Oncolytics Biotech® Collaborates with SOLTI to Conduct a Window of Opportunity Study in Breast Cancer with Pelareorep
10 September 2018 - 1:00PM
Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), currently
developing REOLYSIN® (pelareorep), an intravenously delivered
immuno-oncolytic virus turning cold tumors hot, today announced a
clinical collaboration with SOLTI, an academic research group
dedicated to clinical and translational research in breast cancer.
This clinical collaboration, being sponsored by Oncolytics and
facilitated by SOLTI, is a window of opportunity study (WOO) in the
neoadjuvant setting for breast cancer. Patients will receive the
appropriate standard of care for their cancer subtype plus
pelareorep with or without the anti-PD-L1 cancer immunotherapy
atezolizumab (Tecentriq®). Patients are biopsied on day one,
followed immediately by treatment and a final biopsy after three
weeks, on the day of their mastectomy. Data generated from this
study is intended to confirm that the virus is acting as a novel
immunotherapy and to provide comprehensive biomarker data by breast
cancer sub-type, to support Oncolytics’ phase 3 study in metastatic
breast cancer and is expected in mid 2019.
“We are thrilled to enter into this
collaboration with SOLTI and sponsor this window of opportunity
study. We expect that this study will provide additional
biomarker and immunological data to support our planned phase three
study in metastatic breast cancer,” said Matt Coffey, President and
CEO of Oncolytics Biotech. “This data should confirm the findings
of our phase two study and generate a robust biomarker plan
designed to potentially enhance our phase three program.
Importantly, it will also generate additional data demonstrating
how the promotion of a virally induced inflamed phenotype should
synergise with checkpoint inhibitors targeting PD-L1 like
atezolizumab.”
The study, facilitated by SOLTI, will be
coordinated by Dr. Aleix Prat, Head of Medical Oncology at the
Hospital Clínic of Barcelona, Associate Professor of the University
of Barcelona and the Head of the Translational Genomics and
Targeted Therapeutics in Solid Tumors Group at August Pi i Sunyer
Biomedical Research Institute (IDIBAPS) and member of Oncolytics’
Scientific Advisory Board. SOLTI has a network of more than 300
professionals, mostly medical oncologists, in over 80 hospitals in
Spain, Portugal, France and Italy. Final study design and other
details will be announced upon enrollment of the first patient,
expected around the end of 2018 or very early 2019.
“It has been demonstrated that when reovirus
infects a tumor, it promotes the release of immuno-stimulatory
signals. This in turn results in the upregulation of PD-L1 on tumor
cells and the recruitment of inflammatory immune cells like
NK-cells and cytotoxic T-cells to the tumor, which are required
prerequisites for checkpoint inhibitors to function
effectively. In short, it turns cold tumors hot,” said Dr.
Prat. “We believe pelareorep can demonstrate the necessary inflamed
tumor phenotype to prime tumors for PD-L1 blockade, which could
potentially represent a promising form of cancer immunotherapy
combination with atezolizumab. Results from this study will seek to
establish the virus as an important immuno-oncology agent in breast
cancer, which could ultimately support the expansion of pelareorep
beyond metastatic breast cancer into first-line therapy.”
About Breast Cancer Breast
cancer is the most common cancer in women worldwide, with nearly
1.7 million new cases diagnosed in 2012, representing about 25 per
cent of all cancers in women. Incidence rates vary widely across
the world, from 27 per 100,000 in Middle Africa and Eastern Asia to
92 per 100,000 in Northern America. It is the fifth most common
cause of death from cancer in women, with an estimated 522,000
deaths (6.4 per cent of the total).
Breast cancer starts when cells in the
breast begin to grow out of control. These cells usually form a
tumor that can often be seen on an x-ray or felt as a lump. The
tumor is malignant (cancer) if the cells can grow into (invade)
surrounding tissues or spread (metastasize) to distant areas of the
body.
