SAB Biotherapeutics, a clinical-stage biopharmaceutical company with a novel immunotherapy platform that produces specifically targeted, high-potency, fully-human, multi-epitope binding immunoglobulin (hIgG) antibodies, without the need for human donors, has been granted Fast Track designation from the US Food and Drug Administration (FDA) for SAB-176, an investigational therapeutic for Type A and Type B influenza illness in high-risk patients, including those who have anti-viral resistant strains.
The Fast Track designation is designed to facilitate accelerated development and expedited review of medicines that treat critical illnesses and address an unmet medical need, with the goal of having promising treatments reaching approval and patients as quickly as possible.
SAB also received FDA guidance and regulatory alignment on advancing SAB-176 into the next phase of development through initiation of a Phase 2b dose-range finding efficacy and safety trial in patient populations at high-risk for developing severe disease.
SAB-176 is a novel, highly potent immunotherapy that is grounded in fundamentals of the natural immune response to neutralize Type A and Type B influenza viruses, which mutate rapidly. SAB-176 is also being studied in emerging and mutating pandemic strains by targeting multiple epitopes of the virus rather than a single epitope. The treatment is produced using SAB’s proprietary DiversitAb™ platform, which enables—for the first time—rapid, scalable production of highly potent, fully-human polyclonal IgG antibodies, without the need for human donors. The platform is capable of addressing the emergence and diversity of modern health challenges, including seasonal and pandemic influenza, COVID-19, Clostridioides difficile (C. diff), and autoimmune disorders, such as type 1 diabetes, and cancers.
“We are pleased to receive the FDA Fast Track designation for SAB-176. Influenza continues to be one of the biggest public health challenges the world faces on a continuing basis, with an excessively high number of hospitalizations and deaths each year,” said Eddie Sullivan, PhD, co-founder, president & CEO of SAB Biotherapeutics. “We are excited about the potential role SAB-176 can play in tackling a highly mutagenic pathogen like influenza.”
SAB-176 has undergone multiple clinical and pre-clinical studies, including a Phase 1 trial in healthy volunteers and a Phase 2a challenge study completed last year. The data indicate that SAB-176 offers broad antibody protection against multiple strains of this rapidly mutating virus. In the Phase 2a study, SAB-176 showed broad cross protection that included strains that were not specifically targeted in the manufacturing of the therapeutic.
In addition to the Fast Track designation, SAB Biotherapeutics has also received FDA guidance and regulatory alignment on advancing SAB-176 into the next phase of development, including a Phase 2b trial study design. The study will evaluate the safety and efficacy of SAB-176 in high-risk patients with Type A or Type B influenza illness, including those who have anti-viral treatment resistant strains. In addition, the FDA aligned with SAB’s manufacturing approach, which includes a plasma pooling strategy allowing hyperimmunization to address multiple strains of influenza on an annual basis. This paves the way for SAB to address strain changes, similar to how seasonal influenza vaccines are developed.
“SAB-176 has the potential to be a game-changer in the fight against influenza,” said Alexandra Kropotova, MD, chief medical officer of SAB Biotherapeutics. “Its multi-pronged mechanism of action, long half-life, and low risk of emergence of resistant strains could make it a superior therapeutic to achieve and sustain efficacy against this ever-evolving virus. We see this Fast Track designation as a testament to the promise of our innovative DiversitAb platform, which is equipped to rapidly respond to mutating infectious diseases like influenza.”
The CDC estimates that there are an average of 9 to 41 million cases of influenza each year in the US, with 140,000-710,000 hospitalizations and 12,000-52,000 deaths per year. While Tamiflu® is an effective therapy for treating influenza if used within two days of symptom onset, some patients still develop severe disease and resistant strains of influenza to anti-viral drugs has increased in recent years. SAB-176 offers the potential for an additional treatment for influenza, particularly in higher-risk patients.
The DiversitAb platform is a first-of-its-kind technology capable of producing large amounts of fully-human high-titer, high-avidity multi-epitope binding antibodies across multiple targets without a need for human donors. SAB is leveraging its proprietary platform to discover and develop product candidates with the potential to be first-in-class or best-in-class against complex targets to treat or prevent diseases with significant unmet medical needs. These include infectious respiratory and gastroenterological diseases, immune and autoimmune disorders, and oncology.
