Core Viewpoint - SAB Biotherapeutics, Inc. is advancing its clinical-stage biopharmaceutical product, SAB-142, aimed at delaying the onset or progression of type 1 diabetes (T1D), as highlighted by multiple presentations at the EASD Annual Meeting [1][5]. Company Developments - The company presented four oral presentations and one invited presentation at the EASD, showcasing preclinical and Phase 1 data for SAB-142, which is currently being evaluated in a Phase 2b SAFEGUARD clinical study for new-onset Stage 3 autoimmune T1D patients [2][3]. - SAB-142 demonstrated a clinically validated, multi-specific mechanism of action with sustained immunomodulation in a Phase 1 clinical study, distinguishing itself from rabbit ATG by not causing sustained lymphodepletion [4][5]. - The Phase 1 study involved 68 healthy volunteers and T1D patients, indicating the potential of SAB-142 to be a best-in-class T1D immunotherapy [4]. Clinical Study Insights - A novel pharmacokinetic assay for SAB-142 showed a dose-proportional and reproducible pharmacokinetic profile, with optimal short PK profile and sustained immunomodulatory effect observed up to Day 120 [4]. - The INNODIA-sponsored MELD-ATG study confirmed the disease-modifying potential of rabbit ATG in new-onset Stage 3 autoimmune T1D patients, achieving primary endpoint of C-peptide preservation at 12 months with a 2.5 mg/kg dose [6][7]. Collaborations and Partnerships - SAB is collaborating with INNODIA, which is leading the charge to bring revolutionary disease-modifying therapies to T1D patients, leveraging their clinical trial network in Australia and New Zealand [4][6]. - The partnership with INNODIA and leading European T1D centers aims to advance SAB-142 into the Phase 2b clinical study [6][8].
SAB BIO Highlights Data in Multiple Presentations at EASD