SAB’s novel approach generates targeted human antibodies without the need for human donors; on-track to have therapeutic candidate ready by summer 2020

Sioux Falls, S.D., April 16, 2020 – SAB Biotherapeutics (SAB), a clinical-stage biopharmaceutical company with a proprietary technology to produce fully human polyclonal antibodies without the need for human donors, announced today that it has been awarded expanded scope on their Rapid Response contract for their new therapeutic drug candidate to treat COVID-19, from the Department of Defense (DoD) Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEO – CBRND) Joint Project Lead for Enabling Biotechnologies (JPL-EB). This work, up to $9.4M, is supported by the Biomedical Advanced Research Development Authority (BARDA), part of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services.

SAB’s therapeutic candidate, SAB-185, is a new immunotherapy generated from the company’s proprietary technology, the DiversitAbTM platform, to produce fully human polyclonal antibodies that target SARS-CoV-2, the virus that causes COVID-19. SAB has the unique capability to scale like no other polyclonal antibody program in that it produces fully human antibodies without the need for convalescent plasma blood donations from people who have recovered from the virus. This approach, once enabled, is expected to produce greater quantities of a consistent, high potency neutralizing antibody product than is currently possible, while overcoming other challenges of traditional human antibody donor methods, such as the need to identify, screen, and draw blood from recovering volunteers that can limit production.

“SAB has developed a unique system to naturally, rapidly, and consistently produce large amounts of targeted human antibodies without human donors, as we have done with MERS and Ebola,” said Eddie J. Sullivan, PhD, SAB Biotherapeutics president, CEO and co-founder. “Our targeted high-potency immunotherapies leverage the native immune response thereby providing a highly-specific match against the complexity, diversity and mutation of a disease. We have data in other indications demonstrating that our therapies are much more potent than those produced from convalescent plasma from recovered patients and data showing SAB’s therapies remain effective when other therapeutics may develop resistance.”

“SAB Biotherapeutics’ unique antibody platform shows real potential to address the critical need for fighting coronavirus and establishing a truly responsive model for combatting future threats,” said Matthew Hepburn, M.D., Joint Project Lead CBRN Defense Enabling Biotechnologies. “We are continually exploring new technologies to ensure the security and safety of our armed forces as well as the American and global public,” he added.

“Public health threats and emerging infectious diseases has been a strategic proving ground for SAB’s platform. For a novel unknown target, we’re able to move quickly to a proof-of-concept in about 90 days,” added Sullivan. “SAB Biotherapeutics has a successful preclinical track record in this space having developed more than a dozen effective antibodies from our DiversitAb platform in response to infectious disease targets during outbreaks of Ebola, Zika, Dengue, Hantavirus, and others.”

“The current pandemic is shining a light on the direct need for new and innovative therapies in addition to being prepared to react quickly for global health security,” added Sullivan, “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,” added Sullivan. “More importantly, we’re providing an innovative solution, to address COVID-19 and be responsive to future emerging threats.”

This expanded scope and funding was awarded by the Department of Defense as a new stage, ‘Stage 4: COVID-19 Pandemic Response’, of SAB’s current JPL-EB rapid response contract. SAB expects to have initial lots of their SAB-185 therapeutic candidate available for clinical evaluation as early as summer 2020 and has activated its network of collaborators to prepare for rapid transition to clinical studies and progress quickly toward FDA submission and approval.

“SAB Biotherapeutics has successfully demonstrated their speed and capability to produce safe and efficacious cGMP material at an accelerated rate,” added Dr. Hepburn. “The company is significantly ahead of schedule within the Rapid Response Antibody Program and is increasing the scale of production to meet demands for large volumes of a prototype drug product that can be produced within months.”

BARDA supports the development of innovative products and approaches, like SAB’s technology, that aim to solve major health security challenges through innovative approaches and products and has partnered with SAB on its MERS therapeutic. BARDA is working with its partners across industry and government to build a portfolio of medical countermeasures, including drugs, vaccines and diagnostic tests, for this COVID-19 pandemic and future coronavirus outbreaks.

