Mediar Therapeutics Announces Clinical Candidates for Lead Fibrosis Programs, Strategic Collaborations and Key Leadership Addition

2023-10-25

高管变更临床1期

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