HDT Bio, a clinical-stage biotechnology company based in Seattle, Washington,announced that it received the Medical CBRN Defense Consortium (MCDC) Innovation Prototype Award. The award recognizes HDT Bio's MCDC project "Development of Crimean-Congo Hemorrhagic Fever and Henipavirus Vaccines" for successfully advancing HDT-321, its lead biodefense vaccine candidate, from laboratory research into Phase 1 clinical investigation.

The MCDC Innovation Prototype Award is presented annually to recognize outstanding innovation and progress in the development of medical countermeasures supporting CBRN (chemical, biological, radiological, and nuclear) defense.

From Discovery to the Clinic

HDT-321 is a clinical-stage prophylactic developed for protection against Crimean-Congo hemorrhagic fever (CCHF), one of the most widespread viral hemorrhagic fevers in the world and a recognized emerging infectious disease of concern. Spread through tick bites and contact with infected animals, CCHF continues to emerge in new regions driven by warmer winters and expanding tick habitats. 

With support from MCDC and the U.S. Department of War, and in collaboration with the National Institute of Allergy and Infectious Diseases (NIH/NIAID) and The University of Texas Medical Branch (UTMB), HDT Bio conducted rigorous preclinical studies at NIAID's Rocky Mountain Laboratories (RML) in Montana. HDT-321 demonstrated protection against CCHF virus infection in pre-clinical models. The vaccine's formulation is built on HDT Bio's proprietary LION^™ delivery system — a platform that has demonstrated tolerability in previous clinical investigations and offers key advantages including scalability and deployability without cold-chain infrastructure.

Following extensive process development and GMP-grade manufacturing, HDT Bio submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA). HDT-321 received FDA clearance and is currently in an ongoing Phase 1 clinical trial. Preliminary data received in early 2026 demonstrates a strong safety profile and robust immunogenicity — a significant milestone for both HDT Bio and the broader biodefense community.

"We are honored to receive this recognition from MCDC, which reflects the dedication of our team and the strength of our partnerships with NIH/NIAID, UTMB, and the Department of War," said Steve Reed, PhD, Chief Executive Officer of HDT Bio, whose sentiment was echoed by Jesse Erasmus, PhD, Director of Virology and Principal Investigator of the program, "Taking HDT-321 from early preclinical work through process development, GMP manufacturing, and into a Phase 1 clinical trial represents a major step forward in our mission to protect people against some of the world's most dangerous infectious threats while establishing a platform to address broader unmet needs in human health."

At the same meeting, HDT Bio also received first place in the Health Security Innovation Pitch Challenge. "This recognition for our broad-spectrum antiviral program is especially timely as multiple viral outbreaks continue to emerge worldwide, underscoring the urgent need for rapidly deployable antiviral countermeasures." said Bryan Berube, PhD, Associate Director of Preclinical Development, who presented the pitch.