Effective Date: October 21, 2026
SAB Biotherapeutics, Inc. (SAB BIO) is a clinical-stage biopharmaceutical company focused on developing multi-specific, high-potency, human immunoglobulin G (hIgG) as potential treatments and prevention of immune and autoimmune disorders. The company’s lead asset, SAB-142, is an investigational product being evaluated in clinical trials as a potential disease-modifying therapy for autoimmune Type 1 Diabetes (T1D), including in individuals with diagnosed Stage 3 T1D up to 2 years. SAB-142 has not been approved by the U.S. Food and Drug Administration (FDA) or any other regulatory authority, and its safety and efficacy have not been established. SAB‑142 has received Fast Track designation from the FDA, reflecting the significant unmet medical need in new onset T1D and the potential of SAB‑142 to address it.
Expanded access, sometimes called “compassionate use,” is a regulatory pathway that may allow the use of an investigational drug outside a clinical trial for patients with serious or immediately life-threatening conditions who have exhausted their treatment options and are not eligible for or able to participate in a clinical trial.
SAB BIO believes that participation in one of our clinical trials is the most appropriate way to access our investigational drugs because clinical trials generate the data needed to evaluate the safety and efficacy of an investigational drug and to support regulatory review for broader patient access. Information on SAB BIO’s ongoing clinical trial SAB-142-201 (NCT07187531) is available at https://clinicaltrials.gov/.
If SAB BIO makes an investigational drug available through expanded access, requests will be evaluated on a case-by-case basis, consistent with FDA regulations (21 CFR Part 312, Subpart I) and applicable local requirements. Factors considered include:
- The patient’s condition must be serious or immediately life-threatening with no other satisfactory treatment options available, and the patient is not eligible for, or able to enroll in, an ongoing clinical trial.
- Potential benefit to the patient justifies the potential risks of the treatment, and those risks are not unreasonable in the context of the disease or condition being treated.
- There is an active Investigational New Drug application held by SAB BIO for the requested investigational drug.
- There is an adequate supply of the investigational drug.
- Use of the investigational drug will not compromise or delay the conduct of clinical trials or associated regulatory review/approval of the investigational drug for broader patient access.
- The requested physician is licensed and qualified and agrees to assume all responsibilities and obligations to comply with applicable regulations, including obtaining FDA authorization, IRB approval, and informed consent, and completing required safety reporting.
At this time, SAB BIO is not providing expanded access to SAB-142 because clinical trials are ongoing, and the data needed to support an appropriate benefit-risk assessment outside of a clinical trial are not yet available. We recognize the significant unmet medical need faced by many patients and will continue to evaluate our policy as additional data become available from ongoing and future clinical trials.
Inquiries can be made to expandedaccess@sab.bio.