SAB Biotherapeutics Enters Exclusive Manufacturing Services Agreement with BioSolutions Inc.

SAB Biotherapeutics, a clinical-stage biopharmaceutical company with a novel immunotherapy platform that produces specifically targeted, high-potency, fully-human polyclonal antibodies without the need for human donors, has entered into an exclusive manufacturing services agreement with Emergent BioSolutions Inc.
 
Emergent will provide contract development and manufacturing (CDMO) services to produce SAB’s fully-human polyclonal antibody products. Currently, SAB has clinical-stage programs in pan-influenza treatment, treatment of acute and recurrent C. diff., prevention of Type 1 diabetes, and discovery assets in immunology and oncology.

Terms of the Agreement

Under the terms of the agreement, Emergent will provide end-to-end Good Manufacturing Practice (cGMP) manufacturing services to SAB, including process development and manufacturing clinical investigational drug product to support SAB’s clinical programs, and commercial manufacturing services upon regulatory approval of SAB’s therapeutics.
 
The agreement also provides the opportunity for Emergent to utilize SAB’s novel DiversitAb platform, the only one in the world that produces fully-human polyclonal antibodies utilizing transchromosomic cows, for future development of undisclosed programs. Financial details of the agreement were not disclosed.
 
“Emergent is a world leader in plasma purification from both humans and animals and excels in this specialized area of drug development and manufacturing,” said Eddie Sullivan, co-founder, president and chief executive officer of SAB Biotherapeutics. “Partnering with Emergent at this stage allows SAB to focus solely on research and development of our polyclonal antibody drug candidates. In Emergent, we’ve found a terrific partner with highly specialized expertise and experience with our novel approach.”

About SAB’s Technology Platform

SAB’s technology platform leverages the natural human immune response to develop next-generation, fully-human polyclonal antibody therapeutics without the need for human plasma, extending both safety and potency. These high-avidity antibodies have proven to neutralize a broad spectrum of pathogens and treat disease, and address mutation, an advantage over monoclonal antibody therapeutics.
 
SAB’s platform represents, for the first time, the ability to produce targeted, fully-human, high-potency polyclonal therapies on a commercial scale. SAB’s novel platform can consistently and reliably produce fully human antibodies without the need for convalescent plasma from human donors. Tc Bovine – SAB’s genetically engineered cows – mount the same immune response as humans, only with a much higher concentration and potency of targeted neutralizing antibodies directed at multiple pathogens and in large quantities, through a more simplified and controlled process than has previously been possible.
 
“Emergent is pleased to leverage its deep expertise in the complex process development and manufacturing of plasma-derived therapies to support SAB’s clinical and potentially commercial therapeutic programs,” said Bill Hartzel, senior vice president and Head of the CDMO Business at Emergent BioSolutions. “As one of Canada’s most successful, longest standing pharmaceutical manufacturing sites, Emergent’s Winnipeg facility is uniquely equipped to offer integrated drug substance and drug product manufacturing services to help bring SAB’s critical and novel drug candidates to patients around the globe.”
 
Emergent has deep expertise with plasma products generated for targeted therapies. For decades, Emergent’s hyperimmune specialty plasma antibody manufacturing platform has been used to create multiple drugs up to a scale of 1000L. This includes its human platform, purified gamma globulin (IgG) containing polyclonal antibodies to specific antigens obtained from human plasma, and its equine platform, purified immunoglobulin fragments derived from polyclonal antibodies to specific antigens obtained from equine plasma.