New research initiative to investigate multi-species response to novel coronavirus

Scientists at Texas Biomedical Research Institute (Texas Biomed) today announced the launch of a comprehensive research initiative to investigate multiple animal species and their response to the novel coronavirus disease (COVID-19). This study expands on a previously launched study to validate a baboon animal model for SARS-CoV-2, the causative agent of COVID-19. The research, which is expected to be complete in the next four weeks, will allow scientists to pinpoint the best animal model to move diagnostics, vaccines, and therapies forward that will combat COVID-19. Animal studies support research on the pathogenesis and transmission, as well as the development of countermeasures, against SARS-CoV-2. Four additional species have been included in the extended study: macaques, marmosets, mice and guinea pigs.

As the leading independent, non-profit biomedical research organization in the country focused on eradicating infectious disease threats in the world, we believe it is our duty and responsibility to help find the necessary animal model to treat COVID-19. In the interest of saving human lives, research on multiple species provides us a greater understanding of disease pathology and progression and gives us a better probability of finding the best model. However, science is often slowed by red tape. I am proud that Texas Biomed is agile, nimble and quick-to-action as an independent institution. This flexibility allowed us to prioritize regulatory and approval processes, and with the help of our funding partners, start the research faster."

Dr. Larry Schlesinger, Professor, President and CEO of Texas Biomed

In the span of two weeks, the Texas Biomed secured all required regulatory approvals, grew and cultured the virus and moved animals into the Biosafety level (BSL)-3 and BSL-4 labs to begin work. Texas Biomed and the Southwest National Primate Research Center (SNPRC) on its campus have experience and success in creating animal models for diseases, such as Ebola, HIV, tuberculosis, Hepatitis-C and Zika, and experience evaluating candidate therapeutics and vaccines for a number of virus threats including SARS.

This expertise has been combined with the development and implementation of reverse genetics approaches to generate recombinant SARS-CoV-2 to facilitate the study of the virus in vitro (culture) and in vivo (living organism) in order to develop novel therapeutics and vaccine candidates. And, expertise in primate clinical biology, imaging and immunology technologies is being applied to ensure a comprehensive evaluation and understanding of the disease's causes and effects.

"To move a new drug or vaccine to market, biopharmaceutical companies must ensure that the intervention works and is safe for human use," explains Dr. Schlesinger. "The FDA requires that these safety and efficacy studies be performed in animals whenever possible before researchers can ethically move on to humans. Nonhuman primates are the most closely relevant models of human disease while other animal models are helpful in understanding infection and pathology of the disease, as well as the immune response."

Beyond safety and efficacy research, animal models provide researchers significant information about how the virus causes disease - how it enters cells, how it replicates, how it attacks other cells. This information allows scientists to develop drugs targeting these various processes. Animal studies also provide information on how the human body responds to the virus. Humans and nonhuman primates share 97-99% genetic similarity. Understanding how one animal's immune system protects against the disease while another's does not helps scientists discover ways to boost immunity.

Several vaccine and antiviral candidates for COVID-19 are currently being discovered, including some undergoing phase 1 human trials, aiming to determine if the intervention is safe. Further testing and refinement of drug candidates will be required as studies progress to Phase 2 and 3.

"Just because we have one drug candidate, we don't stop looking for other ways to stop a virus," said Dr. Deepak Kaushal, Professor, Director of the SNPRC and one of the principal investigators of the Texas Biomed study. "A vaccine is 12-18 months out at a minimum, and while antivirals could come sooner, they will need to undergo testing to ensure they work and are safe for humans. A validated NHP model of COVID-19 disease will significantly hasten these vaccine/therapeutic development activities. With this study, we are positioned to partner with companies and researchers to accelerate the development and approval of therapies and vaccines."

The Texas Biomed scientific team is supporting nearly a dozen COVID-19 projects internally and externally and has begun developing a pipeline of studies with collaborators and business partners worldwide.

"Texas Biomed is the only private research organization with both BSL3 and BSL4 facilities along with maintaining multiple colonies of non-human primate species and other animals capable of providing such a comprehensive study in such a short turnaround time," Schlesinger adds. "We mobilized a tremendous base of supporters to raise more than $3 million toward the completion of this study. This is an excellent example of the power of public/private partnerships to move scientific discovery and ultimately healthcare forward."