An ongoing Phase 1 clinical trial evaluating the experimental new vaccine MVI-118 for prostate cancer treatment has been extended to Rutgers Cancer Institute of New Jersey. Patient enrollment is currently open. The trial began last year with patient participation at the University of Wisconsin – Madison.
The vaccine was created by Madison Vaccines Incorporated (MVI). Initial data from the first 13 patients included in the trial (NCT02411786) was recently presented at the Prostate Cancer Foundation’s annual scientific retreat in Carlsbad, California.
MVI-118 targets the human androgen receptor, a protein that plays a key role in the progression of prostate cancer and can contribute to the cancer’s resistance to therapies. The vaccine was designed to prolong the duration of disease control gained from standard hormone deprivation therapies.
“This expanded clinical trial gives us an important opportunity to evaluate the safety of serial vaccinations with the vaccine and to see if we can slow the progression of prostate cancer in patients receiving standard of care therapy for their disease,” Anna Ferrari, MD, the trial’s lead researcher at Rutgers Cancer Institute, said in a news release. “A well-tolerated treatment that slows disease progression while it diminishes resistance to current therapies, would be a much-needed addition to our options. We are pleased to give patients here in [New Jersey] the chance to take part in this early testing.”
But MVI-118 is not the only prostate cancer vaccine under development by MVI. A second vaccine, called MVI-816, is currently being assessed in a Phase 2 trial with patients whose cancer shows signs of recurrence after an initial treatment.
Current options after a first treatment include vigilance to PSA levels (the biomarker for prostate cancer) or hormonal deprivation therapy. If successful, MVI-816 may become a tolerable third option for patients with cancer recurrence.
MVI-816 is also being evaluated in advanced metastatic cancer in combination with a PD-1 inhibitor, which enhances the immune system’s activity against cancer cells but does not work alone in prostate cancer. The results from the trial will be presented at the Society for Immunotherapy of Cancer’s annual meeting Nov. 9-13 in National Harbor, Maryland.
Both vaccines can be rapidly and inexpensively manufactured, are relatively more stable than other types of vaccines upon storage, and do not have to be produced according to each individual patient.
“MVI is developing our two DNA vaccines for men throughout the spectrum of progressive prostate cancer, in pre-metastatic, in early metastatic, and in late-stage disease,” said Richard Lesniewski, PhD, president and CEO of MVI. “We are pleased with the progress we are making with expansion of our clinical trials and positive trends in the early data. We expect to report final Phase 2 data on our lead vaccine, MVI-816, in 2018.”