SAN DIEGO, April 18, 2016 /PRNewswire/ -- Halozyme
Therapeutics (NASDAQ: HALO), a biotechnology company developing
novel oncology and drug-delivery therapies, today announced
preclinical data for the discovery and early development of two
potential drug candidates, an immune checkpoint inhibitor targeting
adenosine and a novel antibody-drug conjugate (ADC) targeting
epidermal growth factor receptor (EGFR).
These new preclinical programs complement Halozyme's lead
oncology asset, PEGPH20, an investigational new drug (IND) under
clinical evaluation for the treatment of pancreatic, lung and
gastric cancers.
The potential drug candidates are PEGylated adenosine deaminase
2, or PEG-ADA2, an immune checkpoint inhibitor that targets
immuno-suppressive adenosine, which may accumulate to high levels
in the tumor microenvironment. PEG-ADA2 is currently in early
preclinical development with the next milestone expected to be
final drug candidate selection by the end of 2016.
HTI-1511 is a novel anti-EGFR ADC to treat solid tumors,
including those with drug-resistant mutations. It is also in
pre-clinical development, with a drug candidate selected, good
laboratory practices (GLP) toxicity studies planned for 2017 and
chemistry, manufacturing and controls (CMC) development activities
to support a future IND filing underway.
"We expand our oncology pipeline today with two assets that
complement our growing body of research into the structural,
biochemical and immunological properties of the tumor
microenvironment," said Dr. Helen
Torley, president and chief executive officer. "Our new
PEG-ADA2 and HTI-1511 anti-EGFR ADC show early promise as our
scientists continue to characterize them for potential clinical
study in the future.
"In addition, our ongoing research of lead asset, PEGPH20,
continues to build scientific evidence of potential benefits in
remodeling the tumor microenvironment, including the potential to
increase access of immune therapies and chemotherapies. This week
we will share new research in animal models showing increased tumor
regression when immune checkpoint inhibitors are used in
combination with PEGPH20 in tumor models with high levels of
hyaluronan."
The new studies are being introduced during poster presentations
at the American Association for Cancer Research (AACR) annual
conference, taking place April 17-20
in New Orleans.
PEG-ADA2
Halozyme's PEG-ADA2 was engineered to decrease the concentration
of adenosine in the tumor microenvironment, and PEGylated to
prolong its circulation in the body. Accumulation of adenosine is
believed to contribute to a suppressed immune response to certain
solid tumors.
In preclinical studies, Halozyme's PEG-ADA2 demonstrated tumor
growth inhibition in certain colon, lung and pancreatic cancer
models. Treatment with PEG-ADA2 resulted in an increase in
infiltration of T cells and lowering of tumor adenosine levels.
Halozyme scientists have also identified a potential biomarker for
tumors that may respond to PEG-ADA2 therapy.
The company plans to continue its ongoing study and
characterization of PEG-ADA2 with the goal of determining its
suitability as a targeted therapy for clinical study.
HTI-1511 Anti-EGFR ADC
Halozyme's HTI-1511 was engineered to bind to EGFR at the low pH
of the tumor microenvironment while decreasing or attenuating the
binding at the neutral pH of skin. The result in preclinical
studies to date is a targeted therapy with an acceptable safety
profile.
HTI-1511 has been developed as a next generation ADC with a
potent cytotoxin, monomethyl auristatin E to treat EGFR-positive
tumors, including those with KRAS and BRAF mutations. In
preclinical studies, HTI-1511 has demonstrated tumor growth
inhibition or regression in colon, lung and cholangiocarcinoma
models, including patient derived xenograft (PDx) models with known
KRAS and BRAF mutations.
The company has initiated a range of studies to prepare for an
IND filing for HTI-1511 with the target of initiating early
clinical study in 2018.
Halozyme Webcast and Conference Call
Dr. Torley and Halozyme Chief Scientific Officer, Dr.
Michael LaBarre will host a meeting
for investment professionals today, Monday,
April 18 at 4 p.m. ET
(3 p.m. CT, 1
p.m. PT). The event will be webcast live through the
"Investors" section of Halozyme's corporate website and a recording
will be made available following the close of the event.
To access the webcast and additional documents related to the
event, please visit www.halozyme.com approximately fifteen minutes
prior to the start time to register, download and install any
necessary audio software. The live event may be accessed by calling
(877) 410-5657 (domestic callers) or (334) 323-7224 (international
callers) using passcode 987221. A telephone replay will be
available after the event by dialing (877) 919-4059 (domestic
callers) or (334) 323-0140 (international callers) using replay
passcode 13259083.
Halozyme's AACR Poster Presentations include:
- PEGylated recombinant hyaluronidase PH20 enhances pemetrexed
antitumor efficacy in a human non-small cell lung cancer model,
Sun., April 17, 1-5 p.m. CT
- Preclinical evaluation of a next-generation EGFR targeting
antibody-drug conjugate that promotes regression in KRAS and BRAF
tumors, Mon., April 18, 8 a.m. – noon
CT
- Enzymatic depletion of adenosine by PEGylated, engineered
adenosine deaminase 2 (PEG-ADA2): a novel immunotherapeutic
approach to treat solid tumors, Mon., April
18, 8 a.m. – noon CT
- PEGPH20 increases the anticancer activity of standard
chemotherapy combinations, vincristine (VIN) and D actinomycin
(DACT), in a Wilms xenograft model, Mon.,
April 18, 1-5 p.m. CT
- PEGylated recombinant hyaluronidase PH20 (PEGPH20) enhances
checkpoint inhibitor efficacy in syngeneic mouse models of cancer,
Weds., April 20, 8 a.m. – 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. 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.
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, PEG-ADA2 and HTI-1511, their possible
method of action, potential application to improve cancer therapies
and statements concerning future actions and clinical trials
relating to their development) 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 recently 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.