SAB-142 / SAb Biotherap - LARVOL DELTA

SAFEGUARD: SAFety and Efficacy of Human Anti-thymocyte ImmunoGlobUlin SAB-142 ARresting Progression of Type 1 Diabetes (clinicaltrials.gov) - P2 | N=159 | Recruiting | Sponsor: SAb Biotherapeutics, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

SAFEGUARD: SAFety and Efficacy of Human Anti-thymocyte ImmunoGlobUlin SAB-142 ARresting Progression of Type 1 Diabetes (clinicaltrials.gov) - P2 | N=159 | Not yet recruiting | Sponsor: SAb Biotherapeutics, Inc.

New P2 trial • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Novel pharmacokinetic assay for measuring SAB-142, a fully human anti-thymocyte globulin (EASD 2025) - P1 | "The novel SAB-142 PK assay was developed and validated with a Lower Limit of Quantification (LLOQ) in human serum of 0.25 µg/mL. This assay has been utilized for monitoring PK in a first-in-man, randomized, double-blind, placebo-controlled Phase I study (SAB-142-101). Results from this study demonstrated that the overall drug exposure of free SAB-142, as assessed by Cmax and AUClast, increased in dose proportional manner as the dose was increased from 1.5 to 2.5 mg/kg."

PK/PD data • Metabolic Disorders

Mechanism of action of a fully human anti-thymocyte globulin, SAB-142, for the treatment of type 1 diabetes (EASD 2025) - P1 | "These data suggest SAB-142's MoA involves the activation of CD4 and CD8 T-cells, promoting their differentiation and increased inhibitory receptor expression in the absence of cytotoxicity. Activation of Tregs may contribute to sustained suppression of CD4 and CD8 T-cells involved in antigen specific killing of beta islet cells. Similarities to rATG include Treg preservation and inhibitory receptor induction in CD4 T-cells."

IO biomarker • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus • CD4 • CD8 • PD-1 • TIGIT

Immunomodulation without sustained lymphodepletion: SAB-142, a fully human anti-thymocyte globulin (EASD 2025) - P1 | "For the SAB-142-101 trial, only transient peripheral lymphopenia was observed over the initial days of dosing. The emerging safety profile of SAB-142, with lack of sustained lymphopenia, is a major safety advantage of SAB-142. No sustained depletion of major blood cells, coupled with the lack of serum sickness and immunogenicity, creates a favorable SAB-142 safety profile for the target patient population across adult, adolescent, and pediatric age groups."

Immunomodulating • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus • CD4

SAB BIO Announces Q1 2025 Financial Results and Provides Company Updates (GlobeNewswire) - "R&D expenses were $7.7 million and $8.1 million for the three months ended March 31, 2025 and March 31, 2024, respectively. The modest decline resulted from the fluctuation of priority spending for the SAB-142 program, a disease-modifying human hIgG aimed at preventing onset or disease progression of T1D."

Commercial • Type 1 Diabetes Mellitus

SAB BIO Announces Q1 2025 Financial Results and Provides Company Updates (GlobeNewswire) - "In April 2025, SAB BIO concluded patient dosing in the last cohort of the Phase 1 clinical study of SAB-142....The Company has successfully obtained a Qualified Person (QP) declaration for SAB BIO’s in-house CMC manufacturing process for SAB-142. This milestone represents a key cGMP compliance achievement enabling SAB BIO to meet European manufacturing standards for an investigational medical drug product (IMPD) designated for upcoming clinical trials in the EU."

Commercial • New trial • Trial status • Type 1 Diabetes Mellitus

SAB BIO Announces Positive Topline Phase 1 Clinical Results with Potentially Disease-Modifying T1D Therapy SAB-142 (GlobeNewswire) - P1 | N=78 | ACTRN12623001089628 | Sponsor: Sab BioTherapeutics | "SAB BIO...announced positive topline data from a Phase 1 trial of SAB-142 in a single-ascending dose among healthy volunteers....Favorable Safety Profile: SAB-142 was generally well-tolerated and demonstrated a favorable safety profile that supports the chronic dosing of SAB-142 in an ambulatory setting. The SAB-142 Phase 1 dose range was between 0.03mg/kg up to 2.5mg/kg, which demonstrated favorable safety profile based on the 0% reported serum sickness and anti-drug antibodies. Sustained Immunomodulation: SAB-142 demonstrated a clinically validated multi-target MOA with sustained immunomodulation."

P1 data • Type 1 Diabetes Mellitus

SAB BIO Announces R&D Webinar Event to Review Phase 1 Topline Results for SAB-142, a Disease-Modifying T1D Therapy (GlobeNewswire) - "SAB BIO...announced today that the Company will host a Research and Development webinar on January 28, 2025 to discuss the topline data for Phase 1 clinical trial for its lead candidate, SAB-142."

P1 data • Type 1 Diabetes Mellitus

A Phase I Randomised, Double-Blinded, Placebo-Controlled, Single Ascending Dose Adaptive Design Study Assessing the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous SAB-142 (ANZCTR) - P1 | N=78 | Recruiting | Sponsor: Sab BioTherapeutuics | N=38 ➔ 78

Enrollment change • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus • Type 2 Diabetes Mellitus

IND-Enabling Assessment of Tolerance and Safety for SAB-142—A First-in-Class Fully Human Polyclonal Antithymocyte Immunoglobulin to Delay the Progression of Type 1 Diabetes (ADA 2024) - "At the end of the study, no pathological findings were observed in native organs. Our results indicate that SAB-142 is well tolerated and should be immunomodulatory in humans."

Clinical • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

A Phase I Randomised, Double-Blinded, Placebo-Controlled, Single Ascending Dose Adaptive Design Study Assessing the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous SAB-142 (ANZCTR) - P1 | N=38 | Recruiting | Sponsor: Sab BioTherapeutuics | Not yet recruiting ➔ Recruiting | N=68 ➔ 38 | Initiation date: Nov 2023

Enrollment change • Enrollment open • Trial initiation date • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus • Type 2 Diabetes Mellitus

A Phase I Randomised, Double-Blinded, Placebo-Controlled, Single Ascending Dose Adaptive Design Study Assessing the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous SAB-142 (ANZCTR) - P1 | N=68 | Not yet recruiting | Sponsor: Sab BioTherapeutuics

New P1 trial • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

SAB Biotherapeutics Receives Australian Approval to Commence Phase 1 Clinical Trial of SAB-142, a Potential Disease-Modifying Treatment for Type 1 Diabetes (GlobeNewswire) - "SAB Biotherapeutics, Inc...today announced that it completed the approval process to commence a first-in-human Phase 1 clinical trial investigating SAB-142 in Australia. The Phase 1 trial will evaluate the company’s lead therapeutic candidate, SAB-142, a first in-class fully-human anti-thymocyte immunoglobulin being developed as a disease-modifying treatment to delay the onset and progression of T1D. This first-in-human trial is designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of the SAB-142. Approval by the HREC is confirmation that SAB has successfully completed all pre-clinical safety and efficacy testing required to commence a Phase 1 clinical trial. SAB also intends to submit an Investigational New Drug (IND) application for SAB-142 to the U.S. Food and Drug Administration (FDA) to commence clinical trials in the United States."

New P1 trial • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus