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news.ContraFect Corporation, a biotechnology company focused on the discovery and development of protein therapeutics and antibody products for life-threatening, drug-resistant infectious diseases, announced that the U.S. Patent and Trademark Office issued U.S. Patent No. 9,034,322.
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This patent, entitled "Streptococcus bacteriophage lysins for detection and treatment of gram positive bacteria," contains composition claims for the CF-301 sequence and variants having at least 80% identity.
This patent, which expires on April 20, 2032, is exclusively licensed to ContraFect from The Rockefeller University, the assignee. CF-301 is currently in Phase I and is the first lysin allowed by FDA to be tested in humans.
By killing bacteria immediately upon contact, lysins are fundamentally different than conventional antibiotics and most cytotoxic agents, which require bacterial cell division and metabolism to occur in order to exert their effect.
"ContraFect is pleased to have strong patent protection in place for this new class of anti-bacterial medicines that we believe have the potential to transform the treatment paradigm for drug-resistant Staph infections, including the MRSA superbug," said Julia P. Gregory, ContraFect’s Chief Executive Officer. "We would also like to congratulate Dr. Vincent A. Fischetti, who pioneered the work on lysins at Rockefeller University."
CF-301 is a bacteriophage lysin with potent activity against Staph aureus infections. CF-301 has the potential to be a first-in-class treatment for Staph bacteremia as it has a new mechanism of action for eliminating bacteria. It has specific and rapid bactericidal activity against Staph aureus and does not impact the body’s good bacteria.
By targeting a conserved region of the cell wall that is vital to bacteria, resistance is less likely to develop to CF-301. In vitro and in vivo experiments have shown that CF-301 clears biofilm. Combinations of CF-301 with standard of care antibiotics increased survival significantly in animal models of disease when compared to treatment with antibiotics or CF-301 alone. CF-301 was licensed from The Rockefeller University and developed at ContraFect.
ContraFect is conducting a single Phase 1 randomized, double-blind, placebo-controlled, dose-ranging trial in healthy volunteers in the United States to evaluate the safety, tolerability and pharmacokinetics of CF-301 alone. A data safety monitoring board will review the safety and pharmacokinetic data for each dose level in order to recommend proceeding to the next higher dose.