MVI-118 is an experimental cancer vaccine being developed by Madison Vaccines (MVI) to treat men with metastatic prostate cancer. It is a gene-based therapy intended to stimulate an immune response that targets prostate cancer cells.
How MVI-118 works
MVI-118 consists of DNA that has been engineered to carry a genetic code for the ligand binding domain (LBD) of the androgen receptor (AR), a protein overproduced by many prostate cancer cells that plays an important role in tumor growth. When androgen, a male hormone, binds to ARs on prostate cancer cells, it stimulates the growth of the tumor. The LBD is the area of the receptor that binds to androgen.
After it is injected into the body, the genetic code in MVI-118 causes cells to produce the LBD of the AR protein. The immune system responds by mounting an attack directed against prostate cancer cells that express AR, slowing down tumor growth.
MVI-118 is designed to be used along with androgen deprivation therapy (ADT), a prostate cancer treatment that reduces the supply of the male hormones that fuel cancer growth. MVI-118 complements ADT because the immune response that targets AR receptors limits the cancer cells’ ability to use any remaining hormones.
MVI-118 in clinical trials
A randomized, Phase 1 multi-center clinical trial (NCT02411786) of MVI-118 in men with metastatic prostate cancer is currently underway. The trial, which tests both the safety of the vaccine and its ability to stimulate an immune response, aims to compare treatment with MVI-118 alone and in combination with granulocyte macrophage colony-stimulating factor (GMC-SF), an adjuvant or “helper drug” that enhances the immune response to a drug.
Men are randomized into one of four arms. Patients in one arm receive a 100 mcg injection of MVI-118 alone every two weeks (on weeks 0,2,4,6,8, and 10), and then every four weeks (weeks 12, 24, 36, and 48), for a total of 10 doses.
Those in the second arm receive 100 mcg of MVI-118 alone on a staggered schedule once every two weeks (on weeks 0, 2, 12, 14, 24, 26, 36, 38, 48, and 50) for a total of 10 doses.
Participants in the third arm receive MVI-118 in combination with GMC-SF on the same schedule as the first arm, and those in the fourth arm receive MVI-118 and GMC-SF on the staggered schedule. MVI-118 is administered as an injection into the skin.
Safety will be measured by the number and seriousness of adverse events that occur during treatment and up to 18 months from the first vaccination. The study will also assess the number of patients who show a T-cell immune response as well as measures of survival.
Men included in the study must have a diagnosis of adenocarcinoma of the prostate, must have metastatic disease (cancer that has spread beyond the prostate), and must have started ADT within six months of the start of the study and at least one month before enrollment. Participants will remain on ADT for the duration of the study.
The trial, which began in July 2015, expects to enroll 40 men and is currently recruiting participants at study locations in New Jersey, Washington state, and Wisconsin.
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