Genomic research has led to a better
understanding of how genes and proteins classify breast cancer as
hormone receptor positive, human epidermal growth factor
receptor 2 negative (HR+/HER2-), hormone receptor positive,
human epidermal growth factor receptor 2 positive (HR+/HER2+),
hormone receptor negative, human epidermal growth factor
receptor 2 positive (HR-/HER2+) or triple negative breast
cancer (TNBC).
About
Pelareorep Pelareorep, is a non-pathogenic,
proprietary isolate of the unmodified reovirus: a first-in-class
intravenously delivered immuno-oncolytic virus being evaluated for
the treatment of solid tumors and hematological malignancies. The
compound induces selective tumor lysis and promotes an inflamed
tumor phenotype through innate and adaptive immune responses to
treat a variety of cancers.
About SOLTISOLTI is a
non-profit association with more than 20 years of experience in
conducting innovative clinical and translational research to
address unmet medical needs in breast cancer that answer questions
of major scientific interest and relevance in the field of
oncology. SOLTI has a network of more than 300 professionals,
mostly medical oncologists, distributed in over 80 hospitals in
Spain, Portugal, France and Italy. For more information, please
visit: www.gruposolti.org.
About Oncolytics Biotech
Inc.Oncolytics is a biotechnology company developing
pelareorep, an intravenously delivered immuno-oncolytic virus. The
compound induces selective tumor lysis and promotes an inflamed
tumor phenotype -- turning "cold" tumors "hot" -- through innate
and adaptive immune responses to treat a variety of cancers.
Oncolytics' clinical development program emphasizes three pillars:
chemotherapy combinations to trigger selective tumor lysis and
immuno-therapy and immune modulator (IMiD) combinations to produce
innate and adaptive immune responses. Oncolytics is currently
conducting and planning additional studies in combination with
checkpoint inhibitors and targeted and IMiD therapies in solid and
hematological malignancies, as it prepares for a phase 3
registration study in metastatic breast cancer. For further
information, please visit: www.oncolyticsbiotech.com.
Tecentriq® (atezolizumab) is a registered
trademark of Genentech, a member of the Roche Group
This press release contains forward-looking
statements, within the meaning of Section 21E of the Securities
Exchange Act of 1934, as amended and forward-looking information
under applicable Canadian securities laws (such forward-looking
statements and forward-looking information are collectively
referred to herein as “forward-looking statements”).
Forward-looking statements, including the Company's belief as to
the potential and mode of action of REOLYSIN, also known as
pelareorep, as a cancer therapeutic; and other statements related
to anticipated developments in the Company's business and
technologies involve known and unknown risks and uncertainties,
which could cause the Company's actual results to differ materially
from those in the forward-looking statements. Such risks and
uncertainties include, among others, the availability of funds and
resources to pursue research and development projects, the efficacy
of pelareorep as a cancer treatment, the success and timely
completion of clinical studies and trials, the Company's ability to
successfully commercialize pelareorep, uncertainties related to the
research and development of pharmaceuticals, uncertainties related
to the regulatory process and general changes to the economic
environment. Investors should consult the Company's quarterly and
annual filings with the Canadian and U.S. securities commissions
for additional information on risks and uncertainties relating to
the forward-looking statements. Investors are cautioned against
placing undue reliance on forward-looking statements. The Company
does not undertake to update these forward-looking statements,
except as required by applicable laws.
Company ContactMichael MooreVice President,
Investor Relations & Corporate
Communications858-886-7813mmoore@oncolytics.ca |
|
|
Investor RelationsRobert UhlWestwicke
Partners858-356-5932 robert.uhl@westwicke.com |
Media ContactJason SparkCanale
Communications 619-849-6005jason@canalecomm.com |
Oncolytics Biotech (TSX:ONC)
Historical Stock Chart
Von Nov 2024 bis Dez 2024
Oncolytics Biotech (TSX:ONC)
Historical Stock Chart
Von Dez 2023 bis Dez 2024