SAN DIEGO, Oct. 16, 2017 /PRNewswire/ -- Halozyme
Therapeutics, Inc. (NASDAQ: HALO) today announced initiation of a
clinical trial evaluating its investigational new drug PEGPH20 with
atezolizumab (TECENTRIQ®), an anti-PDL1 cancer
immunotherapy from Genentech, a member of the Roche Group, in
patients with previously untreated, unresectable, locally advanced,
or metastatic cholangiocarcinoma and gallbladder
adenocarcinoma.
"Through the initiation of our HALO-110-101 study, we continue
to explore the pan-tumor potential of PEGPH20 and seek new
therapeutic options for patients with high unmet need cancers,"
said Dr. Dimitrios Chondros, chief
medical officer. "We are pleased to progress our clinical
collaboration studies with Genentech to evaluate the potential for
novel groundbreaking treatments for cancer patients."
The Halozyme-sponsored 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. The study will be conducted at more
than 40 sites in three countries and is part of a clinical
collaboration agreement announced last year to evaluate PEGPH20 and
atezolizumab in up to eight tumor types.
Following a safety run-in portion to determine the tolerability
of PEGPH20 in combination with atezolizumab, an expansion phase is
planned to determine preliminary antitumor activity including
overall response rate, duration of response and progression-free
survival in patients with high levels of hyaluronan (HA). During
the expansion portion, the study seeks to enroll approximately 50
unresectable, locally advanced, or metastatic cholangiocarcinoma
(bile duct cancer) and gallbladder adenocarcinoma patients who have
not previously been treated.
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.
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, Lilly and Bristol-Myers
Squibb 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
View original content with
multimedia:http://www.prnewswire.com/news-releases/halozyme-initiates-clinical-trial-of-pegph20-with-anti-pdl1-immunotherapy-in-cholangiocarcinoma-and-gallbladder-cancer-patients-300536723.html
SOURCE Halozyme Therapeutics, Inc.