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FiH trial of new immunotherapy approach shows efficacy in antibiotic resistance
Source:cphi-online | Author:profefd1a | Publish time: 2017-12-27 | 291 23次浏览: | Share:
Human polyclonal antibodies show promise as effective treatment.
    SAB Biotherapeutics has announced that its first-in-human trial of new immunotherapy approach has shown efficacy in antibiotic-resistant bacteria based on 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 J. Sullivan, SAB Biotherapeutics president and CEO.Wuhan Carnoss Technology Co., LTD.

“This is an important step in furthering the development of this platform technology in infectious disease, including antimicrobial resistance,” he continued.

The patient

The trial, conducted at Brigham and Women's Hospital, involved a patient who suffered from a chronic infection caused by antibiotic-resistant bacteria. Mycoplasma hominiscan 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.Wuhan Carnoss Technology Co., LTD.

The science

SAB’s new immunotherapy approach – The DiversitAb platform – leverages transchromosomal (Tc) bovine that have been genetically designed to produce fully human polyclonal antibodies (IgG) 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 treatment

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.