OSE Pharma SA Release: Presentation Of Tedopi's Clinical Trial Data For Patients With Brain Metastasis Treated Due To Lung Cancer At The 16th World Conference On Lung Cancer
Paris, July 23rd, 2015 - 6:00 pm - OSE Pharma SA (ISIN: FR0012127173; Mnémo: OSE), a biotechnology company based in France, developing T specific immunotherapy treatments against invasive and metastatic cancers, is pleased to announce that clinical trial results on Non Small Cell Lung Cancer patients with Brain metastases treated with Tedopi will be presented at the World Conference on Lung Cancer (WCLC) in Denver, Colorado, taking place from September 6th to 9th 2015.
John Nemunaitis (Executive Medical Director Mary Crowley Cancer Research Center, Dallas, TX) and main investigator of the OSE-2101 (Tedopi) Phase 2 trial will present at the World Conference on Lung Cancer an abstract entitled « T-Cytotoxic Specific Immunotherapy in Non Small Cell Lung Cancer with Brain Metastases » on September 8th in Denver, Colorado.
« Being selected to present in such a prestigious lung cancer congress highlights the potential of our product and reiterates our belief in Tedopi as a potential treatment for patients with Non Small Cell Lung Cancer at advanced stage» says Alain Chatelin, Chief Medical Officer.
The 16th World Conference on Lung Cancer, September 6 - 9 2015 is organized by the International Association for the Study of Lung Cancer (IASLC) in Denver, Colorado, USA. This is the world's largest meeting dedicated to lung cancer and other thoracic malignancies.
About OSE Pharma OSE Pharma is a European cancer immunotherapy company with a multi-epitope technology named Memopi® that directs the body's immune system to generate a specific cytotoxic T response to prevent cancer cell growth.
OSE Pharma's lead product, Tedopi®, combines 10 "neo-epitopes" directed against five tumour associated antigens. In its most advanced application, it is about to enter a pivotal Phase III study in patients with advanced non-small cell lung cancer (NSCLC) who express HLA-A2 and failed first line therapy. Tedopi® has orphan drug status in the USA and is considered as personalized medicine in Europe in HLA-A2 positive patients.
OSE Pharma is also planning a new Phase II clinical trial in combination with another immunotherapy treatment in NSCLC.
Tedopi® targets five tumour associated antigens (TAA), selected because their presence is linked to a poor prognosis and the severity of various cancers. Tedopi® contains ten optimized epitopes, or "neo- epitopes", designed on the binding of HLA-A2 and TCR. These neo-epitopes generate strong specific T cytotoxic responses that fight cancer and prevent tumour escape.
OSE PHARMA: a new T specific immunotherapy weapon against advanced cancers
• Immunotherapy in oncology is becoming a clinical reality and raises hope for patients by mobilizing their own immune defence to fight against cancer.
• For OSE Pharma's lead product Tedopi®: the Phase 3 clinical programme is scheduled in 2015 and will be active in Europe and in the USA, in order to obtain registration in non-small cell lung cancer. The study will recruit patients with invasive/metastatic non-small cell lung cancer (NSCLC), expressing the HLA-A2 receptor (45% of the NSCLC population).
• Tedopi® is a patented combination of 10 epitopes. The epitopes (small peptides triggering immune response) are optimized. They have been selected and modified for a stronger binding with immune response receptors (HLA-A2 and TCR). These neo-epitopes trigger a stronger immune response and target 5 tumor associated antigens expressed in several cancers.
• Tedopi® will enter in new therapeutic combinations in Phase 2 studies with industrial partnerships (other immunotherapy treatments or targeted therapies) to increase clinical efficacy while maintaining high quality of life with late-stage patients. • Tedopi® has been granted "orphan drug" status in the USA and is considered a personalised medicine in Europe, enabling accelerated clinical development.
PIVOTAL PHASE 3 STUDY IN LUNG CANCER LAUNCHED IN 2015 IN EUROPE AND IN THE USA Tedopi® has been tested in a phase 2 study in patients with non-small cell lung cancer[1] (NSCLC- the most common form of lung cancer). These patients were HLA-A2 positive, had an invasive or metastatic disease and had received at least one previous line of treatment. The results of this phase 2 trial showed that Tedopi® generated a significant increase in the survival times of patients with NSCLC, which correlates with immune response.
