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-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 works in concert with the androgen deprivation therapy the men are already receiving.
The combination provides a powerful dual attack on the cancer – the androgen deprivation depletes the fuel supply of male hormones that drives the cancer, while MVI-118 limits the ability to use remaining hormone by stimulating a response against cancer cells that express more androgen receptors.
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 (+/- 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