SAN DIEGO, April 20, 2015 /PRNewswire/ -- Halozyme
Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company
developing novel oncology and drug-delivery therapies, today shared
highlights of new data it presented at the American Association for
Cancer Research (AACR) annual meeting. Halozyme also announced
plans to present interim results of its randomized Phase 2 study in
pancreatic cancer, Study 202, next month at the annual meeting of
the American Society of Clinical Oncology (ASCO).
In an oral presentation at the AACR meeting titled "Hyaluronan
(HA) Depletion Increases Tumor Accessibility of T cell and
Therapeutic PD-L1 Monoclonal Antibody in HAhigh Tumors,"
findings in an animal model of non-small-cell lung cancer
included:
- Tumors with high levels of HA – a structural carbohydrate that
accumulates in the areas surrounding cancer cells --form a natural
HA-rich barrier that restricted T-cell access to tumor cells;
- Halozyme's investigational new drug, PEGPH20, depletes HA and
increases T-cells access to tumor cells in an animal models;
- HA removal by PEGPH20 enhanced anti-PD-1 or anti-PD-L1
dependent tumor-cell killing in cell based assays;
- HA depletion by PEGPH20 increased the access of T cell and
anti-human PD-L1antibody in HA-high xenograft tumors, suggesting
that PEGPH20 may have the potential to enhance the efficacy of
immune checkpoint inhibitors in human HA-high tumors
This new preclinical data adds to the growing body of evidence,
generated in multiple animal tumor models, demonstrating increased
efficacy when a range of different cancer therapeutics are
administered with PEGPH20.
Halozyme also presented findings relevant to the development of
a companion diagnostic test for PEGPH20 in a poster presentation
titled, "Development and Analytical Validation of a Novel Assay for
Tissue Detection of Hyaluronan in the Tumor Microenvironment to
Select Patients for Molecularly Targeted Pancreatic Cancer
Therapies." These findings include:
- Halozyme's companion diagnostic assay and proprietary HTI-601
binding probe were sensitive, specific and met the company's
acceptability criteria for the detection and measurement of HA
levels in archival samples from multiple different tumors types;
and
- HTI-601 may be appropriate as a companion diagnostic approach
for the selection of patients with high HA levels suitable for
therapy using PEGPH20.
The company announced on April 8
plans to proceed with a Phase 3 clinical study (Study 301) of
PEGPH20 in patients with metastatic pancreatic cancer using a
companion diagnostic to prospectively identify patients with high
levels of HA.
"The findings we presented at AACR highlight the progress we are
making with PEGPH20 development, with the preclinical data
providing further support for the initiation of the planned
combination trial with a PD1 inhibitor in non-small-cell lung
cancer," said Athena Countouriotis, senior vice president and chief
medical officer. "The evidence of HTI-601 as a sensitive and
specific assay for HA was one of the key steps in our plans to have
the companion diagnostic ready for Phase 3 initiation in the first
quarter of 2016."
Two additional poster presentations at AACR will be presented
today (April 20):
Title: "PEGPH20 Enhances Chemotherapy in Patient-Derived
and Traditional Cell-Derived Xenograft NSCLC Models"
Abstract #: 2547, April 20, 2015, 1:00PM - 5:00PM EDT (Poster)
Location: Section 27, Poster 29
Title: "Hyaluronan-Dependent Growth of Human Triple
Negative Breast Cancer MDA-MB-468 in Mouse Xenograft Models"
Abstract #: 2392, April 20, 2015, 1:00PM - 5:00PM EDT (Poster)
Location: Section 19, Poster 25
ASCO Session
Session titles posted today for next
month's ASCO annual meeting included, "High Response Rate and PFS
with PEGPH20 added to Nab-Paclitaxel/Gemcitabine in Stage IV
Previously Untreated Pancreatic Cancer Patients with High-HA
Tumors: Interim Results of a Randomized Phase 2 Study."
During this session Dr. Sunil
Hingorani, a principal investigator, will share interim
results of Study 202, a phase 2 study of Halozyme's PEGPH20
combined with nab-paclitaxel (ABRAXANE®) and gemcitabine
compared with nab-paclitaxel (ABRAXANE®) and gemcitabine
alone in metastatic pancreatic cancer patients.
About PEGPH20
PEGPH20 is an investigational PEGylated
form of Halozyme's proprietary recombinant human hyaluronidase
under clinical development for the systemic treatment of tumors
that accumulate hyaluronan.
FDA granted orphan drug designation to PEGPH20 for treatment of
pancreatic cancer and fast track for PEGPH20 in combination with
gemcitabine and nab-paclitaxel for the treatment of metastatic
pancreatic 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 pancreatic
cancer.
Clinical trials are currently ongoing for development of PEGPH20
in pancreatic ductal adenocarcinoma and in non-small cell lung
cancer. More information may be found at:
http://oncologytrials.halozyme.com/pancreatic/.
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, our investigational drug
PEGPH20, applies a unique approach to targeting solid tumors,
allowing increased access of co-administered cancer drug therapies
to the tumor. PEGPH20 is currently in development for
metastatic pancreatic cancer and non-small cell lung 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, Pfizer, Janssen
and Baxter for its drug delivery
platform, ENHANZE™, which enables biologics and small molecule
compounds that are currently administered intravenously to be
delivered subcutaneously. Halozyme is headquartered in San
Diego. For more information on how we are innovating, 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 Annual
Report on Form 10-K filed with the Securities and Exchange
Commission on March 2, 2015.
Contacts:
Schond Greenway
Halozyme Therapeutics
858-704-8352
ir@halozyme.com
Jim Mazzola
Halozyme Therapeutics
858-704-8122
ir@halozyme.com
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SOURCE Halozyme Therapeutics, Inc.