This study showed a one year survival rate of 59% for the group treated with Tedopi®. This compares favourably with the 33% one year survival rate in patients treated with currently approved second line treatments[2]. The median survival in the group treated was 17 months, compared with 12 months in the group of patients who did not receive the treatment. In addition, 25% of patients treated were still alive after 4 years, with a good quality of life, which is important for patients suffering from principally metastatic tumours[3].
OSE Pharma is currently preparing to start a phase 3 study of Tedopi®. The trial protocol is common to Europe and to the USA. The launch of the Phase 3 study of Tedopi® is planned for the second half of 2015.
It will look to enrol 500 patients with invasive/metastatic non-small cell lung cancer (NSCLC), expressing the HLA-A2 receptor. Tedopi® will be used as a second line treatment for patients for whom first line treatments (such as chemotherapy) have not been able to control their disease. Preparatory works and manufacturing of the clinical supplies have started. An agreement has been signed in January 2015 with Orion-Symbec, CRO based in Great-Britain for this international Phase 3 study.
ADVANCED LUNG CANCER: A STRONG MEDICAL NEED
Lung cancer is the deadliest cancer in the world. In 2012, there were 1.58 million new diagnosed lung cancer cases and 1.39 million deaths from this disease globally4. Despite the different treatments available today (surgery, radiotherapy, chemotherapy, targeted therapy), the relative survival rates of these patients at metastatic stage remains very low3.
Given the large incidence of NSCLC, OSE Pharma estimates that the potential global sales at peak for Tedopi® for this single indication could be about €2 billion[4].
Press Contacts
OSE Pharma sa
Dominique Costantini, CEO
dominique.costantini@osepharma.com
Mob +33 6 13 20 77 49
Alexis Peyroles, CFO
Alexis.peyroles@osepharma.com
Mob : +33 6 11 51 19 77
Citigate Dewe Rogerson
Laurence Bault / Lucie Larguier
+33 1 53 32 84 78
laurence.bault@citigate.fr
Alize RP
Florence Portejoie
+33 1 44 54 36 64 - + 33 6 47 38 90 04
fportejoie@alizerp.com
Help employers find you! Check out all the jobs and post your resume.
John Nemunaitis (Executive Medical Director Mary Crowley Cancer Research Center, Dallas, TX) and main investigator of the OSE-2101 (Tedopi) Phase 2 trial will present at the World Conference on Lung Cancer an abstract entitled « T-Cytotoxic Specific Immunotherapy in Non Small Cell Lung Cancer with Brain Metastases » on September 8th in Denver, Colorado.
« Being selected to present in such a prestigious lung cancer congress highlights the potential of our product and reiterates our belief in Tedopi as a potential treatment for patients with Non Small Cell Lung Cancer at advanced stage» says Alain Chatelin, Chief Medical Officer.
The 16th World Conference on Lung Cancer, September 6 - 9 2015 is organized by the International Association for the Study of Lung Cancer (IASLC) in Denver, Colorado, USA. This is the world's largest meeting dedicated to lung cancer and other thoracic malignancies.
About OSE Pharma OSE Pharma is a European cancer immunotherapy company with a multi-epitope technology named Memopi® that directs the body's immune system to generate a specific cytotoxic T response to prevent cancer cell growth.
OSE Pharma's lead product, Tedopi®, combines 10 "neo-epitopes" directed against five tumour associated antigens. In its most advanced application, it is about to enter a pivotal Phase III study in patients with advanced non-small cell lung cancer (NSCLC) who express HLA-A2 and failed first line therapy. Tedopi® has orphan drug status in the USA and is considered as personalized medicine in Europe in HLA-A2 positive patients.
OSE Pharma is also planning a new Phase II clinical trial in combination with another immunotherapy treatment in NSCLC.
