SAN DIEGO, July 13, 2017 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced the initiation of a multi-arm clinical trial evaluating PEGPH20, Halozyme's investigational new drug, in combination with atezolizumab (TECENTRIQ®), an anti-PDL1 cancer immunotherapy from Genentech, a member of the Roche Group. The combination will be tested in patients with previously treated metastatic pancreatic ductal adenocarcinoma. The study is sponsored by and funded by Genentech.
The study is part of a clinical collaboration agreement announced by the companies last year to evaluate PEGPH20 and atezolizumab in up to eight tumor types, including pancreatic and gastric cancers.
The 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.
Patients will be enrolled regardless of their hyaluronan (HA) level, with analysis conducted retrospectively on a subset population of HA-high patients identified using the Ventana HA companion diagnostic assay.
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.
The study will be conducted in the U.S., as well as countries outside the U.S.
The collaboration between Halozyme and Genentech includes testing the experimental combination in MORPHEUS, Roche's Novel Cancer Immunotherapy Development Platform. MORPHEUS is a Phase 1b/2 adaptive platform to develop combinations of cancer immunotherapies more rapidly and efficiently.
"This clinical trial expands the study of PEGPH20 in pancreatic cancer, evaluating previously treated pancreas cancer patients and combining PEGPH20 with an anti-PDL1 monoclonal antibody for the first time," said Dr. Helen Torley, president and chief executive officer. "We are pleased to provide PEGPH20 in this collaboration study, to evaluate and potentially advance new treatment options for patients with pancreatic cancer, one of the hardest to treat cancers."
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.
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 and Lilly 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.
SOURCE Halozyme Therapeutics, Inc.