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Phase 1 study of MTX-463 initiated after FDA Clearance of IND IND-enabling studies completed for second antibody program with Phase 1 expected to start in Q3 Clinical Advisory Board (CAB) of global experts in fibrosis formed to advance clinical development New preclinical data to be presented at upcoming medical meetings on WISP-1 and EphrinB2 and their roles in Idiopathic Pulmonary Fibrosis (IPF) and Systemic Sclerosis (SSc), respectively BOSTON, May 6, 2024 /PRNewswire/ -- Mediar Therapeutics, Inc., a biotechnology company advancing a portfolio of first-in-class therapies that halt fibrosis progression, today announced that, following FDA clearance of its investigational new drug (IND) application, the first cohort of participants has been dosed in a Phase 1 trial evaluating the safety and tolerability of MTX-463. MTX-463 is a first-in-class human IgG1 antibody designed to neutralize WISP-1-mediated fibrotic signaling to address IPF and other fibrotic diseases. The Phase 1 study for MTX-463 is designed to assess its safety at multiple dose levels, tolerability, and pharmacokinetics, while also assessing the ability of MTX-463 to engage its target, WISP-1. The trial is enrolling healthy participants and consists of staggered single ascending dose (SAD) and multiple ascending dose (MAD) cohorts. "Advancing our first-in-class portfolio to the clinic is an important milestone for Mediar, and an exciting moment envisioned by our founders at Mass General Brigham and advanced by our team," said Mediar's Chief Executive Officer Rahul Ballal, Ph.D. "MTX-463 is the first of two programs to begin clinical trials this year and we look forward to initiating a second Phase 1 study with our first-in-class anti-EphrinB2 molecule, MTX-474, in the third quarter." As Mediar advances MTX-463 and MTX-474 into human studies, it will be guided by its clinical advisory board, comprising world renowned leaders in fibrosis across pulmonology, rheumatology, hepatology, and regulatory. "With the formation of our CAB, we bring together a wealth of experience and expertise to help advance the clinical development of our pipeline as we work to address the significant unmet need in fibrosis," said Mediar's Chief Medical Officer Jeff Bornstein, M.D. The newly appointed members of the clinical advisory board are: Flavia Castelino, M.D., Associate Professor of Medicine, Harvard Medical School, Division of Rheumatology, Massachusetts General Hospital Lara Dimick-Santos, M.D., Medical Director, CTI Clinical Trial & Consulting Services, former FDA medical reviewer Scott Friedman, M.D., Dean for Therapeutic Discovery, Fishberg Professor of Medicine, Director, Institute for Liver Research, Icahn School of Medicine at Mount Sinai Robert Lafyatis, M.D., Professor of Medicine, Division of Rheumatology & Clinical Immunology, University of Pittsburgh Medical Center Rohit Loomba, M.D., MHSc, Professor of Medicine, Chief of the Division of Gastroenterology and Hepatology, University of California San Diego Toby Maher, M.D., Ph.D., Professor of Medicine, Director of Interstitial Lung Diseases, University of Southern California Sydney Montesi, M.D., Assistant Professor of Medicine, Harvard Medical School, Pulmonary and Critical Care Medicine, Massachusetts General Hospital John Varga, M.D., Professor of Medicine, Chief of the Division of Rheumatology, University of Michigan In addition, new preclinical data supporting the application of MTX-463 in IPF will be presented at the 2024 American Thoracic Society (ATS) meeting in San Diego, May 17-22, 2024. Data supporting MTX-474 in Systemic Sclerosis (SSc) will be presented in an oral presentation at the Congress on the EPH/Ephrin System in Parma, Italy, May 16-17, 2024. About MTX-463 MTX-463 