SAB Biotherapeutics concludes IND-enabling GLP toxicology study for SAB-142

SAB Biotherapeutics announced the successful completion of an IND-enabling GLP-tox study for SAB-142, further progressing the therapeutic as a way to prevent and/or delay onset and progression of type 1 diabetes and potentially other T-cell mediated autoimmune diseases. The study assessed the toxicity and pharmacodynamic effects of SAB-142 against an FDA-approved T-cell depleting therapeutic at varying doses and found it to be well tolerated and showed a desired dose-dependent pharmacologic effect. SAB will submit the IND filing within approximately 12 months. SAB-142 is the first fully-human anti-thymocyte hpAB therapeutic currently being developed for delaying the progression and onset of type 1 diabetes, among other autoimmune indications. Commercially available products for T-cell mediated autoimmune diseases, such as fully-animal antibodies and other monoclonal lymphodepletion therapeutics, require re-dosing and often induce immune-mediated reactions such as serum sickness. As a fully-human polyclonal antibody therapeutic, SAB-142 may be administered multiple times without causing these immune-related adverse reactions, a desired factor when treating life-long diseases such as type 1 diabetes. In the study, SAB-142 was dosed at 1, 5, and 10 mg/kg and commercially available anti-thymocyte globulin was dosed at 5 mg/kg. The study results showed that both SAB-142 and its active control, FDA-approved animal-derived polyclonal anti-thymocyte immunoglobulin, induced transient lymphodepletion confirming the SAB-142 mechanism of action. The dynamics of the depletion appeared to be more prolonged in the cohort with SAB-142 treatment, which could create the opportunity for an optimized dosing regimen.