Vicus Therapeutics Issued Key Japanese Patent Covering the Composition of Matter of VT-122 into 2025
MORRISTOWN, N.J., October 31, 2014 – Vicus Therapeutics, an immuno-oncology company focused on bringing breakthrough immunotherapies to patients with solid tumor cancers, today announced patent approval of its investigational oral compound VT-122 by the Japanese Patent Office (JPO). Japanese Patent Number 5273721 contains broad claims covering controlled release (CR) compositions of etodolac and propranolol combined in a single dosage form. These two drugs are the active constituents in VT-122, the Company’s lead immunotherapy product candidate for the treatment of hepatocellular carcinoma (HCC).
“The Japanese composition of matter patent significantly improves the value of the VT-122 program and extends exclusivity through 2025,” said John Maki, CEO of Vicus Therapeutics. “The Japanese patent approval of VT-122 is a strong bellwether for Vicus and the global patentability of VT-122, especially in industrialized nations with strong IP laws.”
Vicus recently filed additional patents for VT-122, which extend patent coverage globally, to include triple and quadruple therapeutic combinations into 2034. These additional patents will enable Vicus to invest in expanding the clinical benefit of VT-122 for patients with cancer worldwide.
VT-122 is a proprietary formulation developed by Vicus designed to improve the chrono-pharmacodynamic properties (or efficacy and tolerability) by altering the pharmacokinetic profile of the original products. Etodolac and propranolol were selected based on Vicus proprietary system biology technology that identified their ability both to damp tumor-promoting inflammation and to switch the immune system to a tumor suppressing state when used together. In a Phase 2 clinical trial, VT-122 in combination with sorafenib showed an 11-month increase in median overall survival versus sorafenib alone. VT-122 is expected to enter a global Phase 3 study for the treatment of HCC in 2015 with results anticipated in 2017.
About Vicus Therapeutics
Vicus Therapeutics (www.vicusrx.com) is an immuno-oncology company bringing breakthrough immunotherapies to patients with solid-tumor cancers. Vicus’ lead drug product, VT-122, is a novel combination of etodolac and propranolol and is the first immunotherapy to inhibit both prostaglandin and beta-adrenergic signaling to the immune system. With its dual mode of action, unique chrono-pharmacodynamic properties, convenient oral dosing, and the well-established safety profiles of its component drugs, VT-122 has the potential to enhance the clinical benefit of proven anticancer therapies. VT-122 is currently being investigated in combination with sorafenib in a Phase 2 clinical study of patients with advanced liver cancer (http://clinicaltrials.gov/show/NCT01265576); in combination with androgen inhibition therapy in a Phase II clinical study involving patients with prostate cancer prior to chemotherapy (http://clinicaltrials.gov/show/NCT01857817); and in combination with standard-of-care anticancer therapies in investigator-initiated studies of brain, pancreatic, and other solid-tumor cancers.