SAB BIO Updates SAB-142 Clinical Trial at EASD Annual Meeting

SAB Biotherapeutics (SAB), a clinical-stage biopharmaceutical company, has made significant strides with its novel immunotherapy, SAB-142, aimed at delaying the onset and progression of type 1 diabetes (T1D). The company recently completed the Phase 1 enrollment of all planned cohorts for healthy volunteers and is now moving forward to enroll type 1 diabetes patients in the final cohort of the study. SAB-142 has shown promising results, particularly in its target dose of 2.5 mg/kg, where no cases of serum sickness were observed. The company remains on track to deliver topline Phase 1 data by the end of the year.

On September 9, 2024, during the European Association for the Study of Diabetes (EASD) 60th Annual Meeting in Madrid, SAB’s Executive Vice President and Chief Medical Officer, Dr. Alexandra Kropotova, presented an update on SAB-142. Her presentation, titled “Protecting pancreatic beta cells with multi-target immunotherapy: SAB-142,” highlighted the progress and emerging safety profile of this first-in-class human anti-thymocyte immunoglobulin.

Dr. Kropotova expressed satisfaction with the ongoing trial results, emphasizing the absence of serum sickness, a notable differentiation from rabbit anti-thymocyte globulin (ATG). She pointed out that SAB-142 demonstrates an improved safety profile and has the potential to preserve endogenous C-peptide, thereby preventing the progression of T1D. The data collected so far aligns with SAB’s commitment to developing a disease-modifying immunotherapy that could significantly impact people with type 1 diabetes.

The Phase 1 clinical trial of SAB-142 began in November 2023, focusing on assessing the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of the treatment. This randomized, double-blind, placebo-controlled, single-ascending dose, adaptive design study first targeted healthy volunteers and will now include participants with T1D. The primary objectives of the trial are to gather differentiated safety and immunogenicity data and to establish proof of biological activity (POBA) for SAB-142.

With the enrollment of healthy volunteers completed for all planned cohorts, SAB has moved on to dose the targeted 2.5 mg/kg of SAB-142 without observing any serum sickness. The company has decided to include a cohort of T1D patients to further establish the safety and tolerability profile of SAB-142 before initiating a Phase II SAFEGUARD study targeting new-onset T1D patients. This next step involves progressing to enroll type 1 diabetes patients to finalize the last cohort of the study.

SAB-142 is a human alternative to rabbit ATG, targeting multiple immune cells involved in the destruction of pancreatic beta cells. By halting these immune attacks, SAB-142 aims to preserve insulin-producing beta cells. Unlike rabbit ATG, which often leads to serum sickness and anti-drug antibodies due to its animal origin, SAB-142 is a human antibody designed to allow safe and consistent re-dosing for type 1 diabetes without significant adverse immune reactions.

SAB Biotherapeutics is dedicated to developing human, multi-targeted, high-potency immunoglobulins (IgGs), utilizing advanced genetic engineering and antibody science. Their proprietary Transchromosomic (Tc) Bovine™ technology enables the production of a diverse range of high-potency human IgGs, addressing serious unmet needs in various human diseases. The lead asset, SAB-142, represents a novel therapeutic approach aiming to alter the treatment paradigm for type 1 diabetes by delaying onset and potentially preventing disease progression.