First Gastric Cancer Patient Dosed In Clinical Trial Collaboration Evaluating Halozyme's PEGPH20 In Combination With Anti-PDL1 Immunotherapy

SAN DIEGO, CA, USA I October 24, 2017 I 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, locally advanced unresectable or metastatic gastric or gastroesophageal junction cancer.

The study is sponsored by and funded by Genentech as part of a clinical collaboration agreement announced last year to evaluate PEGPH20 and atezolizumab in up to eight tumor types. Genentech initiated the first study in July to evaluate the combination in patients with previously treated metastatic pancreatic ductal adenocarcinoma.

The gastric cancer study is a Phase 1b/2, open-label, multicenter, randomized clinical trial designed to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of immunotherapy-based treatment combinations compared with the standard chemotherapy regimens. It will enroll an all-comer population regardless of hyaluronan (HA) level. The overall analysis plan includes a retrospective analysis of the HA-high population 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.

"PEGPH20 is currently under evaluation in six indications with potential across a range of difficult to treat solid tumors," said Dr. Helen Torley, president and chief executive officer. "Our hope is to advance new treatment options for patients with each ongoing study."

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.

SOURCE: Halozyme

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