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SAB Biotherapeutics Initiates IND-Enabling GLP Toxicology Study for SAB-142, Novel Immunotherapeutic for Type 1 Diabetes
Study of SAB’s fully-human polyclonal therapeutic to delay onset or progression of type 1 diabetes is the last step before investigational new drug (IND)
About this update from Sab Biotherapeutics, Inc.
[{"type":"text","content":"Study of SAB’s fully-human polyclonal therapeutic to delay onset or progression of type 1 diabetes is the last step before investigational new drug (IND) filing\nSIOUX FALLS, S.D., Nov. 21, 2022 (GLOBE NEWSWIRE) -- SAB Biotherapeutics (Nasdaq: SABS), (\"SAB”), a clinical-stage biopharmaceutical company with a novel immunotherapy platform that produces specifically targeted, high-potency, fully-human polyclonal antibodies without the need for human donors, today announced SAB-142 is being progressed as a therapeutic agent to prevent and/or delay onset and progression of Type 1 diabetes (T1D) and potentially other T-cell mediated autoimmune diseases. In an IND-enabling GLP study, SAB-142 will be compared to an FDA-approved T-cell depleting therapeutic, to assess toxicity and pharmacodynamic effects. Because SAB-142 is a fully-human polyclonal antibody, it is expected to be much less immunogenic, safer, and more effective in preventing and/or delaying onset and progression of T1D as compared to other commercially available products such as fully-animal antibodies and other monoclonal lymphodepletion therapeutics. SAB-142 is fully-human therapeutic that may be administered multiple times without inducing immune-mediated reactions including immediate anaphylaxis or delayed serum sickness. “Type 1 diabetes is an autoimmune disease that represents a staggering unmet patient need,” said Alexandra Kropotova, MD, Chief Medical Officer of SAB Biotherapeutics. “Patients in the Americas are disproportionally affected by Type 1 diabetes. From 1990 to 2019, the death rate increased in the Americas by 13.5%, in contrast to a decreasing global rate of –9.3%. The initiation of this study supports the progression of our SAB-142 immunotherapeutic towards IND filing. As such, we are aiming toward a successful IND submission for this novel immunotherapy that can positively impact the health of millions of patients with Type 1 diabetes across the globe.” In the GLP toxicology study, conducted in an appropriate model, SAB-142 will be dosed at 1, 5, and 10 mg/kg and commercially available anti-thymocyte globulin will be dosed at 5 mg/kg. The study is expected to be completed in the first quarter of 2023. About SAB Biotherapeutics SAB Biotherapeutics, Inc. (SAB) We are a clinical-stage biopharmaceutical company focused on the development of powerful and ...