Early 2000 Halozyme PEGylates its proprietary recombinant human hyaluronidase enzyme (rHuPH20), which temporarily degrades hyaluronan (HA), to increase the plasma half-life of the enzyme. PEGylation enables Halozyme to investigate the enzyme (named PEGPH20 [pegvorhyaluronidase alfa]) for the treatment of solid tumors.
April 2008 At the American Association for Cancer Research (AACR) Annual Meeting, Halozyme presents PEGPH20’s ability to enzymatically degrade tumor HA in preclinical prostate cancer models. Read the press release
January 2009 Halozyme presents positive preclinical animal efficacy data for PEGPH20 monotherapy, specifically that PEGPH20 inhibited growth of HA-rich prostate cancer tumors, at the AACR Advances in Prostate Cancer Research meeting. Read the press release
March 2009 Halozyme begins a Phase 1 clinical study to explore the safety, tolerability, pharmacokinetics, and radiologic assessment of PEGPH20 as a single agent in cancer patients with refractory solid tumors.
April 2009 Halozyme presents that PEGPH20 produced anti-cancer activity in HA-producing models of breast, prostate, and brain metastases. Treatment with PEGPH20 significantly delayed tumor growth in breast and prostate cancer models. In a brain metastasis model, PEGPH20 combined with chemotherapy showed increased efficacy, and PEGPH20 combined with radiation prolonged survival.
August 2010 U.S. patent issued for rHuPH20, including PEGylated variants. European protection also granted.
October 2010
Halozyme scientists publish results of preclinical animal models showing that enzymatic depletion of tumor HA with PEGPH20 induces anti-tumor responses. Read the article
October 2011 Halozyme begins global randomized, controlled Phase 2 study testing safety, tolerability, and efficacy of PEGPH20 plus gemcitabine in patients with untreated stage IV pancreatic cancer. Read the press release
October 2011 At the EORTC-NCI-ASCO Annual Meeting, Halozyme announces data from two Phase 1 studies that support the hypothesis that PEGPH20 can favorably alter the tumor stroma of HA-rich tumors as well as the ongoing Phase 2 study.
April 2013 Halozyme begins a Phase 2, randomized, controlled clinical study (HALO-109-202) evaluating PEGPH20 as a first-line therapy for stage IV pancreatic cancer in combination with ABRAXANE® (nab-paclitaxel) and gemcitabine. View the study design
June 2013 At the ASCO Annual Meeting, Halozyme presents early Phase 1b clinical study results of PEGPH20 in combination with gemcitabine, indicating positive activity against pancreatic cancer.
September 2013 At the European Cancer Congress, Halozyme presents an exploratory analysis of Phase 1b study data, which suggests a potential clinical benefit of using PEGPH20 with gemcitabine in patients with high levels of tumor-associated HA.
2014 U.S. FDA Fast Track designation granted. U.S. FDA orphan drug designation granted. European orphan drug designation granted.
April 2015 FDA Type B meeting allows for potential marketing application based on progression-free survival in pivotal Phase 3 pancreatic cancer study.
May 2015 Halozyme and Ventana Medical Systems, Inc., enter into collaboration to develop a companion diagnostic (CDx) assay for identifying high levels of the tumor-associated HA biomarker, for use with PEGPH20. Read the press release
May 2015 At ASCO, Halozyme presents interim findings from the Phase 2 clinical study of PEGPH20 plus ABRAXANE and gemcitabine, showing a doubling of progression-free survival and an improvement trend in overall survival in patients with metastatic pancreatic cancer that is high in HA.
November 2015 First patient dosed in Phase 1b study of PEGPH20 in combination with KEYTRUDA® (pembrolizumab) for HA-HIGH advanced non-small cell lung and gastric cancers. Read the press release
March 2016 First patient dosed in a global, randomized, double-blind, placebo-controlled Phase 3 study of PEGPH20 with ABRAXANE and gemcitabine in patients with untreated, HA-HIGH metastatic pancreatic cancer.

Ventana CDx IDE granted, allowing Halozyme to use the assay to prospectively identify HA-HIGH patients for study inclusion.
Read the press release View the study design
June 2016 Halozyme announces results from analysis of patients treated in Stage 1 of the Phase 2 study of PEGPH20 with ABRAXANE and gemcitabine (PAG), with an increase in progression-free survival for HA-HIGH patients treated with PAG versus chemotherapy alone.
November 2016 Halozyme enters collaboration agreement to evaluate PEGPH20 with Genentech’s anti-PD-L1 immunotherapy TECENTRIQ® (atezolizumab) in up to eight tumor types. Read the press release
January 2017 Results of combined Stages 1 and 2 of the Phase 2 study of PEGPH20 with ABRAXANE and gemcitabine (PAG) meet the key endpoints, showing improved progression-free survival for both total patients and HA-HIGH patients in the PAG arm.