Biotech Synergy verwerft fase 2 activa voor NSCLC kankervaccin
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heeft de overdracht afgerond van de activa voor een multi-epitoop kankervaccinproduct, voorheen bekend als EP-2101. Volgens dr. Emile Loria, managing director bij Biotech Synergy en voormalig president en CEO van Epimmune, is het gelukt de kerncompetenties voor het bij Epimmune ontwikkelde potentiele kankervaccin snel te reactiveren.
Biotech Synergy is nu klaar om de mogelijkheden te bespreken met verschillende potentiele partners in Europa en de Verenigde Staten. Doel is het op de markt brengen van een gebruiksklaar vaccin voor de behandeling van longkanker.
Engelstalig bericht:
Objective is to bring to commercialization an “off the shelf†ready to use therapeutic vaccine for lung cancer patients
SAN DIEGO–(BUSINESS WIRE)– 20110418 —
BiotechSynergy has concluded the asset transfer of multi-epitope cancer vaccine product formerly known as EP-2101 and cancer epitopes related portfolio. Emile Loria, M.D., former President and Chief Business Officer of IDM and former President & CEO of Epimmune, is the founder of Biotech Synergy.
“We have been able to reactivate very quickly the core competences needed to bring this cancer vaccine opportunity developed while at Epimmune. We are now ready to discuss this opportunity with various potential partners in Europe and U.S.,†said Dr. Emile Loria, Managing Director for Biotech Synergy.
“Immunotherapy is making some inroads in the treatment scheme of cancer with recent successes from Dendreon and BMS. EP-2101 is made of 10 peptides and will be a readily available, off the shelf therapeutic vaccine for the HLA-A2 population, which represents 45% of the global NSCLC patients (100,000 patients in the U.S.),†added Mike Nicolaou, who was instrumental in establishing the 10-peptide vaccine formulation.
About EP-2101
The EP-2101 cancer vaccine candidate used in the phase 2 trial includes nine CTL epitopes from four tumor associated antigens (TAA). Two are proprietary native epitopes and seven are modified, or analog, epitopes. Tolerance to TAA, which is a failure of the immune system to recognize the cancer as diseased tissue, is broken by using these analog epitopes, which enhance the potency of the T cell response. The open label, non-randomized phase 2 was designed to assess overall survival at one year and vaccine safety, with vaccine immunogenicity as a secondary endpoint, in HLA-A2 positive patients with stage IIIb, IV or recurrent non-small cell lung cancer (NSCLC). Sixty-eight patients were enrolled in the trial (sixty-three treated). Patients were also required to have tumor volume less than 125 cm2 with no limits on prior chemotherapy.
One-year survival in patients treated with EP-2101 was 60%, compared to 49% in a group of patients who were HLA-A2 negative but otherwise comparable (concurrent controls). Median survival for patients treated with EP-2101 was 583 days compared to 361 days for patients in the control group. Ninety-one percent of patients treated with EP-2101, who were tested for immune response, had a measurable response to at least one of the epitopes included in the vaccine with 64% responding to at least three of the epitopes. (Journal of Clinical Oncology, Vol. 26, Number 27, Sept 20, 2008, Dr. John Nemunaitis and all).
About Lung Cancer
Lung cancer continues to be a major health problem with a very high mortality rate and represents the leading cause of cancer death in the United States. According to the American Cancer Society, approximately 222,580 new lung cancer cases will be diagnosed in the United States in 2010, and an estimated 157,000 patients will die from lung cancer.
About Biotech Synergy
Biotech Synergy has secured in San Diego the necessary competences to bring this promising multi epitope cancer vaccine to latest stage development. Contrary to Dendreon individualized vaccine, EP-2101 is made of 10 peptides and is an off the shelf readily available vaccine for the HLA-A2 population, which represents 45% of the global NSCLC patients (100,000 patients in USA and 100,000 patients in Europe).
