Aegis Life Announces Start of Phase 1/2 Trial of the Entos COVID-19 DNA Vaccine, Covigenix VAX-001, with First Participants Dosed

Aegis Life, Inc. announced today that the first participants have been dosed in a Phase 1/2 clinical trial with parent company Entos Pharmaceuticals’ (Entos) Covigenix VAX-001, a novel DNA vaccine to stimulate immunity against SARS-CoV-2. Covigenix VAX-001 encodes the SARS-CoV-2 Spike (S) protein and uses novel Fusogenix technology for delivery. Using a next-generation gene delivery technology to the existing and approved mRNA vaccines, the VAX-001 DNA vaccine delivers the information needed inside cells to make the viral protein. In preclinical animal studies, VAX-001 induced a potent humoral immunity, and a balanced cell-mediated response against the novel coronavirus.

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A participant receives a dose marking the start of Phase I trials for Aegis Life/Entos Pharmaceuticals COVID-19 DNA vaccine, Covigenix VAX-001. (Canadian Center for Vaccinology, IWK Health Centre, Nova Scotia).

Fusogenix technology effectively and safely delivers nucleic acid cargo directly inside cells using advanced and proprietary lipid formulations, making it the ideal platform to develop and manufacture hundreds of millions of doses of safe, stable and effective vaccines. DNA vaccines also offer the advantage of stability at room temperature for one month and 4 to 8 °C for one year, which significantly simplifies shipping, storage and distribution. Aegis and Entos have also developed a second DNA vaccine candidate, in preclinical studies now, called Covigenix VAX-002, that is designed as a pan-coronavirus and emerging variant vaccine.

"We're excited that the Phase 1/2 trials have begun with our COVID-19 DNA vaccine,” said John Lewis, CEO, Aegis Life. “This milestone brings us one step closer to providing this vaccine to people in the US and the rest of the world.”

The trial is being conducted by the Canadian Center for Vaccinology (CCfV) and the IWK Health Centre in Nova Scotia, Canada. Phase 1 will evaluate the safety and immunogenicity of the Covigenix VAX-001 DNA vaccine. Since preclinical studies demonstrated promising results for administering Covigenix VAX-001 in a single dose, the phase 2 trial design includes a single-dose regimen.

Aegis is a US biotechnology company dedicated to the development, manufacturing, and global distribution of novel DNA vaccines using Fusogenix technology. Aegis is actively seeking US and international investment to:

• advance its DNA-based vaccine candidates through late-stage clinical trials to assess vaccine safety and effectiveness,
• accelerate the scaling of commercial manufacturing capacity to produce millions of vaccine doses; and
• facilitate distribution of vaccine doses to the US and international markets.

About Aegis Life, Inc.

At Aegis Life, we develop the next generation of DNA vaccines and therapies for the world's most dangerous diseases, leveraging Fusogenix gene delivery platform, developed by parent company Entos Pharmaceuticals. This breakthrough non-viral gene delivery platform allows us to rapidly prototype and advance DNA medicines through the clinical trial process. For more information, visit http://www.aegis.life.

About Entos Pharmaceuticals, Inc.

Entos develops next generation nucleic acid-based therapies using its proprietary Fusogenix drug delivery system. Fusogenix is a proteo-lipid vehicle (PLV) formulation that uses a novel mechanism of action to deliver molecules, intact and unmodified, directly into the cytosol of target cells. The technology applies a wide range of therapeutic types including gene therapy, mRNA, miRNA, RNAi, CRISPR and small molecule drugs. For more information, visit http://www.entospharma.com.

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