Halozyme Provides Summary Results Of Data For PEGPH20 Combination Treatments Presented At ESMO 2018 Congress

SAN DIEGO, /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced the presentation of data from two clinical trials for PEGPH20 (pegvorhyaluronidase alfa) in patients with advanced pancreas and metastatic breast cancer. The presentations were made at the annual European Society for Medical Oncology (ESMO) 2018 Congress, taking place October 19-23 in Munich. PEGPH20 is Halozyme’s proprietary PEGylated recombinant human hyaluronidase enzyme that degrades hyaluronan (HA), a glycosaminoglycan or naturally occurring sugar in the body. HA accumulates in many solid tumors, potentially impeding the immune response and the access of anti-cancer therapies. PEGPH20 is being developed as an investigational new drug for the treatment of advanced pancreas cancer, specifically in patients with tumors that accumulate HA, referred to as HA-high.

“These data reinforce the potential for PEGPH20 in combination with chemotherapy in these well-defined patient populations. It adds to the supportive evidence that suggests PEGPH20 could play a critical role in degrading tumor HA, allowing greater penetration of chemotherapy and improved access of the immune system into the tumor,” said Dr. Helen Torley, president and chief executive officer of Halozyme. “PEGPH20 may provide a unique targeted approach for patients with late-stage cancers where new treatment options are needed.”

Poster Presentations of PEGPH20 Clinical Studies at ESMO 2018

Abstract 5965/730P – A pilot study of gemcitabine, nab-paclitaxel, PEGPH20 and rivaroxaban for advanced pancreatic adenocarcinoma: interim safety and efficacy analysis
K. Yu, Memorial Sloan-Kettering Cancer Center, et al.

This investigator sponsored study has enrolled 60 patients with advanced pancreatic adenocarcinoma (PDAC), 42 patients without prior thromboembolic events (TE) in cohort 1 and 18 patients with prior TE in cohort 2. Patients received PEGPH20 (3 ug/kg, the same dose as is being evaluated in HALO-301), plus the standard dose and schedule for nab-paclitaxel (125 mg/m²), and gemcitabine (1000 mg/m²), plus rivaroxaban (15 mg PO BID for 21 days induction, then 20 mg PO QD), an oral anticoagulant that has been shown to reduce TE in patients receiving chemotherapy. The primary objective was the rate of symptomatic TE events, and the secondary objectives included PFS, OS and major bleeding rate.

All 60 patients are evaluable for safety and efficacy. Two (3%) grade 3/4 TE events occurred (one in each cohort), and two grade 3 GI hemorrhages; these AEs resolved with supportive treatment. There were three (5%) complete responses, 28 (47%) partial responses, 20 (33%) stable disease responses, and 9 (15%) progressive disease/non-evaluable responses. Median PFS is 7.0 months across both cohorts, and median overall survival has not been reached. Efficacy and safety are similar for patients with and without prior TE. Tissue biopsies have been collected to evaluate response by HA level but the analysis is not yet completed.

Abstract 5999/311P – Early results from an Open-label Phase 1b/2 study of eribulin mesylate (EM) + pegvorhyaluronidase alpha (PEGPH20) combination for the treatment of patients with HER2-negative, high-hyaluronan (HA) metastatic breast cancer (MBC)
M. Shum, The Oncology Institute Whittier, et al.

The Phase 1b portion of the study enrolled 14 patients with HER2 negative metastatic breast cancer without regard for HA status. Patients were treated with IV PEGPH20 plus eribulin mesylate (HALAVEN^®), a microtubule inhibitor approved for the treatment of metastatic breast cancer in patients previously treated with up to two lines of systemic anticancer therapy. Two different dose-levels of PEGPH20 (3ug/kg and 1.6ug/kg) were tested in combination with 1.4 mg/m² EM. The data cut-off date for this analysis was February 2018. The median number of 21-day treatment cycles in this trial was six. No complete responses were reported, four (28.6%) patients had a partial response and three (21%) had stable disease. Drug related treatment emergent adverse events (TEAEs) occurred in 86% of patients, with 79% of patients experiencing grade 3 or higher TEAEs. There were three serious adverse events, and the overall safety profile for PEGPH20 + eribulin mesylate was in line with previous observations, with no new safety signals identified. As a result of dose limiting toxicities at the higher dose,1.6ug/kg was determined to be the appropriate dose for this combination. An additional response was confirmed following the data cutoff, increasing the overall response rate to 36%. The overall response rate is encouraging and the PEGPH20 + eribulin mesylate combination warrants further investigation.

About PEGPH20

PEGPH20 is an investigational PEGylated form of Halozyme’s proprietary recombinant human hyaluronidase enzyme under clinical development for the potential systemic treatment of tumors that accumulate hyaluronan (HA). PEGPH20 targets and degrades hyaluronan, a glycosaminoglycan or naturally occurring sugar in the body. HA accumulates in many solid tumors, potentially constricting blood vessels, impeding the immune response and the access of anti-cancer therapies. PEGPH20 is being studied in a Phase 3 trial in patients with late stage HA-high pancreas tumors.

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 pegvorhyaluronidase alfa (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 the treatment of several cancers and has the potential to be used 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, Bristol-Myers Squibb and Alexion for its ENHANZE^® drug delivery technology. Halozyme is headquartered in San Diego. For more information visit www.halozyme.com.

Halozyme 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:
Robert H. Uhl
Managing Director
Westwicke Partners, LLC
858-356-5932
robert.uhl@westwicke.com

Laurie Stelzer
858-704-8222
ir@halozyme.com

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SOURCE Halozyme Therapeutics, Inc.