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iStock, Andrii Yalanskyi The panelists flagged safety concerns with Blenrep and GSK’s failure to optimize its dosing regimen for the antibody-drug conjugate in multiple myeloma. The FDA’s external cancer advisors found that the benefits of GSK’s antibody-drug conjugate Blenrep to patients with relapsed or refractory multiple myeloma do not outweigh its risks. The Oncologic Drugs Advisory Committee convened Thursday to vote on two proposed Blenrep combo regimens. With a 7–1 split, the panel agreed that Blenrep plus the chemotherapy pomalidomide and steroid dexamethasone had an unfavorable benefit-risk pro this indication, while they voted 5–3 against the combination of Blenrep with bortezomib, another chemotherapy, and dexamethasone. “The efficacy data were strong but the toxicity data were also very strong,” Neil Vasan, assistant professor at the Columbia University Medical Center, said in explaining his two no votes. “I really think this was just a missed opportunity over the course of many years of development of this drug to explore these different dosages.” In a briefing document released ahead of the meeting, the FDA’s internal reviewers said that GSK had not “adequately optimized” its dosing for Blenrep, as illustrated by “high rates of ocular toxicity and poor tolerability.” The FDA reviewers also flagged the “high rates of dose modifications” in both Phase III studies used by GSK to support its Blenrep application. The briefing document also pointed out that “in both trials, there was limited enrollment in the U.S., and limited enrollment of Black or African American patients and those 75 years of age and older,” noting that this may “limit applicability” of the results to U.S. patients. Daniel Spratt of Case Western Reserve University raised the same demographic issue on Thursday. “This is the United States FDA, so the proposed patient population [are] the United States patients. The clinical development program enrolled almost no patients in the United States,” he said. “It precludes any assessment of the benefit-risk pro the U.S.” Blenrep was first approved in August 2020 for patients with relapsed or refractory multiple myeloma under the regulator’s accelerated pathway but was pulled from the market in November 2022 after it failed the confirmatory Phase III DREAMM-3 trial. Last year, however, GSK began plotting Blenrep’s comeback with data from the Phase III DREAMM-7 and DREAMM-8 trials, which demonstrated progression-free survival improvements after treatment with the drug. The pharma in June 2024 even indicated that Blenrep could hit “ multi-blockbuster ” status when positioned as a second-line treatment for multiple myeloma.

Preliminary clinical data from Xabg, Xeltis' coronary artery bypass conduit (CABG), demonstrating positive safety and patency In an earlier, separate trial, Xabg recently demonstrated patency with excellent flow in a 24-month trial – the first time ever this duration has been achieved Supports potential of Xabg to transform CABG surgery landscape and eliminate need for vein harvesting EINDHOVEN, Netherlands, 17 July 2025 /PRNewswire/ -- Xeltis, a leading developer of transformative implants that enable the natural creation of living and long-lasting vessels, today announces encouraging preliminary data for Xabg, its coronary artery bypass conduit (CABG), demonstrating positive safety and patency among patients with multi-vessel atherosclerotic coronary artery disease. Xabg is a novel, biorestorative, polymeric conduit which enables continued blood flow in coronary artery disease patients. Developed using Xeltis' proprietary Endogenous Tissue Restoration (ETR) platform based on Nobel Prize winning polymer technology, Xabg has unique regenerative properties, enabling living tissue to replace it over time. Cardiovascular disease is the leading cause of mortality globally, with coronary artery bypass surgery being the most common cardiac surgery performed worldwide. CABG is an invasive procedure, often requiring multiple painful vein grafts with a high risk of complications. The global CABG market is projected to reach more than $20 Billion by 2035, driven by the growing prevalence of cardiovascular disease[i]. A clinical trial is underway at various sites in the EU with positive, preliminary data demonstrating Xabg to be functioning well with excellent flow in patients. This underscores the potential of Xabg to eliminate the need for vein harvesting and transform the bypass surgery landscape with the goal of longer-term durability. With no approved off-the-shelf, small-diameter vascular grafts with good patency rates available, Xabg has the potential to address this large unmet clinical need of suboptimal conduits in bypass surgery. In an earlier trial, Xabg recently demonstrated patency after bypass surgery in a patient with excellent flow in a 24-month follow-up, marking the first time any artificial bypass surgery conduit has remained open and functional in humans for this duration. This clinical example provides continued validation of Xeltis' ETR scientific technology in action, redefining the landscape of vascular grafts and solutions. Paulo Neves, Chief Medical Officer, Xeltis, commented: "Despite suboptimal performance, 80% of CABG procedures rely on vein grafts – Xeltis has the potential to revolutionize that. The encouraging safety and patency data is a major milestone for Xeltis and demonstrates that Xabg has the potential to significantly improve outcomes for patients with coronary artery disease. We are grateful to all those involved in the trial and look forward to continuing patient enrolment and treatment." Dr Isaac George, Surgical Director at Columbia University Medical Center, added: "Xeltis is pushing the boundaries of innovation in vascular access solutions. The recent 24-month follow-up data is remarkable, the first of its kind to remain open at 24 months and demonstrate excellent flow. This, combined with the safety and patency results in Europe, underscores the potential of Xabg to improve long-term outcomes, reduce the need for