Madison
Vaccines Incorporated (MVI), a clinical stage biopharmaceutical company focused
on advancing innovative therapies for prostate cancer, today announced an
initial close of an $8 million Series A financing. The round was led by
Venture Investors, LLC, and joined by Wisconsin Alumni Research Foundation
(WARF), Venture Management, LLC (VM), the State of Wisconsin Investment Board
(SWIB), and others. The proceeds will support ongoing development of
MVI’s pipeline, including completion of an expanded Phase 2 clinical trial for
MVI-816 in non-metastatic prostate cancer patients with rapidly rising PSA,
before the need for surgical or chemical castration (androgen deprivation therapy
or ADT). These are patients with the highest risk of developing bone or
other metastases after their initial prostate cancer therapy.
MVI-816
is a DNA vaccine, called a plasmid DNA vaccine because human genetic material
is produced in small pieces of circular bacterial DNA known as plasmids, which
are purified and used to genetically induce an immune response to the cancer.
Plasmid DNA vaccines have several advantages compared to protein or
peptide vaccines: DNA can be rapidly and inexpensively purified, there
are no problems with solubility, and DNA vaccines are relatively more stable in
storage. MVI-816 targets prostatic acid phosphatase (PAP), a well-defined
prostate antigen suitable for prostate vaccines.
“Our
goal in developing MVI-816 is to significantly delay both the onset of
metastases and the initiation of ADT for these patients,” said Richard Lesniewski,
PhD, President of MVI. “This $8 million financing will allow MVI to
advance our efforts to establish a safe and approvable immune activation
therapy for men with early malignant prostate cancer.”
Patients
with PSA-recurrent prostate cancer currently face two options: to watch
and wait (and worry) while their PSA continues to rise after their initial
surgery or radiation, or to start some form of castration therapy, and expose
themselves to the significant decline in quality of life associated with this
type of hormonal deprivation. MVI-816 is intended to provide a third
option to take action against the cancer without the need for castration.
“The
Series A financing of MVI is important because it enables us to advance our
work with MVI-816 beyond our basic research and previously completed Phase 1
studies, through proof-of-concept in early stage patients,” added Douglas
McNeel, MD, PhD, Professor of Medicine at the University of Wisconsin-Madison,
and Scientific Co-Founder of MVI.
MVI-118
is a second DNA vaccine being developed by MVI. This vaccine targets the
human androgen receptor, the critical biological target responsible for driving
prostate cancer progression and, in many cases, resistance to current
therapies.
Dr.
McNeel highlighted the importance of the Series A financing to also advancing
MVI-118, stating, “MVI is now well-positioned to support completion of both
preclinical and Phase 1 safety studies which are critical to enable future
efficacy studies of MVI-118 as monotherapy, and in combination with standard
ADT therapies, in early metastatic disease.”
“MVI
represents an exciting investment opportunity that facilitates clinical Phase 2
proof-of-concept studies for MVI-816 in a very capital-efficient manner,”
stated Paul Weiss, PhD, Managing Director at Venture Investors. “With an
experienced biopharmaceutical team, and the support of other local investors,
including WARF, VM, and SWIB, this financing will also allow the company to
take MVI-118 through an initial Phase 1 clinical trial in prostate cancer
patients.”
About
MVI-816
MVI-816
is currently being evaluated in a randomized, double-blinded,
placebo-controlled Phase 2 clinical trial in men with PSA-recurrent prostate
cancer who are not being treated with testosterone-lowering therapies, who do
not have evidence of metastases by imaging, and whose PSA doubling times are < 12
months. MVI-816 was shown to be safe in a Phase 1 trial, and elicited
antigen-specific CD8+ cytotoxic T-cell responses. Also
observed were biochemical changes (slowing of PSA doubling times) in > 30%
of Phase 1 patients. The current Phase 2 trial will measure metastasis
free survival at 24 months and changes in median time to disease progression.
About
MVI
The principal mission of Madison, Wisconsin-based MVI is the
development of therapeutic plasmid DNA vaccine products for patients with
prostate cancer. MVI is also developing a sensitivity test to identify
those patients who will derive clinical benefit from these vaccines. MVI
has licensed patented technologies from WARF, which were developed in the
laboratory of Dr. Douglas McNeel at the University of Wisconsin-Madison. More information is
available at www.madisonvaccines.com.
Contact
Corporate:
Richard Lesniewski, PhD, President, Madison Vaccines Incorporated, +1
(610) 850-4697
Media:
Initiate PR, Jennifer Anderson in NY +1 (646) 237-6926 or Stephen Gendel
in LA +1 (310) 878-3652
;
