Halozyme Therapeutics is an American

biotechnology Biotechnology is the integration of natural sciences and engineering sciences in order to achieve the application of organisms, cells, parts thereof and molecular analogues for products and services. The term ''biotechnology'' was first used b ...

company. It develops

oncology Oncology is a branch of medicine that deals with the study, treatment, diagnosis and prevention of cancer. A medical professional who practices oncology is an ''oncologist''. The name's etymological origin is the Greek word ὄγκος (''ó ...

therapies designed to target the

tumor microenvironment The tumor microenvironment (TME) is the environment around a tumor, including the surrounding blood vessels, immune cells, fibroblasts, signaling molecules and the extracellular matrix (ECM). The tumor and the surrounding microenvironment are cl ...

. The company was founded in 1998 and went public in 2004. Halozyme is headquartered in

San Diego, California San Diego ( , ; ) is a city on the Pacific Ocean coast of Southern California located immediately adjacent to the Mexico–United States border. With a 2020 population of 1,386,932, it is the eighth most populous city in the United States ...

.Company Overview of Halozyme Therapeutics, Inc. Bloomberg.com. https://www.bloomberg.com/research/stocks/private/snapshot.asp?privcapId=7931206. Accessed October 20, 2016.

Company history

Halozyme's business is primarily focused on its proprietary and patented recombinant human hyaluronidase enzyme, rHuPH20. The company's development pipeline is concentrated in clinical stage and pre-clinical stage oncology products, including its proprietary investigational drug, PEGPH20, a pegylated version of rHuPH20, which targets hyaluronan (HA) high

tumors A neoplasm () is a type of abnormal and excessive growth of tissue. The process that occurs to form or produce a neoplasm is called neoplasia. The growth of a neoplasm is uncoordinated with that of the normal surrounding tissue, and persists ...

. The company is in various phases of

clinical trials Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietar ...

with PEGPH20 across multiple solid tumor types, including

pancreatic cancer Pancreatic cancer arises when cell (biology), cells in the pancreas, a glandular organ behind the stomach, begin to multiply out of control and form a Neoplasm, mass. These cancerous cells have the malignant, ability to invade other parts of t ...

, non-small cell lung cancer (NSCLC), and

gastric cancer Stomach cancer, also known as gastric cancer, is a cancer that develops from the lining of the stomach. Most cases of stomach cancers are gastric carcinomas, which can be divided into a number of subtypes, including gastric adenocarcinomas. Lymph ...

, to test the drug's safety and efficacy. Halozyme has one

FDA The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food s ...

approved product (Hylenex recombinant, hyaluronidase human injection). The company also licenses its drug delivery technology Enhanze to other biopharmaceutical companies, including

Roche F. Hoffmann-La Roche AG, commonly known as Roche, is a Swiss multinational healthcare company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. Its holding company, Roche Holding AG, has shares listed on the SIX S ...

Baxalta Baxalta (''Bax'' from the name of its former parent company; ''alta'' a Latin adjective meaning 'high' or 'profound') is a biopharmaceutical company founded on 1 July 2015 after its parent company, Baxter International, spun off biopharmaceutica ...

Pfizer Pfizer Inc. ( ) is an American multinational pharmaceutical and biotechnology corporation headquartered on 42nd Street in Manhattan, New York City. The company was established in 1849 in New York by two German entrepreneurs, Charles Pfizer ...

, Janssen, AbbVie, and Lilly.

Company leadership

Since January 2014, Helen Torley has been Chief Executive Officer and President of Halozyme.

Approved products

Hylenex: Approved by the U.S. Food and Drug Administration (FDA) on 12/02/2005. Hylenex is a hyaluronidase (human recombinant) injection indicated for use in subcutaneous fluid administration, dispersion and absorption of injected drugs, and subcutaneous urography.Full Prescribing Information. Hylenex.com. http://hylenex.com/downloads/approved-uspi-lbl301feb2016.pdf. Updated February 2016. Accessed January 27, 2017.

