SAN DIEGO, April 3, 2017 /PRNewswire/ -- Halozyme
Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company
developing novel oncology and drug-delivery therapies, demonstrated
in preclinical models that its investigational drug PEGPH20
increases the number of cancer-fighting white blood cells
accumulating in the tumor and the effectiveness of immunotherapies.
The research was presented at the 108th annual meeting
of the American Association of Cancer Research (AACR) and builds
upon prior preclinical findings.
"We are encouraged that these findings from our animal models
continue to support the potential benefits of remodeling the tumor
microenvironment in stimulating an immune response and improving
the efficacy of checkpoint inhibitors and cell-based
immunotherapies," said Dr. Helen
Torley, president and CEO. "We are pleased that PEGPH20
continues to demonstrate significantly improved tumor growth
inhibition in certain hard-to-treat hyaluronan-rich cancer models
when administered in combination with additional cancer fighting
agents."
PEGPH20 is a proprietary enzyme that targets and degrades
hyaluronan (HA), a glycosaminoglycan or naturally occurring sugar
in the body. HA accumulates in higher concentrations around many
solid tumors, potentially constricting blood vessels, impeding the
immune response and the access of other therapies.
Research to be presented includes data from a breast cancer
mouse model treated with PEGPH20 which showed a significant
increase in the accumulation of cancer-fighting CD8+ T
cells, also called tumor infiltrating lymphocytes (TILs), compared
to mice untreated with PEGPH20. Additional research shows that
PEGPH20 administered in combination with an anti-PD-L1 immune
checkpoint inhibitor and with Aduro's Listeria-based vaccine
immunotherapy facilitated CD8+ T-cell accumulation
and improved effectiveness over what was achieved with either the
anti-PD-L1 or Listeria immunotherapy alone.
PEGPH20 increased the anti-PD-L1 effectiveness by 411 percent
compared to anti-PD-L1 alone as measured by tumor growth inhibition
(93% vs 18.2%, p<0.0001) and increased the accumulation of
CD8+ T cells by 176 percent (p=0.0025) in an HA-rich
mouse model. Taken together, these data suggest that tumor HA
accumulation may act as a barrier to immune cell access and that
PEGPH20-mediated HA reduction facilitates increased access of
CD8+ T cells.
Halozyme and other researchers are conducting further
investigations to determine the potential of combining PEGPH20 with
adoptive T cell and other immunotherapies. Halozyme has ongoing
clinical studies of PEGPH20 in combination with chemotherapy and
immunotherapies, with plans to initiate new studies in a previously
announced clinical collaboration with Genentech combining PEGPH20
with atezolizumab, an anti-PD-L1 therapy, in up to eight tumor
types.
Halozyme's AACR abstracts include:
PEGylated recombinant hyaluronidase PH20 (PEGPH20) enhances
tumor infiltrating CD8+ T-cell accumulation and improves
checkpoint inhibitor efficacy in murine syngeneic breast cancer
models. Abstract 641. Sunday, April
2, 1 to 5 p.m. ET
HTI-1511, a novel anti-EGFR-ADC, overcomes mutation
resistance and demonstrates significant activity against
multiple tumor types in preclinical studies. Abstract 50.
Sunday, April 2,
1 to 5 p.m. ET
Evaluating clinically relevant pharmacological agents in a
rat ambulation model to ameliorate PEGylated recombinant
hyaluronidase PH20 (PEGPH20)-mediated musculoskeletal adverse
events. Abstract 1240. Monday, April
3, 8 a.m. to noon ET
A Phase 1b study of PEGPH20 plus pembrolizumab in patients
with selected hyaluronan-high solid tumors. Abstract CT032.
Monday, April 3, 8 a.m. to noon ET.
Global phase 3, randomized, double-blind, placebo-controlled
study evaluating PEGylated recombinant human hyaluronidase PH20
(PEGPH20) plus nab-paclitaxel and gemcitabine in patients with
previously untreated, hyaluronan (HA)-high, stage IV pancreatic
ductal adenocarcinoma. Abstract CT066. Monday, April 3, 1 to 5
p.m. ET
Combination of PEGylated recombinant hyaluronidase PH20
(PEGPH20) with Live-attenuated, Double-Deleted (LADD) Listeria
enhances tumor infiltrating
CD8+ T cell
response and antitumor efficacy in mice. Abstract LB-198.
Tuesday, April 4, 8 a.m. to noon ET
PEGylated adenosine deaminase 2 (PEG-ADA2) abrogates the
cytoprotective effects of adenosine against chronic
lymphocytic leukemia cells. Abstract 5583. Wednesday, April 5, 8 a.m.
to noon ET
About PEGPH20
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. In January, Halozyme announced the
positive topline results as of December
2016 of its randomized phase 2 HALO-202 study of PEGPH20 in
combination with ABRAXANE (nab-paclitaxel) and gemcitabine
chemotherapy in metastatic pancreatic cancer. In the study, PEGPH20
met key endpoints, including in the targeted HA-High patient
population.
FDA granted orphan drug designation to PEGPH20 for
treatment of pancreas cancer and fast track 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 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.