Entos Pharmaceuticals Announces Selection of Lead DNA Vaccine Candidates for COVID-19 and a $4.2M Award to Move Forward with Phase I/II Human Trials

In preclinical studies, two lead Fusogenix DNA vaccine (Covigenix) candidates demonstrated high immunogenicity and efficacy

Lead candidates to be evaluated in SARS-CoV-2 animal challenge studies and advanced to human clinical trials during summer 2020

Canadian Institutes of Health Research (CIHR) awards $4.2M grant to John Lewis, PhD., to be used for development of COVID-19 DNA vaccine

EDMONTON, Canada I June 25, 2020 I Entos Pharmaceuticals (Entos), a healthcare biotechnology company developing nucleic acid medicines with its Fusogenix drug delivery platform, today announced the selection of two lead candidates for a pan-coronavirus Fusogenix DNA vaccine (Covigenix) from its prototyping program launched at the onset of the global COVID-19 pandemic. The selection of two lead candidates is based on strong preclinical results demonstrating high immunogenicity, high levels of SARS-CoV-2 neutralizing antibodies, and the potential for no antibody-dependent enhancement (ADE).

DNA vaccine approaches are advantageous over traditional and mRNA vaccines because they can be developed to express multiple epitopes, which may be essential for generating protection from pan-coronavirus infection. In collaboration with academic and industrial partners, Entos rapidly developed a panel of recombinant plasmid DNA vaccine candidates encoding in silico-optimized and conserved regions of the SARS-CoV-2 spike protein.

The two lead Covigenix candidates showed robust preclinical in vivo results, achieving all vaccine profile targets, including potency, ADE safety assessment, high immunogenicity, and efficacy. Lead Covigenix candidates stimulated neutralizing antibody levels and balanced T helper cell immunity in mouse models. In addition, no weight loss was observed at multiple doses of vaccine candidates.

“Based on the preclinical in vivo safety and efficacy data, we believe our Fusogenix DNA vaccine candidates have the potential to be safe and highly potent vaccines that will provide protection against COVID-19 as well as future coronavirus threats,” said John Lewis, CEO of Entos Pharmaceuticals. “These results reflect the potential of our Fusogenix drug delivery platform which has allowed us to quickly advance lead vaccine candidates to animal challenge studies. We look forward to continue working closely with our collaborators to initiate Phase I/II human clinical trials this summer.”

A $4.2M grant from the Canadian Institutes of Health Research (CIHR), Research Nova Scotia (RNS), and the Institute for Ageing (IA) will be used to further develop the Covigenix vaccine candidates through animal challenge studies and human clinical trials. Entos will partner with the Clinical Trials Research Center at the Canadian Center for Vaccinology (CCfV) in Nova Scotia, Canada to initiate Phase I/II human clinical trials which will evaluate the safety, tolerability, immunogenicity and efficacy of the Covigenix vaccine candidates in late July.

Entos aims to develop a safe and effective Covigenix DNA vaccine for COVID-19 in one year. Its Fusogenix drug delivery technology provides the ability to rapidly develop and scale up production of the optimal Covigenix vaccine candidate. Partnering with other institutions and companies will allow Entos to scale GMP-manufacturing capacity with the goal of providing millions of doses of the vaccine.

About the Canadian Institutes of Health Research
At the Canadian Institutes of Health Research (CIHR) we know that research has the power to change lives. As Canada's health research investment agency, we collaborate with partners and researchers to support the discoveries and innovations that improve our health and strengthen our health care system.

About the Canadian Center for Vaccinology
CCfV, a Dalhousie University Center affiliated with the IWK Health Centre and the Nova Scotia Health Authority, is an integrated, collaborative, interdisciplinary research group that spans the full spectrum of vaccine research from basic vaccine discovery to evaluation to policy, programs, and implementation.

About Entos Pharmaceuticals, Inc.
Entos develops next generation nucleic acid-based therapies using their 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 is applicable to a wide range of therapeutic types including gene therapy, mRNA, miRNA, RNAi, CRISPR and small molecule drugs. For more information www.entospharma.com.

SOURCE: Entos Pharmaceuticals

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