TARGET: MVI-816 induces immune responses to cells expressing prostatic acid phosphatase (PAP), an antigen specific to prostate cells.
INDICATION: MVI-816 is being evaluated in a fully-enrolled, randomized, double-blinded, placebo-controlled Phase 2 clinical trial, as a single agent, in men with BIOCHEMICALLY RECURRENT PROSTATE CANCER.
In this trial, men with rising PSA after primary surgery or radiation, but before these patients have detectable metastases (tumor spread), are being dosed with MVI-816 for up to 2 years. This trial will inform MVI whether metastases can be delayed or prevented by immunotherapy, which may have the added benefit of delaying the need for androgen deprivation therapy.
INDICATION: MVI-816 is also being explored in a clinical trial with a checkpoint inhibitor (pembrolizumab), in men with metastatic, castrate-resistant prostate cancer.
Early data from a 12-week pilot study show good safety and tolerability, and consistent signals of anti-tumor activity.
MVI-816 is being explored in a clinical trial with a checkpoint inhibitor (pembrolizumab), in men with metastatic, castrate-resistant prostate cancer.
Based on other preclinical findings, MVI is planning additional drug combinations with MVI-118, including addition of a PD-1 inhibitor, also known as a checkpoint inhibitor, and other androgen receptor blocking agents that help make the cancer cells more vulnerable to the immune attack driven by MVI-118.
TARGET: MVI-118 targets the human androgen receptor that drives the progression of prostate cancer and, in many cases, is responsible for the resistance to current treatments. This gene-based immunotherapy is being evaluated for safety and efficacy in concert with the androgen deprivation therapy (ADT) the men are receiving as standard of care.
INDICATIONS: MVI-118 is being explored for use in combination with androgen deprivation therapy (ADT), to delay resistance and prolong duration of disease control in men with metastatic prostate cancer.
A multi-center, Phase 1 clinical study is underway to determine safety and detect a response by the immune system.
Preclinical data suggest repeat injections of MVI-118 in combination with ADT can produce a potent immune response against the tumor.
“Prostate tumors do not elicit a large immune response, so there may not be many immune cells to activate by checkpoint inhibitors alone. MVI-816 activates and increases the number of immune system cells. They recognize cancer cells expressing the PAP antigen, and then the PD-1 inhibitor enables these T-cells to more efficiently kill the cancer.”
Douglas McNeel, MD, PhD.
MVI Chief Scientific Founder and Medical Officer.
MVI-118 Expanded Role in Oncology
Female Cancers - What We Know:
• Androgen Receptor (AR) is expressed in multiple female cancers: breast, ovarian, uterine
• ~20-30% of aggressive, triple negative breast cancers express AR
• Emerging clinical evidence that AR antagonists (bicalutamide, Xtandi®) provide clinical responses (including CRs) in triple negative, AR + breast cancers and demonstrate that AR is driving the oncogenic phenotype in these tumors
MVI-118 (+/- AR axis antagonists) could provide safe, well-tolerated therapy to control certain female cancers & expand the clinical potential for MVI-118 and AR antagonists
Potential for a “basket trial” in breast, uterine and ovarian cancers, enrolling only patients with AR + tumors to seek evidence of clinical efficacy