The trial, conducted at Brigham and Women's Hospital, involved a patient who suffered from a chronic infection caused by antibiotic-resistant bacteria.
Mycoplasma hominis can be an infectious pathogen in immunosuppressed individuals. The patient was diagnosed with M. hominis septic polyarthritis 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 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 (M. hominis). After 10 days the antibodies began circulating in the bovine blood stream and were harvested in plasma over several weeks.
The plasma was purified in the company's cGMP manufacturing facilities to isolate the antibodies–designated SAB-136. The patient–the first to be treated with human polyclonal IgG harvested from Tc bovine–received infusions to combat the infection.
After one year, the high-dose therapy resulted in reduced M. hominis burden and improved clinical parameters.
The infusions were well tolerated and with no significant adverse events. Safety was assessed with laboratory values, physical exam and subjective reports.
Therapeutic efficacy was evaluated with samples collected from the primary infection site, and laboratory studies to monitor inflammation as well as a patient journal.
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.
SAB Biotherapeutics, headquartered in Sioux Falls, S.D. is a clinical-stage, biopharmaceutical development company leading the science and manufacturing of antibody therapeutics.
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