is a first-in-class human IgG1 antibody developed against WNT1-inducible signaling pathway protein-1 (WISP-1). WISP-1 is a secreted matricellular protein shown to have a relevant role in fibrosis progression, measurable in human blood, and correlates with disease severity. Initial data indicates that MTX-463 neutralizes WISP-1-mediated fibrotic signaling that spans several fibrotic indications and significantly reduced fibrosis in vitro and in preclinical mouse models. MXT-463 is currently in Phase 1 clinical evaluation to assess its safety and tolerability in healthy participants (NCT06401213). About MTX-474 MTX-474 is a first-in-class human IgG1 antibody designed to neutralize the EphrinB2 signaling that causes the onset and progression of fibrosis. Ephrin ligands and Eph receptors mediate biological processes involved in tissue fibrosis including cell migration, myofibroblast activation, and tissue remodeling. A growing body of evidence has implicated EphrinB2 in the fibrosis of the skin, lungs, and heart. Expression of EphrinB2 and its receptors are measurable in human blood and correlates with disease severity. Initiation of Phase 1 clinical studies for this program is anticipated in Q3-2024. About Mediar Therapeutics Mediar Therapeutics is pioneering a new approach to fibrosis treatment that halts the disease at a different source – the myofibroblast, the key pathogenic cell in fibrosis that drives scarring, disease progression, and ultimately organ failure. Mediar was founded based on a deep understanding of the complex science underlying fibrosis onset and progression. By combining novel targets with reliable, easily detectable blood biomarkers and familiar modalities, Mediar is derisking the path forward for fibrosis therapies in clinical development. For more information, contact [email protected] or follow us on LinkedIn. SOURCE Mediar Therapeutics

Mediar's new partnerships follow an $85 million series A closed in March. Mediar Therapeutics is tapping the business development well early, teaming up with Pfizer and WuXi Biologics as two assets near the clinic.  The fibrosis-focused biotech will be lent Pfizer’s assistance on R&D work, test development and IND-enabling studies for its first two assets, MTX-463 and MTX-474, according to an announcement Wednesday. Though financial details weren’t disclosed, the biotech says it will retain full decision-making authority and rights to both programs. China's WuXi will assist with providing drug substance for the trials and bolstering manufacturing capabilities. Both partnerships are a function of Mediar’s nearing clinical arrival, with the two assets expected to reach phase 1 trials next year. The first candidate, MTX-463, is a monoclonal antibody targeting WISP-1, a kind of protein that often operates in the extracellular matrix and regulates cell function. Elevated levels of the protein have been associated with fibrosis progression. MTX-474 targets EphrinB2, which similarly impacts disease progression.  Mediar is not just bolstering external efforts to support its clinical progress, however. Jeffrey Bornstein, M.D., is joining as chief medical officer, moving across from Eledon Pharmaceuticals where he held the same role. Before that, he was a leader in Takeda’s gastroenterology unit, elevating from executive medical director to VP and head of clinical science over a four-year span. He also spent more than six years combined at Biogen and Gilead.  With the latest partnerships and a clinical leader on board, all systems appear ready to go. Mediar previously took care of the necessary fundraising to afford this stage of development, inking $85 million from a series A back in March. Novartis’ venture fund and Soffinova co-led the round, with help from Bristol Myers Squibb and Pfizer. 

