Profile: Halozyme Therapeutics Inc (HALO.O)
Halozyme Therapeutics, Inc., incorporated on August 23, 2007, is a biotechnology company focused on developing and commercializing oncology therapies. The Company operates in research, development and commercialization of enzymes segment. This segment also includes research and development, and bulk rHuPH20 manufacturing activities conducted under its collaborative agreements with third parties, and product sales of Hylenex recombinant. Its research activities focus on human enzymes that alter the extracellular matrix and tumor microenvironment. Its enzymes are used to facilitate the delivery of injected drugs and fluids. The Company's rHuPH20 is the active ingredient in its commercially approved product, Hylenex recombinant, and it works by temporarily breaking down hyaluronan (HA), a naturally occurring complex carbohydrate that is a component of the extracellular matrix in tissues throughout the body, such as skin and cartilage. The Company refers to the application the delivery of other drugs or fluids as its ENHANZE Technology. It licenses the ENHANZE Technology to form collaborations with biopharmaceutical companies that develop or market drugs requiring injection through the subcutaneous route of administration.
The Company's development pipeline consists of clinical-stage product candidates in oncology. Its lead oncology program is PEGPH20 (polyethylene glycol (PEG)ylated recombinant human hyaluronidase), a molecular entity that the Company is developing for the systemic treatment of tumors, which accumulate HA. PEGPH20 works by temporarily degrading HA surrounding cancer cells resulting in reduced pressure and increased blood flow to the tumor thereby enabling increased amounts of anticancer treatments administered concomitantly gaining access to the tumor. It is in Phase II and Phase III clinical testing for PEGPH20 in stage IV pancreatic ductal adenocarcinoma (PDA) (Studies 109-202 and 109-301); Phase Ib clinical testing in non-small cell lung cancer (Study 107-201), and in Phase Ib clinical testing in non-small cell lung cancer and gastric cancer (Study 107-101). It has approximately one marketed product and over one product candidate targeting several indications in various stages of development.
The Company's Hylenex recombinant is a formulation of rHuPH20 that has received the United States Food and Drug Administration (FDA) approval to facilitate subcutaneous fluid administration for achieving hydration, to increase the dispersion and absorption of other injected drugs and, in subcutaneous urography and to improve resorption of radiopaque agents. Hylenex recombinant is a prescribed branded product.
The Company is developing PEGPH20 as a candidate for the systemic treatment of tumors that accumulate HA in combination with approved cancer therapies. PEGPH20 lasts for an extended duration in the bloodstream and therefore can be administered systemically to maintain its therapeutic effect to treat disease. The FDA granted Fast Track designation for its program investigating PEGPH20 in combination with gemcitabine and nab-paclitaxel for the treatment of patients with stage IV PDA to demonstrate an improvement in overall survival. The FDA granted Orphan Drug designation for PEGPH20 for the treatment of pancreatic cancer. The European Committee for Orphan Medicinal Products of the European Medicines Agency (EMA) also designated PEGPH20 an orphan medicinal product for the treatment of pancreatic cancer.
The Company has conducted a 109-201 multi-center, international open label dose escalation Phase Ib clinical study of PEGPH20 in combination with gemcitabine for the treatment of patients with stage IV PDA. This study enrolled approximately 30 patients with previously untreated stage IV PDA. Patients were treated with one of three doses of PEGPH20 (1.0, 1.6 and 3.0 microgram/kilogram twice weekly for four weeks, then weekly thereafter) in combination with gemcitabine 1000 milligram per square meter administered intravenously. It has initiated Study Halo 109-301, a Phase III multicenter randomized clinical trial evaluating PEGPH20 as a first-line therapy for patients with stage IV PDA.
The Company has initiated a Phase Ib/II randomized clinical trial for examining PEGPH20 in combination with modified FOLFIRINOX chemotherapy (mFOLFIRINOX) compared to mFOLFIRINOX treatment alone in patients with stage IV PDA. It has initiated a Phase Ib/II trial, to evaluate PEGPH20 in second line in combination with docetaxel (Taxotere) in non-small cell lung cancer patients. It has initiated a Phase Ib study exploring the combination of PEGPH20 and KEYTRUDA, an immuno-oncology agent in relapsed non-small cell lung cancer and gastric cancer.
The Company competes with Valeant Pharmaceuticals International, Inc. and Amphastar Pharmaceuticals, Inc.
Halozyme Therapeutics Inc
11388 Sorrento Valley Rd
SAN DIEGO CA 92121-1345
Company Web Links
- BRIEF-Halozyme to resume enrollment in Phase 1B trial evaluating PEGPH20
- BRIEF-Halozyme announces agreement to refinance debt
- BRIEF-Halozyme Q1 loss per share $0.16
- BRIEF-Halozyme Therapeutics expands oncology pipeline with two compounds designed for activity in tumor microenvironment
- BRIEF-Halozyme doses first patient in phase 3 clinical trial of PEGPH20 in combination with ABRAXANE and Gemcitabine