Agenus has granted NewVac an exclusive license to manufacture, market, and sell renal cancer vaccine Oncophage in the Russian Federation and CIS countries. NewVac may also initiate a development program in its designated regions of Oncophage in combination with its co-adjuvant technology. Agenus is entitled to receive a transfer price and/or royalties upon Oncophage product sales plus potential milestone payments.
In April 2008, Oncophage was approved in Russia for the adjuvant treatment of kidney cancer patients at intermediate risk for disease recurrence. Derived from each individual's tumor, Oncophage contains the antigenic fingerprint of the patient's particular cancer and is designed to reprogram the body's immune system to target only cancer cells bearing this fingerprint. Oncophage is intended to leave healthy tissue unaffected and limit the debilitating side effects typically associated with traditional cancer treatments such as chemotherapy and radiation therapy.
Oncophage has been studied in Phase III trials for the treatment of kidney cancer and metastatic melanoma and is currently being investigated in a Phase II study in recurrent and newly diagnosed glioma. It has fast track from FDA for metastatic melanoma as well as orphan drug designation from FDA and EMEA for kidney cancer and glioma.
Nearly 800 patients in clinical trials throughout Russia, North America, and Europe have reportedly been treated with Oncophage produced in Agenus’ facility located in Lexington, MA. Studies with Oncophage have demonstrated efficacy signals in multiple cancers including melanoma, glioma, non-Hodgkin lymphoma, as well as colorectal, pancreatic, renal cell, and gastric cancers.
“We are very excited to work with NewVac as an innovative scientific partner that is ready to both establish an Oncophage manufacturing facility in Russia and to commercialize this unique personalized cancer vaccine,” says Garo H. Armen, Ph.D., chairman and CEO of Agenus. “In addition, the planned development efforts for Oncophage in combination with NewVac’s co-adjuvant will provide us with an opportunity to explore how Oncophage can contribute even more to patient care.”
Nikolay Savchuk, chairman of NewVac's board, says, “We analyzed all available types of cancer immunotherapies from the Russian and global markets and selected the Agenus technology to advance our development programs. NewVac is planning clinical studies of a new co-adjuvant to be used in combination with immunotherapeutic tumor vaccines.”