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Patent Awarded for Whooping Cough Antibodies

Child coughing

(Ryan Boren, Flickr)

13 December 2016. An experimental treatment for pertussis, also known as whooping cough, using engineered humanized antibodies received a patent in the U.S. Patent number 9,512,204 was awarded to four inventors and assigned to its owners, University of Texas and biotechnology company Synthetic Biologics Inc. in Rockville, Maryland.

Whooping cough is a highly contagious bacterial infection of the respiratory tract that affects primarily children, and results in a severe hacking cough, followed by high-pitched breathing that sounds like a “whoop.” The number of pertussis cases is growing in the U.S. due to parents delaying or avoiding vaccinations for their children, and particularly in low-resource countries where many families do not have access to vaccines. Centers for Disease Control and Prevention estimates 16 million cases of pertussis occur each year, resulting in some 195,000 deaths worldwide.

Synthetic Biologics is licensing the research of chemical engineering professor Janet Maynard at University of Texas in Austin, and the lead inventor on the patent. Maynard and colleagues discovered two antibodies, hu1B7 and hu11E6, that aim to neutralize the toxins caused by bacterial infections from whooping cough causing the severe coughing symptoms. The antibodies act first by binding to the whooping cough toxin, preventing it from attaching to healthy cells, and then blocking the toxin from reaching its target inside healthy cells.

The patent, known as a composition of matter patent, covers the specific amino acid sequences in the antibodies, as well as pharmaceutical formulations of those antibodies that bind to whooping cough toxins and block their access to healthy cells. Synthetic Biologics is developing a whooping cough therapy code-named SYN-005 designed for treating infants with the disease. The company is collaborating with Intrexon Corporation and Maynard’s lab on SYN-005.

As reported in Science & Enterprise, preclinical tests of the antibodies in SYN-005 with young lab animals conducted by Maynard and colleagues show that the treatments can prevent and reduce the severity of whooping cough symptoms and white blood cell counts indicating infection. Antibodies given to mice prevented their contracting infections when exposed to airborne bacteria. Young baboons were given the antibodies after developing infections, with the treatments reducing both heavy coughing symptoms and white blood cell counts.

In September 2014, SYN-2005 received an orphan drug designation from the Food and Drug Administration. The agency can designate an orphan drug, for treatments in development that target diseases affecting fewer than 200,000 Americans. Therapies, both drugs and biologics, designated as orphan drugs qualify for incentives such as tax credits for clinical trials and exemptions from marketing application fees.

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