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

What we do

 

MVI is developing Simple, Safe, Effective and Economical immune-activating therapies for men with all stages of prostate cancer.

Future opportunities

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.

 

 

product Candidates

MVI-118 (pTVG-AR)

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.

 

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.

 

COMBINATION TRIAL

 

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-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

Potential

MVI-816 (pTVG-HP)