UNMC, COVAXX sign agreement paving way for clinical trials

UNMC has signed a master clinical trial agreement with COVAXX, a subsidiary of United Biomedical (UBI), a recognized leader in antibody diagnostics and vaccine development. The agreement provides a framework for UNMC to conduct clinical trials, using COVAXX-created therapeutics.

“We are excited to partner with COVAXX on the study and testing of vaccines and diagnostics, as we continue to search for ways in which the country can safely recover from the pandemic,” said Jeffrey P. Gold, M.D., chancellor of UNMC.

With respect to the COVID-19 pandemic, UNMC trials will focus preliminarily on conducting Phase I/II human trials in the United States of COVAXX’s UB-612 vaccine.

The COVAXX vaccine is designed to provide both humoral and cellular immune responses. The UBI has a 30-year history of successfully producing more than five billion doses of safe and effective animal vaccines to fight infectious disease.

The vaccine clinical trial agreement between UNMC and COVAXX is the second COVID-19 related partnership in 2020 between the two organizations. In May, UNMC and COVAXX signed a memorandum of understanding that allowed for large-scale, high-quality COVID-19 antibody diagnostic testing and processing.

“Through our partnership with COVAXX this summer, we have seen that they were able to bring scientific, business expertise in trusted, lab-based antibody blood testing and development,” Dr. Gold said. “We hope that through our effort in conducting clinical trials with COVAXX, we will attain our important goal of returning American citizens to work safely and with confidence.”

“Working with UNMC is an extraordinary opportunity, as the medical center is second-to-none in epidemiology and infectious disease,” said Jon Harrison, chief strategy officer for COVAXX.

UNMC’s expertise in biopreparedness and infectious diseases is well noted. It is home to the Global Center for Health Security, as well as the National Training, Simulation and Quarantine Center and one of the nation’s premier biocontainment units. Most recently UNMC announced the NeXT project, to build a state-of-the-art academic medical center that will transform the quality and practice of health education, training, research and care for all Nebraskans, and serve as a model for the entire U.S.

The project also is a federal all-hazard disaster response military civilian partnership to provide training and treatment for U.S. military and civilian personnel.

“We are privileged to once again have the opportunity to work with Dr. Gold and his team at UNMC, to conduct the first human trials of our vaccine in the United States,” said Mei Mei Hu, co-founder and co-CEO of COVAXX. “We share the important values of following science and putting diagnostics and solutions-thinking at the center of our approach to safeguard the health and well-being of our communities.”