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Technology Overview

MVI is developing plasmid DNA vaccines to treat men with prostate cancer. Our vaccines are designed to re-activate the body’s own immune system to kill prostate cancer cells.

Plasmid DNA vaccines differ from other vaccines because they can be rapidly and inexpensively manufactured, they are readily soluble, and DNA vaccines are highly stable in storage. MVI plasmid DNA vaccines are delivered to patients by simple intradermal injection.

MVI DNA vaccines represent discoveries made in the laboratory of Dr. Douglas McNeel at the University of Wisconsin-Madison. Licenses to these vaccine technologies have been secured by MVI through the Wisconsin Alumni Research Foundation (WARF).

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Product Candidates

MVI-816 (pTVG-HP)

TARGET: Prostatic acid phosphatase (PAP), a well-defined prostate antigen that is clinically validated as a prostate cancer vaccine target.

INDICATION - BIOCHEMICALLY RECURRENT PROSTATE CANCER: Men with rapidly rising PSA after prostatectomy or radiation therapy for curative intent are at especially high risk for development of bone metastases. Once metastatic to bone, prostate cancer is incurable and frequently fatal. MVI is testing the hypothesis that vaccination with MVI-816 will provide clinical benefit when used in the minimal residual disease setting, before overt metastases can be detected by standard imaging technologies.

CLINICAL STATUS: Two Phase 1 trials have been completed. Good safety and persistent PAP-specific Th1-biased immune responses were observed in patients with early biochemically recurrent prostate cancer. Favorable changes (slowing) in patient PSA doubling times were observed after vaccination in Phase 1 patients during these trials. MVI-816 is currently progressing in a randomized, double blinded, placebo controlled, multi-center Phase 2 trial in hormone naïve, non-metastatic prostate cancer patients with PSA DT <12 months after primary therapy for curative intent with surgery or radiation. The primary endpoint is metastasis free survival at 24 months.

INDICATION - METASTATIC, CASTRATE-RESISTANT PROSTATE CANCER: This is a combination clinical trial that will test the hypothesis that MVI-816 and a PD-1 inhibitor will work together synergistically. In this trial MVI-816 is paired with pembrolizumab (Keytruda®). A PD-1 inhibitor, also called a checkpoint inhibitor, works by exposing cancer cells to immune system recognition and attack, by inactivating strong regulatory signals used by cancer cells to block an effective immune response.

CLINICAL STATUS: This is a Phase 1/2 trial funded by a 2014 Movember-PCF Challenge Award to Dr. McNeel and the University of Wisconsin-Madison and by MVI.

This is important validation for our young company, to have our lead vaccine selected as part of a competitive grant by the leading philanthropic organization funding and accelerating prostate cancer research globally. This trial supplements MVI’s current clinical strategies, and may advance the timetable for demonstrating clinical efficacy of our lead vaccine.

Richard Lesniewski, Ph.D., President of MVI.

MVI-118 (pTVG-AR)

TARGET: MVI-118 is intended to provide persistent activation of CD8+ T-cells that target the androgen receptor, a key tumor cell protein that drives prostate cancer replication and survival, and is frequently and highly overexpressed in prostate cancer cells as resistance to standard androgen deprivation therapy (ADT) emerges.

Androgen Receptor (AR) is up-regulated in >80% of castrate-resistant prostate cancer patients. High expression of AR correlates with poor prognosis. Some prostate cancer patients are known to break tolerance to AR – suggesting the potential to augment this response with a vaccine.

INDICATION: Men with metastatic prostate cancer who are initiating androgen deprivation therapy. As many as a third of patients initially treated for prostate cancer will experience disease recurrence, and approximately half of these men will progress to bone metastases and reach a stage where it cannot be cured. In pre-clinical models, MVI-118 was safe and demonstrated evidence of AR-specific T-cell activation, and a survival benefit.

CLINICAL STATUS: Dosing began for a Phase 1 clinical trial in September 2015. The trial is being conducted at the University of Wisconsin–Madison Carbone Cancer Center, and will be expanded to include two additional medical centers