SAB Biotherapeutics Provides SAB-142 Trial Update

Rhea-AI Summary

SAB Biotherapeutics, Inc. (Nasdaq: SABS) provides an update on the SAB-142 trial, reporting completion of dosing the third cohort with no observation of serum sickness. The Phase 1 clinical trial aims to investigate safety, tolerability, pharmacokinetics, and immunogenicity of SAB-142, a human anti-thymocyte immunoglobulin for delaying the onset or progression of type 1 diabetes (T1D).

MIAMI BEACH, Fla., April 16, 2024 (GLOBE NEWSWIRE) -- SAB Biotherapeutics, Inc. (Nasdaq: SABS), (“SAB” or the “Company”), a clinical-stage biopharmaceutical company with a novel immunotherapy platform that is developing human anti-thymocyte immunoglobulin (hIgG) for delaying the onset or progression of type 1 diabetes (T1D), today announced their Chief Medical Officer, Dr. Alexandra Kropotova, MD, MBA disclosed that SAB has completed dosing the third cohort for SAB-142 with no observation of serum sickness thus far.

In October 2023, SAB received approval by the Australian Human Research Ethics Committee (HREC) to commence the Phase 1 clinical trial investigating safety, tolerability, pharmacokinetic, pharmacodynamic, and immunogenicity of SAB-142. The primary objective of the trial is two-fold: 1) to generate data on differentiated safety and immunogenicity of this human immunoglobulin, and 2) to establish a Proof of Biological Activity (POBA) for SAB-142.

Phase 1 of SAB-142 is a randomized, double-blind, placebo-controlled, single-ascending dose, adaptive design clinical study was designed to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of intravenous SAB-142 in healthy volunteers and participants with T1D. SAB-142 is a first-in-class human anti-thymocyte immunoglobulin being developed as a disease-modifying treatment to delay the onset and progression of T1D.

About SAB-142

SAB-142 is a human alternative to rabbit anti-thymocyte globulin (ATG). SAB-142’s mechanism of action is analogous to that of rabbit ATG, which has been clinically validated in multiple clinical trials for type 1 diabetes, demonstrating the ability to slow down disease progression in patients with new or recent onset of Stage 3 type 1 diabetes.

Two clinical trials have shown that a single, low dose of rabbit ATG has demonstrated the ability to modulate the body’s immune response to help slow beta cell destruction and preserve the ability of these cells to generate insulin, which the body needs to regulate blood sugar and carry out all human activities.

SAB-142, like rabbit ATG, directly targets multiple immune cells involved in destroying pancreatic beta cells. By stopping immune cells from attacking beta cells, this treatment has potential to preserve insulin-producing beta cells. However, most humans treated with rabbit ATG develop serum sickness and anti-drug antibodies from exposure to the rabbit-derived antibody. SAB-142 is a human antibody, intended to allow safe, consistent re-dosing for type 1 diabetes, a lifelong chronic disease, without the potential risk of inducing the major adverse immune reactions that can occur with administration of an animal ATG.

About SAB Biotherapeutics, Inc.

SAB Biotherapeutics (SAB) is a clinical-stage biopharmaceutical company focused on developing human, multi- targeted, high-potency immunoglobulins (IgGs), without the need for human donors or convalescent plasma, to treat and prevent immune and autoimmune disorders. The Company’s lead asset, SAB-142, targets type 1 diabetes (T1D) with a disease-modifying therapeutic approach that aims to change the treatment paradigm by delaying onset and potentially preventing disease progression. Using advanced genetic engineering and antibody science to develop Transchromosomic (Tc) Bovine™, the only transgenic animal with a human artificial chromosome, SAB’s DiversitAb™ drug development production system is able to generate a diverse repertoire of specifically targeted, high-potency, human IgGs that can address a wide range of serious unmet needs in human diseases without the need for convalescent plasma or human donors. For more information on SAB, visit: https://www.SAB.bio/ and follow SAB on Twitter and LinkedIn.

Forward-Looking Statements

Cautionary Note Regarding Forward-Looking Statements

Certain statements made in this current report that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “believe,” “may,” “will,” “to be,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook,” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding future events, including the development and efficacy of our T1D program, and other discovery programs, the closing of each tranche of the Company’s private placement offering, the timely funding to the Company by each investor in the private placement offering, financial projections and future financial and operating results (including estimated cost savings and cash runway), the outcome of and potential future government, and other third-party collaborations or funded programs.

These statements are based on the current expectations of SAB and are not predictions of actual performance, and are not intended to serve as, and must not be relied on, by any investor as a guarantee, prediction, definitive statement, or an assurance, of fact or probability. These statements are only current predictions or expectations, and are subject to known and unknown risks, uncertainties and other factors which may be beyond our control. Actual events and circumstances are difficult or impossible to predict, and these risks and uncertainties may cause our or our industry’s results, performance, or achievements to be materially different from those anticipated by these forward-looking statements. A further description of risks and uncertainties can be found in the sections captioned “Risk Factors” in our most recent annual report on Form 10-K, subsequent quarterly reports on Form 10-Q, as may be amended or supplemented from time to time, and other filings with or submissions to, the U.S. Securities and Exchange Commission, which are available at https://www.sec.gov/. Except as otherwise required by law, SAB disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events, or circumstances or otherwise.

CONTACTS

Media Relations:
khollon@sab.bio

Investor Relations:
matt@milestone-advisorsllc.com

FAQ

What is the purpose of the Phase 1 clinical trial for SAB-142?

The Phase 1 clinical trial aims to investigate safety, tolerability, pharmacokinetics, and immunogenicity of SAB-142, a human anti-thymocyte immunoglobulin for delaying the onset or progression of type 1 diabetes (T1D).

What is the primary objective of the trial for SAB-142?

The primary objective of the trial is to generate data on differentiated safety and immunogenicity of SAB-142 and to establish a Proof of Biological Activity (POBA) for the drug.

What is the design of the Phase 1 trial for SAB-142?

Phase 1 of SAB-142 is a randomized, double-blind, placebo-controlled, single-ascending dose, adaptive design clinical study designed to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of intravenous SAB-142 in healthy volunteers and participants with T1D.

What is SAB-142 being developed for?

SAB-142 is a first-in-class human anti-thymocyte immunoglobulin being developed as a disease-modifying treatment to delay the onset and progression of T1D.