HDT Bio


HDT Bio is a Seattle-based clinical stage biopharmaceutical company developing advanced RNA vaccine products to treat and prevent infectious diseases and cancers. Leveraging its proprietary LION™ technology, the company aims to redefine the global vaccine landscape with a transformative repRNA platform that offers superior safety, potency, durability, and manufacturing advantages. HDT Bio focuses on harnessing the immune system to combat difficult-to-treat conditions, with a strong emphasis on infectious diseases and oncology, and is committed to global health equity through international partnerships and rigorous clinical research.

Industries

biopharma
biotechnology
pharmaceutical

Nr. of Employees

medium (51-250)

HDT Bio

1150 Eastlake Ave E, Suite 200A, Seattle, WA 98109


Patents

RNA vaccines against infectious diseases

US-12350329-B2

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SARS-CoV-2 RNA vaccine compositions and methods of use

US-12257299-B2

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Dried nanoparticle compositions

US-12233160-B2

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Compositions and methods for delivery of RNA

US-12133894-B2

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Compositions and methods for delivery of RNA

US-11896677-B2

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Nucleic acid-small diameter and liquid core nanoparticle complexed compositions

US-11752218-B2

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Products

Clinical-stage self-amplifying RNA vaccine candidates (infectious diseases and oncology)

Pipeline of clinical and preclinical vaccine candidates based on self-amplifying RNA and cationic nanocarrier delivery for prevention or treatment of infectious diseases and cancer; targets reported in public materials include COVID-19, enterovirus D68, Zika, HIV, and candidates licensed for malaria development.

Intranasal RNA-based antiviral prophylactic candidate

Early-stage intranasal RNA therapeutic designed to act as an innate immune (RIG-I) agonist for pre-exposure or post-exposure prophylaxis against respiratory viruses; supported by grant and early funding programs.


Services

Licensing of RNA formulation and delivery technology and collaborative development partnerships to support local clinical trials and manufacturing.

Design and execution of dose‑ranging and safety/tolerability clinical studies, including international Phase 1 trials with defined immunogenicity endpoints and long-term follow-up.

Creation of rapid‑response roadmaps and workflows to accelerate RNA vaccine candidate generation for pathogens of pandemic potential as part of multi‑institutional consortia.

Expertise Areas

  • Self-amplifying RNA vaccine development
  • RNA delivery formulation and nanoparticle engineering
  • Preclinical immunogenicity and animal efficacy studies
  • Clinical trial design and multinational execution
  • Show More (5)

Key Technologies

  • Self-amplifying replicon RNA (repRNA)
  • Cationic nanocarrier nanoparticle RNA delivery (external RNA attachment)
  • Nanoparticle formulations for localized immune responses
  • Thermostable vaccine formulation
  • Show More (5)

News & Updates

HDT bio’s Rapid-Response Roadmap for RNA vaccines (R4) project granted a five-year subaward for $2M per year. The project aims to develop strategies for rapid creation of RNA vaccines against pathogens with pandemic potential, utilizing HDT Bio’s AMPLIFY™ self-amplifying replicon RNA (repRNA) platform and LION™ nanoparticle delivery system.

Self-amplifying RNA vaccine, delivered by cationic nanocarrier (LION™), elicits neutralizing antibody responses in mice and nonhuman primates and protects mice from enterovirus D68 (EV-D68) respiratory infection and disease.

HDT Bio announced its participation at the World Vaccine Congress West Coast 2023 in Santa Clara, California, showcasing its advanced RNA vaccine technologies.

HDT Bio announced that Dr. Steven Reed, CEO, will present at the Society for Immunotherapy of Cancer (SITC) 2023 Annual Meeting, highlighting its innovative RNA vaccine platforms.

The award will fund the development of HDT-201, a thermo-stable, broad-spectrum intranasal RIG-I Agonist RNA SARS-CoV-2 antiviral candidate, investigated as pre-exposure or post-exposure prophylactic.

A study demonstrating that HDT Bio's self-replicating RNA vaccine can induce durable immunity against SARS-CoV-2 in nonhuman primates, even after neutralizing antibodies decline.

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