HDT BIO Receives NIH Contract to Advance Novel RNA/LION™ COVID-19 Vaccine Into Clinical Trials

  • HDT Bio Corp. announces award of $8.2M contract by the National Institute of Allergy and Infectious Diseases.
  • Contract will support GMP manufacturing as well as clinical testing of HDT-301, a COVID-19 vaccine based on the company’s RNA/LION technology platform.
  • Collaborators on the contract providing manufacturing and clinical services include Gennova Biopharmaceuticals, Aldevron, Seattle Children’s Research Institute, and Kaiser Permanente Washington.
  • The Phase 1 clinical trial is slated to begin in 2020 in the US.

SEATTLE, WA & BETHESDA, MD, USA I September 01, 2020 I HDT Bio Corp. recently received a notice of award from the National Institute of Allergy and Infectious Disease at the National Institutes of Health. The approved contract provides $8.2M in support of pre-clinical and clinical activities to be conducted by HDT and collaborators to accelerate development of HDT-301 a COVID-19 vaccine candidate.

“This important collaboration will advance clinical development of our COVID-19 vaccine candidate, HDT-301, and we are pleased to partner with NIAID in this effort,” commented Steven Reed, Ph.D., Chief Executive Officer of HDT Bio and Principal Investigator on the contract. HDT-301 combines RNA with HDT Bio’s proprietary LION system comprised of formulation and adjuvant components previously established as safe for use in human vaccines. The RNA sequence was designed immediately following publication of the first SARS-CoV-2 genome sequence. Subsequent validation in animal models, recently published in Science Translational Medicine, established important metrics for vaccine success including antibody response, T-cell profile, dose sparing, and response in aged animals. To date, more than 835,000 people have died from COVID-19 since the disease emerged in late 2019.

Further describing the vaccine candidate, Reed said, “HDT-301 represents the latest in RNA vaccine technology. Reflecting on the broader collaborations, Reed observed, “We have a long-standing history of working with NIAID and are eager to join with them and our other collaborators on this program.”

ABOUT HDT BIO CORP: HDT Bio’s mission is to bring immunotherapies to people around the world. With a focus on RNA, formulation, and adjuvant technologies, HDT Bio is developing biotherapeutics for oncology and infectious disease applications. HDT Bio simultaneously works to integrate therapeutic approaches for first-in-class medicines while building on decades of development experience with well-established pharmaceutical ingredients. The resulting products are poised to significantly improve the lives of millions of people worldwide and to provide access to lifesaving therapies for underserved populations. One of the company’s core technologies, RNA/LION, combines formulation and adjuvant ingredients to stabilize and deliver RNA to the immune system to stimulate responses for therapy or vaccination. http://hdt.bio


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