Milestone: Kidney Cancer Vaccine Oncophage Approved in Russia

On April 8, 2008, the Russian Ministry of Public Health granted approval for the world’s first patient-specific, therapeutic cancer vaccine to be made available to cancer patients. The vaccine, called Oncophage® (vitespen), is designed to prevent recurrence of disease in kidney cancer patients by instructing the immune system to target gp96, a Heat Shock Protein (HSP) found on patients’ cancer cells. Based on results from the largest, randomized, Phase 3 kidney cancer trial ever completed in the adjuvant treatment setting, patients with stage I or II kidney cancer and who were at intermediate risk for recurrence who received Oncophage® demonstrated a clinically significant improvement in recurrence-free survival of about 45 percent over patients who did not receive the vaccine. Oncophage® extended recurrence-free survival by approximately 1.7 years.

CRI-funded scientist and Scientific Advisory Council member Dr. Pramod K. Srivastava first established the link between HSPs and cancer and first conceived the idea of creating immune-based cancer therapies that utilize HSPs. Dr. Srivastava has received support from CRI for more than twenty years, starting in 1987 as the CRI/John Hans Old & Edna Alice Old Postdoctoral Fellow in the laboratory of Dr. Lloyd J. Old, director of the CRI Scientific Advisory Council. He later received a CRI Investigator Award and is currently a professor at the University of Connecticut School of Medicine, the director of the Center for Immunotherapy of Cancer and Infectious Diseases, and the scientific director of the University Cancer Center. In 1994, he founded Antigenics Inc., the New York-based biotech company that created the Oncophage® vaccine.

Oncophage® has received fast track and orphan drug designations from the U.S. Food and Drug Administration for both kidney cancer and metastatic melanoma and has orphan drug status for kidney cancer from the European Medicines Agency.

References:

• Srivastava PK, Das MR. The serologically unique cell surface antigen of Zajdela ascitic hepatoma is also its tumor-associated transplantation antigen. Int J Cancer. 1984 Mar 15;33(3):417-22
• Srivastava PK, DeLeo AB, Old LJ. Tumor rejection antigens of chemically induced sarcomas of inbred mice. Proc Natl Acad Sci U S A. 1986 May;83(10):3407-11
• Suto R, Srivastava PK. A mechanism for the specific immunogenicity of heat shock protein-chaperoned peptides. Science. 1995 Sep 15;269(5230):1585-8
• Testori A, Richards J, Whitman E, Mann GB, Lutzky J, Camacho L, Parmiani G, Tosti G, Kirkwood JM, Hoos A, Yuh L, Gupta R, Srivastava PK. Phase III comparison of vitespen, an autologous tumor-derived heat shock protein gp96 peptide complex vaccine, with physician’s choice of treatment for stage IV melanoma: the C-100-21 Study Group. J Clin Oncol. 2008 Feb 20;26(6):955-62