November 18, 2015
By Alex Keown, BioSpace.com Breaking News Staff
SAN DIEGO— In an attempt to expand its clinical programs and potential commercialization of its investigational new drug, oncology drugmaker Halozyme Therapeutics, Inc. will open a satellite office in San Francisco, the company announced Wednesday.
Helen Torley, president and chief executive officer of Halozyme, said in a statement that the San Francisco office will give the company the ability to augment its workforce of about 200 in San Diego. However, Torley did not specify how many individuals would staff the satellite office, or if the company will be hiring new employees or relocating existing ones.
Halozyme’s lead product is PEGPH20, an investigational PEGylated form of Halozyme‘s proprietary recombinant human hyaluronidase under clinical development for the potential systemic treatment of tumors that accumulate hyaluronan. The U.S. Food and Drug Administration (FDA) granted PEGPH20 orphan drug designation for treatment of pancreatic cancer and fast track for PEGPH20 in combination with gemcitabine and nab-paclitaxel for the treatment of metastatic pancreatic cancer. In addition to positive expectations from the FDA, the European Commission designated PEGPH20 an orphan medicinal product for the treatment of pancreatic cancer.
Halozyme is conducting combination trials of PEGPH20 in combination with Merck & Co. ’s immuno-oncology therapy Keytruda to determine its efficacy in the treatment of gastric cancers and Non-Small Cell Lung Cancer. PEGPH20 (PEGylated recombinant human hyaluronidase) targets hyaluronan (HA), a glycosaminoglycan, which is a chain of natural sugars throughout the body that can accumulate around cancer cells, inhibiting other therapies. PEGPH20 is designed to degrade HA to improve the access to tumor cells for chemotherapy, monoclonal antibodies and other immuno-therapy agents. Keytruda has been shown to be effective in treating patients with three types of cancer, melanoma, lung cancer and mesothelioma.
Earlier this month, Halozyme announced the first patient in a Phase Ib clinical trial received the first does of PEGPH20 in combination with Merck’s Keytruda to determine the maximum tolerated dose of PEGPH20 and antitumor activity of the combined therapies. The study is expected to be expanded to determine antitumor activity including overall response rate, duration of response and progression-free survival in patients with high levels of hyaluronan.
Halozyme is also conducting a Phase II study of PEGPH20 in combination with gemcitabine and Abraxane (nab-paclitaxel) in pancreatic cancer and is expecting to begin a Phase III trial by the end of the first quarter of 2016. Additionally.
Halozyme is conducting a Phase Ib/II study of PEGPH20 in combination with docetaxel in Non-Small Cell Lung Cancer (NSCLC).
Halozyme is up today, trading at $17.23 per share. The stock has seen a steady rise since it was trading at $8.44 in November of 2014. The stock rose as high as $25.25 per share in July. Earlier in November, the company did report a loss of $24.5 million in the third quarter. Halozyme Therapeutics expects full-year revenue in the range of $110 million to $115 million, the Associated Press reported.
In June, Halozyme and AbbVie struck a deal which incorporates Halozyme‘s Enhanze technology, which speeds the dispersion and absorption injectables, into injectable drugs that AbbVie is developing. Enhanze is based on its patented recombinant human hyaluronidase enzyme (rHuPH20), which has been shown to increase the volume of biologics that can be delivered subcutaneously.
Halozyme has multiple partnership with pharmaceutical heavy hitters include Roche , Pfizer Inc. , Janssen and Baxalta .