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.