Summary :
– In the FDA-conducted study, SAB-185 consistently demonstrated high avidity and high potency for effectively neutralizing a broad range of SARS-CoV-2 strains and variants through Delta
-SAB-185 additionally outperformed convalescent plasma
-Findings published in The Journal of Infectious Diseases
SAB Biotherapeutics (SAB), a clinical-stage biopharmaceutical company with a novel immunotherapy platform that produces specifically targeted, high-potency, fully-human polyclonal antibodies without the need for human donors, today announced the publication of nonclinical data from a study conducted in collaboration with the Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) Division of Viral Products highlighting that SAB-185 effectively neutralizes multiple SARS-CoV-2 strains and that it is superior to convalescent plasma in neutralizing COVID variants. SAB-185, a fully-human, specifically targeted, broadly neutralizing polyclonal antibody candidate for the treatment of high-risk non-hospitalized patients with mild to moderate COVID-19, is currently being assessed in the US National Institutes of Health (NIH) COVID-19 Phase 3 ACTIV-2 Trial.
SAB Biotherapeutics
The article, “Increased antibody avidity and cross-neutralization of SARS-CoV-2 variants by hyperimmunized Tc-Bovine derived human immunoglobulins for treatment of COVID-19,” is published in the online edition of The Journal of Infectious Diseases. SAB-185 demonstrated high antibody avidity and potency of cross-neutralizing activity in the tested variants and outperformed convalescent plasma in these assays. The study concluded that SAB-185 offers potential as a therapeutic candidate for treatment of SARS-CoV-2, including potentially addressing variants of concern.
“These promising nonclinical data, generated by the FDA, are another indicator that SAB-185 may have broad potential as an effective therapy for the treatment of COVID-19 infections across both circulating and emerging variants,” said Tom Luke, MD, Chief Medical Officer for SAB Biotherapeutics. “SAB-185 retained its ability to neutralize all of the tested SARS-CoV-2 mutant strains, and as we expected, outperformed convalescent plasma in the study.”
Dr. Luke continued, “The loss of efficacy of some current COVID-19 therapies against the prevalent Omicron strain highlights the potential of high potency, broadly neutralizing fully human polyclonal therapies such as SAB-185 against COVID-19 and other rapidly mutating viruses.”
Study researchers conducted neutralization assays with seven variant SARS-CoV-2 strains, including the Alpha, Epsilon, Iota, Gamma, Beta, Kappa and Delta strains, comparing performance of convalescent plasma from recovered COVID-19 patients against several variants of SAB-185. They evaluated antibody binding, avidity maturation, and SARS-CoV-2 virus neutralizing capacity. Compared with post-infection human convalescent plasma, SAB-185 demonstrated higher antibody avidity and more potent cross-neutralizing activity of both the variants of interest and variants of concern.The study authors concluded that SAB-185 may likely lead to effective virus neutralization and protection against previous, current and/or emerging SARS-CoV-2 strains and could potentially serve as an effective therapy for the treatment of COVID-19 patients.
In September 2021, a pre-specified interim analysis of ACTIV-2 Phase 2 data, reviewed by a Data Safety Monitoring Board, concluded that SAB-185 met the efficacy and safety criteria for advancement to the ACTIV-2 Phase 3 trial.
About SAB Biotherapeutics, Inc.
SAB Biotherapeutics, Inc. (SAB) 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 (Tc) Bovine™ 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 currently has multiple drug development programs underway and collaborations with the US government and global pharmaceutical companies.