SAB Biotherapeutics: rapidly responding to COVID-19
SAB Biotherapeutics has spent 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 platform 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 new treatment for a new disease
SAB is rapidly advancing the development of an antibody therapeutic to treat COVID-19. We’re on track to have a candidate ready as early as summer 2020. Our unique capability is enabling us to move quickly towards a treatment, however the timeline for its availability will ultimately be driven by the federal oversight agencies.
SAB’s human polyclonal antibody therapeutic may be used both therapeutically for treating patients already infected with the virus and for immediate protection (passive immunity) where a vaccine is not an option.
This new therapy could have significant value for prophylactic use to protect front-line responders, mission-critical staff, and high-risk populations, such as the elderly and immune compromised. A preventative therapeutic would be available much sooner than the first vaccines are expected to be in use.
Progress to date:
SAB has sourced several antigens—inactivated subunits of the SARS-CoV-2 virus that causes COVID-19—and prepared them as specialized Tc Bovine vaccines.
Our Tc Bovine have been vaccinated with these antigens and have begun producing antibodies.
We have activated our network of collaborators for assay development, animal testing and clinical studies, so we’ll be ready when we have specific guidance on requirements working closely with the FDA.
We are preparing to quickly scale production and distribution capacity, working with collaborators on strategies for expanding large-scale manufacturing, supply chain and distribution.
Competence with coronaviruses
SAB has proven experience 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.
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. This is one of the compelling reasons why polyclonal antibodies should be the primary line of defense against mutating viral targets like COVID-19.
SAB has shown that our antibodies are effective even when antivirals or monoclonal antibodies have become ineffective due to virus or pathogen mutation. The fact that companies need to combine multiple monoclonal antibodies in a cocktail is a clear indication that a monoclonal approach is not entirely effective.
Polyclonal antibodies offer a better solution because that’s the way our bodies naturally fight disease. 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’s streamlined proprietary development process eliminates the discovery step and need 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.
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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