March 31, 2020

Sioux Falls-based SAB Biotherapeutics will receive up to $27 million from the U.S. Department of Defense to develop and test a rapid-response antibody program.

The progressive and competitive, three-stage, multiyear contract calls for the development of a state-of-the-art, pharmaceutical platform technology capable of rapidly and reliably producing antibody-based medical countermeasures for biological threats.

The goal of the program is to accelerate the delivery of potent human polyclonal antibody therapeutics to address known and novel emerging biodefense viral, bacterial or toxin threats.

Using advanced genetic engineering and antibody science, SAB has developed the DiversitAb platform to naturally and rapidly produce large amounts of targeted human antibodies without human donors.

Stage 1 of the contract, totaling $3.4 million, began in September of 2019 and continues through May 2020. It will demonstrate the platform’s potential to meet the Defense Department’s requirements for producing safe and efficacious cGMP, or cleanly manufactured, material in less than six months at current scale.

Stage 2 increases the scale of production to meet the department’s target number of doses of prototype drug product and fully implemented demonstration of readiness.

Stage 3 calls for production of an antibody product to an unknown threat, selected by the Defense Department in a “live fire” exercise as well as clinical activity through a Phase 1 trial.

“We have an obligation to apply our proprietary capabilities to produce high-potency immunotherapies to virtually any target on a large scale, to a rapid-response capacity,” Eddie Sullivan, SAB Biotherapeutics president, CEO and co-founder, said in a statement. “Our therapies leverage the native immune response, thereby providing a highly specific match against the complexity, diversity and mutation of disease.”

The company has developed more than a dozen effective antibodies from its DiversitAb platform in response to infectious disease targets during outbreaks of Ebola, Zika, Dengue and others.

It has been working on producing antibodies to COVID-19 and hopes to have a therapeutic ready for testing by early summer. The work around COVID-19 is separate from the newly announced funds from the Department of Defense.

“For a new disease target, we’re able to move quickly to a proof of concept in about 90 days,” Sullivan said.

“Infectious disease has been a strategic proving ground for our platform. If we can perform under the most demanding of scenarios to challenging targets, it builds confidence that translates to a broader array of therapeutic programs,” Sullivan said.

SAB also is advancing a therapeutic pipeline, including potential treatments for autoimmune diseases, inflammation, infectious diseases and cancers. The company recently entered a research collaboration with CSL Behring to explore innovative immunotherapies, including human immunoglobulins.

“This initiative is solidifying a place for targeted human polyclonal antibodies in the immunotherapy space, showcasing the power of the native human biological immune response,” Sullivan said. “More importantly, we’re providing an innovative new tool in the medical countermeasures toolbox.”

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