SAB Biotherapeutics, Inc. (SAB), a clinical-stage biopharmaceutical development company, has been awarded a contract for up to $5.3 million by the Biomedical Advanced Research and Development Authority (BARDA) within the Office of the Assistant Secretary for Preparedness and Response in the US Department of HHS. The funding will be used for advanced clinical manufacturing and testing for SAB’s novel antibody therapeutic (SAB-301) to treat MERS-CoV.
“SAB has developed a unique production platform to rapidly respond to emerging infectious disease threats,” said SAB president and CEO Dr. Eddie Sullivan. “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-301 was produced utilizing the DiversitAb platform, which leverages transchromosomic cattle (Tc Bovine). These cattle have been genetically designed to produce large amounts of human polyclonal antibodies (immunoglobulin G) in response to an antigen such as MERS in a brief period of time.
Currently, there are no approved vaccines or specific treatments for MERS, a severe respiratory disease akin to the Severe Acute Respiratory Syndrome (SARS) with a high fatality rate. Since it was first identified in Saudi Arabia in 2012, MERS has infected more than 1,700 people and killed nearly 40% of those infected. According to the World Health Organization, cases have now been confirmed in 27 countries in the Middle East, Europe, Asia and the United States. A 2015 outbreak in the Republic of Korea is the largest outbreak outside of the Middle East.
BARDA, which manages the procurement and advanced development of medical countermeasures for pandemic influenza and other emerging infectious diseases, 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.
Phase I clinical trials are currently underway for SAB-301 with the National Institutes of Health (NIH) evaluating dosage and safety with a final report expected in the first quarter of 2017. Once these trials in healthy candidates have been completed with no significant safety concerns, the potency and dosing of the treatment can be evaluated in phase 2 trials in patients with MERS in endemic countries utilizing the product specified in the BARDA contract also conducted by the NIH.
“We are also advancing treatments for Ebola, Influenza and Zika with the goal of leveraging our platform as a countermeasure against emerging infectious diseases,” added Sullivan. “SAB is dedicated to partnering with government and other organizations to address this current and future threats to human health.”
The Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response in the US Department of Health and Human Services, provides an integrated, systematic approach to the development and purchase of the necessary vaccines, drugs, therapies, and diagnostic tools for public health medical emergencies.