November 5, 2021
Company Name: AnGes Inc.
Presentative: Ei Yamada, President & CEO

Novel Coronavirus (COVID-19) DNA Vaccine: Results of Phase 1/2 and Phase 2/3
Clinical Trials
November 5, 2021 - AnGes, Inc. (hereafter, AnGes) today announced the results of a series ofclinical trials conducted since 2020 on the novel coronavirus (COVID-19) DNA vaccine as follows.
In each of the clinical trials, the safety of the vaccine was confirmed. As for the efficacy, although
cellular immune response was confirmed to some extent, humoral immune response, a primary
endpoint, observed was not as much as expected. AnGes will hereafter focus on a clinical trial of ahigh-concentration (high-conc.) vaccine, which already started in August 2021, as an effort to further
improve efficacy.
<Phase 1/2 Clinical Trial of COVID-19 DNA Vaccine (1) Overview>
Study design: An open-label, non-controlled study to evaluate the safety and immunogenicity of theintramuscular DNA vaccine injection in healthy adult volunteers
Target enrollment: 30 participants
Administration: Intramuscular injection
Results: No safety issues were observed. Although induction of humoral immune response wasobserved in some subjects as efficacy, it was not as much as expected. AnGes decided to proceedfurther development with an improved vaccine.
<Phase 1/2 clinical trial of COVID-19 DNA vaccine (2) Overview>
Study design: An open-label, non-controlled study to evaluate the safety and immunogenicity of
the intramuscular DNA vaccine injection in healthy adult volunteers
Target enrollment: 30 participants
Administration: Intramuscular injection
Results: There were no safety issues. We confirmed cellular immune response to some extent asefficacy. Although induction of humoral immune response was observed in some subjects, AnGes
judged it is necessary to confirm this in a larger-scale trial.
<Phase 2/3 Clinical Trial of COVID-19 DNA Vaccine Overview>
Study design: A randomized, double-blind, placebo-controlled study to evaluate the safety andimmunogenicity of the intramuscular DNA vaccine injection in healthy adult volunteers
Target enrollment: 500 participants
Administration: Intramuscular injection
Results: There were no safety issues. We confirmed cellular immune response to some extent asefficacy. Although induction of humoral immune response was observed in some subjects, it was
not as much as expected, leading AnGes to address further improvement in efficacy.
In order to enhance efficacy, AnGes started Phase 1/2 clinical trial in August 2021 using the highconc. DNA vaccine as follows.

<Phase 1/2 Clinical Trial of COVID-19 High-Conc. DNA Vaccine>
Study design: A randomized, open-label study to evaluate the safety and immunogenicity of thehigh-conc. DNA vaccine in healthy adult volunteers
Target enrollment: 400 participants
Administration

Intramuscular

Intradermal

Dose

2mg

4mg

8mg

1mg

1mg

Frequency

2 wks. interval
3 times

4 wks. interval
2 times

4 wks. interval
2 times

2 wks. interval
3 times

4 wks. interval
2 times

Total dose

6mg

8mg

16mg

3mg

2mg

Target enrollment

80808080

80

Number of clinical trial sites: 6 sites in Kansai and Kanto area
This research is supported by the Japan Agency for Medical Research and Development (AMED)
under the Vaccine Development Support Project "Clinical Development of DNA Vaccines Targeting
Novel Coronavirus (COVID-19)".
＜About the novel coronavirus DNA vaccine>
The novel coronavirus DNA vaccine produces antibodies against pathogens by inoculating circular
DNA (plasmid) that encodes a part of the virus protein in the body, and induce the immune-response
against target SARS-CoV-2. By producing antibodies in the body that recognize antigens (foreignsubstances recognized by the body's immune system) as part of the structure of the virus, resisting
power to the virus is created to exert the effect. We are proceeding the research and developmentof DNA vaccines by based on the experience on the development of HGF gene therapy productusing plasmid DNA.

AnGes, Inc.
Public Relations & Investor Relations GroupFor Inquiry: https://www.anges.co.jp/en/contact/
Website: https://www.anges.co.jp/en/