Synedgen

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Overview

Synedgen is a biotechnology company specializing in developing therapies that enhance and mimic the innate immune system to treat various mucosal and dermal diseases. Founded in 2009 and based in Claremont, California, the company was co-founded by Shenda Baker and William Wiesmann. Synedgen focuses on addressing gastrointestinal diseases through its innovative Multivalent Innate Immune Signaling Target (MIIST) platform. Over the years, the company has received significant backing, raising over $27.4 million from government grants and private investors, including the United States Army Medical Research Acquisition Activity and the National Institutes of Health.

Recent Developments

  • February 2025: Synedgen announced the publication of preclinical data in Gut Microbes demonstrating that their lead asset, MIIST305, mitigates gastrointestinal acute radiation syndrome (GI-ARS) in animal models. This advances their target to provide therapies for significant radiation injuries in collaboration with Columbia University's Center for Radiological Research.
  • February 2025: Appointment of Dr. Laura Saward as Chief Scientific Officer, bringing extensive experience in therapeutic drug development and government collaboration. Her role will focus on advancing Synedgen’s pipeline and strengthening partnerships.
  • October 2024: Synedgen received a $119 million contract from the Biomedical Advanced Research and Development Authority (BARDA) to develop MIIST305 as a medical countermeasure against GI-ARS, addressing radiation exposure risks.
  • October 2024: The company completed Investigational New Drug (IND) enabling studies for MIIST305, setting the stage for clinical trials targeting ulcerative colitis and GI-ARS.
  • April 2024: Synedgen received funding and initiated a Phase 1 clinical study to advance MIIST305 in treating both ulcerative colitis and GI-ARS, with significant backing from the Congressionally Directed Medical Research Program.
  • November 2024: A $2.2 million award from the Joint Warfighter Medical Research Program was granted to further develop MIIST305 for prophylactic radiation countermeasure.

Company Information

AttributeInformation
Founding Date2009
HeadquartersClaremont, California, USA
FoundersShenda Baker, William Wiesmann
RevenueNot disclosed
ProfitsNot disclosed
Key InvestorsUS Army Medical Research, NIH, DARPA
IndustryBiotechnology
Number of Employees19

Early History

Synedgen was founded in 2009 by Shenda Baker and William Wiesmann with a vision to leverage glycopolymer technology for medical applications. The company's platform aimed to address unmet needs in inflammatory and infectious disease treatments by enhancing innate immune responses. Initial funding and support were garnered through substantial government grants, which laid the foundation for extensive research and development activities. The collaborative efforts with universities and research institutions facilitated the acceleration of their technology towards clinical applications, marking its entrance into the biotech sector focused on innate immune signaling.

Company Profile and Achievements

Synedgen operates using its proprietary MIIST platform, which targets human innate immunity to treat gastrointestinal diseases. Their approach has led to several significant achievements:

  • Development of MIIST305: A non-systemic therapeutic aimed at repairing GI mucosal injuries and reducing systemic hyperinflammation in both radiation exposure and gastrointestinal conditions like ulcerative colitis.
  • FDA Regulatory Progress: Multiple products developed through the MIIST platform have advanced to clinical trial phases, showcasing promising safety and efficacy outcomes.
  • Innovative Partnerships: Establishing key partnerships, such as with the Biomedical Advanced Research and Development Authority and support from the Department of Defense, which include substantial funding agreements for product development.
  • Product Pipeline Expansion: Initiating clinical trials for ulcerative colitis and radiation syndrome, backed by multi-million dollar grants to extend treatment capabilities into new therapeutic areas.

Current Operations and Market Position

Synedgen continues to pioneer the field of glycobiology with its highly specialized therapeutic offerings. As of 2025, the company positions itself at the forefront of biotechnology with an emphasis on innovating solutions for gastrointestinal and other mucosal diseases. A key strength is its ability to secure significant government contracts and funding, which enhances its research and development capacity. The strategic development of MIIST305 as both a commercial therapeutic and a biodefense medical countermeasure highlights Synedgen’s dual-market strategy within healthcare and national defense sectors.

Conclusion

Synedgen's journey from inception to its current status as a leading biotechnology firm underscores its commitment to solving complex medical challenges through advanced biopolymer research. With a robust pipeline and strategic government partnerships, Synedgen is well-positioned for continued growth and impact in the biotech field, particularly in addressing critical therapeutic needs in radiation and inflammatory diseases. Its future trajectory looks promising, as it continues to translate its innovative research into impactful medical solutions.

References

  1. Synedgen Official Website
  2. Business Wire
  3. Pharmaceutical Technology
  4. Gut Microbiome Publication
  5. LiveMint