Clinical trial will explore first-time use of SurVaxM vaccine in combination with REVLIMID® to treat rare blood cancer
BUFFALO, N.Y. — An immune-based therapy developed at Roswell Park Comprehensive Cancer Center is moving forward with its third clinical trial. The early-stage clinical trial will assess whether SurVaxM — a cancer vaccine developed at Roswell Park — is a safe and effective treatment option for patients with multiple myeloma, a rare type of blood cancer. The vaccine will be tested in combination with REVLIMID® (also known as lenalidomide) as maintenance therapy for adults with multiple myeloma.
“Almost all patients with multiple myeloma who go into remission will still have microscopic amounts of disease left following treatment, and this residual cancer eventually can grow back and cause a relapse. It’s a problem compounded by the fact that these patients eventually become resistant to current therapies,” says Kelvin Lee, MD, Jacobs Family Chair of Immunology, who is leading the phase I clinical trial. “But, in combination with oral lenalidomide, which exhibits both immune-modifying and tumoricidal effects, we believe that this vaccine may trigger antimyeloma immune responses, which may prevent recurrences and eradicate the disease.”
Created by Roswell Park faculty members Robert Fenstermaker, MD, Chair of Neurosurgery, and Michael Ciesielski, PhD, Assistant Professor of Neurosurgery, the SurVaxM vaccine stimulates the immune system to target the survivin protein, which helps cancer cells survive under stressful conditions. SurVaxM was first tested in brain cancer patients, and it may prove effective against other types of cancer as well. A phase I study of SurVaxM in some brain cancers concluded last year, and a phase II study of the vaccine as part of combination treatment for patients with newly diagnosed glioblastoma is ongoing at Roswell Park, the Cleveland Clinic and Dana-Farber Cancer Institute.
“Vaccines are typically thought of as things to prevent diseases like measles, polio and mumps. But vaccines are a form of immunotherapy that can also be used to treat cancer. They can be used in a therapeutic mode, rather than a preventive mode,” says Dr. Fenstermaker, Chair of Neurosurgery. “And cancer vaccines, in general, tend to have few serious side effects.”
“We are the first team to test this approach as a therapy for multiple myeloma, and it’s very exciting,” adds Dr. Lee, who notes that the study will be conducted in adults whose disease is in remission following completion of standard therapy for multiple myeloma. “The primary purpose of this study is to determine whether this therapy is safe, but our investigations will also allow us to explore new ways of stimulating the immune system to fight cancer cells.”
Roswell Park is partnering on this research with Celgene Corp., manufacturer of REVLIMID, and MimiVax LLC, the licensed developer of SurVaxM.
Drs. Ciesielski and Fenstermaker credit early seed funding from donations to the Roswell Park Alliance Foundation with moving their vaccine research forward. The Alliance Foundation raises funds on behalf of Roswell Park in support of research and patient-care programs.
The patented SurVaxM vaccine, invented at Roswell Park Comprehensive Cancer Center and being developed in collaboration with MimiVax, LLC, is an immunotherapy that targets survivin, a cell-survival protein that is present in most cancers. A peptide mimic, the vaccine is engineered to recognize survivin-expressing cancer cells as foreign, stimulating immune responses to control tumor growth and recurrence.
About MimiVax, LLC
MimiVax, LLC, is a clinical-stage biotechnology company focused on the development and commercialization of immunotherapeutic vaccines and targeted therapies for cancer treatment. Its lead candidate, SurVaxM, an immunotherapy developed at Roswell Park Comprehensive Cancer Center, is currently undergoing Phase 1 study in multiple myeloma and Phase 2 study in glioblastoma. For more information, visit www.mimivax.com.
In the United States, REVLIMID is approved in combination with dexamethasone for the treatment of patients with multiple myeloma. REVLIMID is also approved in combination with dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy in nearly 70 countries, encompassing Europe, the Americas, the Middle East and Asia, and in combination with dexamethasone for the treatment of patients whose disease has progressed after one therapy in Australia and New Zealand.
In addition, REVLIMID and dexamethasone have been approved in combination with multiple therapies in relapsed/refractory multiple myeloma, including elotuzumab, cafilzomib and ixazomib.
About Roswell Park
The mission of Roswell Park Comprehensive Cancer Center is to understand, prevent and cure cancer. Founded in 1898, Roswell Park is one of the first cancer centers in the country to be named a National Cancer Institute-designated comprehensive cancer center and remains the only facility with this designation in Upstate New York. The Institute is a member of the prestigious National Comprehensive Cancer Network, an alliance of the nation’s leading cancer centers; maintains affiliate sites; and is a partner in national and international collaborative programs. For more information, visit www.roswellpark.org, call 1-800-ROSWELL (1-800-767-9355) or email AskRoswell@Roswellpark.org. Follow Roswell Park on Facebook and Twitter.
Annie Deck-Miller, Senior Media Relations Manager