hENT1 antibody to be used in diagnostic test to identify cancer patients who may most significantly benefit from Clavis Pharma's novel cancer drugs
Oslo, Norway, 30 April 2010
Clavis Pharma ASA (OSE: CLAVIS), the Norwegian cancer drug development company, is pleased to announce that it has entered into a licence agreement with Ventana Medical Systems, Inc. ("Ventana") providing Ventana with exclusive access to Clavis Pharma's monoclonal antibody targeting human nucleoside transporter 1 (hENT1) and to the hybridoma cell line that produces the antibody. The hENT1 antibody will be used in the development of a companion diagnostic for Clavis Pharma's drug candidate CP-4126, which is in Phase II clinical trials for the treatment of pancreatic cancer. The antibody has excellent specificity for hENT1 and has , to date, been used successfully in Clavis Pharma's clinical programme with CP-4126.
Today's agreement reinforces the collaboration agreement announced on April 22, 2010 between Ventana, one of the world's leading developers and manufacturers of medical diagnostics, and Clovis Oncology, Clavis Pharma's partner for CP-4126, for the development of a companion diagnostic to CP-4126 (also known as CO-101) for clinical and commercial use.
Under the terms of today's agreement, Ventana gains exclusive access from Clavis Pharma to the hENT1 antibody and hybridoma line around which Ventana will seek to develop an immuno-histochemistry (IHC) assay for use in Clovis Oncology's clinical trials to identify patients with low level of hENT1 expression in the tumor. All costs under this agreement will be borne by Clovis Oncology.
Clavis Pharma also retains the rights to use the hENT1 antibody to develop companion diagnostics on other assay platforms for the evaluation of hENT1 status in regard to clinical and commercial use with its other product candidates, such as elacytarabine and CP-4200.
Olav Hellebø, Clavis CEO, commented: "We are pleased to be able to contribute in such a significant way to the collaboration between our partner Clovis Oncology and Ventana Medical Systems to develop a companion diagnostic for CP-4126. Our hENT1 antibody has already demonstrated its potential to successfully identify patients with low hENT1 tumour expression and we believe it provides Ventana with an excellent starting pointing to rapidly develop a diagnostic product. We also look forward to continuing our collaboration with the University of Alberta researchers regarding the further development of companion diagnostics for elacytarabine and CP-4200."
"As the exclusive technology transfer agent for the University of Alberta, and in partnership with Alberta Health Services, TEC Edmonton is pleased that Dr. Cass's discovery which has been licensed to Clavis will be used and commercialized by Ventana ," said Chris Lumb, CEO of TEC Edmonton. "It is through relationships like this that technology developed on campus moves forward, and in this case, towards a diagnostic to improve treatment outcomes for cancer patients."
Background on the hENT1 antibody
The hENT1 monoclonal antibody to human equilibrative nucleoside transporter 1 ("hENT1 Antibody") was first developed at the University of Alberta. Dr. Carol Cass and her colleagues Drs. James Young and Steven Baldwin, were among the first to describe and characterize the nucleoside transporter protein, (hENT1). hENT1 is one member of a large family of cellular proteins through which drugs called nucleoside analogues enter cancer cells. A hybridoma cell line later developed by Cass and her colleagues produces an antibody that is able to identify and react with the hENT1 protein. Dr. John Mackey used the hENT1 antibody to demonstrate a direct correlation between the lack of hENT1 on a pancreatic cancer patient's tumour cells and their poor response to gemcitabine therapy.
For further information contact:
Olav Hellebø
Chief Executive Officer
+47 24 11 09 50
+44 7833904901 (UK mob)
olav.hellebo@clavispharma.com
Gunnar Manum
Chief Financial Officer
+47 24 11 09 71
+47 95 17 91 90 (mob)
gunnar.manum@clavispharma.com
Mark Swallow / Nina Enegren / David Dible
Citigate Dewe Rogerson
+44 207 282 2948
clavispharma@citigatedr.co.uk
About CP-4126
CP-4126 is a novel, patented, lipid-conjugated form of the well-established cancer drug gemcitabine (Gemzar®) that has the
potential to improve treatment outcomes in patients with pancreatic cancer as other solid tumours who have low levels of hENT1.
CP-4126 will shortly be directly compared to gemcitabine in an international, randomised, controlled trial in patients newly diagnosed with metastatic pancreatic cancer. The study will enroll approximately 250 patients, randomized between gemcitabine and CP-4126, and measures overall survival (OS) in prospectively-defined hENT1-low patients as the primary endpoint. Expression of hENT1 in tumour tissue will be measured during the trial and patients categorized into hENT1-high or hENT1-low groups prior to final analysis. This study is a prospective test of two hypotheses: (1) that low pancreatic tumour hENT1 expression is associated with poor outcome after gemcitabine therapy, and (2) that CP-4126 has superior efficacy (measured by OS) in hENT1-low patients compared with gemcitabine. This trial will commence enrollment in the second quarter of 2010, and data from this trial are expected in the first half of 2012.
CP-4126 has been granted orphan drug status for the treatment of pancreatic cancer in both the U.S. and the European.
