Global biotherapeutics leader, CSL Behring and innovative human antibody development company SAB Biotherapeutics (SAB) announced 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 DiversitAb™ 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 DiversitAb™ platform.