Oncophage is approved in Russia for the treatment of renal cell carcinoma, also known as kidney cancer, in patients at an intermediate risk of recurrence.
Under the agreement, NewVac will have an exclusive license to manufacture, market and sell Oncophage, as well as pursue a development program of the vaccine in combination with NewVac's co-adjuvant technology, in the Russian Federation and CIS countries.
As such, Agenus will be entitled to receive a transfer price and/or royalties upon Oncophage product sales, and potential milestone payments.
"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," said chairman and CEO of Agenus, Garo H. Armen.
"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.
"This agreement brings us a step closer to making this product available to patients and driving further innovation in the cancer immunotherapy field."
NewVac is a subsidiary of ChemRar High Tech Center, one of the top Russian non-governmental research and development centres for life sciences.
In December 2010, NewVac became one of the first resident companies of the Skolkovo Innovation Center, whose aim is to become the principal Russian centre for economic and technological innovation.
NewVac chairman, Nikolay Savchuk, added: "Our goal is to create an innovative world-class biomedical platform for the treatment of oncologic diseases based on immunotherapeutic approaches in Russia.
"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 has established clinical studies of a co-adjuvant small molecule to be used in combination with immunotherapeutic tumor vaccines."
NewVac said it plans to conduct clinical studies with Oncophage in Russia in 2012. The company also plans to establish GMP manufacturing for the vaccine in Russia, making it more easily accessible to Russian patients.
Renal cell carcinoma is the most common type of kidney cancer accounting for almost 90 percent of all kidney tumors. By the time it is is diagnosed, about one third of patients will have developed metastatic disease. The cancer also recurs in 20 to 40 percent of patients with localized tumors.
The most recent data published by the International Agency for Research on Cancer estimated that there were approximately 16,329 new cases of kidney cancer in Russia in 2004, and about 10,872 people died from the disease.
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.
The vaccine is designed to leave healthy tissue unaffected and limit the debilitating side effects typically associated with chemotherapy and radiation.
Oncophage has been studied in phase 3 clinical trials for the treatment of kidney cancer and metastatic melanoma and is currently being investigated in a phase 2 trial in recurrent and newly diagnosed glioma.