Eisai and Halozyme Sign Collaboration Agreement to Investigate Halaven® (Eribulin) and PEGPH20 in Metastatic Breast Cancer

News provided by

Eisai

31 Jul, 2015, 04:31 BST

HATFIELD, England and SAN DIEGO, July 31, 2015 /PRNewswire/ --

Clinical trial will explore whether eribulin in combination with PEGPH20 can improve overall response rate in women with advanced breast cancer

Eisai Co., Ltd. and Halozyme Therapeutics, Inc. (NASDAQ: HALO) today sign a clinical collaboration agreement that will evaluate Halaven® (eribulin) in combination with Halozyme's investigational PEGPH20 (PEGylated recombinant human hyaluronidase) in first line HER2-negative metastatic breast cancer. Under the agreement, the companies will jointly conduct and share the costs of a Phase 1b/II clinical study seeking to determine whether the combination therapy of eribulin and PEGPH20 can improve overall response rate (the proportion of women that have a predefined reduction in tumour burden), in advanced breast cancer patients with high levels of hyaluronan.

PEGPH20 is an investigational drug administered intravenously that targets the degradation of hyaluronan, a glycosaminoglycan - or chain of natural sugars throughout the body - that can accumulate around cancer cells to inhibit other therapies. By degrading hyaluronan, PEGPH20 increases blood flow to the tumour which may allow cancer therapies to be more efficiently delivered to their target. The collaborative study will seek to determine whether the combination therapy of eribulin and PEGPH20 can improve overall response rate in patients with high levels of hyaluronan. In hyaluronan-rich triple-negative breast preclinical animal models, the addition of PEGPH20 to eribulin significantly increased tumour growth inhibition and overall tumour regressions, when compared to eribulin alone[1].

Eribulin is the first in the halichondrin class of microtubule dynamics inhibitors with a novel mechanism of action. Structurally eribulin is a modified and synthetically produced analog of halichondrin B, a natural product isolated from the marine sponge Halichondria okadai. Eribulin is believed to work by inhibition of the growth phase of microtubule dynamics which prevents cell division. Eribulin is currently approved in more than 60 countries around the world, which include all of the European Union, Canada, United States, Russia, Switzerland, South Korea, Japan and Singapore.

"This is a very important collaboration in our continual drive to beat advanced breast cancer and further confirms the distinct mode of action of eribulin. We look forward to enrolling patients in the clinical trial and obtaining the results," comments Gary Hendler, President and CEO Eisai EMEA and President, Eisai Oncology Global Business Unit.

"This agreement marks the first clinical collaboration agreement for Halozyme and extends the study of PEGPH20 to a substantially wider population of patients with a partner that is a clear leader in the treatment of metastatic breast cancer," said Dr. Helen Torley, President and CEO, Halozyme Therapeutics.

Eribulin remains the only single agent chemotherapy to significantly improve overall survival in women with advanced breast cancer after anthracycline and taxane treatment. Advanced or metastatic breast cancer is a very difficult condition to treat and only 25.9% of women will survive beyond five years[2].

Eribulin is indicated in the European Union for the treatment of women with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimen for advanced disease[3]. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting, unless patients were not suitable for these treatments.

Eisai is dedicated to the discovery, development and production of innovative oncology therapies that can make a difference and impact the lives of patients and their families. This passion for people is part of Eisai's human health care (hhc) mission, which strives to better understand the needs of patients and their families to increase the benefits health care provides.

Notes to Editors  

PEGPH20 

PEGPH20 (PEGylated recombinant human hyaluronidase) is an investigational drug administered intravenously that targets the degradation of hyaluronan (HA), a major component of the extracellular matrix. By disrupting HA, PEGPH20 may inhibit tumour growth and promote the dispersion of chemotherapeutic agents.

PEGPH20 is currently under development in combination with chemotherapies for the treatment of metastatic pancreatic cancer and non-small cell lung cancer[4],[5] with plans later for it to be studied in combination with an immunotherapy agent later this year.

Halaven® (eribulin)  

Eribulin is indicated for the treatment of women with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimen for advanced disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting, unless patients were not suitable for these treatments[3].

Metastatic Breast Cancer and the HER2 Protein 

Over 300,000 women are diagnosed with breast cancer in Europe every year, of whom about one third subsequently develop metastatic disease[6],[7]. Metastatic disease is an advanced stage of the disease that occurs when cancer spreads beyond the breast to other parts of the body.

