Synedgen Wins $2.2M JWMRP Award for Radiation Countermeasure MIIST305

Synedgen, Inc., a biotechnology firm located in Claremont, California, has secured a $2.2 million contract from the Joint Warfighter Medical Research Program (JWMRP). The funding is aimed at advancing the development of their primary therapeutic candidate, MIIST305, as a preventive measure against radiation effects. MIIST305 is an orally administered, shelf-stable therapy specifically designed for the gut. It aids in the regeneration of the gut barrier and reduces systemic hyperinflammation driven by gastrointestinal issues.

MIIST305 is currently being developed by Synedgen for the treatment of Ulcerative Colitis (UC). Additionally, with the support of the Biomedical Advanced Research and Development Authority (BARDA), MIIST305 is also being developed as a countermeasure for acute radiation syndrome (ARS) when administered after exposure to ionizing radiation. The new contract from JWMRP will enhance the understanding of MIIST305's capacity to prevent radiation damage when given before exposure. The funding will cover the manufacturing of the drug substance and product for animal studies in two species to determine the optimal timing for dose administration.

Dr. Shenda Baker, President and CEO of Synedgen, emphasized the increasing risk of exposure to ionizing or nuclear radiation for military personnel, first responders, and civilians. Currently, there is no FDA-approved therapeutic available for protecting the gastrointestinal tract from radiation injury. Synedgen aims to develop MIIST305 to address this unmet need and provide preventive measures for those at risk of radiation exposure. Baker also expects the JWMRP-funded program to yield beneficial insights for their ongoing UC and post-exposure ARS programs.

Constantinos Broustas, Associate Professor of Radiation Oncology at Columbia University Vagelos College of Physicians and Surgeons, and the principal investigator of a study on the drug’s efficacy after radiation exposure, noted the vulnerability of the gastrointestinal tract to radiation injury. This type of damage is not only a concern for those exposed to weaponized or accidental radiation but is also observed in cancer patients undergoing certain radiation treatments. Broustas highlighted the potential of MIIST305 as a prophylactic treatment, which could have significant implications for both radiation countermeasures and protective measures for oncology patients.

Currently, there are several FDA-approved drugs to counteract the late effects of hematopoietic acute radiation syndrome (H-ARS). However, no FDA-approved medical countermeasures exist for mitigating gastrointestinal radiation injury scenarios. In the case of gastrointestinal acute radiation syndrome (GI-ARS), radiation toxicity leads to the destruction of the intestinal epithelial barrier. This allows bacteria to invade the mucus layer, causing inflammation, bacterial translocation, further damage to the GI tract, and potentially death. MIIST305's proven activity in the GI tract allows for its development both as a potential preventive measure and a post-exposure treatment for GI-ARS.

The MIIST platform by Synedgen targets receptors in the glycocalyx, which is crucial for human innate immunity. Historically overlooked in drug development, the glycocalyx is now recognized as essential for maintaining intestinal homeostasis. Developed with extensive peer review and government funding, the MIIST platform is advancing various therapeutics aimed at mucosal barrier protection and regeneration. Synedgen continues to develop its GI-ARS program with the support of key U.S. government agencies.