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SAB Biotherapeutics, a Sioux Falls clinical-stage biopharmaceutical development company, has announced that its first-in-human trial of a new immunotherapy approach has shown efficacy in antibiotic-resistant bacteria. The results were detailed in a recent paper published online in Clinical Infectious Diseases.
“This study provides the first clinical evidence showing the human polyclonal antibody therapeutic — produced from our natural DiversitAb immunotherapy platform — is safe and provides an option for recalcitrant infection-resistant bacteria where antibiotics and multiple other therapies were ineffective,” said Eddie Sullivan, SAB Biotherapeutics president and CEO.
“This is an important step in furthering the development of this platform technology in infectious disease, including antimicrobial resistance.”
The trial, conducted at Boston-based Brigham and Women’s Hospital, involved a patient who suffered from a chronic infection caused by antibiotic-resistant bacteria.
The patient was diagnosed in 2009 and was treated with multiple courses of antibiotics with no improvement. A target-specific human polyclonal antibody was pursued as a potentially more effective therapeutics strategy.
SAB’s new immunotherapy approach — the DiversitAb platform — leverages transchromosomal cattle, or Tc Bovine, that have been genetically designed to produce fully human polyclonal antibodies in response to a bacteria, virus or toxin. To create the targeted treatment, SAB vaccinated a Tc Bovine with inactivated isolates of the patient’s bacteria. After 10 days, the antibodies began circulating in the cow’s bloodstream and were harvested in plasma over several weeks.
The plasma was purified in the company’s CGMP manufacturing facilities to isolate the antibodies, which are designated SAB-136. The patient – the first to be treated with human polyclonal immunoglobulin G, or IgG, harvested from Tc Bovine – received infusions to combat the infection.
After one year, the high-dose therapy resulted in reduced infection and improved clinical parameters. The infusions were well tolerated with no significant adverse events.
“This research demonstrates the potential for expanding treatment for immune-deficient patients suffering from infections, which may have low coverage in current antibody-replacement therapies,” said Dr. Duane Wesemann, a physician in the rheumatology, immunology and allergy department at BWH and an assistant professor of medicine at Harvard Medical School. Wesemann was the principal investigator on the study.
“The use of DiversitAb platform begins to explore the relevancy for other patient populations in the setting of chronic, multidrug-resistant infections or viral infections for which there is no effective treatment or prevention strategy,” he added.
SAB’s first two immunotherapies targeting seasonal influenza and MERS-CoV are in clinical trials, with other infectious disease, oncology and autoimmune targets in development.
“With the advancements of modern medicine — and even recent immunotherapies — there are still many human health conditions without solutions,” Sullivan said. “Our hope is that our platform can provide a new rapid response and effective treatment for many of these patients.”
There’s a big development to announce for SAB Biotherapeutics, which has spent the past year testing its technology in a patient.