Phase 1 studies planned for both WISP1 and EphrinB2 candidates in 2024 Company enters strategic collaborations with Pfizer Ignite and WuXi Biologics to accelerate IND-enabling studies and drug product manufacturing Jeffrey D. Bornstein, M.D. joins as Chief Medical Officer, bringing fibrosis expertise and more than 20 years of clinical development experience CAMBRIDGE, Mass., Oct. 25, 2023 /PRNewswire/ -- Mediar Therapeutics Inc., a biotechnology company advancing a portfolio of first-in-class therapies that halt fibrosis progression, today announced several milestones that support clinical advancement of its portfolio of novel antibodies: the nomination of two clinical candidates, key strategic collaborations with Pfizer Ignite and WuXi Biologics, and the appointment of Jeffrey D. Bornstein, M.D., as Chief Medical Officer. Mediar's first candidate, MTX-463, is a first-in-class monoclonal antibody designed to neutralize the WISP-1 signaling that is elevated in and contributes to fibrosis progression. Its second candidate, MTX-474, is a first-in-class monoclonal antibody designed to neutralize the EphrinB2 signaling that causes fibrosis advancement and may play a role in defining the fibrotic niche. Both candidates offer therapeutic potential across multiple indications, including fibrosing diseases of the lung and liver, and are supported by a compelling suite of preclinical in vivo and ex vivo data demonstrating specific anti-fibrotic effects and selective neutralization of their respective targets. Mediar plans to advance both MTX-463 and MTX-474 into Phase 1 clinical development in 2024. The company has also entered a strategic collaboration with Pfizer Ignite, a new end-to-end service for biotech companies with high potential science that leverages Pfizer Inc.'s significant R&D capabilities, scale and expertise to accelerate the development of breakthrough therapies. Research and development efforts, assay development, and IND-enabling studies for MTX-463 and MTX-474 will be conducted with support with Pfizer Ignite. Mediar will retain ongoing decision-making autonomy and rights to all programs throughout the collaboration. In addition, the company has entered a partnership with WuXi Biologics, wherein WuXi Biologics will provide fully integrated CMC development and cGMP manufacturing of clinical supply for drug substance and drug product to support IND-enabling and initial clinical studies for MTX-463 and MTX-474. The appointment of Jeffrey D. Bornstein, M.D., as Chief Medical Officer further supports Mediar's focus on moving its novel pipeline of biologics towards the clinic. "We are excited by this progress and believe that approaches that pinpoint fibrosis progression may be the key step in improving outcomes for patients," said Mediar's Chief Executive Officer Rahul Ballal, Ph.D. "In addition, Jeff's wealth of experience in driving clinical development of fibrosis treatments will be instrumental as we continue to advance our portfolio of first-in-class antibody treatments. We look forward to leveraging his deep insight and KOL connections across a variety of indications to design effective and efficient studies." "Fibrosis is the final common pathway for chronic diseases in multiple organ systems, contributing to a significant number of deaths each year, and creating a large global unmet need that must be addressed," said Dr. Bornstein. "Mediar's novel approach of targeting of fibrotic mediators holds exciting potential offering opportunities to address fibrosis at the later stages of progression either on its own or added to therapies that do not target fibrosis directly or sufficiently. I'm thrilled to join this talented team and advance these candidates into clinical studies." Dr. Bornstein joins Mediar with more than 20 years of clinical development expertise in the biopharmaceutical industry, with deep experience overseeing clinical studies of fibrosis treatments across multiple indications, including idiopathic pulmonary fibrosis (IPF), primary sclerosing cholangitis (PSC) and nonalcoholic steatohepatitis (NASH). Dr. Bornstein previously served as Chief Medical Officer of Eledon Pharmaceuticals and Vice President, Head of Clinical Sciences, Gastroenterology at Takeda Pharmaceuticals. In addition, he directed development programs, including those focused on fibrosis, at Biogen, Gilead Sciences, Elan Pharmaceuticals and other early-stage biotechnology companies. After earning his M.D. and completing a residency in internal medicine at McGill University, Dr. Bornstein completed a fellowship in gastroenterology at Duke Medical Center, where he joined the faculty, conducting clinical research in hepatitis C and providing clinical care in gastroenterology and hepatology as a practicing physician. About Mediar Therapeutics Mediar Therapeutics is a biotechnology company pioneering a new approach to fibrosis treatment that halts the disease at a different source – the fibrotic mediators that drive disease progression. Mediar was founded based on a deep understanding of the complex science underlying fibrosis onset and progression. By combining novel targets with reliable, easily detectable blood biomarkers and familiar modalities, Mediar is derisking the path forward for fibrosis therapies in clinical development. For more information, contact [email protected] or follow us on LinkedIn. SOURCE Mediar Therapeutics