HER2 is a protein that is found on the surface of cells. In HER2-positive breast cancer there is more (over expression) of this protein found on the surface of tumour cells compared with normal breast cells. This protein can be targeted with HER2 targeted therapies such as Herceptin, in people who overexpress HER2, but not in people with normal levels of HER2 protein (HER2-negative) breast cancer. Breast cancers are routinely tested for the presence of HER2 to decide the most appropriate treatment. Triple-negative breast cancer (TNBC) refers to any breast cancer that does not express the genes for oestrogen receptor, progesterone receptor (<1%) and HER2 (<30%).

Eisai in Oncology  

Our commitment to meaningful progress in oncology research, built on scientific expertise, is supported by a global capability to conduct discovery and preclinical research, and develop small molecules, therapeutic vaccines, and biologic and supportive care agents for cancer across multiple indications.

About Eisai Co., Ltd. 

Eisai Co., Ltd. is a leading global research and development-based pharmaceutical company headquartered in Japan. We define our corporate mission as "giving first thought to patients and their families and to increasing the benefits health care provides," which we call our human health care (hhc) philosophy. With over 10,000 employees working across our global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realise our hhc philosophy by delivering innovative products in multiple therapeutic areas with high unmet medical needs, including Oncology and Neurology. 

As a global pharmaceutical company, our mission extends to patients around the world through our investment and participation in partnership-based initiatives to improve access to medicines in developing and emerging countries.

For more information about Eisai Co., Ltd., please visit http://www.eisai.com.  

About Halozyme 

Halozyme Therapeutics is a biotechnology company focused on developing and commercialising novel oncology therapies that target the tumour microenvironment. Halozyme's lead proprietary program, an investigational drug PEGPH20, applies a unique approach to targeting solid tumours, allowing increased access of co-administered cancer drug therapies to the tumour.  PEGPH20 is currently in development for metastatic pancreatic cancer and non-small cell lung cancer and has potential across additional cancers in combination with different types of therapies. In addition to its proprietary product portfolio, Halozyme has established value-driving partnerships with leading pharmaceutical companies including Roche, Pfizer, Janssen, Baxalta and AbbVie for its drug delivery platform, ENHANZE™, which enables biologics and small molecule compounds that are currently administered intravenously to be delivered subcutaneously. Halozyme is headquartered in San Diego. For more information, visit http://www.halozyme.com.

References 

  1. Zhao, C. et al. Hyaluronan-dependent Growth of Human Triple Negative Breast Cancer MDA-MB-468 in Mouse Xenograft Models. Abstract only #2392. Presented at American Association for Cancer Research (AACR) Annual Meeting 2015. Available at: http://www.halozyme.com/files/doc_downloads/Abstracts%20and%20Posters/AACR-2015-ABSTRACT-2392-FINAL-POSTER_v001_q3llpa.pdf Accessed: July 2015
  2. http://seer.cancer.gov/statfacts/html/breast.html Accessed: July 2015
  3. SPC Halaven (updated June 2014). Available at http://www.medicines.org.uk/emc/medicine/24382/SPC/Halaven+0.44+mg+ml+solution+for+injection/ Accessed: July 2015.
  4. Halozyme Therapeutics; PEGPH20 Plus Nab-Paclitaxel Plus Gemcitabine Compared With Nab-Paclitaxel Plus Gemcitabine in Subjects With Stage IV Untreated Pancreatic Cancer (HALO-109-202). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2015 July 21]. Available from: https://clinicaltrials.gov/ct2/show/NCT01839487?term=pegph20&rank=1 NLM Identifier: NCT01839487
  5. Halozyme Therapeutics; A Phase 1b/2, Study of Pegylated Recombinant Human Hyaluronidase Combined With Docetaxel Versus Docetaxel Alone in Subjects With Recurrent Previously Treated Locally Advanced or Metastatic NSCLC. (PRIMAL). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2015 July 21]. Available from: https://clinicaltrials.gov/ct2/show/NCT02346370?term=pegph20&rank=7 NLM Identifier: NCT02346370
  6. World Health Organisation. Atlas of Health in Europe. 2003. World Health Organization, Regional Office of Europe, Copenhagen, Denmark.
  7. Cancer Research UK. Breast cancer incidence statistics. Available at: http://www.cancerresearchuk.org/cancer-info/cancerstats/types/breast/incidence/#world. Accessed: July 2015

Job code: Corporate-UK2032
Date of preparation: July 2015

SOURCE Eisai