reinterventions, and significantly impact patient care and healthcare costs." The single arm, human feasibility study in the EU will evaluate the preliminary safety and performance of the Xabg technology in patients with multi-vessel atherosclerotic coronary artery disease who are scheduled to undergo elective coronary artery bypass (CABG) surgery. Xabg is Xeltis' second product in clinical development, following aXess, its restorative vascular access conduit, for which pivotal trials are underway in the EU and US, showcasing the strength of the Company's clinical pipeline as it advances towards commercialization. About Xeltis Xeltis is a medtech company developing transformative implants that enable the natural creation of living and long-lasting vessels. Xeltis seeks to address the limitations of currently available options for the millions of people requiring hemodialysis access grafts or cardiovascular replacements every year. The Company's proprietary endogenous tissue restoration (ETR) platform utilizes an advanced polymer implant which regenerates the patient's own tissue before gradually being absorbed and leaving new, living, and long-lasting vessels in place. Xeltis' most advanced product currently under clinical development is aXessTM, an implantable blood vessel for hemodialysis vascular access. Xeltis' groundbreaking technology has high potential to be applied to other major vascular and cardiovascular diseases. Xeltis is based in The Netherlands and the USA. Its investors include DaVita Venture Group, EQT Life Sciences, Kurma Partners, VI Partners, Ysios Capital, Grand Pharma Group, the European Innovation Council and Invest-NL, in addition to other public and private investors. Visit the Xeltis website for more details: [i] Coronary Artery Bypass Graft Market Growth 2025 to 2035 SOURCE Xeltis WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

BOSTON, July 15, 2025 (GLOBE NEWSWIRE) -- Aegle Therapeutics, a clinical-stage dermatology-focused biopharmaceutical company developing novel therapies for those living with rare and severe skin diseases, today announced the appointment of Scott Braunstein, M.D., as Chairman of the Board. The company’s lead product candidate AGLE-102, a composite of mesenchymal stem cell derived extracellular vesicles (MSC-EVs), is currently being evaluated in a Phase 1/2a trial for the treatment of recessive dystrophic epidermolysis bullosa (RDEB), a rare pediatric skin blistering disorder. “We are excited to welcome Dr. Braunstein as Chairman and look forward to his guidance as we advance the development of AGLE-102 as a novel therapeutic platform for rare and severe dermatological disorders,” said Shelley Hartman, CEO of Aegle. “Dr. Braunstein’s extensive industry experience will be a valuable addition to our leadership team as we continue to develop AGLE-102 for RDEB and other subtypes of epidermolysis bullosa.” Dr. Braunstein commented, “Aegle is at the forefront of advancing extracellular vesicle-based therapies which have exciting potential across a broad spectrum of refractory dermatological disorders. I look forward to working with Shelley and the management team to advance their current mission of offering patients and their families a novel and simple biological solution for the treatment of EB.” Scott Braunstein, M.D.Scott Braunstein, M.D., brings over 30 years of knowledge and experience from diverse biotechnology and pharmaceutical industry vantage points. Dr. Braunstein served as President and Chief Executive Officer of Marinus Pharmaceuticals, Inc., a company focused on rare forms of epilepsy, until acquired by Immedica Pharma AB. Prior to that, he served as Senior Vice President, Strategy and Chief Operating Officer at Pacira Pharmaceuticals, Inc., a specialty pharmaceutical company. Prior to Pacira, Dr. Braunstein spent 12 years with J.P. Morgan Asset Management as a Managing Director, Healthcare Analyst and the Portfolio Manager of the JP Morgan Global Healthcare Fund. Dr. Braunstein has been an operating partner at Aisling Capital since 2015. He currently serves on the board of directors for atai Life Sciences N.V., Caribou Biosciences, Inc., RAPT Therapeutics and Site One Therapeutics, a clinical-stage neurology company that is being acquired by Eli Lilly. Dr. Braunstein previously served on the board of directors of Trevena Inc., Esperion Therapeutics, Inc., Ziopharm Oncology Inc., Protara Therapeutics, Inc. (previously known as ArTara Therapeutics, Inc.) and Constellation Pharmaceuticals, Inc. Dr. Braunstein began his career as a practicing physician at the Summit Medical Group and as an Assistant Clinical Professor at Albert Einstein College of Medicine and Columbia University Medical Center. Dr. Braunstein received an M.D. from the Albert Einstein College of Medicine and a BASc in biology from Cornell University. About AGLE-102™ AGLE-102 is a composite of extracellular vesicles isolated from allogeneic mesenchymal stem cells using Aegle's proprietary methods. The product is a composite of native EVs and their associated complex assemblies of biologic molecules such as proteins, peptides, ligands and nucleic acids that induce a wide variety of biological effects in recipient cells, including reducing inflammation, modulating the immune system and promoting regenerative healing. About Aegle Therapeutics CorporationAegle Therapeutics is a clinical-stage dermatology-focused biopharmaceutical company developing novel EV therapies to treat rare and severe dermatological disorders with significant unmet medical need. The company’s lead product candidate, AGLE-102, is currently in a phase 1/2a study for the treatment of recessive dystrophic epidermolysis bullosa and has successfully completed a proof-of-concept study in severe burns. AGLE-102 has the potential to treat all subtypes of epidermolysis bullosa as well as a broad range of other dermatological indications characterized by inflammation resulting from an underlying immune imbalance. For more information about Aegle Therapeutics, please visit www.aegletherapeutics.com. For More Information Contact:info@aegletherapeutics.com