Immunovaccine Reports Promising Clinical Activity for Novel T Cell Activating Immunotherapy DPX-Survivac at ASCO 2014
02 6월 2014 - 9:05PM
Marketwired
Immunovaccine Reports Promising Clinical Activity for Novel T Cell
Activating Immunotherapy DPX-Survivac at ASCO 2014
DPX-Survivac triggers a 43% reduction in a patient's tumor and
induces survivin-specific polyfunctional T cell responses; target
immune and clinical responses achieved and maintained with modified
treatment schedule
HALIFAX, NOVA SCOTIA--(Marketwired - Jun 2, 2014) -
Immunovaccine Inc. ("Immunovaccine" or "IMV") (TSX-VENTURE:IMV), a
clinical stage vaccine company, presented positive results from a
Phase I/Ib clinical study of the Company's lead cancer vaccine
candidate, DPX-Survivac, this weekend at the American Society of
Clinical Oncology (ASCO) 2014 Annual Meeting. In a poster
presentation at the conference, Immunovaccine highlighted promising
early evidence of clinical activity for DPX-Survivac in ovarian
cancer patients. One patient, who experienced a 43% reduction in
tumor size, was classified as a partial response (PR) as measured
by Response Evaluation Criteria In Solid Tumors (RECIST 1.1). The
PR, which persisted following discontinuation of treatment, was
accompanied by reduction in levels of a commonly used ovarian
cancer biomarker (CA125) and a significant increase in
vaccine-induced immune responses. The patient's tumor and CA125
levels remain stable eight months following initiation of the
DPX-Survivac therapy demonstrating a potentially durable effect of
the therapy.
Additionally, patients across all vaccine doses exhibited
evidence of desired polyfunctional T cell responses against
survivin, a protein that is over-expressed in ovarian cancer and
several other tumor types. Statistically significant increases in
immune response were achieved with higher doses of DPX-Survivac
(p=0.013) and when DPX-Survivac was combined with low dose oral
cyclophosphamide (CPA) (p=0.015). A modified vaccination schedule,
reducing the dose for the first two vaccinations then boosting with
a lower dose every eight weeks, resulted in a lower frequency of
local injection related adverse events. Importantly, robust immune
responses were produced with the modified immunization schedule,
demonstrating the potency and flexibility of DPX-Survivac. Finally,
DPX-Survivac was well tolerated with no significant vaccine related
systemic adverse events reported.
"With these latest results, we can for the first time point to
the fact that the pronounced and persistent survivin-specific T
cell immune responses we achieve with DPX-Survivac treatment may
translate to a measurable clinical benefit," stated Dr. Marc
Mansour, chief operating officer of Immunovaccine. "This connection
between immune response and clinical activity is exciting,
particularly since we have demonstrated the ability to generate
what we believe are some of the strongest antigen-specific
polyfunctional T cell responses reported in a clinical trial."
The multicenter Phase I/Ib study enrolled 30 stage IIc-IV
first-line or recurrent ovarian cancer patients with no evidence of
disease progression following chemotherapy. The patients were
enrolled across five treatment cohorts to receive various doses of
DPX-Survivac (0.1, 0.25 and 0.5 mL) alone or in combination with
CPA. A modified vaccination schedule was used in two of the cohorts
to evaluate the safety and immune response impact of varying the
timing of treatment.
"With our ongoing clinical development efforts, we continue to
grow our understanding of the potential role that DPX-Survivac may
play in this new cancer immunotherapy environment. In addition to
correlating immune response to clinical benefit, this study has
offered insight into modulating immune response levels and
mitigating adverse events, all through adjusting the vaccine dose
and schedule," said Dr. Mansour. "We are establishing the optimal
dosing regimen for future trials including our planned randomized
Phase II trial in ovarian cancer."
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).
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.
Dr. Marc MansourChief Operating OfficerImmunovaccine Inc.(902)
492-1819mmansour@imvaccine.comTim BronsVida Strategic Partners
(media)(415) 675-7402tbrons@vidasp.com
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