Immunovaccine's Novel Immunotherapy Triggers Partial Response & Generates Potent Immune Responses in Ovarian Cancer Clinical ...
20 Mai 2014 - 2:05PM
Marketwired
Immunovaccine's Novel Immunotherapy Triggers Partial Response and
Generates Potent Immune Responses in Ovarian Cancer Clinical Study
Company to Highlight Promising Clinical Activity of DPX-Survivac
Cancer Vaccine at 2014 ASCO Annual Meeting
HALIFAX, NOVA SCOTIA--(Marketwired - May 20, 2014) -
Immunovaccine Inc. ("Immunovaccine" or "IMV") (TSX-VENTURE:IMV), a
clinical stage vaccine company, announced today that new positive
clinical data on the Company's lead cancer vaccine candidate,
DPX-Survivac, will be presented as a poster at the 2014 ASCO Annual
Meeting in Chicago, IL from May 30 to June 3. Results presented
from the Phase I/Ib clinical study demonstrate promising early
evidence of clinical activity for DPX-Survivac in ovarian cancer
patients, including one patient who experienced a partial response
(PR). The PR, defined as a shrinking of tumor size by at least 30%,
using Response Evaluation Criteria In Solid Tumors (RECIST 1.1),
was accompanied by reduction in levels of a commonly used ovarian
cancer biomarker (CA125) and a significant increase in
vaccine-induced immune responses.
The abstract, "Phase I/Ib Clinical and Immunologic Assessment of
Immunotherapeutic Vaccine, DPX-Survivac in Women with Ovarian,
Fallopian Tube, of Peritoneal Cancer (OC)," will be presented
during the General Poster Session, Gynecologic Cancer, Saturday,
May 31, 2014 from 8:00 a.m. to 11:45 a.m. CDT. The abstract can be
seen at the ASCO Annual Meeting website at:
http://abstracts.asco.org/144/AbstView_144_129990.html.
Highlights from the abstract include:
- One study patient with residual disease following platinum
therapy experienced a PR which correlated with robust immune
responses to DPX-Survivac. The PR persisted following
discontinuation of the treatment.
- Target immune responses were seen across all doses and when
DPX-Survivac was administered alone or with low dose oral
cyclophosphamide (CPA). Statistically significant increases in
immune response were seen with higher doses of DPX-Survivac and
when DPX-Survivac was combined with CPA.
- DPX-Survivac was well tolerated with no significant systemic
adverse events reported
"The durable clinical response highlights the therapeutic
potential of DPX-Survivac," stated Dr. Marc Mansour, chief
operating officer of Immunovaccine. "To our knowledge, the target
immune responses induced by our vaccine approach are among the
strongest of any published immune results in the cancer
immunotherapy field."
In April, Immunovaccine presented positive data from clinical
and preclinical vaccine studies, including DPX-Survivac, at the
American Association for Cancer Research (AACR) 2014 Annual
Meeting. Results demonstrated that metronomic cyclophosphamide
(mCPA), an immune modulating agent, enhanced the immunogenicity of
DepoVax™-based vaccines in preclinical cancer models consistent
with previously reported Phase I data showing a similar enhancement
of DPX-Survivac in patients. Importantly, the animal studies
demonstrated the combination therapy's ability to eliminate
advanced tumors that could not be treated with vaccine or mCPA
alone. The addition of anti-PD-1 checkpoint inhibitor to the
DepoVax vaccine/mCPA combination resulted in further enhanced
anti-tumor activity, which allowed the treatment of more advanced
tumors. The effective tumor regressions that were observed could
not be achieved without the use of vaccine or the use of
anti-PD-1.
Immunovaccine expects a large randomized Phase II trial of
DPX-Survivac to be initiated in 2014 in ovarian cancer. The 250
patient trial will be sponsored and conducted by Canada's NCIC
Clinical Trials Group (NCIC CTG). Additionally, researchers at the
University of Rome are planning to initiate a Phase l/II trial of
DPX-Survivac in glioblastoma (brain cancer) with the first patient
receiving the vaccine in 2014.
About DepoVax™
DepoVax™ is a patented formulation that provides controlled and
prolonged exposure of antigens plus adjuvant to the immune system,
resulting in a strong, specific and sustained immune response with
the capability for single-dose effectiveness. The DepoVax platform
possesses impressive flexibility, allowing it to work with a broad
range of target antigens in various therapeutic applications. The
technology is also commercially scalable, with potential for years
of stability and ease of use in the clinic.
About DPX-Survivac
DPX-Survivac consists of survivin-based peptide antigens
formulated in the DepoVax™ adjuvanting platform. Survivin has been
recognized by the National Cancer Institute (NCI) as a promising
tumor-associated antigen (TAA) because of its therapeutic potential
and its cancer specificity. Survivin is broadly over-expressed in
solid tumors and blood cancers including ovarian, breast, colon and
lung cancers, among others. Survivin plays an essential role in
antagonizing apoptosis, supporting tumor-associated angiogenesis,
and promoting resistance to various anti-cancer therapies. Survivin
is also a prognostic factor for many cancers and it is found in
high percentage of cancer patients.
The DPX-Survivac vaccine is thought to work by eliciting a
cytotoxic T-cell immune response against cells presenting survivin
peptides on HLA class I molecules. This targeted therapy attempts
to use the immune system to actively search for tumor cells
expressing survivin and destroy them.
About Immunovaccine
Immunovaccine Inc. develops cancer immunotherapies and
infectious disease vaccines based on the Company's DepoVax™
platform, a patented formulation that provides controlled and
prolonged exposure of antigens and adjuvants to the immune system.
Immunovaccine has advanced two T cell activation therapies for
cancer through Phase I human clinical trials. Lead cancer vaccine
therapy, DPX-Survivac, is expected to enter Phase II clinical
studies in 2014, in ovarian cancer and glioblastoma (brain cancer).
The Company is also advancing an infectious disease pipeline
including innovative vaccines for respiratory syncytial virus (RSV)
and anthrax.
Connect at www.imvaccine.com.
This press release contains forward-looking information
under applicable securities law. All information that addresses
activities or developments that we expect to occur in the future,
is forward-looking information. Forward-looking statements are
based on the estimates and opinions of management on the date the
statements are made. However, they should not be regarded as a
representation that any of the plans will be achieved. Actual
results may differ materially from those set forth in this press
release due to risks affecting the company, including access to
capital, the successful completion of clinical trials and receipt
of all regulatory approvals. Immunovaccine Inc. assumes no
responsibility to update forward-looking statements in this press
release except as required by law.
Neither TSX Venture Exchange nor its Regulation Services
Provider (as that term is defined in the policies of the TSX
Venture Exchange) accepts responsibility for the adequacy or
accuracy of this release.
Immunovaccine Inc.Dr. Marc MansourChief Operating Officer(902)
492-1819mmansour@imvaccine.comwww.imvaccine.comVida Strategic
Partners (media)Tim Brons(415) 675-7402tbrons@vidasp.com
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