SAN DIEGO, Nov. 10, 2016 /PRNewswire/ -- Halozyme
Therapeutics, Inc. (NASDAQ: HALO), an oncology biotech developing
novel oncology and drug-delivery therapies, and Genentech, a member
of the Roche Group, today announced an agreement to collaborate on
clinical studies evaluating up to eight different tumor types
beginning in 2017.
The first study will be a Phase 1b/2 open-label, multi-arm
randomized global study, led by Genentech to evaluate their cancer
immunotherapy Tecentriq® (atezolizumab), an anti-PD-L1
monoclonal antibody, in combination with Halozyme's investigational
drug, PEGPH20 in six tumor types. Halozyme will supply drug only
for the Genentech study. This study will have an initial focus on
gastrointestinal malignancies, including pancreatic and gastric
cancers.
The second study will be a Phase 1b open-label randomized study
led by Halozyme to assess Tecentriq in combination with PEGPH20 and
chemotherapy in advanced or metastatic biliary and gallbladder
cancers.
"High levels of hyaluronan (HA) have been shown in retrospective
clinical reviews to be associated with a poor prognosis when
compared to low-HA and in animal models to potentially impede the
access of cancer therapy," said Dr. Helen Torley, president and chief executive
officer of Halozyme. "We look forward to exploring this
combination therapy with our partner in a range of
tumors given our shared focus on the tumor
microenvironment and longstanding
relationship working together on the development
of Roche's Herceptin SC® and MabThera
SC® products for the EU market."
PEGPH20 is an enzyme that temporarily degrades HA, a dense
component of the tumor microenvironment that can accumulate in
higher concentrations around certain cancer cells, potentially
constricting blood vessels and impeding the access of other
therapies.
Following the phase 1b portions to assess safety and
tolerability of the combinations, the study designs may scale to
registration trials. The Halozyme-led study will enroll only
patients who are prospectively identified as having tumors with
high levels of HA, while initial phases of the Genentech-led study
will focus on an all-comer population with a target number of
HA-high patients to be enrolled.
About Halozyme
Halozyme Therapeutics is a
biotechnology company focused on developing and commercializing
novel oncology therapies that target the tumor microenvironment.
Halozyme's lead proprietary program, investigational drug PEGPH20,
applies a unique approach to targeting solid tumors, allowing
increased access of co-administered cancer drug therapies to the
tumor in animal models. PEGPH20 is currently in development for
metastatic pancreatic cancer, non-small cell lung cancer, gastric
cancer, metastatic breast cancer and has potential across
additional cancers in combination with different types of cancer
therapies. In addition to its proprietary product portfolio,
Halozyme has established value-driving partnerships with leading
pharmaceutical companies including Roche, Baxalta, Pfizer, Janssen,
AbbVie and Lilly for its ENHANZE™ drug delivery platform. Halozyme
is headquartered in San Diego. For
more information visit www.halozyme.com.
Safe Harbor Statement
In addition to historical
information, the statements set forth above include forward-looking
statements (including, without limitation, statements concerning
the possible activity, benefits and attributes of PEGPH20, the
possible method of action of PEGPH20, its potential application to
improve cancer therapies and statements concerning future actions
relating to the development of PEGPH20) that involve risk and
uncertainties that could cause actual results to differ materially
from those in the forward-looking statements. The forward-looking
statements are typically, but not always, identified through use of
the words "believe," "enable," "may," "will," "could," "intends,"
"estimate," "anticipate," "plan," "predict," "probable,"
"potential," "possible," "should," "continue," and other words of
similar meaning. Actual results could differ materially from the
expectations contained in forward-looking statements as a result of
several factors, including unexpected expenditures and costs,
unexpected results or delays in development and regulatory review,
regulatory approval requirements, unexpected adverse events and
competitive conditions. These and other factors that may result in
differences are discussed in greater detail in the Company's most
recent Annual and Quarterly Reports filed with the Securities and
Exchange Commission.
Contacts:
Jim
Mazzola
858-704-8122
ir@halozyme.com
Chris Burton
858-704-8352
ir@halozyme.com
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SOURCE Halozyme Therapeutics, Inc.