April 08, 2020 at 8 a.m. ET

COVID-19 treatment candidate, a high-potency immunotherapy delivering human polyclonal antibodies targeted to SARS-CoV-2, generated from SAB’s novel platform technology, on-track for clinical evaluation as early as summer

King of Prussia, Pa. and Sioux Falls, S.D., April 8, 2020 – Global biotherapeutics leader, CSL Behring and innovative human antibody development company SAB Biotherapeutics (SAB) announced today their partnership to combat the coronavirus pandemic with the rapid development of SAB-185, a COVID-19 therapeutic candidate on track for clinical evaluation by early summer. The partnership joins the forces of CSL Behring’s leading protein science capabilities with SAB’s novel immunotherapy platform capable of rapidly developing and producing natural, highly-targeted, high-potency, fully human polyclonal antibodies without the need for blood plasma donations from recovered patients.

The therapeutic candidate, SAB-185, is generated from SAB’s proprietary DiversitAbTM platform producing large volumes of human polyclonal antibodies targeted specifically to SARS-CoV-2, the virus that causes COVID-19. Driven by advanced genetic engineering and antibody science, SAB’s novel approach, leveraging genetically engineered cattle to produce fully human antibodies, enables a scalable and reliable production of targeted, higher potency neutralizing antibody product than has been previously possible. SAB’s approach has expedited the rapid development of a novel immunotherapy for COVID-19 deploying the same natural immune response to fight the disease as recovered patients, but with a much higher concentration of targeted antibodies.

“COVID-19 is a nearly unprecedented public health crisis,” said CSL Behring’s Executive Vice President and Head of R&D Bill Mezzanotte, M.D. “That’s why we’re combining our leading capabilities in plasma product development and immunology with external collaborators to help find multiple, rapid solutions. In the near-term, SAB Biotherapeutics’ novel immunotherapy platform provides a new and innovative solution to rapidly respond without the need for human plasma adding a different dimension to the industry-wide plasma-derived hyperimmune alliance effort we recently launched for the COVID-19 crisis. For future pandemics, SAB’s platform may allow us to even more rapidly respond to patients’ needs.”

“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,” said Eddie J. Sullivan, PhD, SAB Biotherapeutics president, CEO and co-founder. “Our partnership with CSL Behring shifts our development trajectory to more rapidly scale-up and delivery of our highly targeted and potent COVID-19 therapeutic candidate, and deploy our unique capabilities to help combat this crisis. We have a successful preclinical track record for addressing infectious disease targets including Ebola, MERS, and SARS with our proprietary platform and appreciate that this collaboration with a global biopharmaceutical powerhouse will magnify the potential impact of a COVID-19 immunotherapy and provide an important framework for establishing sustainable solutions for the future.”

CSL Behring has provided seed funding to offset some initial development costs that were funded by SAB in good faith, responding to the global pandemic as quickly as possible. SAB has already secured approximately $7.2 million in funding through an interagency agreement with the Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEO – CBRND) and Biomedical Advanced Research and Development Authority (BARDA) to support SAB to complete manufacturing and preclinical studies. CSL Behring will then commit its clinical, regulatory, manufacturing and supply chain expertise and resources to deliver the therapeutic to the market as soon as possible, on terms to be agreed with SAB.

Earlier this year, the companies announced a collaboration to investigate SAB’s platform technology as a new source for human immunoglobulin G (IgG) and the potential for new therapies to treat challenging autoimmune, infectious and idiopathic diseases by leveraging SAB’s DiversitAbTM platform.

About CSL Behring

CSL Behring is a global biotherapeutics leader driven by its promise to save lives. Focused on serving patients’ needs by using the latest technologies, we develop and deliver innovative therapies that are used to treat coagulation disorders, primary immune deficiencies, hereditary angioedema, inherited respiratory disease, and neurological disorders. The company’s products are also used in cardiac surgery, burn treatment and to prevent hemolytic disease of the newborn. CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. The parent company, CSL Limited (ASX:CSL;USOTC:CSLLY), headquartered in Melbourne, Australia, employs more than 26,000 people, and delivers its life-saving therapies to people in more than 70 countries. For more information, visit www.cslbehring.com and for inspiring stories about the promise of biotechnology, visit Vita www.cslbehring.com/Vita

About SAB Biotherapeutics, Inc.

SAB Biotherapeutics, Inc. (SAB), headquartered in Sioux Falls, S.D. is a clinical-stage, biopharmaceutical development 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, immunotherapies at commercial scale. The company is advancing programs in autoimmunity, infectious diseases, inflammation and exploratory oncology. SAB is rapidly progressing on a new therapeutic for COVID-19, SAB-185, a 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. The company was also recently awarded a $27 million contract from the U.S. Department of Defense (DoD) to leverage its unique capabilities as part of a Rapid Response Antibody Program, valued at up to $27 million. For more information visit: www.sabbiotherapeutics.com.

Media contacts:

SAB Biotherapeutics
Melissa Ullerich
mullerich@sabbiotherapeutics.com
+1 605.679.4609

CSL Behring
Greg Healy
greg.healy@cslbehring.com
+1 610-906-4564

https://www.prnewswire.com/news-releases/csl-behring-and-sab-biotherapeutics-join-forces-to-deliver-new-potential-covid-19-therapeutic-301037503.html