November 19, 2017 7:20 PM ET

Biotechnology

Company Overview of Madison Vaccines, Inc.

Company Overview

Madison Vaccines, Inc., a biopharmaceutical company, develops therapeutic plasmid DNA vaccines. It focuses on bone metastases and prostate cancer. The company is based in United States.

505 South Rosa Road

Suite 201

Madison, WI 53719

United States

Phone:

608-467-5269

Key Executives for Madison Vaccines, Inc.

Chief Scientific Founder & Chief Medical Officer
Compensation as of Fiscal Year 2017.

Madison Vaccines, Inc. Key Developments

Madison Vaccines Incorporated Appoints Jeff Bailey to its Board of Directors

Madison Vaccines Incorporated announced the appointment of Jeff Bailey to the company's Board of Directors. Mr. Bailey brings nearly 30 years of experience based on a diverse set of leadership positions to aid MVI mission to bring immunotherapies to their full potential for treating prostate cancer. Mr. Bailey has a track record of delivering compelling business performance based on building and leading teams in both mature and early stage organizations. Most recently, he was the Chairman and CEO of Neurovance, leading its acquisition by Otsuka earlier 2017.

Madison Vaccines Announces First Patient Dosed in an Expanded Combination Trial of MVI-816 Plus Keytruda® for Metastatic, Treatment-Resistant Prostate Cancer

Madison Vaccines Incorporated (MVI) announced the first patient has been dosed in an expanded clinical trial to further extend the potential benefits of checkpoint inhibitors to men with advanced prostate cancer. Known PD-1 and PDL-1 checkpoint inhibitors work well as monotherapy in many cancers, but not very well by themselves in prostate cancer. MVI is exploring the use of its gene based immune-activator MVI-816 in combination with checkpoint inhibitors to extend their use to treatment of prostate cancer. Now, based on initial findings from a Phase 1b pilot study of MVI-816 plus Keytruda® (pembrolizumab), MVI has begun dosing an expanded cohort of 20 patients with metastatic, castrate-resistant prostate cancer, who will be offered the combination regimen for up to 48 weeks. Checkpoint inhibitors have captured the attention of oncologists with their ability to fight many forms of cancer by blocking PD-1 and PDL-1, a regulatory mechanism that dampens the immune system’s ability to fight the cancer. However, they have not been as affective in prostate tumors, possibly because prostate tumors do not elicit a large enough immune response, leaving too few immune cells to be activated by checkpoint inhibitors alone.

Madison Vaccines Incorporated Expands Clinical Trial of MVI-118 for Prostate Cancer to University of Washington

Madison Vaccines Incorporated announced that the Phase 1 clinical trial of MVI-118 for metastatic prostate cancer, is expanding to a third clinical site - The University of Washington-Seattle. 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. The Phase 1 clinical study, to determine safety and detect a response by the immune system, is already underway at the University of Wisconsin-Madison and at the Rutgers Cancer Institute in New Jersey. MVI-118 uses plasmid DNA (genetically engineered material encoding a human antigen) to activate the body’s own immune system to target specific features of prostate cancer cells. In this case the target is 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. This plasmid DNA immunotherapy can be rapidly manufactured, is more stable in storage relative to many forms of vaccines, and represents off-the-shelf therapies that do not have to be individually engineered for each individual patient. They are easily administered with simple intradermal injections under the skin. Preclinical data suggest repeat injections of MVI-118 in combination with ADT can produce a potent immune response against the tumor. 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. A second MVI immune-activating therapy, MVI-816, is 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 consistent signals of anti-tumor activity. MVI-816 induces immune responses to cells expressing prostatic acid phosphatase (PAP), an antigen specific to prostate cells. MVI-816 is also being evaluated in a fully enrolled Phase 2 clinical trial, as a single agent, in men with earlier stage 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. Taken together, this means MVI is developing immune-activating therapies for men throughout the entire spectrum of prostate cancer progression, from premetastatic (MVI-816), to newly metastatic (MVI-118) to late stage metastatic disease (MVI-816 + checkpoint inhibitor).

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