SIOUX FALLS, S.D.--(BUSINESS WIRE)--SAB Biotherapeutics, a clinical-stage biopharmaceutical development company, announced today it has received a Small Business Innovation Research (SBIR) Grant from the National Institutes of Health (NIH) for up to $1.42M to advance its treatment for influenza. The funding–specifically for the production and preclinical testing of its novel antibody therapeutic targeting influenza viruses–is a research collaboration project with the University of South Dakota (USD) Sanford School of Medicine. The project was initiated through the BioSNTR, a distributed research initiative that facilitates academic and industry research collaborations to advance biotechnology and commercialize innovations.
The treatment is produced from SAB’s unique DiversitAb™ Platform leveraging transchromosomic cattle (Tc Bovine™) that have been genetically designed to produce fully human antibodies (immunoglobulin G) in response to an antigen–in this case influenza viruses.
“We’ve already had success targeting other single virus antigens, such as MERS-CoV, and in fact, this therapeutic is now in human trials,” said Eddie Sullivan, Ph.D., President and CEO of SAB. “Now, to combat influenza, the antigen we are developing contains a combination of four strains of influenza viruses, the same ones contained in the 2016-2017 vaccine–so this collaboration with USD is a significant one.”
The SAB-USD collaboration received a significant boost from a BioSNTR seed grant that provided $50,000 to develop the in vivo model and generate key preliminary data needed to secure the SBIR funding.
“This collaboration is a great example of how the BioSNTR links academic and industry researchers to address a specific scientific problem,” said Adam Hoppe, Ph.D., Director of the BioSNTR. “The BioSNTR’s investment yielded a significant return for research in our state, while advancing a potentially life-saving treatment. That’s the type of impact the BioSNTR was designed to create.”
Influenza, or “the flu” is a contagious respiratory illness caused by influenza viruses that infect the nose, throat, and lungs. It can cause mild to severe illness, and at times the flu and its complications can be life threatening. Annual vaccination is recommended to prevent or lessen the severity of the flu.
“Depending on the season, there are 3,000-49,000 influenza virus-associated deaths in the U.S. each year,” said influenza expert Victor Huber, Ph.D. Huber is an Associate Professor in the Division of Basic Biomedical Sciences at the University of South Dakota, who studies immunology, virology, and vaccinology and is leading this project at USD to test SAB’s treatment.
To begin the testing, Tc Bovine will be inoculated with the influenza vaccine, against which the cattle will begin producing antibodies in response. SAB scientists will then harvest the antibodies from plasma collected in a similar manner as in humans. The plasma will then be purified using the cGMP facility at SAB resulting in the clinical grade therapeutic that will be evaluated in Huber’s laboratory. In addition, BioSNTR faculty Adam Hoppe, Ph.D. and Feng Li, Ph.D., both from South Dakota State University, joined the collaboration team, bringing additional intellectual expertise and resources. The team is now working on new ideas to expand this research direction.
“SAB’s technology is on the forefront of treating viruses like influenza with antibody therapeutics that can complement vaccine efforts,” added Huber. “This funding is important to advance the development of solutions that address the rapid spread of viruses that continue to threaten human health in the U.S., and around the world.”
The DiversitAb platform works well to address evolving and complex viruses, such as influenza. In a very short period of time, the Tc Bovine can produce antibodies against specific viruses – which then can be used as a treatment for those who are already comprised, for which the vaccine wasn’t effective or if the strains have changed since vaccination.
The two-year research project was approved August 3, 2016 when the initial year’s funding of $756,080 granted. The contract runs through July 23, 2018 with an additional disbursement of $670,476 for year two awarded based on availability of funds and satisfactory progress. Results of the testing are expected in 2018.
“SAB works with researchers, laboratories and organizations around the world to address emerging health threats such as MERS-CoV, Ebola and Zika,” added Sullivan. “It’s also rewarding to be able to utilize the resources we have in South Dakota towards developing a new product and advancing our platform, while potentially treating a significant target like influenza.”
About SAB Biotherapeutics, Inc.
SAB Biotherapeutics, Inc. (SAB), headquartered in Sioux Falls, S.D. is a clinical stage, biopharmaceutical development company leading the science and manufacturing of antibody therapeutics. Utilizing some of the most advanced antibody science in the world, SAB is delivering the world’s first large-scale platform to create immunoglobulins. This natural production platform holds the potential for treatment of public health problems, rare conditions, long-term diseases and global pandemic threats.
About Small Business Innovation Research (SBIR) Program
The National Institutes of Health (NIH) Small Business Innovation Research (SBIR) program, also part of America’s Seed Fund, is one of the largest sources of early-stage capital for technology commercialization in the U.S. The program funds early stage U.S.-owned businesses that are seeking to commercialize innovative biomedical technologies. This competitive program helps small businesses participate in federal research and development, develop life-saving technologies, and create jobs.
The BioSNTR “bio center” is focused on bridging the gap between academia and industry to create a bio-economy in South Dakota through high impact science. The center is a distributed research initiative based on a systems biology approach and translational research model that enables research, development and education using state-of-the-art imaging and bioinformatics to accelerate biotechnology. The BioSNTR aims to advance the frontier of science through a collaborative spirit across disciplines and organizations to tackle ambitious challenges that have a societal and economic impact.
The BioSNTR was developed with funding from the State of South Dakota through a South Dakota Research Innovation Center award and the National Science Foundation (NSF) through an EPSCoR RII Track-1 award. The BioSNTR is currently comprised of more than 30 academic researchers at major research institutions.