24 September 2021 - - An independent Data Safety Monitoring Board has completed its prespecified interim analysis data review of the safety and efficacy of SAB-185 in the Phase 2 portion of the ACTIV-2 trial and has recommended advancement to Phase 3, US-based biopharmaceutical company SAB Biotherapeutics said.

SAB-185 is a fully-human, specifically-targeted, broadly-neutralizing polyclonal antibody therapeutic candidate for the treatment of non-hospitalized patients with mild to moderate COVID-19.

It is being assessed in the ACTIV-2 trial funded and conducted by the National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health in collaboration with the AIDS Clinical Trials Group. SAB-185 is advancing to the Phase 3 trial based on meeting pre-defined graduation criteria.

Both the low and high doses of SAB-185 tested in Phase 2 met the pre-defined efficacy goal for advancement to Phase 3 and appeared safe at the interim analysis. NIAID and SAB researchers are finalizing the preferred dose to assess in Phase 3.

The Phase 3 portion of the ACTIV-2 trial is a randomized, unblinded, active comparator-controlled adaptive platform study that will assess the clinical safety and efficacy of SAB-185 compared to active control monoclonal antibody treatment in people with mild to moderate COVID-19 who are at higher risk for progression to hospitalization, enrolling approximately 600 participants to receive the investigational agent SAB-185 and 600 to receive an active comparator.

The primary outcome measures of the Phase 3 trial will include safety and non-inferiority for the prevention of a composite endpoint of either hospitalization or death from any cause through study day 28.

For more information on the Phase 3 trial, visit clinicaltrials.gov (Identifier: NCT04518410).
On June 22, 2021, SAB announced a planned merger with Big Cypress acquisition Corp. (NASDAQ: BCYP). The transaction is expected to close in the fourth quarter of 2021.

SAB-185 is a fully-human polyclonal antibody therapeutic entering a Phase 3 study for the treatment of non-hospitalized patients with mild to moderate COVID-19.

It was developed in collaboration with the US government using SAB's novel proprietary DiversitAb Rapid Response Antibody Program, as part of the Countermeasures Acceleration Group, formerly Operation Warp Speed.

In nonclinical studies, the novel therapeutic candidate has shown potent neutralization of the Munich, Washington and other variant strains, including Delta and Lambda.

Preclinical data has also indicated that SAB-185 is significantly more potent than human-derived convalescent immunoglobulin G.

Direct support for the development of SAB-185 is provided by the US Department of Defense's Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) on behalf of the Office of the Assistant secretary of Defense for Health Affairs (OASD(HA)) and the Defense Health Agency and the Biomedical Advanced Research and Development Authority (BARDA), part of the Department of Health and Human Services Office of the Assistant secretary for Preparedness and Response, under contract #MCDC 2019-448.

SAB Biotherapeutics, Inc. is a clinical-stage, biopharmaceutical company advancing a new class of immunotherapies leveraging fully human polyclonal antibodies.

SAB has applied advanced genetic engineering and antibody science to develop transchromosomic Bovine herds that produce fully-human antibodies targeted at specific diseases, including infectious diseases such as COVID-19 and influenza, immune system disorders including type 1 diabetes and organ transplantation, and cancer.

SAB's versatile DiversitAb platform is applicable to a wide range of serious unmet needs in human diseases.

It produces natural, specifically targeted, high-potency, human polyclonal immunotherapies. SAB is currently advancing multiple clinical programs and has a number of collaborations with the US government and global pharmaceutical companies.