First Patient Dosed in Clinical Trial of Halozyme Investigational Drug PEGPH20 in Combination With Merck Immuno-oncology Drug KEYTRUDA

Nov 05, 2015, 08:30 ET from Halozyme Therapeutics, Inc.

SAN DIEGO, Nov. 5, 2015 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced the first patient has received its investigational new drug, PEGPH20 in combination with Merck's KEYTRUDA (pembrolizumab) in a clinical trial to determine the maximum tolerated dose of PEGPH20 and antitumor activity of the combined therapies.

The Halozyme sponsored Phase 1b study is being conducted at a number of leading sites in the U.S., and is evaluating patients with advanced non-small cell lung and gastric cancers.

Following an initial dose escalation portion to determine the maximum tolerated dose of PEGPH20 in combination with KEYTRUDA, the study will be expanded to determine antitumor activity including overall response rate, duration of response and progression-free survival in patients with high levels of hyaluronan (HA). HA is a glycosaminoglycan, or chain of natural sugars in the body that can accumulate around cancer cells creating high pressure in a tumor, constricting blood flow and thereby reducing access of chemotherapy and immunotherapeutic agents, like KEYTRUDA. PEGPH20 degrades HA, reducing tumor pressure and increasing blood flow to treat the tumor.

During the expansion portion, the study seeks to enroll approximately 50 patients with high HA tumors who have relapsed or refractory stage IIIB/IV non-small cell lung cancer treated with at least one platinum-based regimen, or who have recurrent locally advanced/metastatic gastric adenocarcinoma who are also PDL-1 positive and have failed at least one chemotherapy regimen.

"Our goal is to make a difference in the lives of patients, and that starts by studying the safety, tolerability and efficacy of PEGPH20 in a broad range of tumor types and in combination with a broad range of therapeutic agents," said Dr. Helen Torley, president and CEO of Halozyme. "With this study, we see an opportunity to expand the potential benefits of immunotherapy through the novel combination of KEYTRUDA and PEGPH20, targeting two of the most difficult to treat cancers."

For information on Keytruda, please go to keytruda.com.

About PEGPH20

PEGPH20 (PEGylated recombinant human hyaluronidase) targets the degradation of hyaluronan (HA), a chain of natural sugars that can accumulate around cancer cells, inhibiting other therapies. By degrading HA, PEGPH20 may increase the access of co-administered chemotherapeutic and immunotherapeutic agents.

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. PEGPH20 is currently in development for metastatic pancreatic cancer, non-small cell lung 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 and AbbVie 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 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 of product candidates 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 Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 10, 2015.

Contacts: Jim Mazzola 858-704-8122 ir@halozyme.com

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SOURCE Halozyme Therapeutics, Inc.



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