital followed by hematology research focusing on neutrophil motility and phagocytosis at the Massachusetts General Hospital. For more than a decade, prior to joining industry at Merck, Mark cared for patients in the ambulatory and hospital setting; taught medical students, house officers and fellows; chaired the hospital Pharmacy and Therapeutics Committee; initiated an antibiotic-stewardship program; and pursued clinical investigation and basic research, largely related to host defense and immunosuppression. David Fajgenbaum, MD, MBA, MSc, is a physician-scientist at the University of Pennsylvania, co-Founder & President of the Castleman Disease Collaborative Network, and founding director of the Center for Cytokine Storm Treatment and Laboratory. He is also the national bestselling author of “Chasing My Cure: A Doctor’s Race to Turn Hope Into Action”. Dr. Fajgenbaum is also a patient battling a deadly disease which he discovered a treatment for that is saving his life and others. Through his work at Penn, he has identified and advanced 11 other treatments for autoimmunity and cancer. He recently co-founded Every Cure, a non-profit on a mission to unlock the full potential of FDA-approved medicines to treat every disease possible. He has been profiled by The NY Times, TODAY, GMA, and others and received numerous awards including the 2016 Atlas Award along with then VP Joe Biden and Forbes 30 Under 30. Dr. Fajgenbaum earned a BS from Georgetown University, MSc from the University of Oxford, MD from the University of Pennsylvania, and MBA from The Wharton School. About BioAegis BioAegis Therapeutics Inc. is a NJ-based clinical-stage, private company whose mission is to capitalize on a key component of the body’s innate immune system, plasma gelsolin, to prevent adverse outcomes in diseases driven by inflammation and infection. BioAegis’ platform is built upon the recombinant form of plasma gelsolin, a highly conserved abundant human protein in healthy individuals. Its role is to keep inflammation localized to the site of injury and to boost the body’s ability to clear pathogens, but normal levels are depleted by diverse inflammatory conditions. Restoring gelsolin levels with the human recombinant form, rhu-pGSN, helps immune cells fight infection and controls inflammation so it does not spread and cause damage. Rhu-pGSN is a non-antibiotic, host-directed, non-immunosuppressive treatment for inflammation due to both infectious and non-infectious causes. BioAegis has the exclusive license to broad, worldwide intellectual property through Harvard-Brigham and Women’s Hospital. It holds over 40 patents issued for coverage of inflammatory disease, infection, renal failure, and neurologic disease. BioAegis will also have US biologics exclusivity and has recently filed new IP in areas of unmet need. Investor Inquiries: Steven Cordovano 203-952-6373 scordovano@bioaegistx.com Media Inquiries: Christine Lagana clagana@bioaegistx.com This press release contains express or implied forward-looking statements, which are based on current expectations of management. These statements relate to, among other things, our expectations regarding management’s plans, objectives, and strategies. These statements are neither promises nor guarantees but are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. BioAegis assumes no obligation to update any forward-looking statements appearing in this press release in the event of changing circumstances or otherwise, and such statements are current only as of the date they are made.