Human Vaccines & Immunotherapeutics Special Focus Highlights a Paradigm Shift in Cancer Vaccine Development
Vaccinogen’s Dr. Michael Hanna discusses the heterogeneity of cancer cells, and the false premise of tumor homogeneity that cancer vaccines have been based upon
Aug 27, 2012
Frederick, MD, August 27, 2012 -- Vaccinogen, Inc. today announced Dr. Michael G. Hanna, Jr., Vaccinogen CEO and co-founder, has served as guest-editor and contributor for the Human Vaccines & Immunotherapeutics Special Focus on cancer vaccines and immunotherapeutics, one of the most comprehensive peer-reviewed discussions published on the field. The Special Focus highlights nearly two decades of research and clinical development programs and, for the first time, identifies tumor heterogeneity among the factors in the success or failure of cancer immunotherapies. The Special Focus also includes direct commentary on the technology platforms for products, clinical trial design issues, and manufacturing hurdles that factor into cancer vaccine development. Dr. Hanna contributed to an introductory overview of the cancer vaccine field, authored a paper on Vaccinogen’s lead product OncoVAX®, and provided the summary titled “Cancer vaccines: Are we there yet?”
“There is a new paradigm in patient-specific immunotherapy using cancer vaccines. For decades, researchers developed cancer vaccines using off the shelf presumptive antigen(s) based on a false premise that cancer cells are alike, or homogeneous,” said Dr. Hanna. “The vast amount of second generation DNA sequencing data generated over the past few years has clearly demonstrated that tumors are not homogenous. Instead there is heterogeneity in and among tumors of the same classification and pathological stage. These facts indicate that the best immunotherapeutic benefits will be achieved using patient specific therapies. Vaccinogen’s Phase III cancer vaccine for Stage II colon cancer, called OncoVAX, uses this validated approach with the patient’s own live tumor cells as the source of the vaccine.”
Ronald Ellis, Ph.D, Editor-in-Chief of Human Vaccines & Immunotherapeutics, said, “One of the central themes attributing to the success and failure of cancer vaccines is the heterogeneity of cancer. This principle simply indicates that cancer cells are genetically unique. This means that single-marker therapies that do not account for the diversity of cancer cells might not be successful, or may turn out to have the limited efficacy exhibited by previous monotherapies.”
The Special Focus appearing in the August 2012 issue includes an introduction, five original papers, and a guest editorial. The Special Focus can be accessed online at http://www.landesbioscience.com/journals/vaccines/toc/volume/8/issue/8/.
OncoVAX® is a patient specific cancer vaccine that unleashes the body’s own immune system to fight cancer cells that it otherwise would not have recognized. Currently in Phase III development, OncoVAX is designed to use a patient’s own cancer cells to block the return of colon cancer following surgery. OncoVAX is comprised of sterile, live but non-dividing tumor cells obtained following gold-standard surgical tumor resection for Stage II colon cancer. Within 35 days following surgery, patients are vaccinated with OncoVAX to prevent disease recurrence, which is incurable and occurs in as much as 35% of the patients. Patients are given three vaccinations once per week for three weeks, followed by a booster vaccination after six months. A previously completed Phase III trial published in Lancet showed that OncoVAX cut the risk of recurrence by 61% in patients with Stage II colon cancer.
Vaccinogen, Inc. is a cancer vaccine company developing OncoVAX® as a treatment to prevent the recurrence of colon cancer and potentially other solid tumors. Vaccinogen has developed proprietary technology to use the patient’s own live tumor cells as the source of the vaccine. OncoVAX has completed five dose and regimen finding clinical studies, including one Phase III trial with the optimum dose and regimen and will begin a pivotal phase III trial under an FDA Special Protocol Acceptance (SPA) classification, by the end of 2012. More information is available at www.vaccinogeninc.com.
Jason I. Spark