Advertisement Biothera seeks FDA approval for anticancer drug - Pharmaceutical Business review
Pharmaceutical Business review is using cookies

ContinueLearn More
Close

Biothera seeks FDA approval for anticancer drug

Biothera, a biotechnology company focusing on the immune system, has filed an investigational new drug application with the FDA for its drug Imprime PGG for the treatment of cancer in combination with approved monoclonal antibodies, including Genentech's Herceptin.

Preclinical research has indicated that Imprime PGG significantly enhanced the effectiveness of monoclonal antibody therapy to both kill tumors and increase long-term survival rates.

Imprime PGG recruits and primes neutrophils, the most abundant type of immune cell in the body, to kill cancer cells targeted by monoclonal antibodies. Neutrophils and other innate immune cells are generally not involved in the fight against cancer because they usually fail to see cancer as “non-self.”

“The significance of this technology is that it engages a whole new arm of the immune system against cancer,” said Dr Ketan Desai, chief medical officer of Biothera. “Imprime PGG represents a platform technology that could work with a broad range of monoclonal antibodies.”

Imprime PGG is an intravenous drug candidate derived from the cell walls of a proprietary form of Saccharomyces cerevisiae (Baker’s yeast). There is a growing body of data supporting the ability of yeast beta glucans to benefit immune function and the body’s efforts to protect itself from disease. Biothera’s cancer application is the result of years of research, primarily with the James Graham Brown Cancer Center at the University of Louisville.