Halozyme Therapeutics, Inc. 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 HA^high Tumors," findings in an animal model of non-small-cell
lung cancer included:
o 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;
o Halozyme's investigational new drug, PEGPH20, depletes HA and increases
T-cells access to tumor cells in an animal models;
o HA removal by PEGPH20 enhanced anti-PD-1 or anti-PD-L1 dependent
tumor-cell killing in cell based assays;
o 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:
o 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
o 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
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