INOVIO (NASDAQ:INO), a biotechnology company focused on bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases, cancer, and HPV-associated diseases, today announced that it has received regulatory authorization from Brazil's ANVISA (Agência Nacional de Vigilância Sanitária), the national health regulatory agency of Brazil, to initiate the global Phase 3 segment of its Phase 2/3 trial, INNOVATE (INOVIO INO-4800 Vaccine Trial for Efficacy), for INO-4800, its DNA vaccine candidate for COVID-19. INOVIO plans to conduct the global INNOVATE Phase 3 segment in multiple countries, including Brazil, with partner Advaccine Biopharmaceuticals Suzhou Co., Ltd. (Advaccine).
The global Phase 3 segment of the INNOVATE Phase 2/3 clinical trial will evaluate the efficacy of INO-4800 in a two-dose regimen (2.0 mg per dose), administered one month apart, in a two-to-one randomization in men and non-pregnant women 18 years of age and older in several countries across Latin America, Asia, and Africa. The primary endpoint of this case-driven Phase 3 trial is virologically confirmed COVID-19.
Dr. J. Joseph Kim, President and CEO of INOVIO, 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."
INOVIO's DNA medicines have shown the following overall characteristics:
Well-tolerated and Easy to Administer: INO-4800 has a strong safety profile and, unlike other COVID-19 vaccine candidates, INO-4800 is administered intradermally and has caused only very limited side effects (mostly mild injection site reactions).
Immunogenic: INO-4800 demonstrated robust immune responses: 100% of Phase 1 participants demonstrated overall immunological response rates and had balanced neutralizing antibodies and favorable T-cell responses (CD8 and CD4).
Stable and Transportable: INO-4800 has a favorable thermostability profile. The vaccine candidate is projected to be stable at room temperature for more than a year, at 37°C for more than a month, has a 3 to 5-year projected shelf life at 2-8°C and does not need to be frozen during transport or storage – a critical element when considering the feasibility of global distribution.
Characterizable and Scalable: INO-4800 is highly characterizable, scalable to population levels, and safe. The highly characterizable nature of the vaccine enables timely scaling of manufacturing with multiple manufacturing facilities able to be utilized.
Repeat Administration: INO-4800 can be safely readministered offering the potential for seasonal boosting usage without any concerns of generating an anti-vector response or formulation related issues.
The global Phase 3 segment of the Phase 2/3 INNOVATE trial builds upon the Phase 2 segment conducted in the U.S., which was funded by the U.S. Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense, (JPEO-CBRND) in coordination with the Office of the Assistant Secretary of Defense fo...
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