AG0301 COVID-19 Vaccine Description

The AG0301 vaccine candidate is a plasmid DNA vaccine that disables the connection between the coronavirus's protein spikes and receptors in human cells. 

AnGes, Inc.'s vaccine candidate encodes the SARS-CoV-2 spike protein that opens the door to infection. It is expected to prevent COVID-19 or the condition of COVID-19 patients from deteriorating. Since the vaccine is engineered to express only the spikes on the viral surface, thereby producing antibodies, it is nonpathogenic and safe.

The manufacturing process can be established in a shorter period of time with the manufacture of DNA vaccines, compared with the vaccine using inactivated viruses (attenuated vaccines) or the vaccine using genetically modified virus protein.

AnGes, Inc. is based in Osaka, Japan.

AG0301 COVID-19 Vaccine Indication

AnGes Coronavirus Vaccine candidate is indicated to prevent COVID-19 disease associated with the SARS-CoV-2 vaccine.

AG0301 COVID-19 Vaccine News

September 8, 2020 - COVID-19 DNA vaccine development: Announcement of Collaboration Agreement with Brickell Biotech. “We are excited by the opportunity to work with AnGes, a leading vaccine developer in Japan, to potentially bring a COVID-19 vaccine to the U.S. and other countries to help address the global pandemic. AnGes is at the forefront of developing a vaccine for COVID-19 and was the first company in Japan to initiate a COVID-19 vaccine clinical study,” commented Robert Brown, Chief Executive Officer of Brickell. “While Brickell remains firmly focused on initiating its U.S. Phase 3 pivotal program for sofpironium bromide for the treatment of primary axillary hyperhidrosis later this year, we look forward to reviewing AnGes’ clinical study results and then working together with them and the FDA to determine the best path forward.

June 30, 2020 - The first clinical trial on humans of a potential vaccine for the new coronavirus has begun. AnGes vaccine candidate will inject a genetically engineered circular DNA into the body that produces "spike proteins," which are a characteristic of the coronavirus, according to the company. When such proteins are made, the body's immune system is stimulated to make antibodies against the virus.

June 11, 2020 - Japanese biotech AnGes expects its coronavirus vaccine to be ready as early as the first half of 2021 if it can overcome supply chain and production hurdles, the company’s founder has said. “The future of COVID-19 is very mysterious,” said Morishita, adding that any vaccine would likely need constant tweaking as the virus mutates and returns.

AG0301 COVID-19 Vaccine Clinical Trials

Clinical Trial NCT04655625A Phase II / III Randomized, Double-blind, Placebo-Controlled Study to Assess Safety, Immunogenicity, and Efficacy of Twice Dosing of Intramuscular AG0302-COVID19 (2mg) in Healthy Adults-- Last Update Posted: December 7, 2020 

Approximately 500 healthy volunteers, male or female, aged 18 years or older, will be randomized to one of the following two groups:

Group A: Vaccination twice at 2-week intervals (n = 250) Group B: Vaccination twice at 4-week intervals (n = 250)

Fifty subjects in each group will receive placebos.

Clinical Trial NCT04463472: A Non-randomized, Open-label, Non-controlled Phase I/II Study to Assess Safety and Immunogenicity of Two Doses of Intramuscular AG0301-COVID19 (1mg/2mg) in Healthy Adults

This is a Phase 1/2, single-center, non-randomized, open-label, non-controlled trial. Approximately 30 healthy volunteers, male or female, aged 20-65, will be enrolled in the low dose group for the first 15 and the high dose group for the remaining 15.

Low dose group: 1.0 mg AG0301-COVID19 intramuscular (IM) (n = 15) High dose group: 2.0 mg AG0301-COVID19 IM (n = 15)

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