Funding for therapeutic manufacturing and testing from rapid response platform
SIOUX FALLS, S.D. - Thursday, August 25th 2016 [ME NewsWire]
(BUSINESS WIRE)-- SAB Biotherapeutics, Inc. (SAB), a clinical-stage biopharmaceutical development company, announced today that it 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 U.S. Department of Health and Human Services (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 $2.4M for clinical grade product for human trials, with an option for an additional $2.9M 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.”
About SAB Biotherapeutics, Inc. (SAB)
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.
Contacts
SAB Biotherapeutics, Inc.
Melissa Ullerich, 605-695-8350
media@sabbiotherapeutics.com
Permalink: http://me-newswire.net/news/18517/en
SIOUX FALLS, S.D. - Thursday, August 25th 2016 [ME NewsWire]
(BUSINESS WIRE)-- SAB Biotherapeutics, Inc. (SAB), a clinical-stage biopharmaceutical development company, announced today that it 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 U.S. Department of Health and Human Services (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 $2.4M for clinical grade product for human trials, with an option for an additional $2.9M 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.”
About SAB Biotherapeutics, Inc. (SAB)
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.
Contacts
SAB Biotherapeutics, Inc.
Melissa Ullerich, 605-695-8350
media@sabbiotherapeutics.com
Permalink: http://me-newswire.net/news/18517/en