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SAB Biotherapeutics, Inc. (Nasdaq: SABS), ("SAB" or the "Company"), a clinical-stage biopharmaceutical company with a novel immunotherapy platform that is developing fully-human anti-thymocyte immunoglobulin (hIgG) for delaying the onset or progression of type 1 diabetes (T1D), today announced that the Navy Medical Research Command (NMRC) is moving forward with a safety and tolerability study to evaluate SAB-176, a therapy being investigated for use as a pre- and post-exposure prophylactic treatment for influenza type A and type B, pursuant to the Cooperative Research and Development Agreement that governs the relationship between SAB and the NMRC.
With funding for research provided by the Henry Jackson Foundation, this partnership will move forward a pharmacokinetic (PK), safety and tolerability study designed as a double-blinded, randomized study with intramuscular SAB-176 administered to healthy volunteers. The NMRC Clinical Trials Center, located in Bethesda, Maryland, will be conducting this PK study under the leadership of Cmdr. Nehkonti Adams, Director, NMRC Clinical Trials Center.
SAB has utilized its proprietary DiversitAb™ platform to manufacture SAB-176, fully human polyclonal antibodies targeting influenza from Transchromosomic (Tc) Bovine™. SAB-176 is a novel multi-target biologic that has shown sustained neutralization activity across multiple virus strains of Influenza A and B. In 2023, the U.S. Food and Drug Administration granted Breakthrough Therapy and Fast Track Designations to SAB-176 based on the results of the completed clinical proof-of-concept Phase 2 study in an influenza challenge model with intravenous (IV) formulation. SAB-176, along with several other fully human anti-infective immunoglobulins developed by SAB have been administered through IV to over 700 healthy volunteers and patients. This will be the first study to examine intramuscular administration of any DiversitAb™ platform product. The DiversitAb™ platform produces fully human target-specific biologics that can be delivered across a range of therapeutic areas, including infectious diseases and autoimmune conditions like type 1 diabetes (T1D).
SAB Chairman and CEO Samuel J. Reich stated that "we are pleased to continue our collaboration with the NMRC to explore new routes of administration for our products. While T1D remains our primary focus, studying the novel administration of a therapy using our proprietary platform could have tremendous positive health impacts and is a logical next step for SAB's other therapeutic products as well."
"It is important to support studies that advance therapeutics that can be feasibly delivered in a deployed setting," explained Cmdr. Nehkonti Adams, in a recent NMRC press release. "This research could impact thousands of lives, providing the capacity to rapidly respond to influenza and other infectious diseases."
According to the CDC, influenza causes substantial morbidity and mortality worldwide despite available antivirals and vaccines. Influenza is responsible for approximately 226,000 excess hospitalizations and 30,000 to 50,000 deaths each year in the United States alone. Despite the demonstrated reduction in disease rates following vaccination, the efficacy of annual influenza vaccination peaks around 60%. This sub-optimal effect is often due to antigenic drift and mismatches between the vaccine and circulating strains in any given influenza season, thus, one potential solution is to utilize fully human IgG isolated from transchromosomic bovine hyperimmunized with numerous representative influenza strains.
Posted In: SABS
