SAB Biotherapeutics: rapidly responding to COVID-19
SAB Biotherapeutics has spent nearly two decades developing a unique technology that harnesses the native human response to disease to rapidly generate targeted, high-potency immunotherapies on a large scale.
A novel, quickly spreading infectious disease like COVID-19 is exactly the type of challenge our technology is ideally suited to address. The speed and sophistication of this platform – leveraging genetically engineered cattle to produce fully human antibodies – enables us to address this global health threat in ways no one else can.
A potential new treatment for a new disease
SAB is rapidly advancing the development of an antibody therapeutic candidate, SAB-185, for COVID-19. We’re on track to have a therapeutic candidate ready for clinical trials by early summer 2020.
SAB is working to develop a human polyclonal antibody therapeutic candidate for COVID-19 that may be used both therapeutically as a treatment for patients already infected with the virus, and for immediate protection (passive immunity) where a vaccine is not an option.
If approved, a preventative therapeutic, could be a critical asset in protecting front-line responders, mission-critical staff, and high-risk populations, such as the elderly and immune compromised.
SAB-185 progress to date:
RESEARCH AND DEVELOPMENT
- On track to begin clinical testing in July.
- Completed manufacturing product for initial clinical trials on June 4.
- Drug product release and preclinical safety and efficacy testing in progress with network of collaborators.
- Increasing antibody production by continuing hyperimmunization, collecting plasma, and adding additional animals to the program.
- In just seven weeks, SAB confirmed production of potent neutralizing human polyclonal antibodies to SARS-CoV-2, the virus that causes COVID-19.
- Virus neutralization potency of SAB-185 was significantly higher relative to convalescent plasma from recovered COVID-19 patients.
- Working closely with FDA for specific guidance on regulatory requirements to progress quickly toward submission.
- Increasing capacity to meet near-term manufacturing.
- Deploying strategies to maximize production to quickly scale commercial production capabilities.
- SAB has been awarded funding, up to $9.4M, for the development of SAB-185 through preclinical studies, as part of an expanded scope, Stage 4: COVID-19 Pandemic Response, within SAB’s current Rapid Response contract with the U.S. Department of Defense (DoD) Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEO – CBRND) Joint Project Lead for Enabling Biotechnologies (JPL-EB).
- This funding is supported by the Biomedical Advanced Research Development Authority (BARDA), part of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services.
- Expanded collaboration with CSL Behring (CSL) to encompass COVID-19.
- Partnering with CSL in clinical activities, manufacturing, supply chain and distribution.
- Follow-on effort with BARDA to previous MERS-CoV clinical trials.
- Extension of Rapid Response initiative with DoD JPEO-CBRND that began in Sept. 2019.
“SAB Biotherapeutics’ novel immunotherapy platform provides a new and innovative solution to rapidly respond without the need for human plasma. For future pandemics, SAB’s platform may allow us to even more rapidly respond to patients’ needs.”
—BILL MEZZANOTTE, M.D., EXECUTIVE VICE PRESIDENT AND HEAD OF R&D–CSL BEHRING
A modernized approach to convalescent plasma & the future of pandemic response
SAB’s DiversitAb™ platform has a greater capability to target and scale than other human polyclonal antibody programs. Our platform can consistently and reliably produce fully human antibodies without the need for convalescent plasma from human donors. Tc Bovine–our genetically-engineered cattle–mount the same immune response as survivors of a disease, such as COVID-19, with a much higher concentration of targeted neutralizing antibodies. In addition eliminating the need to identify, screen, and draw blood from recovering volunteers, our novel approach opens the door to medicines that are potentially more potent, safer, and longer-lasting than current antibody therapies.
As a ruminants, cows inherently have a more robust immune response than humans. This response is stimulated when an immunogen specifically and exclusively targeted to a virus, such as SARS-CoV-2, is introduced, activating the entire disease fighting force of human antibodies. We further boost the response with a specialized vaccine formulation and strategy that maintains a high level of antibody production over an extended period of time and targets plasma collection at the highest levels. These optimized technologies result in large amounts of diverse, high-titer, high-avidity antibodies resulting in a high-potency therapy.
As a large animal production system, greater volumes of neutralizing antibodies are generated that can be collected up to three times per month per animal. Production can be ramped up by simply continuing to immunize and collect plasma, and by adding more animals to the effort.
SAFETY & CONSISTENCY
Unlike human plasma donors, who may have previous exposures to many pathogens and varying genetic backgrounds, SAB’s platform offers a large scale, consistently managed donor pool, genetically representing a single human donor. In addition, because our Tc Bovine are injected with a non-infectious subunit, they produce antibodies to the immunogen without becoming infected or getting sick.
A novel approach using nature’s genius to fight disease
Our therapies leverage the native human immune response, providing a highly specific match against the complexity, diversity and mutation of disease.
SAB’s streamlined proprietary development process eliminates the selection step needed to select the most potent antibody candidates. Rather, a specifically designed immunization for genetically engineered cattle activates the entire disease fighting force of fully human antibodies. Hyperimmunization of the cattle results in diverse, high-titer, high-avidity antibodies that are then captured in the large amounts of plasma resulting in a high-potency therapy.
Tc Bovine-produced human antibodies have shown to “behave” identically to those produced in humans. As such, our therapeutic works with a patient’s own immune system to both neutralize a virus and activate the other components of the immune system that are important in helping the body fight disease. SAB data from across our clinical platform has shown that our antibodies are effective even when antivirals or monoclonal antibodies have become ineffective due to virus or pathogen mutation. This is one of the compelling reasons why polyclonal antibodies have the potential to serve as the primary line of defense against mutating viral targets like COVID-19.
Competence with coronaviruses
SAB has proven experience that has prepared us to address the current COVID-19 threat and future threats. Since 2014, we have produced more than a dozen antibodies to combat infectious diseases, including Zika, Ebola and Middle East Respiratory Syndrome (MERS), a coronavirus.
SAB-301, a treatment for MERS-CoV, is one of the most advanced therapeutics against a coronavirus. It has completed a Phase I clinical safety trial in healthy volunteers and is progressing to a Phase 2/3 trial in the Middle East–both sponsored by NIH NIAID and with support from BARDA.
More than a decade ago, we developed human antibodies to the past Severe Acute Respiratory Syndrome, or SARS-1, a precursor to the virus causing COVID-19, SARS-CoV-2. Our tremendous amount of historical information and data from working with coronaviruses is informing how we target antibodies to this new coronavirus.
An SAB therapeutic has demonstrated safety and efficacy in a successful first-in-human clinical trial for Antibiotic Resistant Mycoplasma, sponsored by Brigham and Women’s Hospital and Harvard Medical School.
It’s global. And it’s personal.
At SAB, this pandemic allows us to deliver on the promise of our technology: to make a positive impact on human health with our novel, breakthrough technology. COVID-19 is a global problem that has quickly become very personal to all of us.
And it will take all of us working together, using all of our innovations and technologies, to address the current pandemic and to be ready to alleviate the next threat.
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