SAN DIEGO, July 13, 2017 /PRNewswire/ -- Halozyme
Therapeutics, Inc. (NASDAQ: HALO) today announced the initiation of
a multi-arm clinical trial evaluating PEGPH20, Halozyme's
investigational new drug, in combination with atezolizumab
(TECENTRIQ®), an anti-PDL1 cancer immunotherapy from
Genentech, a member of the Roche Group. The combination will be
tested in patients with previously treated metastatic pancreatic
ductal adenocarcinoma. The study is sponsored by and funded by
Genentech.
The study is part of a clinical collaboration agreement
announced by the companies last year to evaluate PEGPH20 and
atezolizumab in up to eight tumor types, including pancreatic and
gastric cancers.
The Phase 1b/2, open-label, multicenter, randomized clinical
trial is designed to assess the safety, tolerability,
pharmacokinetics and preliminary anti-tumor activity of
immunotherapy-based treatment combinations compared with the
standard chemotherapy regimens.
Patients will be enrolled regardless of their hyaluronan (HA)
level, with analysis conducted retrospectively on a subset
population of HA-high patients identified using the Ventana HA
companion diagnostic assay.
HA is a glycosaminoglycan, or chain of natural sugars in the
body that can accumulate around cancer cells creating high pressure
in a tumor, constricting blood flow and thereby reducing access of
chemotherapy and immunotherapeutic agents. PEGPH20 is an enzyme
that temporarily degrades HA, reducing tumor pressure and
potentially increasing blood flow, allowing greater access for
chemotherapies and immunotherapies to treat the tumor.
The study will be conducted in the U.S., as well as countries
outside the U.S.
The collaboration between Halozyme and Genentech includes
testing the experimental combination in MORPHEUS, Roche's Novel
Cancer Immunotherapy Development Platform. MORPHEUS is a Phase 1b/2
adaptive platform to develop combinations of
cancer immunotherapies more rapidly and efficiently.
"This clinical trial expands the study of PEGPH20 in pancreatic
cancer, evaluating previously treated pancreas cancer patients and
combining PEGPH20 with an anti-PDL1 monoclonal antibody for the
first time," said Dr. Helen Torley,
president and chief executive officer. "We are pleased to provide
PEGPH20 in this collaboration study, to evaluate and potentially
advance new treatment options for patients with pancreatic cancer,
one of the hardest to treat cancers."
About PEGPH20 (pegvorhyaluronidase alfa)
PEGPH20 is an
investigational PEGylated form of Halozyme's proprietary
recombinant human hyaluronidase under clinical development for the
potential systemic treatment of tumors that accumulate hyaluronan.
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.
FDA granted orphan drug designation to PEGPH20 for
treatment of pancreas cancer and fast track designation for PEGPH20
in combination with gemcitabine and nab-paclitaxel for the
treatment of metastatic pancreas cancer. Additionally,
the European Commission, acting on the recommendation from the
Committee for Orphan Medicinal Products of the European
Medicines Agency, designated investigational drug PEGPH20 an orphan
medicinal product for the treatment of pancreas cancer.
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
technology. Halozyme is headquartered in San Diego. For more information visit
www.halozyme.com.
TECENTRIQ® (atezolizumab) is a registered trademark
of Genentech, a member of the Roche Group.
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.