MADISON, Wis. & NATIONAL HARBOR, Md.--(BUSINESS WIRE)--Madison Vaccines Incorporated (MVI), a clinical stage biopharmaceutical company, says early research shows the combination of a PD-1 inhibitor with its MVI-816 vaccine is safe, and does stimulate an immune response (tumor-specific T-cells) in patients with advanced prostate cancer. MVI-816 targets prostatic acid phosphatase (PAP), a well-defined prostate antigen. The role of a PD-1 pathway inhibitor, in this case pembrolizumab, is to expose the cancer cells to attack by the immune system. PD-1 inhibitors have been successful against many types of cancer, but have been less successful as single agents in prostate cancer. These early data show promise in prostate cancer using MVI-816 and pembrolizumab together to enable immune cells to attack the cancer.
The clinical trial to test this combination therapy is being conducted by Douglas McNeel, MD, PhD, at the University of Wisconsin and funded with a $1.5 million 2014 Movember-Prostate Cancer Foundation Challenge Award. These early findings will be presented at the Society for Immunotherapy of Cancer (SITC) Annual Meeting, November 11th in National Harbor, MD, just south of Washington, DC.
Dr. McNeel commented, “These are encouraging results that give us an indication of potential beyond the laboratory in actual patients. Based on these early findings, we are currently exploring expansion of this trial to treat patients over an extended period of time and treat patients with an earlier stage of disease.”
Specifically, the data to be presented show decreases in blood PSA levels, (increasing PSA is an indicator of prostate cancer progression), tumor regressions in some patients, and an increase in relevant T-cells to fight the cancer. There were no unexpected side effects.
“Using PD-1 inhibitors to make cancer cells vulnerable to the immune system is impressive science, however, it has not been available in the fight against prostate cancer until now,” says Richard Lesniewski, PhD, President of MVI. “Although these are very early findings, we at MVI are encouraged by the positive trend we are seeing here.”
Dr. Lesniewski added, “Our vaccines do not have to be tailored to each individual patient, and unlike other investigational vaccines, ours can be delivered by simple injections into the skin.”
MVI-816 is also currently being tested as a single agent in men with earlier stage, non-metastatic prostate cancer. Findings from the trial to be reported at the SITC meeting will guide expanded trials to evaluate its potential for also treating late-stage cancers. A second vaccine, MVI-118, is also being developed for men with metastatic disease, to help prolong the duration of disease control they receive from current androgen deprivation therapies. Both are DNA plasmid vaccines, are readily manufactured in a cost-effective manner, and are highly stable.
The principal mission of Madison, Wisconsin-based MVI is the development of therapeutic plasmid DNA vaccine products for patients with prostate cancer. These are therapeutic vaccines that act on existing disease, rather than preventing disease as do the familiar vaccines against viral infections. MVI has licensed patented technologies that were developed in the laboratory of Dr. Douglas McNeel at the University of Wisconsin-Madison. More information is available at www.madisonvaccines.com.