SAB Biotherapeutics said today it has won an up-to-$5.3 million contract from the Biomedical Advanced Research and Development Authority (BARDA), U.S. Department of Health and Human Services (HHS), toward advanced clinical manufacturing and testing for the company’s novel antibody therapeutic (SAB-301) to treat Middle East respiratory syndrome coronavirus (MERS-CoV).
“This partnership with BARDA is instrumental in advancing the MERS treatment, while creating a clinical development pathway for other therapeutics produced from our novel rapid response platform,” SAB president and CEO Eddie Sullivan, Ph.D., said in a statement.
SAB-301 was produced through SAB’s DiversitAb™ platform, which uses transchromosomic cattle (Tc Bovine™) that are genetically designed to produce large amounts of immunoglobulin G in response to an antigen such as MERS in a brief period of time.
Phase I clinical trials have been launched for SAB-301 with the NIH evaluating dosage and safety. A final report is expected in the first quarter of 2017.
Once these trials in healthy candidates have been completed with no significant safety concerns, SAB said, the potency and dosing of SAS-301 will be assessed in Phase II trials with patients with MERS in endemic countries. Those trials will also be conducted by the NIH.
BARDA will provide an initial $2.4 million for clinical-grade product for human trials, with an option for an additional $2.9 million to produce more doses if needed, SAB said.