Pre-clinical animal studies are required for vaccines and medicines to be tested in humans and ultimately approved by the US FDA. Our team partnered with Pfizer to run the pre-clinical trials of the company’s COVID-19 mRNA vaccine candidates in our animal models from April to July 2020. The detailed data collected during these trials showed the vaccine was safe and effective, and helped Pfizer and BioNTech determine which version of the vaccine to move forward with. Ultimately, it became the first COVID-19 vaccine to be granted emergency authorization use, and later full approval, by the FDA. More than 300 million doses have been administered in the U.S. as of January 2022.

Learn more: Texas Biomed shares critical work in development of Pfizer COVID-19 vaccine

Paper: Vogel, A. B. et al. Immunogenic BNT162b vaccines protect rhesus macaques from SARS-CoV-2 – Nature, Feb. 2021, DOI:10.1038/s41586-021-03275-y.

We conducted pre-clinical animal studies, which are required by the FDA, for Regeneron’s monoclonal antibody treatment, which has continued to be effective at neutralizing SARS-CoV-2 and many variants of concern.

Learn more: Antibody Cocktail Effective Against COVID-19 Variants

Paper: Copin, R. et al, The monoclonal antibody combination REGEN-COV protects against SARS-CoV-2 mutational escape in preclinical and human studies – Cell, June 2021, DOI: 10.1016/j.cell.2021.06.002

Professor Luis Martinez-Sobrido and his colleagues at Texas Biomed and University of Alabama at Birmingham discovered potent antibodies collected from an infected patient, and are working with Aridis Pharmaceuticals to bring the treatment to market.

Learn more: Aridis’ antibody cocktail shows activity against Covid-19 variants

Professor Luis Martinez-Sobrido and his lab are experts in generating versions of the SARS-CoV-2 virus through advanced, reverse genetic approaches. This provides them the full genetic sequence to analyze, especially by knocking out genes to to see how it affects the virus, and by adding genes to make the virus glow. Being able to see the virus makes is much faster and easier to assess if a vaccine or medicine is effective at stopping the virus, or not. Before, scientists would have to run longer and more expensive chemical detection tests to quantify how much virus is present in a sample. Now they can use visual observations.

The lab has shared non-infectious versions of these strains, called plasmids, with more than 100 labs all over the world.

Learn more:

Watching SARS-CoV-2 spread in animal models in real time

Cutting out the proteins that give SARS-CoV-2 its power

 

Our scientists received two Department of Defense’s (DoD) Defense Health Agency subcontracts to assess the efficacy of surface coating and aerosolized decontamination technologies to combat SARS-CoV-2 and other respiratory pathogens on surfaces and in the air, in partnership with the the 59^th Medical Wing Science and Technology Office.

Learn more: Scientists partner with DoD to test SARS-CoV-2 surface and air decontamination technologies

We tested the efficacy of the Xenex LightStrike Robot against SARS-CoV-2. The LightStrike disinfection robot inactivated SARS-CoV-2, which is the virus that causes COVID-19, on both hard surfaces and N95 masks. This study was done in the BSL4 lab as contract research for Xenex Disinfections Services. The study was completed in just two weeks from the time of contract signature to QC results reported.

Watch: Xenex UV robot disinfects, destroys coronavirus on surfaces

One of the biggest issues in the pandemic is identifying how many people are infected, which help provide insight into asymptomatic infections, detecting variants, and calculating a true fatality rate. Point-of Care diagnostics are needed for diagnosis without having to send samples to a lab for processing. Texas Biomed scientists have two projects with UCSC and UCSF one in nanopore-based multi-target analysis and a new CRISPR diagnostic test of SARS-CoV-2.

Scientists are working to identify several human monoclonal antibodies(BNhMAbs) that can bind to and neutralize SARS-CoV-2, for potential therapeutic and prophylactic activity against COVID-19 infection.

Our scientists aim to successfully identify an attenuated form of COVID-19 that can be used as a live attenuated vaccine, which could provide strong protection against many coronavirus variants.

Learn more: Intranasal vaccine may block COVID-19 where it starts

Paper: Immunogenicity and protective efficacy of an intranasal live-attenuated vaccine against SARS-CoV-2 – Jun-Gyu Park et al, iScience, Aug. 2021, DOI:10.1016/j.isci.2021.102941

Professor Luis Martinez-Sobrido and his lab are experts in generating versions of the SARS-CoV-2 virus through advanced, reverse genetic approaches. These viruses facilitate the study of COVID-19 infections, including the identification of antivirals and neutralizing antibodies for the treatment of COVID-19 infections.

The lab has shared non-infectious versions of these strains, called plasmids, with more than 100 labs all over the world.

Production of viral stocks and complete genomic analyses to ensure consistency across all experiments on SARS-CoV-2 that occur at Texas Biomed.

Soon after the start of pandemic, we launched studies in ABSL3 and ABSL4 to determine the best non-human primate (NHP) species for modeling human disease. Texas Biomed investigators studied rhesus macaques, baboons and marmosets of two different ages with the goal to identify the best model that can be used to test vaccines and therapeutics for human use.

Scientists aim to demonstrate that the baboon can serve as a validated animal model for consistent infection with SARS-CoV-2. The availability of a valid NHP model of SARS-CoV-2 infection will facilitate studies related to diagnosis, pathogenesis and transmission, as well as pre-clinical testing of vaccines and therapeutics against this virus.

Read: Texas Biomed accelerates novel multi-species, comprehensive study to identify COVID-19 animal model supporting drug development efforts

Papers: Responses to acute infection with SARS-CoV-2 in the lungs of rhesus macaques, baboons and marmosets, Singh, D.K. et al, Nature Microbiology, Dec. 2020, DOI: 10.1038/s41564-020-00841-4

Studies of immune function in elderly rhesus macaques, and determine if re-infection is possible. These studies will help determine why the elderly are more susceptible to COVID-19. Studies are pending a supplement approval and potential award from NIA.

Mice are being infected with SARS-CoV-2, virus isolated, and re-infected to the same species. The goal is to drive mutations in the virus that make it adapted to infected mice and guinea pigs a manageable model to quickly understand disease and immunity.

Study of SARS-CoV-2 disease and immunity in a transgenic mouse model that expresses the human ACE2 receptor (the receptor for SARS-CoV-2). This provides a small rodent model for rapid screening of vaccines and therapeutics. Studies are pending IACUC approvals and shipment of mice from an external vendor.

Study of SARS-CoV-2 in Syrian Hamsters, a natural model of infection. Studies include determining natural transmission, the impact of the lung alveolar lining fluid, and disease outcome with increasing age.

The San Antonio Partnership for Precision Therapeutics and the Vaccine Development Center have awarded $200,000 for a collaborative study between Southwest Research Institute, Texas Biomedical Research Institute, UTHealth San Antonio and the University of Texas at San Antonio to develop a novel vaccine to combat COVID-19. The team’s goal is to develop a novel vaccine to combat COVID-19 based on decades of work on a tularemia vaccine platform.

Learn more: San Antonio Partnership for Precision Therapeutics awards $200,000 toward COVID-19 vaccine project

 

Texas Biomed is participating in a rapid response pilot grant to study the role of a polybasic furin cleavage site in SARS-CoV-2 biology and therapeutic implications.

Texas Biomed researchers have established agreements with a variety of research partners around the world to study various proprietary diagnostic tests, therapeutics and vaccines, as well as test disinfection tools and decontamination protocols.

We are working to understand how SARS-CoV-2 affects the body in a number of ways and how it interacts with other diseases and conditions, including pregnancy and heart disease, as well as its impact on interactions between the gut, brain and lungs.