About Pancreatic Cancer
Pancreatic cancer presents a major unmet medical need due to the poor survival outcomes and limited number of therapeutic
options available to patients. Approximately 37,000 new cases of pancreatic cancer were recorded in the US in 2007. The
1-year and 5-year overall survival rates are estimated at 23% and 4%, respectively. The majority of pancreatic cancer patients
are diagnosed with locally advanced (unresectable) or metastatic disease. Median overall survival in these advanced patients
is 4-10 months.
About Clavis Pharma
Clavis Pharma ASA is a clinical stage oncology drug development company based in Oslo, Norway with a portfolio of novel anti-cancer
drugs in development. These patented New Chemical Entities (NCEs) are novel, improved versions of commercially successful
drugs, made using Clavis Pharma's Lipid Vector Technology (LVT) chemistry. Data generated suggests these potential breakthrough
products may offer improved efficacy and reduced side effects through enhanced pharmacokinetic properties, greater tissue
penetration, altered metabolism and, in certain cases, additional modes of action.
Clavis Pharma's has several drug candidates in formal development studies:
- Elacytarabine, an improved form of Ara-C, a leukaemia drug - about to commence a Phase III randomized, controlled registration study in late-stage acute myeloid leukaemia;
- Intravenous CP-4126, an improved version of gemcitabine - currently in a Phase II comparative study with gemcitabine for the treatment of pancreatic cancer;
- CP-4200, an azacitidine derivative - in preclinical development for myelodysplastic syndrome (MDS), often a precursor to myeloma or leukaemia.
Clavis Pharma intends to commercialise its products through strategic alliances and partnerships with experienced oncology businesses and, where and when commercially appropriate, by establishing its own sales and marketing capabilities. CP-4126 is licensed to Clovis Oncology in the Americas and Europe. Clavis Pharma has retained rights in other territories and an option to co-promote CP-4126 in Europe.
The shares of Clavis Pharma ASA are listed on the Oslo Stock Exchange (ticker: CLAVIS).
About Ventana Medical Systems, Inc.
Ventana develops, manufactures, and markets instrument/reagent systems that automate tissue preparation and slide staining in clinical histology and drug discovery laboratories worldwide. The Company's clinical systems are important tools used in the diagnosis and treatment of cancer and infectious diseases. Ventana's drug discovery systems are used to accelerate the discovery of new drug targets and evaluate the safety of new drug compounds. In addition, the Company offers premier workflow solutions designed to improve laboratory efficiency, providing safeguards to enhance the quality of healthcare. Ventana is a wholly owned member of the Roche Group. For more information on Ventana Medical Systems, Inc. visit www.ventanamed.com.
Disclaimer
This news release contains forward-looking statements and forecasts based on uncertainty, since they relate to events and depend on circumstances that will occur in the future and which, by their nature, will have an impact on results of operations and the financial condition of Clavis Pharma. There are a number of factors that could cause actual results and developments to differ materially from those expressed or implied by these forward-looking statements. Theses factors include, among other things, risks associated with technological development, the risk that research & development will not yield new products that achieve commercial success, the impact of competition, the ability to close viable and profitable business deals, the risk of non-approval of patents not yet granted and difficulties of obtaining relevant governmental approvals for new products.
No expressed or implied representations or warranties are given concerning Clavis Pharma or the accuracy or completeness of the information provided herein, and no claims shall be made by the recipient hereof by virtue of this News Announcement or the information contained herein.
Clavis Pharma(TM) is a registered trademark of Clavis Pharma ASA.
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References:
1. Jennings, L. L., Hao, C., Cabrita, M. A., Vickers, M. F., Baldwin, S. A., Young, J. D., and Cass, C. E. (2001) Distinct regional distribution of human equilibrative nucleoside transporter proteins 1 and 2 (hENT1 and hENT2) in the central nervous system, Neuropharmacology 40, 722-731.
2. Spratlin, J., Sangha, R., Glubrecht, D., Dabbagh, L., Young, J. D., Dumontet, C., Cass, C., Lai, R., and Mackey, J. R. (2004) The absence of human equilibrative nucleoside transporter 1 is associated with reduced survival in patients with gemcitabine-treated pancreas adenocarcinoma, Clin Cancer Res 10, 6956-6961.
3. Farrell, J. J., Elsaleh, H., Garcia, M., Lai, R., Ammar, A., Regine, W. F., Abrams, R., Benson, A. B., Macdonald, J., Cass, C. E., Dicker, A. F., and Mackey, J. R. (2009) Human Equilibrative Nucleoside Transporter 1 Levels Predict Response to Gemcitabine in Patients With Pancreatic Cancer, Gastroenterology 136, 187-195.
4. Marechal, R., Mackey, J. R., Lai, R., Demetter, P., Peeters, M., Polus, M., Cass, C. E., Young, J., Salmon, I., Deviere, J., and Van Laethem, J. L. (2009) Human Equilibrative Nucleoside Transporter 1 and Human Concentrative Nucleoside Transporter 3 Predict Survival after Adjuvant Gemcitabine Therapy in Resected Pancreatic Adenocarcinoma, Clin Cancer Res 15, 2913-2919.