Chronic and infectious disease vaccine developer COVAXX announced pre-clinical data for its lead vaccine. The Hauppauge, N.Y.-based COVAXX plans to deliver the first 100 million doses to patients with what it claims is the most efficacious vaccine available to date.
The first Multitope Peptide-based Vaccine (MPV) against SARS-CoV-2 and will enter human trials next month, the company noted in webinar presentation on Wednesday, adding that it has developed “a well-balanced B-cell and T-cell vaccine designed to activate both arms of the patient’s humoral and cellular immune responses.”
“I am very excited about the COVAXX vaccine platform,” Dr. George Siber, a world-renown developer of multiple licensed vaccines, advisor to the Gates Foundation and scientific advisor to the company, said in a statement. “It is very quick, it is very scalable, and the neutralizing responses they are seeing are extremely impressive. They frankly knocked my socks off!”
“We are optimistic that our vaccine can move quickly through clinical trials and that we will be able to produce up to 100 million vaccination doses by 1Q 2021,” Lou Reese, co-CEO of COVAXX, added.
A summary of their pre-clinical data includes:
- Vaccine titers are 400x higher than convalescent plasma
- Virus neutralizing titers are 200x higher than Oxford/AstraZeneca (see attached comparison chart: COVAXX vs. other vaccines)
- Entering phase one/two human trials next month in parallel in the U.S. w/ UNMC-National Pandemic Center and also in Taiwan
- The vaccine is the first “Multitope Peptide-Based Vaccine” activating both B-Cells and T-Cells
- Ability to manufacture 100 million doses by Q1 2021 and 1 billion doses by Q4 2021
- Parent company United Biomedical currently produces 500 million vaccine doses per year in foot and mouth (for Asia)
- Their Science Advisory Board includes top virologists/immunologists who have developed and commercialized over 10 vaccines.
Human trials
The company is planning to begin Phase I human trials next month in Taiwan, one of the leading countries in the COVID-19 pandemic response.
COVAXX is also filing an IND with the U.S. FDA to initiate clinical trials this fall in the U.S. in collaboration with the University of Nebraska Medical Center (UNMC) as its core site for its Phase I/II trial.
The vaccine clinical trial partnership between COVAXX and UNMC is the second COVID-19 related partnership of 2020 between the two organizations. In May, COVAXX and UNMC announced an exciting partnership that is envisioned to provide a comprehensive end-to-end solution to process tens of thousands of COVID-19 antibody tests per day.
Under the testing partnership, COVAXX and UNMC are focused on providing large-scale COVID-19 testing for organizations, including those in health care, emergency services, the military, education, business, agriculture, sports and entertainment and non-profits.
UNMC is the home of the National Training, Simulation and Quarantine Center, the nation’s only federal quarantine unit where advanced research, training and treatment regarding COVID-19, Ebola and other infectious diseases is undertaken.
“We know that working with UNMC is an extraordinary opportunity,” Jon Harrison, Chief Strategy Officer for COVAXX, concluded. “They are second-to-none in epidemiology and infectious disease research. Their partnership will only increase our odds at reaching a successful human trial outcome, and ultimately a COVID-19 vaccine that can aid the world.”
With more than 20 years serving financial markets, John Sullivan is the former editor-in-chief of Investment Advisor magazine and retirement editor of ThinkAdvisor.com. Sullivan is also the former editor of Boomer Market Advisor and Bank Advisor magazines, and has a background in the insurance and investment industries in addition to his journalism roots.
