SAN DIEGO, June 1, 2018 /PRNewswire/ -- Halozyme
Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company
developing novel oncology and drug-delivery therapies, will present
data evaluating certain biomarkers as potential predictors of
survival in patients with previously untreated metastatic
pancreatic ductal adenocarcinoma at the American Society of
Clinical Oncology (ASCO) annual meeting, which takes place
June 1-5 in Chicago. In addition, Halozyme partner Janssen
will present five posters of clinical studies involving
subcutaneous daratumumab using Halozyme ENHANZE®
technology.
"Our goal at Halozyme is to develop new therapies for cancer
patients, while minimizing the burden and impact of treatment on
their lives," said Helen Torley,
president and chief executive officer. "The exploratory plasma
biomarker data may support efforts to identify patients who benefit
from our investigational drug, PEGPH20, through a simple blood draw
rather than a needle biopsy.
"Our ENHANZE technology allows certain drugs to be given
subcutaneously in a shorter, simpler injection than when the drug
is delivered intravenously, thereby reducing the treatment burden
for patients. We are delighted that Janssen will be presenting five
posters on their exploration of a subcutaneous version of
daratumumab that can be given in 5 minutes or less using our
ENHANZE technology."
The Halozyme research of peptide biomarkers measured maturation
and degradation of type III collagen, a key component of the
extracellular matrix, using baseline plasma samples from patients
in Halozyme's HALO-202 Phase 2 clinical study of PEGPH20
(pegvorhyaluronidase alfa) in combination with ABRAXANE®
(nab-paclitaxel) and gemcitabine (PAG arm) as compared to ABRAXANE
and gemcitabine only (AG arm).
Highlights from the Halozyme biomarker analysis include:
- In the Discovery cohort (Stage 1), median progression-free
survival (PFS) was 8.0 months in the PAG arm versus 5.3 months in
the AG arm for patients whose biomarker scores were equal or above
a specific cut-off value. The proportion of this patient population
to all subjects tested in Stage 1 is 50 percent.
- In the Validation cohort (Stage 2), patients whose biomarker
scores were equal to or above the cut-off value derived from the
Discovery cohort experienced a median PFS of 8.8 months in the PAG
arm versus 3.4 in the AG arm, as well as overall survival of 13.8
months in the PAG arm versus 8.5 months in the AG arm. The
proportion of this patient population to all subjects tested in
Stage 2 is 47 percent.
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.
Janssen's daratumumab
Janssen (Janssen Research & Development, LLC) presentations
will highlight development of subcutaneous daratumumab using
Halozyme ENHANZE technology. Results from the Phase 1b PAVO study of patients with relapsed or
refractory multiple myeloma showed daratumumab co-formulated with
ENHANZE enabled dosing in 3 to 5 minutes and was well tolerated
with low infusion-related reactions.
Additional Updates and Presentations at ASCO
In an update on the HALO-101 Lung/Gastric Phase 1b study, Halozyme said that in light of the
evolution in the standard of care in first-line non-small-cell lung
cancer, it is closing enrollment in the lung cohort in the study.
Investigators are being given the option to continue treatment of
ongoing patients, and data will be submitted to medical forum later
this year.
Halozyme's ASCO abstracts include:
Extracellular matrix (ECM) circulating peptide biomarkers as
potential predictors of survival in patients (pts) with untreated
pancreatic ductal adenocarcinoma (mPDA) receiving
pegvorhyaluronidase alfa (PEPGH20), nab-paclitaxel (A), and
gemcitabine (G). Abstract 12030. Monday, June 4,
1:15 to 4:45 p.m. CT.
Tumor hyaluronan (HA) as a novel biomarker to taxane therapy
in non-small cell lung cancer (NSCLC). Publication only.
A Pilot study of Gemcitabine, Nab-paclitaxel, PEGPH20 and
Rivaroxaban for Advanced Pancreatic Adenocarcinoma: Interim Safety
and Efficacy Analysis. Publication only.
Pegvorhyaluronidase alfa (PEPGH20) enhances FOLFIRINOX
efficacy in a preclinical model of human pancreatic ductal
adenocarcinoma. Publication only.
Affinity histochemical evaluation of hyaluronan accumulation
in solid malignancies of the digestive system. Publication
only.
About PEGPH20
PEGPH20 (pegvorhyaluronidase alfa) 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
pegvorhyaluronidase alfa (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,
Bristol-Myers Squibb and Alexion for its ENHANZE® drug
delivery technology. 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 Company's future expectations and plans for growth in 2018,
entering into new collaboration agreements, the development and
commercialization of product candidates, including timing of
clinical trial results announcements and future development and
commercial activities of our collaboration partners, the potential
benefits and attributes of such product candidates and expected
financial outlook for 2018) 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 fluctuations or changes in revenues, including revenues
from collaborators, unexpected delays in entering into new
collaboration agreements, unexpected results or delays in
development of product candidates, including delays in clinical
trial patient enrollment and development activities of our
collaboration partners, 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 Quarterly Report on
Form 10-Q filed with the Securities and Exchange Commission on
May 10, 2018.
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.