Study shows SAB’s fully-human polyclonal therapeutic that has potential to delay the onset or progression of type 1 diabetes is well tolerated; next step is investigational new drug (IND) filing
SIOUX FALLS, S.D., Jan. 10, 2023 (GLOBE NEWSWIRE) — SAB Biotherapeutics (Nasdaq: SABS), (“SAB”), a clinical-stage biopharmaceutical company with a novel immunotherapy platform that produces specifically targeted, high-potency, high-avidity, fully-human polyclonal antibodies (hpAB) without the need for human donors, today 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 (T1D) 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.
“The completion of this GLP-tox study is an early, but significant milestone in the development of SAB-142 that enables a successful IND submission,” said Alexandra Kropotova, MD, Chief Medical Officer of SAB. “We are eager to continue progressing this therapeutic, which we believe has the potential to impact the lives of millions of patients with varying autoimmune diseases, including those with 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.
About SAB Biotherapeutics
SAB Biotherapeutics, Inc. (SAB) is a clinical-stage biopharmaceutical company focused on the development of powerful and proprietary immunotherapeutic polyclonal human antibodies to treat and prevent infectious diseases and immune and autoimmune disorders. Our development programs include infectious diseases resulting from outbreaks and pandemics, as well as immunological, gastroenterological, and respiratory diseases that have significant mortality and health impacts on immune compromised patients. SAB has applied advanced genetic engineering and antibody science to develop Transchromosomic (Tc) Bovine™. Our versatile DiversitAb™ platform is applicable to a wide range of serious unmet needs in human diseases. It produces natural, specifically targeted, high-potency, fully-human polyclonal immunotherapies without the need for human donors. SAB currently has multiple drug development programs underway and collaborations with the US government and global pharmaceutical companies. For more information on SAB, visit: https://www.SAb.bio/ and follow SAB on Twitter and LinkedIn.
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