Halozyme To Present Data From Six Nonclinical Studies At American Association Of Cancer Research Annual Conference

SAN DIEGO, March 14, 2018 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, will present nonclinical data from six studies at the 109^th annual meeting of the American Association of Cancer Research (AACR) next month, including ongoing research evaluating the potential ability of its lead investigational drug, PEGPH20 (pegvorhyaluronidase alfa), to increase the effectiveness of immunotherapies. The AACR annual conference takes place April 14-18 in Chicago.

"We are pleased to present additional nonclinical data in support of our ongoing clinical evaluation of PEGPH20 in combination with checkpoint inhibitors," said Dr. Helen Torley, president and chief executive officer. "The data presented demonstrate that the presence of hyaluronan can create an immunosuppressive tumor microenvironment and that PEGPH20 increases immune cell infiltration and tumor growth inhibition when used in combination with immunotherapy in hyaluronan-rich tumor animal models."

PEGPH20 is a proprietary enzyme that targets and degrades hyaluronan (HA), 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.

Highlights from the studies include:

• Accumulation of HA in a pancreatic cancer syngeneic mouse model induced several aspects of immunosuppression, restricting the number of tumor-infiltrating lymphocytes, skewing tumor-associated macrophages and dendritic cells toward immunosuppressive phenotypes. (Abstract 1747)
• MC38 colon tumors in mice treated with PEGPH20 combined with anti-PD-L1 treatment experienced a significant increase in CD8+ T cells (2.8-fold, p<0.05) and NK cells (3-fold, p<0.0001) compared with anti-PD-L1 antibody alone.
  CT26-HAS3 colon tumors in mice treated with PEGPH20 alone experienced 43 percent tumor growth inhibition. When combined with anti-CTLA4 treatment, PEGPH20 further enhanced tumor growth inhibition (79 percent, p<0.002) versus anti-CTLA4 alone or PEGPH20 alone. (Abstract 1743)
• Orthotopic breast tumors in mice treated with PEGPH20 in combination with anti-PD-L1 experienced a significant increase of CD8+ T cells (p=0.0007) and became sensitive to anti-PD-L1 immunotherapy. Research also showed that PEGPH20 combined with anti-PD-L1 led to 64 percent tumor growth inhibition versus PEGPH20 alone (10.7 percent) or anti-PD-L1 antibody alone (-5.1 percent). (Abstract 2740)

Halozyme has ongoing clinical studies of PEGPH20 in combination with chemotherapy and immunotherapies, including a Phase 1b/2 study of PEGPH20 and KEYTRUDA^® (pembrolizumab), an anti-PD1 therapy, in gastric and lung cancer patients, as well as a clinical collaboration with Genentech combining PEGPH20 with TECENTRIQ^® (atezolizumab), an anti-PD-L1 therapy, in up to eight tumor types.

Halozyme's AACR abstracts:

Hyaluronan (HA) accumulation restricts CD8+ T cell numbers and skews tumor-associated macrophage (TAM) phenotype in mouse syngeneic pancreatic tumors. Abstract 1747. Monday, April 16, 8 a.m. to noon CT

PEGylated recombinant hyaluronidase PH20 (pegvorhyaluronidase alfa; PEGPH20) converts HA-rich tumors from resistant to sensitive to anti-PD-L1 immunotherapy in murine syngeneic breast cancer models. Abstract 2740. Monday, April 16, 8 a.m. to noon CT

PEGylated Adenosine Deaminase (ADA2) Prevents Adenosine-Mediated Increase in Tumor Growth and Improves Anti-Tumor Immune Responses. Abstract 1755. Monday, April 16, 8 a.m. to noon CT

Rationale for evaluating PEGylated recombinant human hyaluronidase PH20 (pegvorhyaluronidase alfa; PEGPH20) in patients with hyaluronan (HA)-accumulating colorectal cancer. Abstract 1743. Monday, April 16, 1 to 5 p.m. CT

The growth of xenograft breast cancer tumor model with engineered hyaluronan-accumulating stroma is dependent on hyaluronan and independent of CD44. Abstract 2101. Monday, April 16, 1 to 5 p.m. CT

PEGylated Hyaluronidase Increases Tumor Uptake of ⁸⁹Zr-DFO-HuMab-5B1 (MVT-2163) in a CA19-9 Positive Hyaluronan-Accumulating Pancreatic Cancer Model. Abstract 3036. Tuesday, April 17, 8 a.m. to noon CT

About PEGPH20
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. In January, Halozyme announced the positive topline results as of December 2016 of its randomized phase 2 HALO-202 study of PEGPH20 in combination with ABRAXANE^® (nab-paclitaxel) and gemcitabine chemotherapy in metastatic pancreatic cancer. In the study, PEGPH20 met key endpoints, including PFS in the targeted HA-High patient population.

FDA granted orphan drug designation to PEGPH20 for treatment of pancreas cancer and fast track 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 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 metastatic pancreatic cancer, non-small cell lung cancer, and gastric 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, Bristol-Myers Squibb and Alexion for its ENHANZE^® drug delivery technology. 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 Company's future expectations and plans for growth in 2018, entering into new collaboration agreements, the development and commercialization of product candidates, including timing of clinical trial results announcements and future development and commercial activities of our collaboration partners, the potential benefits and attributes of such product candidates and expected financial outlook for 2018) 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 fluctuations or changes in revenues, including revenues from collaborators, unexpected delays in entering into new collaboration agreements, unexpected results or delays in development of product candidates, including delays in clinical trial patient enrollment and development activities of our collaboration partners, 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 Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 20, 2018.

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.