SAB Biotherapeutics announced the presentation of positive safety and pharmacologic data from a GLP toxicology study for SAB-142, a first in class fully human immunotherapeutic being developed for delaying onset and progression of Type 1 Diabetes (T1D), at the Federation of Clinical Immunology Societies (FOCIS) in Boston. Results from the IND-enabling GLP tox study confirmed that SAB-142 affects the same subsets of immune cells associated with T1D as commercially available rabbit-derived anti-thymocyte globulin (rATG) in vivo. SAB-142 is a first-in-class fully-human, multi-target anti-thymocyte immunoglobulin treatment aimed to provide a superior profile for delaying onset or progression of T1D.

SAB-142's unique multi-target strategy can be directed at the multiple immunological cell subsets associated with T1D and other autoimmune diseases. Another anti-thymocyte product produced in rabbits and FDA-approved for kidney transplantation, rATG, was investigated in patients with Type 1 Diabetes and showed significant efficacy in delaying progression of the disease by preserving C-peptide levels, a surrogate measure for endogenous insulin production by pancreatic beta cells. Commercially available products for T-cell mediated autoimmune diseases, such as fully-animal antibodies often induce immune-mediated reactions such as serum sickness.

By contrast, SAB-142, which is a fully-human polyclonal antibody therapeutic, may be administered multiple times without causing these immune-related adverse reactions, which is particularly desirable for patients with lifelong diseases such as T1D. In the in vivo study conducted under GLP conditions, SAB-142 was administered at three dose levels of 1, 5, and 10 mg/kg. Its active control, FDA-approved anti-thymocyte rabbit globulin (ATG) was administered at 5 mg/kg.

The study results showed that both SAB-142 and the rabbit ATG modulate key T-cell subsets relevant for T1D in a similar fashion thus confirming that SAB-142's mechanism of action is similar to rabbit ATG. Based on the absence of SAB-142-related findings in any safety parameter evaluated in the study, the No Observed-Adverse-Effect-Level (NOAEL) was determined to be 10 mg/kg SAB-142, the highest dose level evaluated, thus meeting its main objective to generate preclinical safety data in support of upcoming IND and CTA filings.