INOVIO (NASDAQ: INO) Receives Approval From ANVISA to Commence the Third Phase INNOVATE Clinical Trial

INOVIO (NASDAQ: INO) has announced that Brazil’s national health regulatory agency ANVISA has given it regulatory approval to commence the global third phase segment of the phase 2/3 INNOVATE (INOVIO INO-4800 Vaccine Trial for Efficacy) study for INO-4800.

INOVIO to commence INNOVATE phase 3 study 

INO-4800 is a DNA vaccine drug candidate the company is developing for COVID-19. The company plans to carry the global INNOVATE third phase segment study in several countries, including Brazil, through its partnership with Advaccine Biopharmaceuticals Suzhou CO. Ltd.

The INNOVATE study will evaluate INO-4800’s efficacy in a phase 2/3 clinical study in which a two-dose treatment (2mg per dose) given one month apart in 2-to-1 randomization in non-pregnant women and men aged 18 years and above in various countries in Latin America, Africa, and Asia. The study’s primary endpoint is virologically confirmed COVID-19. 

INOVIO CEO and President J Joseph Kim said, “With many countries in the world experiencing low vaccination rates and seeing an increase in infections, we feel the urgency to advance INO-4800 globally. I am incredibly proud of the INOVIO team and grateful to the health authorities in Brazil for their commitment to advancing the fight against COVID-19. INOVIO’s focus on supporting the global response to the pandemic is unwavering – and will bring forward the potential advantages of INO-4800, which in addition to being well-tolerated with balanced neutralizing antibodies and T cell responses (CD8 and CD4), has a strong thermostability profile, and potentially offers the ability to serve as both a primary as well as a booster vaccine.”

INO-4800 well tolerated 

The company’s DNA treatments have so far demonstrated strong safety profiles compared to other COVID-19 vaccine candidates. Most importantly, INO-4800 is given intradermal and has very minimal side effects. Equally, INO-48700 has an excellent thermostability profile and a strong immune response. Also, the candidate can be readministered safely, thus giving potential for boosting usage with concerns of formulation-related issues or ant-vector response.