Two New DNA Cancer Vaccines in Phase 1 and Phase 2 Clinical Trials

Madison Vaccines Incorporated (MVI, see the linked news release), has begun a Phase 1 clinical trial for MVI-118 (pTVG-AR) in men with metastatic prostate cancer who are initiating androgen deprivation (hormonal) therapy (ADT). MVI-118 targets the human androgen receptor, the critical biological target responsible for driving prostate cancer progression and, in many cases, resistance to current therapies.  MVI-118 is intended to provide persistent activation of immune system CD8⁺ T-cells that target the androgen receptor, a key tumor cell protein that is frequently and highly overexpressed as resistance to ADT emerges. MVI-118 is being developed to prolong the duration of disease control gained from standard androgen deprivation therapies thus delaying resistance to ADT. The trial will be conducted at the University of Wisconsin – Madison Carbone Cancer Center and two additional Medical Centers including Rutgers Cancer Institute in New Jersey. For an overview see the link in the Nov. 7th Prostate Cancer News Today.

This is MVI’s second prostate cancer vaccine, along with MVI-816 (pTVG-HP), MVI’s lead vaccine that has demonstrated clinical evidence of safety, immune activation and biological signals (PSA changes) of activity. Both MVI-816 and MVI-118 are plasmid DNA vaccines that differ from other vaccines because they can be rapidly and inexpensively manufactured, can be administered by simple intradermal injection, and are relatively more stable in storage.

MVI’s lead vaccine, MVI-816, is in a Phase 2 clinical trials in patients with early biochemically recurrent prostate cancer intended to delay the onset of metastatic disease after primary therapy. MVI-816 is also in a second clinical trial in advanced metastatic, hormone-resistant cancer that began this past summer pairing it with an immunomodulatory PD-1 inhibitor which enhances the immune system’s activity against cancer cells but does not work alone in prostate cancer.  Final Phase 2 data on MVI-816, the lead vaccine, is expected in 2018. Both MVI-816 and MVI-118 are intended to address the anticipated surge in prostate cancers over the next two decades as “Baby Boomers” reach the age when men are most commonly diagnosed with the disease.

For MDI-118 clinical trial details concerning enrollment and other criteria, see the following link to the National Institutes of Health (NIH) ClinicalTrials.gov. Patients in the Phase 1 trial of MDI-118 must have metastatic prostate cancer (clinical stage D1 or D2 disease), with previously documented lymph node, soft tissue and/or bone metastases as evidenced by radiographic imaging (including CT (or MRI) of abdomen and pelvis and bone scans). Patients must have started androgen deprivation therapy at least one month (4 weeks) prior to enrollment and no more than six months (24 weeks) prior to enrollment. Patients must continue the androgen deprivation therapy throughout the study period, and patients are not permitted to change the type of androgen deprivation therapy  during the course of investigational therapy.