EFNB2

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

A team of researchers believe they have identified a cell signaling pathway responsible for the development of esophageal adenocarcinomas, an aggressive form of esophageal cancer that has gradually become more common, even in younger people. Of the roughly 20,000 people in the U.S. diagnosed with esophageal cancer this year, just 4,000 are likely to still be alive in 2027. Such dire data has long driven researchers to try to understand the roots of the disease, but they have discovered little -- until now. A team of researchers at the Case Western Reserve University School of Medicine and Case Comprehensive Cancer Center believe they have identified a cell signaling pathway responsible for the development of esophageal adenocarcinomas, an aggressive form of esophageal cancer that has gradually become more common, even in younger people. "The incidence of esophageal cancers has increased several fold over the last few decades, making it the most common esophageal malignancy in the U.S.," said Kishore Guda, associate professor at the School of Medicine and member of the Case Comprehensive Cancer Center. "Like gastric and pancreatic cancers, these are highly aggressive malignancies that can be resistant to treatment, with dismal survival rates and with lack of effective targeted therapies." New research published this month in Gastroenterologyexplains how an important molecular signal, known to scientists as the "Ephrin B2 (EphB2) Tyrosine kinase pathway," is activated during the development of esophageal adenocarcinomas and contributes to cancer growth. The findings also show that the EphB2 pathway appears to control the growth of cancer cells while also regulating the behavior of normal esophageal cells. "From a molecular standpoint, EphB2 induces the levels of a well-recognized pro-cancer gene, called c-MYC. One mechanism by which EphB2 seems to affect MYC levels is through its direct interaction with a protein known as MYCBP2, which is a suppressor of MYC activity," Guda said. "This is the first discovery to our knowledge that demonstrates EphB2 regulation of MYC and its physical interaction with MYCBP2." By analyzing normal, pre-cancer, and cancerous biopsy samples with RNA sequencing, the researchers found that EphB2 signaling is hyperactivated in nearly all instances of esophageal adenocarcinomas as well as a condition called Barrett's esophagus. Barrett's esophagus occurs when the lining of the esophagus becomes damaged by acid reflux, resulting in the replacement of esophageal cells with intestinal-type cells. This condition is linked to an increased risk of developing esophageal cancer, according to the National Institutes of Health (NIH). The scientists believe the EphB2 pathway is an attractive therapeutic target and suppressing its activity in cancer could be a beneficial treatment strategy for these cancers. "Our immediate goal is to explore and develop EphB2 chemical inhibitors and/or EphB2-targeting immune-cell based strategies, and to test their efficacy in preclinical esophageal as well as gastric cancer models, followed by transitioning to human trials," said Guda.