Halozyme Initiates Clinical Trial Of PEGPH20 With Anti-PDL1 Immunotherapy In Cholangiocarcinoma And Gallbladder Cancer Patients

SAN DIEGO, Oct. 16, 2017 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced initiation of a clinical trial evaluating its investigational new drug PEGPH20 with atezolizumab (TECENTRIQ^®), an anti-PDL1 cancer immunotherapy from Genentech, a member of the Roche Group, in patients with previously untreated, unresectable, locally advanced, or metastatic cholangiocarcinoma and gallbladder adenocarcinoma.

"Through the initiation of our HALO-110-101 study, we continue to explore the pan-tumor potential of PEGPH20 and seek new therapeutic options for patients with high unmet need cancers," said Dr. Dimitrios Chondros, chief medical officer. "We are pleased to progress our clinical collaboration studies with Genentech to evaluate the potential for novel groundbreaking treatments for cancer patients."

The Halozyme-sponsored Phase 1b/2, open-label, multicenter, randomized clinical trial is designed to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of immunotherapy-based treatment combinations compared with the standard chemotherapy regimens. The study will be conducted at more than 40 sites in three countries and is part of a clinical collaboration agreement announced last year to evaluate PEGPH20 and atezolizumab in up to eight tumor types.

Following a safety run-in portion to determine the tolerability of PEGPH20 in combination with atezolizumab, an expansion phase is planned to determine preliminary antitumor activity including overall response rate, duration of response and progression-free survival in patients with high levels of hyaluronan (HA). During the expansion portion, the study seeks to enroll approximately 50 unresectable, locally advanced, or metastatic cholangiocarcinoma (bile duct cancer) and gallbladder adenocarcinoma patients who have not previously been treated.

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. PEGPH20 is an enzyme that temporarily degrades HA, reducing tumor pressure and potentially increasing blood flow, allowing greater access for chemotherapies and immunotherapies to treat the tumor.

About PEGPH20 (pegvorhyaluronidase alfa)
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.

FDA granted orphan drug designation to PEGPH20 for treatment of pancreas cancer and fast track designation 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 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, Lilly and Bristol-Myers Squibb for its ENHANZE^® drug delivery technology. Halozyme is headquartered in San Diego. For more information visit www.halozyme.com.

TECENTRIQ^® (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group.

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 most recent Annual and Quarterly Reports 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.