SAB Biotherapeutics Announces Clinical Partnership with Naval Medical Research Center to Advance Potential Influenza Treatment
SAB Biotherapeutics, Inc. (SABS) collaborates with Navy Medical Research Command for a safety study on SAB-176, a therapy for influenza prevention. The study aims to evaluate the safety and tolerability of intramuscular administration of SAB-176, a novel multi-target biologic with sustained neutralization activity against Influenza A and B. The partnership, funded by the Henry Jackson Foundation, utilizes SAB's DiversitAb™ platform to develop fully human polyclonal antibodies. SAB-176 has received Breakthrough Therapy and Fast Track Designations from the FDA. The study marks the first intramuscular administration of a DiversitAb™ platform product, showcasing the potential of SAB's therapeutic products beyond type 1 diabetes treatment.
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Collaboration with Navy Medical Research Command for a safety study on SAB-176 for influenza prevention.
Evaluation of safety and tolerability of intramuscular administration of SAB-176 with sustained neutralization activity against Influenza A and B.
Utilization of SAB's DiversitAb™ platform to develop fully human polyclonal antibodies.
SAB-176 receiving Breakthrough Therapy and Fast Track Designations from the FDA.
First study to explore intramuscular administration of a DiversitAb™ platform product.
The advancement of SAB-176 into a safety and tolerability study is a significant step in the development of preventive treatments for influenza. The utilization of fully human polyclonal antibodies, derived from SAB's DiversitAb™ platform, offers a promising alternative to traditional influenza vaccines. This technology leverages Transchromosomic (Tc) Bovine™, engineered to produce human antibodies, to potentially provide broader protection against the virus by neutralizing multiple strains.
The implications for public health could be profound, especially considering the annual burden of influenza, which remains high despite existing vaccines. The potential for SAB-176 to offer enhanced protection against antigenic drift, which traditional vaccines sometimes struggle with, could translate into reduced hospitalizations and mortality associated with influenza. Additionally, the intramuscular route of administration being explored could improve accessibility and ease of use in various settings, including military deployments where the NMRC's interest is clearly vested.
From a financial perspective, SAB Biotherapeutics' progress with SAB-176 could have a notable impact on its market valuation. The FDA's Breakthrough Therapy and Fast Track Designations are indicative of the treatment's potential and could streamline its regulatory pathway. For investors, the success of this study may signal a promising growth trajectory for the company, given the high demand for effective influenza treatments.
Moreover, the partnership with the Navy Medical Research Command and funding from the Henry Jackson Foundation not only validates the scientific premise but also provides financial support that mitigates the company's R&D expenditure. This strategic collaboration could enhance investor confidence, potentially leading to a positive reaction in the stock market. However, it's important to monitor the outcomes of the study, as any setbacks could adversely affect investor sentiment.
The collaboration between SAB and the NMRC underscores the military's interest in robust and deployable medical solutions. Influenza poses a threat to military readiness and effectiveness, making the development of a versatile and easily administered prophylactic like SAB-176 particularly relevant. The intramuscular administration could be a game-changer in field conditions, where ease and speed of delivery are paramount.
Success in this study would not only benefit the military but could also set a precedent for rapid response mechanisms against other infectious diseases in challenging environments. The potential for SAB-176 to be administered pre- and post-exposure offers a tactical advantage in managing outbreaks and maintaining operational continuity.
03/25/2024 - 10:15 AM
SIOUX FALLS, S.D., March 25, 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 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.
About SAB Biotherapeutics, Inc.
SAB Biotherapeutics (SAB) is a clinical-stage biopharmaceutical company focused on developing fully 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, fully-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
Certain statements made herein 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 SAB 176 influenza program, our T1D program, and other discovery programs, the outcome of the Navy Medical Research Command collaboration, 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, as amended, 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.
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The study aims to evaluate the safety and tolerability of intramuscular administration of SAB-176, a therapy for influenza prevention.
SAB utilizes its proprietary DiversitAb™ platform to manufacture SAB-176.
SAB-176 has received Breakthrough Therapy and Fast Track Designations from the FDA.
The study marks the first intramuscular administration of a DiversitAb™ platform product, showcasing the potential of SAB's therapeutic products beyond type 1 diabetes treatment.
Influenza is responsible for approximately 226,000 excess hospitalizations and 30,000 to 50,000 deaths each year in the United States.