Tedopi® targets five tumour associated antigens (TAA), selected because their presence is linked to a poor prognosis and the severity of various cancers. Tedopi® contains ten optimized epitopes, or "neo- epitopes", designed on the binding of HLA-A2 and TCR. These neo-epitopes generate strong specific T cytotoxic responses that fight cancer and prevent tumour escape.
OSE PHARMA: a new T specific immunotherapy weapon against advanced cancers
• Immunotherapy in oncology is becoming a clinical reality and raises hope for patients by mobilizing their own immune defence to fight against cancer.
• For OSE Pharma's lead product Tedopi®: the Phase 3 clinical programme is scheduled in 2015 and will be active in Europe and in the USA, in order to obtain registration in non-small cell lung cancer. The study will recruit patients with invasive/metastatic non-small cell lung cancer (NSCLC), expressing the HLA-A2 receptor (45% of the NSCLC population).
• Tedopi® is a patented combination of 10 epitopes. The epitopes (small peptides triggering immune response) are optimized. They have been selected and modified for a stronger binding with immune response receptors (HLA-A2 and TCR). These neo-epitopes trigger a stronger immune response and target 5 tumor associated antigens expressed in several cancers.
• Tedopi® will enter in new therapeutic combinations in Phase 2 studies with industrial partnerships (other immunotherapy treatments or targeted therapies) to increase clinical efficacy while maintaining high quality of life with late-stage patients. • Tedopi® has been granted "orphan drug" status in the USA and is considered a personalised medicine in Europe, enabling accelerated clinical development.
PIVOTAL PHASE 3 STUDY IN LUNG CANCER LAUNCHED IN 2015 IN EUROPE AND IN THE USA Tedopi® has been tested in a phase 2 study in patients with non-small cell lung cancer[1] (NSCLC- the most common form of lung cancer). These patients were HLA-A2 positive, had an invasive or metastatic disease and had received at least one previous line of treatment. The results of this phase 2 trial showed that Tedopi® generated a significant increase in the survival times of patients with NSCLC, which correlates with immune response.
This study showed a one year survival rate of 59% for the group treated with Tedopi®. This compares favourably with the 33% one year survival rate in patients treated with currently approved second line treatments[2]. The median survival in the group treated was 17 months, compared with 12 months in the group of patients who did not receive the treatment. In addition, 25% of patients treated were still alive after 4 years, with a good quality of life, which is important for patients suffering from principally metastatic tumours[3].
OSE Pharma is currently preparing to start a phase 3 study of Tedopi®. The trial protocol is common to Europe and to the USA. The launch of the Phase 3 study of Tedopi® is planned for the second half of 2015.
It will look to enrol 500 patients with invasive/metastatic non-small cell lung cancer (NSCLC), expressing the HLA-A2 receptor. Tedopi® will be used as a second line treatment for patients for whom first line treatments (such as chemotherapy) have not been able to control their disease. Preparatory works and manufacturing of the clinical supplies have started. An agreement has been signed in January 2015 with Orion-Symbec, CRO based in Great-Britain for this international Phase 3 study.
ADVANCED LUNG CANCER: A STRONG MEDICAL NEED
Lung cancer is the deadliest cancer in the world. In 2012, there were 1.58 million new diagnosed lung cancer cases and 1.39 million deaths from this disease globally4. Despite the different treatments available today (surgery, radiotherapy, chemotherapy, targeted therapy), the relative survival rates of these patients at metastatic stage remains very low3.
Given the large incidence of NSCLC, OSE Pharma estimates that the potential global sales at peak for Tedopi® for this single indication could be about €2 billion[4].
Press Contacts
OSE Pharma sa
Dominique Costantini, CEO
dominique.costantini@osepharma.com
Mob +33 6 13 20 77 49
Alexis Peyroles, CFO
Alexis.peyroles@osepharma.com
Mob : +33 6 11 51 19 77
Citigate Dewe Rogerson
Laurence Bault / Lucie Larguier
+33 1 53 32 84 78
laurence.bault@citigate.fr
Alize RP
Florence Portejoie
+33 1 44 54 36 64 - + 33 6 47 38 90 04
fportejoie@alizerp.com
Help employers find you! Check out all the jobs and post your resume.