ABIONYX Pharma SA

TOULOUSE, France & FULLERTON, Calif. & LISSES, France--(BUSINESS WIRE)--Regulatory News: ABIONYX Pharma, (FR0012616852 – ABNX – eligible PEA PME), a next-generation biopharma company pioneering a new therapeutic era in sepsis and critical care through its proprietary apoA-I–based technology platform, and SEBIA, a global player in specialized biological diagnostics, today announced an exclusive global strategic partnership in sepsis. New tests for early diagnosis and monitoring of sepsis treatment This partnership will enable the validation of new infectious and metabolic diagnostic tests that allow for earlier and more accurate identification of the severity of sepsis, enabling faster treatment and dynamic monitoring of treatment efficacy, including ABIONYX Pharma's recombinant apoA-I. A global partnership based on scientific excellence and technological complementarity Under this agreement, SEBIA will draw on its unique expertise in preparative analytical chemistry for blood samples and in the development and validation of methods for separating proteins, lipoproteins, and glycoproteins. ABIONYX Pharma, for its part, will contribute its expertise in lipid biology and clinical studies, and its in-depth understanding of sepsis acquired through its recombinant biomedicine in phase 2b/3. The two companies have established a Joint Steering Committee to jointly oversee the program, from initial analytical validations to regulatory approvals. A confidentiality framework necessary for exclusive cooperation Discussions between the two companies, which began several months ago, have led to an extensive and exclusive cooperation agreement. The financial terms, technical milestones, and deployment conditions remain confidential. A major medical and economic challenge Every year, sepsis affects more than 50 million people. Despite advances in intensive care, the mortality rate can exceed 30% in severe cases. Early detection remains one of the most difficult challenges in modern medicine: the signs are diffuse, and the progression is often sudden and severe. The current lack of reliable and rapid diagnostic tools often leads to critical delays in treatment. Every minute counts when it comes to sepsis—this devastating inflammatory syndrome kills more than 11 million people worldwide each year. By combining biotherapy and diagnostics, ABIONYX Pharma and SEBIA are laying the foundations for an integrated approach to sepsis management that can improve survival rates, reduce hospital stays, and optimize healthcare costs. The global market for sepsis diagnostics is estimated to be worth more than $1.5 billion by 2030, with annual growth of close to 9%. The two companies' shared ambition is clear: to make this innovation a global benchmark in emergency diagnostics. About SEBIA : www.sebia.com Founded in 1967, Sebia is one of the world's leading suppliers of equipment and reagents for clinical protein electrophoresis, a technology used for in vitro diagnostic testing. Its systems analyze proteins to screen for and monitor various diseases and conditions, primarily in oncology (multiple myeloma) and metabolic disorders such as diabetes, but also in hemoglobinopathies and rare diseases. Following the acquisition of Orgentec, Corgenix, Arotec in 2021, and Zeus Scientific in 2022, Sebia now develops and markets innovative solutions for the diagnosis of autoimmunity. Based in Lisses, France, the company is present in more than 120 countries. About ABIONYX Pharma : www.abionyx.com ABIONYX Pharma is a next-generation biopharma company pioneering a new therapeutic era in sepsis and critical care through breakthrough biotherapies that address life-threatening conditions with no effective treatments. Leveraging its proprietary apoA-I–based technology platform, ABIONYX Pharma develops innovative biologics and HDL-derived vectors that target the immune and inflammatory dysregulation underlying sepsis and other severe diseases. With a strong scientific foundation and a growing network of global clinical partners, ABIONYX Pharma aims to redefine the standard of care in sepsis and to bring critical care solutions to patients worldwide.

