Drug intelligence / Profile preview

SAV001

Development stage
Phase 1
Lead developer
Sumagen
Modality
Prophylactic Vaccines → Vaccines & Immunotherapeutics, DNA Vaccines → Plasmid DNA → DNA Therapeutics → Nucleic Acid Therapeutics
Administration
Intramuscular
01

Overview

SAV001 is a first-in-class candidate preventive HIV vaccine that uses a genetically modified, whole-killed (inactivated) version of the HIV-1 virus. Developed by Dr. Chil-Yong Kang and his team at Western University’s Schulich School of Medicine & Dentistry in Canada and supported by Sumagen Canada (a subsidiary of Sumagen Co., Ltd.), this vaccine represents a novel approach for HIV prevention. The virus is engineered to remove pathogenic genes (*nef* and *vpu*) and replace the signal peptide with one from honey bee toxin (melittin), enhancing safety and production yield. The resulting virus is grown in human T lymphocytes, purified, then chemically inactivated using AT-2 treatment followed by gamma irradiation to preserve immunogenicity while ensuring it cannot replicate or cause infection[1][2][3][4]. The mechanism aims to present the immune system with the entire structure of the virus—unlike subunit vaccines—potentially inducing broadly neutralizing antibodies effective against multiple strains[4][5][10]. Phase I clinical trials demonstrated safety and tolerability in humans as well as increased anti-HIV antibody responses; all vaccinated subjects produced broadly neutralizing antibodies[3][5][6][10]. Industrial scale-up for further clinical development is ongoing as of 2025[3].

Other names
Killed-whole HIV-1 vaccineGenetically modified whole-killed HIV vaccine
02

Targets

gp41 (Human immunodeficiency virus type 1 glycoprotein 41)

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