Halozyme Presents New Preclinical Data At The American Association for Cancer Research Annual Meeting, Announces Clinical Data Presentation At ASCO

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Data to support ongoing work with Halozyme's investigational new drug PEGPH20 in combination with immuno-oncology agents
Further support for companion diagnostic test to identify patients with high hyaluronan (HA) in tumors
Interim results of randomized Phase 2 study in pancreatic cancer to be presented next month at annual meeting of the American Society of Clinical Oncology

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.

Schond Greenway
Halozyme Therapeutics

Jim Mazzola
Halozyme Therapeutics

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