Ulviprubart

NEWTON, Mass.--( BUSINESS WIRE )--Abcuro, Inc., a clinical-stage biotechnology company developing therapies for the treatment of autoimmune diseases and cancer through precise modulation of cytotoxic T cells, today announced the appointment of Sarah Boyce to its Board of Directors. Ms. Boyce brings more than 25 years of global commercial leadership experience in the life sciences industry. “We are excited to welcome Sarah as a member of the Board and her experience will be instrumental as we focus on advancing ulviprubart in the ongoing Phase 3 MUSCLE trial for the treatment of inclusion body myositis,” said Mark Pruzanski, M.D., Chairman of the Board of Directors. “Sarah has extensive expertise in global product development, rare diseases and commercialization having helped bring over 20 products to market.” Ms. Boyce currently serves as the President and Chief Executive Officer of Avidity Biosciences, a publicly traded biotechnology company developing novel therapies for muscle wasting and other rare diseases. Prior to Avidity, she was President of Akcea Therapeutics and previously in her career held executive roles in business development and global operations for leading life sciences companies, including Ionis Pharmaceuticals, Forest Laboratories, Alexion Pharmaceuticals, Novartis Oncology and F. Hoffmann-La Roche AG. Ms. Boyce was named a Healthcare Technology Report Top 25 Biotech CEO in 2022 and one of the Fiercest Women in Life Sciences. She currently serves as a member of the Board of Directors at OmniAb and Contineum Therapeutics. Ms. Boyce holds a BSc (Hons) degree in microbiology from the University of Manchester, England. “I am thrilled to join Abcuro’s board at this critical point in the Company’s journey,” said Ms. Boyce. “I look forward to collaborating with the management team, providing guidance and sharing my expertise as the company progresses towards potential regulatory approval and readiness for potential commercialization.” About Abcuro Abcuro is a clinical stage biotechnology company developing first-in-class immunotherapies for the treatment of autoimmune diseases and cancer through precise modulation of highly cytotoxic T cells. The company’s lead program is ulviprubart (ABC008) and is currently in clinical trials for inclusion body myositis (IBM) and T cell large granular lymphocytic leukemia. For more information, visit us on LinkedIn and at abcuro.com .

NEWTON, Mass.--(BUSINESS WIRE)-- Abcuro, Inc., a clinical-stage biotechnology company developing therapies for the treatment of autoimmune diseases and cancer through precise modulation of cytotoxic T cells, today announced the completion of enrollment of the registrational Phase 2/3 MUSCLE clinical trial evaluating ulviprubart (ABC008) for the treatment of inclusion body myositis (IBM). “We continue to focus on advancing our product candidate ulviprubart to treat patients with IBM who currently have no treatment options and are therefore delighted to achieve another important milestone for this clinical program,” said H. Jeffery Wilkins, M.D., Chief Medical Officer of Abcuro. “Ulviprubart is a first-in-class therapy targeting KLRG1 and has great potential to transform the treatment paradigm for IBM where there is currently a significant unmet need. We look forward to sharing initial data from the Phase 2/3 MUSCLE trial in the first half of 2026.” "IBM is a tremendously debilitating disease which drastically and irreversibly reduces quality of life. Families are deeply affected as they witness their loved one's decline, while troubleshooting each facet of daily life to accommodate the condition. Living with IBM can make basic daily activities difficult and can negatively impact larger goals like maintaining hobbies and travel,” said Paula J. Eichenbrenner, MBA, CAE, Executive Director of The Myositis Association. "IBM patients have no recourse in the current therapeutic landscape. Exercise and physical therapy can preserve muscle and stave off disease progression, but only to a degree. The lack of disease-modifying treatment options places more burden on IBM families as they must help their loved ones to manage anxiety about the inevitable muscle loss they will endure and feelings of being trapped with this rare, catastrophic disease." The Phase 2/3 MUSCLE clinical trial (NCT05721573) is a global, randomized, double-blind, placebo-controlled, parallel multicenter registrational trial evaluating ulviprubart in patients with IBM. The objectives of the trial are to evaluate efficacy, safety, and tolerability of two dose levels of ulviprubart (0.5 mg/kg and 2.0 mg/kg) compared with placebo at 76 weeks in subjects with IBM followed by a 4-week safety follow-up period. About Ulviprubart Ulviprubart (ABC008) is a first-in-class anti-KLRG1 antibody product candidate capable of selectively depleting highly cytotoxic T cells, while sparing naïve, regulatory and central memory T cells. Ulviprubart is designed to treat diseases mediated by highly cytotoxic T cells, including the autoimmune muscle disease inclusion body myositis (IBM), T cell large granular lymphocytic leukemia (T-LGLL), and mature T cell malignancies. The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have each granted orphan drug designation to ulviprubart for the treatment of IBM. About Inclusion Body Myositis (IBM) IBM is an autoimmune disease in which highly cytotoxic T cells chronically attack muscle tissue leading to progressive weakness and limb muscle atrophy. Patients progressively lose muscle function, including loss of grip, dexterity and mobility. There are currently no available disease-modifying treatment options for IBM. Based on published epidemiology literature, it is estimated that there are more than 50,000 people with IBM across the US and Europe. About Abcuro Abcuro is a clinical stage biotechnology company developing first-in-class immunotherapies for the treatment of autoimmune diseases and cancer through precise modulation of highly cytotoxic T cells. The company’s lead program is ulviprubart (ABC008) and is currently in clinical trials for inclusion body myositis (IBM) and T cell large granular lymphocytic leukemia. For more information, visit us on LinkedIn and at abcuro.com.