Oleg Kouzbit, Online News Managing Editor

In a new international technology transfer success story, Russian biotech company NewVac announces future Russian-based, GMP-standardized production and marketing of a new licensed drug. Originally developed by the U.S.’ Agenus, the Oncophage therapeutic vaccine is expected to make a substantial difference for non-metastatic kidney patients both in Russia and the neighboring states.

Under a license, development and manufacturing technology transfer agreement, Agenus grants NewVac an exclusive right to produce and sell the innovative vaccine to the Russian and CIS markets. The Russian firm is also reportedly licensed to do further Oncophage testing and carry out development programs using its own co-adjuvant technology.

Already approved in Russia for the treatment of renal cell carcinoma in patients at intermediate risk of recurrence, the US-originated vaccine will be manufactured on the premises of Moscow-based ChemRar High Tech Center, NewVac’s parent company. The new production line is being set up, the licensee says; NewVac CEO Sergei Bugrov emphasized that first patients would receive Oncophage therapy “…this year already.”

According to Agenus, Oncophage is an advanced therapeutic cancer drug in a family of the developer’s proprietary Prophage Series vaccine candidates, “tested in more than 850 patients in multiple cancers in more than 15 Phase 1, 2 and 3 clinical trials.”

In Russia, there’s an estimated 2.5 million cancer patients, with about 500,000 new cases added on an annual basis.

The collaborators

Located in the town of Khimki just outside Moscow, NewVac is a biomed start-up established to focus on the development of innovative technology for cancer immunotherapy. According to Mr. Bugrov, the company’s mission is “the creation of a Russian-based innovative, world-class biomed platform for cancer treatment centered on patient-specific immunotherapy.” It is a resident of the Skolkovo innovation hub outside Moscow.

In addition to realizing the Oncophage program NewVac is currently moving to clinical trials of its new low-molecular compounds that could be used as co-adjuvant and are expected to dramatically improve the company’s own therapeutic anti-tumoral vaccine technology.

ChemRar, its parent firm and the Oncophage production site, is one of Russia’s largest private biomed R&D centers with a presence in the US, European and South-East Asian pharma markets.

Set up in 1994 in Lexington, MA, Agenus has been dedicated to developing and commercializing cutting-edge immunotherapies for cancer and infectious diseases.

Hot on the trail of foes

Unlike many existing broad-acting cancer treatments like chemotherapy or radiation therapy that typically cause toxicities and leave other side effects, Oncophage is designed to exclusively attack cancerous cells, reportedly keeping healthy tissues intact.

Tumor antigens, caused by gene mutations, are assumed to be very often unique to the tumor of an individual patient. This premise that reportedly took Agenus almost twenty years to corroborate has formed the basis of its vaccine development.

The heat shock protein (also referred to as ‘stress protein’) and associated peptides are purified directly from a patient’s own tumor. These ‘building blocks’ of the new drug bear what some call ‘the antigen imprint’ of one’s cancer cells and therefore elicit cancer-specific immunity, the developers claim. Aided by the innovative vaccine, the patient’s immune system (particularly its T-cells) generates a targeted immune response and assails the neoplasm-specific antigens it pinpoints as ‘reflecting’ the imprint. In the process, tumor regression has been observed, Agenus says.

The innovation’s primary application in the Russian and CIS markets will be treatment of renal cell carcinoma. However, clinical trials conducted in Russia, the U.S. and Europe have also reportedly proved Oncophage’s validity for a range of multiple cancers, including melanoma, glioma, colorectal cancer, pancreatic cancer, gastrointestinal tract cancer, and non-Hodgkin’s lymphomas.