“We’re proud to continue our work with JPL-EB who recognized the potential of our platform to rapidly and reliably respond to emerging threats with safe and effective human polyclonal antibody therapies,” said Sullivan. “The progress we’ve made with them has given us a head start on our work on SAB-185, and now with an expansion of this contract and our long-time collaboration with BARDA, we are applying this capability as a unified team to combat the COVID-19 public health crisis.”

About the DoD Rapid Response Antibody Program:

The Rapid Response Antibody Program is a progressive and competitive three-stage rapid response contract awarded by the U.S. Department of Defense (DoD). The contract called 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 to accelerate the delivery of a series of potent, fully-human, antibody therapeutics.

  • Stage 1 demonstrates SAB’s platform has the potential to meet the DoD’s requirements for producing safe and efficacious cGMP material in less than six months at current scale. Status: SAB successfully completed Stage 1 at an accelerated rate demonstrating its speed and capability to produce safe and efficacious cGMP material, pending the official release of Drug Substance.
  • Stage 2 increases the scale of production to meet the DoD’s target number of doses of prototype drug product and fully-implemented demonstration of readiness. Status: SAB has been greenlighted to begin Stage 2 significantly ahead of schedule and with an increased scope and SAB is increasing the scale of production to meet demands for large volumes of a prototype drug product that can be produced within months.
  • Stage 3 calls for production of an antibody product to an unknown threat in a “live fire” exercise as well as clinical activity through a Phase 1 trial.
  • Stage 4 is for “COVID-19 Pandemic Response” Status: SAB awarded into Stage 4 in March 2020 to advance the rapid and ongoing development of SAB-185 to target COVID-19 through preclinical studies.

About the JPEO-CBRND:

The Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense is the Joint Service’s lead for development, acquisition, fielding and life-cycle support of chemical, biological, radiological and nuclear defense equipment and medical countermeasures. As an effective acquisition program, we put capable and supportable systems in the hands of the service members and first responders, when and where it is needed, at an affordable price. Our vision is a resilient Joint Force enabled to fight and win unencumbered by a chemical, biological, radiological, or nuclear environment; championed by innovative and state-of-the-art solutions. Joint Project Lead CBRND Enabling Biotechnologies (JPL-CBRND-EB) is an organization established for the purpose of providing medical solutions, during a crisis, against future threats.

About HHS, ASPR, and BARDA

HHS works to enhance and protect the health and well-being of all Americans, providing for effective health and human services and fostering advances in medicine, public health, and social services. The mission of ASPR is to save lives and protect Americans from 21st century health security threats. Within ASPR, BARDA invests in the innovation, advanced research and development, acquisition, and manufacturing of medical countermeasures – vaccines, drugs, therapeutics, diagnostic tools, and non- pharmaceutical products needed to combat health security threats. To date, 54 BARDA-supported products have achieved regulatory approval, licensure or clearance.

About SAB Biotherapeutics, Inc.:

SAB Biotherapeutics, Inc. (SAB) is a clinical-stage, biopharmaceutical company advancing a new class of immunotherapies leveraging fully human polyclonal antibodies. Utilizing some of the most complex genetic engineering and antibody science in the world, SAB has developed the only platform that can rapidly produce natural, highly-targeted, high-potency, human polyclonal immunotherapies at commercial scale. The company is advancing programs in autoimmunity, infectious diseases, inflammation and oncology. SAB is rapidly progressing on a new therapeutic for COVID-19, SAB-185, fully human polyclonal antibodies targeted to SARS-CoV-2 without using human donors. SAB-185 is expected to be ready for evaluation as early as summer 2020.

Media contacts:

Melissa Ullerich

mullerich@sabbiotherapeutics.com

+1 605-679-4609

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