HAUPPAUGE, N.Y. and SAO PAULO, Sept. 9, 2020 /PRNewswire/ -- Dasa, the largest diagnostic medicine company in Brazil and Latin America, and COVAXX, the subsidiary of United Biomedical Inc, a recognized leader in antibody diagnostics and vaccine development, announced today that they have signed a letter of intent to work together to conduct a large scale human efficacy clinical trial in Brazil to develop a vaccine against COVID-19.
Under the agreement, COVAXX will provide Dasa with COVAXX's investigational UB-612 vaccine for the Phase II/III study in Brazil. The study is designed to assess the safety and efficacy of the UB-612 vaccine candidate. Dasa will conduct the Phase II/III expanded clinical trial, based on a protocol designed by both parties, after receiving regulatory approval to proceed in Brazil. The clinical trials will take place at public and private laboratories and hospitals and will be conducted by contract research organizations after approval by ANVISA, the Brazilian regulatory agency.
The clinical research in Brazil relies on donations from other Brazilian companies in addition to Dasa and Mafra. MRV, Localiza and Banco Inter are the other companies in this partnership.
COVAXX is developing the UB-612 COVID-19 multitope peptide-based vaccine candidate, using a high precision, synthetic peptide platform that activates both B-cell and T-cell arms. UB-612 is designed to mimic natural biology and preclinical studies have shown very high immunogenicity and levels of neutralizing titers against SARS-CoV-2. The technology platform has been successful in commercializing blood diagnostics as well as safe and effective vaccines for infectious disease in animal health and has been tested in numerous clinical trials for other indications to date.
"This donation is aligned with other efforts from Dasa to combat the COVID-19 virus and in an effort to help the citizens of our country defeat this pandemic, we researched investigational vaccines, and chose COVAXX for its synthetic, safe approach and efficacy in generating high levels of antibodies. We look forward to moving forward with our partnership and providing a safe and effective vaccine to our citizens," stated Emerson Gasparetto, CMO (Chief Medical Officer) of Dasa.
"Our singular mission at COVAXX is to defeat COVID-19," said Mei Mei Hu, co-Founder and co-CEO of COVAXX. "With this important partnership with Dasa and Mafra, we will be able to test and upon licensing, deliver lifesaving vaccines to the people of Brazil. Our company is well positioned to scale production to hundreds of millions of doses. Dasa and Mafra have secured access to the first 10 million doses of COVAXX's vaccine candidate for distribution to the private markets upon regulatory approval, and COVAXX intends to allocate an additional 50 million doses to the Brazilian public markets."
COVAXX is developing a Multitope Peptide-Based Vaccine for COVID-19. The investigational vaccine has shown promising preclinical safety and efficacy data and is based on a commercially proven, scalable vaccine platform. The mission of COVAXX is to safeguard lives by tackling the global COVID-19 pandemic using cost-effective, scalable and proven science-based solutions delivered to the world.
COVAXX is a subsidiary of United Biomedical Inc (UBI), founded in 1985 and headquartered in New York. UBI has established a long legacy as a scientific trailblazer creating technological firsts, including the manufacture and commercialization of millions of blood diagnostic tests and billions of vaccine doses against virulent diseases in animal health. With exclusive access to UBI's core technology platforms, COVAXX can operate worldwide in developing and commercializing antibody testing and developing a COVID-19 vaccine. For more information, visit www.covaxx.com and follow us on social media.
Dasa is the largest medical diagnostic company in Latin America, and the fifth largest in the world - operating in Brazil and Argentina, with a focus on clinical analysis, diagnostic imaging, and genetic medicine. Dasa has more than 20,000 employees and 2,000 doctors, renowned in Brazil and abroad, working in a robust and capillary health care network across the country. Dasa performs more than 250 million exams on 20 million patients per year, through its more than 40 laboratory networks distributed in approximately 800 units.
SOURCE COVAXX; Dasa