Phase I Clinical Trials Underway for First MERS Treatment
SAB Biotherapeutics, Inc. (SAB) , a leading biopharmaceutical development company, announced today that Phase I Clinical Trials are underway for its human antibody treatment (SAB-301) for MERS-CoV. The goal of the study–sponsored, funded and conducted by National Institutes of Health (NIH)–is to evaluate the dosage and safety of this new therapeutic.
Middle East Respiratory Syndrome (MERS) is a newly discovered, contagious and sometimes fatal respiratory illness, caused by a virus known as MERS coronavirus (MERS-CoV), with no known vaccines or treatments.
SAB produced SAB-301 utilizing its 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.
“Reaching Phase I Clinical Trials is a significant milestone for SAB,” said Eddie Sullivan, SAB President and CEO. “More importantly, is having the NIH consider our technology as one of the rapid response defenses potentially useful against MERS and other emerging infectious diseases such as Ebola and even Zika.”
To produce the therapeutic, the Tc Bovine are vaccinated with an antigen. Within a brief period of time, they produce significant amounts of fully human antibodies to combat the antigen. Plasma is then collected (in the same manner as humans) from the cattle, which is then purified to isolate the antibodies. This then becomes the therapeutic treatment.
Animal antibodies have been made in rabbits, sheep, and horses. However, SAB’s platform is the first to produce fully human antibodies in large animals.
“Our vision was to develop the first large-scale platform technology to produce human antibody therapeutics with Tc Bovine,” explains Sullivan, “and have the animals available so that during outbreaks of infectious diseases they can be put to use to generate a large number of doses within a very short timeframe. These doses can then be administered to patients, and may be able to save lives."
The trials began May 24, 2016 with the clinical report expected end of Q1 2017.
The FDA reviewed SAB-301 pre-clinical data from studies conducted by global infectious disease experts at the Naval Medical Research Center, the University of Maryland, School of Medicine and NIH late last year and allowed the current trials to proceed. Once these trials have been confirmed as successful, the effectiveness of the treatment may next be evaluated in patients with MERS.
“We are gratified that we have succeeded in shepherding this technology and bringing together dedicated scientists, infectious disease experts, state-of-the-art laboratories, leading universities, health organizations and other innovators and supporters who have made this possible,” said Sullivan.
“In addition, we are honored to be working with the NIH towards their goal of protecting and improving health and potentially leveraging our platform to help prevent and treat disease,” added Sullivan.
SAB Biotherapeutics, Inc. (SAB), headquartered in Sioux Falls, S.D. is a clinical stage, biopharmaceutical 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.
SAB Biotherapeutics, Inc.
Melissa Ullerich, 605-695-8350
Information om Business Wire
101 California Street, 20th Floor
CA 94111 San Francisco
Følg pressemeddelelser fra Business Wire
Skrive dig op her og du vil løbende modtage pressemeddelelser på mail. Indtast din mail, klik på abonner og følg instruktionerne i den udsendte mail.
Flere pressemeddelelser fra Business Wire
NJ-CELGENE17.2.2018 22:02 | pressemeddelelse
OTEZLA® (Apremilast) Phase III Data Showed Significant Improvements in Patients with Active Behçet’s Disease with Oral Ulcers
CELLTRION-HEALTHCARE17.2.2018 09:02 | pressemeddelelse
CT-P13 (biosimilar infliximab) is comparable to reference infliximab and adalimumab in highly anticipated real-world study
AVANTI-COMMUNICATIONS16.2.2018 19:28 | pressemeddelelse
Avanti Communications HYLAS 4 Satellite Arrives in French Guiana
KY-GENERAL-CABLE-CORP16.2.2018 18:07 | pressemeddelelse
General Cable Corporation Stockholders Approve Acquisition By Prysmian Group
BOEHRINGER-INGELHEIM16.2.2018 10:05 | pressemeddelelse
Systemic Sclerosis World Congress: Inspirational Patient Stories Reveal the Challenging Realities of Living with Devastating Rare Disease
PHILIP-MORRIS-INTL16.2.2018 09:02 | pressemeddelelse
Philip Morris International Recognized as a Global Top Employer for the Second Year in a Row
I vores nyhedsrum kan du læse alle vores pressemeddelelser, tilgå materiale i form af billeder og dokumenter, og finde vores kontaktoplysninger.Besøg vores nyhedsrum