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HDT-301

Development stage
Phase 2
Lead developer
HDT Bio
Modality
Small Molecules, mRNA Therapeutics → RNA Therapeutics → Nucleic Acid Therapeutics, Nanoparticles → Drug Delivery Systems
Administration
Intramuscular
01

Overview

HDT-301 is an intramuscularly administered mRNA vaccine developed to prevent COVID-19. It is based on an alphavirus-derived replicon RNA platform encoding the SARS-CoV‑2 spike protein and uses a proprietary Lipid InOrganic Nanoparticle (LION) system for delivery. Unlike conventional mRNA vaccines that encapsulate the payload within lipid nanoparticles (LNPs), HDT‑301’s self-amplifying RNA binds to the outside of LION particles. This design allows for lower dosing—potentially as little as 1/100th of current mRNA vaccines—while maintaining robust immunogenicity and simplifying manufacturing and storage requirements (refrigerator temperatures). Preclinical studies demonstrated strong antibody and T-cell responses in animal models. The vaccine has been evaluated both as a primary series and booster against multiple SARS-CoV‑2 variants[1][5][6][7].

Brand names
Gemcovac
Other names
GEMCOVAC-OMHGC-019HGC019HGC 019HGCO19HGCO-19HGCO 19MCTI CIMATEC HDT RNA VaccineQTP 104QTP104QTP-104RNA/LION COVID-19 VaccinerepRNA-CoV2SrepRNA-CoV-2SrepRNA-CoV 2S
02

Targets

SARS-CoV-2 spike

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