Technology

Enhanze: Uses recombinant human hyaluronidase to degrade HA and aids in the absorption and dispersion of co-administered injected drugs. Halozyme licenses its Enhanze drug delivery platform technology to other biopharmaceutical companies to enable intravenous to subcutaneous administration conversion and dose optimization.

Product candidates

PEGPH20: A

PEGylated PEGylation (or pegylation) is the process of both covalent and non-covalent attachment or amalgamation of polyethylene glycol (PEG, in pharmacy called macrogol) polymer chains to molecules and macrostructures, such as a drug, therapeutic protein ...

drug candidate based on Halozyme's proprietary rHuPH20 enzyme (a recombinant human hyaluronidase enzyme). It breaks down or depletes hyaluronan (HA), which can build up in certain tumors. The goal of PEGPH20 is to break down HA so that some anti-cancer therapies and activated immune cells can better reach the cancer cells of HA-high tumors. On November 4, 2019, Halozyme announced it has halted development of PEGPH20.

Pipeline candidates

PEG-ADA2: An engineered human recombinant enzyme, adenosine deaminase 2, for decreasing the concentration of immune-suppressive adenosine in the tumor microenvironment, and PEGylated to prolong its circulation in the body. It has been tested in colon, lung, and pancreatic cancer models in preclinical studies.Halozyme Expands Oncology Pipeline With Two Compounds Designed For Activity In The Tumor Microenvironment (Press release). http://finance.yahoo.com/news/halozyme-expands-oncology-pipeline-two-200100050.html. Published April 18, 2016. Accessed October 19, 2016. HTI-1511 Anti-EGFR ADC: An antibody-drug conjugate (ADC) with a strong cytotoxin, monomethyl auristatin E, designed to treat EGFR-positive tumors, including those with

KRAS ''KRAS'' (Kirsten rat sarcoma virus) is a gene that provides instructions for making a protein called K-Ras, a part of the RAS/MAPK pathway. The protein relays signals from outside the cell to the cell's nucleus. These signals instruct the cell ...

and BRAF mutations. It has been tested in colon, lung, and

cholangiocarcinoma Cholangiocarcinoma, also known as bile duct cancer, is a type of cancer that forms in the bile ducts. Symptoms of cholangiocarcinoma may include abdominal pain, yellowish skin, weight loss, generalized itching, and fever. Light colored stool ...

models in preclinical studies.

Clinical trial pipeline

Halozyme has many ongoing and completed clinical trials testing the safety and efficacy of its primary investigational drug, PEGPH20, in combination with other therapies, with the goal of finding new treatments for pancreatic cancer, NSCLC, gastric cancer,

breast cancer Breast cancer is cancer that develops from breast tissue. Signs of breast cancer may include a lump in the breast, a change in breast shape, dimpling of the skin, milk rejection, fluid coming from the nipple, a newly inverted nipple, or a re ...

, and others. As of October 2016, the company was sponsoring or collaborating on several clinical trials that were recruiting patients, including: * HALO Pancreatic 301 – A Phase 3 study to test the efficacy and safety of a combination of PEGPH20 with Abraxane (nab-paclitaxel) and gemcitabine in participants with previously untreated HA-high stage IV pancreatic cancer. On November 4, 2019, Halozyme announced it has halted development of PEGPH20. * HALO Lung / Gastric 101 – A Phase 1b study to test the efficacy and safety of a combination of PEGPH20 and Keytruda (pembrolizumab) in participants with relapsed/refractory advanced or metastatic NSCLC and relapsed/refractory locally advanced or metastatic gastric adenocarcinoma. * A Phase 1b study to test the efficacy and safety of a combination of PEGPH20 with Halaven (eribulin) in participants with human epidermal growth factor receptor 2 (HER2)-negative, HA-high metastatic breast cancer (MBC).

References

External links

* {{Authority control Biotechnology companies of the United States Companies based in San Diego Pharmaceutical companies established in 1998 2004 initial public offerings Companies listed on the Nasdaq