TOULOUSE, France & FULLERTON, Calif.--(BUSINESS WIRE)--ABIONYX Pharma, (FR0012616852 - ABNX), a next-generation biotechnology company developing breakthrough therapies for severe and underserved diseases, today announced it has entered advanced strategic discussions with IHU SEPSIS, the world’s first and largest integrated center fully dedicated to the research, training, and clinical management of sepsis. IHU SEPSIS stands as the first global center devoted to integrated research, education, and patient care in sepsis, bringing together in a single institution a world-class hub for innovation across pediatric and adult sepsis. it has entered advanced strategic discussions with IHU SEPSIS, the world’s first and largest integrated center fully dedicated to sepsis research, training, and clinical care. IHU SEPSIS (Paris-Saclay University, AP-HP, CEA, and Inserm) unites 275 researchers, 94 clinicians, and 60 multidisciplinary teams in a global network spanning North America, Europe, and emerging regions, making it the leading hub for innovation in sepsis, a life-threatening condition affecting over 50 million people annually. The institute collaborates closely with Sepsis Canada and the Global Sepsis Alliance, reinforcing its global reach and ability to deploy clinical protocols and scalable care solutions worldwide. Through this partnership, ABIONYX Pharma and IHU SEPSIS aim to establish the first fully integrated global platform for sepsis treatment, combining Biopharma’s genetically validated apoA-I–based therapeutics and HDL-derived vectors with IHU SEPSIS’s world-class clinical infrastructure and international patient advocacy network. This innovative alliance accelerates the development of first-in-class therapies, strengthens global visibility, and positions ABIONYX Pharma as a key architect of the next era of precision medicine in critical care. Supported by the recent publication in Nature Scientific Reports demonstrating the causal role of apoA-I in sepsis, this collaboration reinforces the scientific and clinical credibility of ABIONYX Pharma’s pipeline, creating a strategic inflection point with high value potential for investors, global healthcare systems, and patients worldwide. About ABIONYX Pharma : ABIONYX Pharma is a next-generation biotechnology company pioneering a new therapeutic era in sepsis and critical care through breakthrough biotherapies that address life-threatening conditions with no effective treatments. Leveraging its proprietary apoA-I–based technology platform, ABIONYX develops innovative biologics and HDL-derived vectors that target the immune and inflammatory dysregulation underlying sepsis and other severe diseases.

TOULOUSE, France & FULLERTON, Calif.--(BUSINESS WIRE)--ABIONYX Pharma, (FR0012616852 - ABNX - PEA PME eligible), a new generation biotech company dedicated to the world's only recombinant apoA-I, today announced the publication of a ground breaking study in Scientific Reports in Nature Portfolio titled “Plasma apolipoprotein A-I is a causal protective factor in sepsis.” (https://www.nature.com/articles/s41598-025-19204-2#auth-Keith_R_-Walley-Aff1) This landmark publication provides, for the first time, genetic proof of a causal linkage between higher plasma ApoA-I levels and a lower incidence of sepsis and lower mortality in patients who do develop sepsis. At the same time, the publication provides genetic validation of the well-studied mechanism of apoA-I’s beneficial impact on sepsis – the sequestration of the bacterial lipid toxin, LPS, which is responsible for the manifestations of sepsis. The report provides evidence that apoA-I is also effective in reducing mortality in Gram positive sepsis driven by the bacterial toxin lipoteichoic acid. Importantly, the findings were replicated across three independent data sets, including both Caucasian and Asian sepsis sufferers. The structural protein which defines HDL is apoA-I. The study analyzed 442,601 participants from the UK Biobank, including 11,643 sepsis cases, and validated the findings across two large international cohorts. Results demonstrate that each standard deviation increase in plasma apoA-I levels reduces the incidence of sepsis by 13% and 28-day mortality by 27%. Using Mendelian randomization, the researchers confirmed that this protective effect is causal and independent of other lipid fractions (HDL-C, LDL-C, triglycerides). Mechanistically, higher apoA-I levels were linked to a reduction in circulating endotoxin (LPS) levels, reinforcing apoA-I’s role as a central modulator of inflammatory response and innate immunity in sepsis. “This publication is a game-changer,” said Dr. Rob SCOTT, MD, Head of R&D and CMO of ABIONYX Pharma. “For decades, the field of sepsis has searched for a causal target. The mechanistic effect of apoA-I and HDL has been well documented over the last 40 years but now, this new genetic validation provides proof that apoA-I is a major factor determining whether patients develop sepsis and whether they survive it. This major publication in Nature is a significant milestone that reinforces the scientific and strategic value of the company in ongoing discussions with a leading partner in sepsis.