SAN DIEGO, March 14, 2018 /PRNewswire/ -- Halozyme
Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company
developing novel oncology and drug-delivery therapies, will present
nonclinical data from six studies at the 109th annual
meeting of the American Association of Cancer Research (AACR) next
month, including ongoing research evaluating the potential ability
of its lead investigational drug, PEGPH20 (pegvorhyaluronidase
alfa), to increase the effectiveness of immunotherapies. The AACR
annual conference takes place April
14-18 in Chicago.
"We are pleased to present additional nonclinical data in
support of our ongoing clinical evaluation of PEGPH20 in
combination with checkpoint inhibitors," said Dr. Helen Torley, president and chief executive
officer. "The data presented demonstrate that the presence of
hyaluronan can create an immunosuppressive tumor microenvironment
and that PEGPH20 increases immune cell infiltration and tumor
growth inhibition when used in combination with immunotherapy in
hyaluronan-rich tumor animal models."
PEGPH20 is a proprietary enzyme that targets and degrades
hyaluronan (HA), a glycosaminoglycan or naturally occurring sugar
in the body. HA accumulates in many solid tumors, potentially
constricting blood vessels, impeding the immune response and the
access of anti-cancer therapies.
Highlights from the studies include:
- Accumulation of HA in a pancreatic cancer syngeneic mouse model
induced several aspects of immunosuppression, restricting the
number of tumor-infiltrating lymphocytes, skewing tumor-associated
macrophages and dendritic cells toward immunosuppressive
phenotypes. (Abstract 1747)
- MC38 colon tumors in mice treated with PEGPH20 combined with
anti-PD-L1 treatment experienced a significant increase in CD8+ T
cells (2.8-fold, p<0.05) and NK cells (3-fold, p<0.0001)
compared with anti-PD-L1 antibody alone.
CT26-HAS3 colon tumors in mice treated with PEGPH20 alone
experienced 43 percent tumor growth inhibition. When combined with
anti-CTLA4 treatment, PEGPH20 further enhanced tumor growth
inhibition (79 percent, p<0.002) versus anti-CTLA4 alone or
PEGPH20 alone. (Abstract 1743)
- Orthotopic breast tumors in mice treated with PEGPH20 in
combination with anti-PD-L1 experienced a significant increase of
CD8+ T cells (p=0.0007) and became sensitive to anti-PD-L1
immunotherapy. Research also showed that PEGPH20 combined with
anti-PD-L1 led to 64 percent tumor growth inhibition versus PEGPH20
alone (10.7 percent) or anti-PD-L1 antibody alone (-5.1 percent).
(Abstract 2740)
Halozyme has ongoing clinical studies of PEGPH20 in combination
with chemotherapy and immunotherapies, including a Phase
1b/2 study of PEGPH20 and
KEYTRUDA® (pembrolizumab), an anti-PD1 therapy, in
gastric and lung cancer patients, as well as a clinical
collaboration with Genentech combining PEGPH20 with
TECENTRIQ® (atezolizumab), an anti-PD-L1 therapy, in up
to eight tumor types.
Halozyme's AACR abstracts:
Hyaluronan (HA) accumulation restricts CD8+ T cell numbers
and skews tumor-associated macrophage (TAM) phenotype in mouse
syngeneic pancreatic tumors. Abstract 1747. Monday, April
16, 8 a.m. to noon CT
PEGylated recombinant hyaluronidase PH20 (pegvorhyaluronidase
alfa; PEGPH20) converts HA-rich tumors from resistant to sensitive
to anti-PD-L1 immunotherapy in murine syngeneic breast cancer
models. Abstract 2740. Monday, April 16, 8 a.m. to noon CT
PEGylated Adenosine Deaminase (ADA2) Prevents
Adenosine-Mediated Increase in Tumor Growth and Improves Anti-Tumor
Immune Responses. Abstract 1755. Monday, April 16,
8 a.m. to noon CT
Rationale for evaluating PEGylated recombinant human
hyaluronidase PH20 (pegvorhyaluronidase alfa; PEGPH20) in patients
with hyaluronan (HA)-accumulating colorectal cancer. Abstract
1743. Monday, April 16, 1 to 5 p.m.
CT
The growth of xenograft breast cancer tumor model with
engineered hyaluronan-accumulating stroma is dependent on
hyaluronan and independent of CD44. Abstract 2101. Monday,
April 16, 1 to 5 p.m. CT
PEGylated Hyaluronidase Increases Tumor Uptake of
89Zr-DFO-HuMab-5B1 (MVT-2163) in a CA19-9 Positive
Hyaluronan-Accumulating Pancreatic Cancer Model. Abstract
3036. Tuesday, April 17, 8 a.m. to noon
CT
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 PFS 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, and gastric 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 Annual Report on Form
10-K filed with the Securities and Exchange Commission on
February 20, 2018.
Contacts:
Jim
Mazzola
858-704-8122
ir@halozyme.com
Chris Burton
858-704-8352
ir@halozyme.com
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