Vienna (Austria), December 4-7, 2016
Nantes, Paris, September 20, 2016 - OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnémo: OSE), a biotechnology company developing immunotherapies of activation and regulation in immuno-oncology, auto-immune diseases and transplantation, will present a poster describing the updated design of the registration clinical trial Atalante 1, at the next World Conference on Lung Cancer taking place in Vienna (Austria) from December 4th to December 7th, 2016. This trial with Tedopi® is ongoing internationally in Non-Small Cell Cancer (NSCLC).
The Atalante 1 study with Tedopi® is open in nine countries, in the United States and in Europe, where patient enrollment is being actively pursued.
« This pivotal trial triggers strong interest from clinicians. This is a major asset in our strategic plan to create value that determines the registration of Tedopi® and its potential turnover. The company is also planning to develop combinations with checkpoint inhibitors and is exploring other potential indications », commented Dominique Costantini, CEO of OSE Immunotherapeutics.
The clinical trial includes patients with NSCLC expressing HLA-A2, a key receptor for cytotoxic T- immune response (representing 45% of NSCLC population). The HLA-A2 serum test is regularly used at hospital and its result aims to select HLA-A2 positive patients, the population responding to Tedopi®. Quest Diagnostics in the U.S. and Viapath in Europe are conducting this biologic test for Atalante 1.
The World Conference on Lung Cancer is organized by the International Association for the Study of Lung Cancer, the World Conference on Lung Cancer (WCLC) is the world's largest meeting dedicated to lung cancer. The event brings together the world’s lead physicians and researchers to present the latest breakthroughs and findings in the field.
ABOUT OSE IMMUNOTHERAPEUTICS
Our ambition is to become a world leader in activation and regulation immunotherapies
OSE Immunotherapeutics is a biotechnology company led by world-class immunologists and focused on the development of innovative immunotherapies for immune activation and regulation in the fields of immuno-oncology, auto-immune diseases and transplantation.
The company has a balanced portfolio of first-in-class products with a diversified risk profile ranging from clinical phase 3 registration trials to R&D:
? Tedopi®, a combination of 10 optimized neo-epitopes to induce specific T activation in immuno-oncology - currently in registration Phase 3 trial advanced NSCLC HLA A2+ patients EU /US - Orphan Status in the US - registration expected in 2019 - a Phase 2 with Tedopi® in combination with a checkpoint inhibitor in NSCLC is considered in 2017 - the product is also considered in other cancer indications.
? FR104, CD28-antagonist in immunotherapy - Phase 1 trial completed - targets autoimmune diseases and transplantation - licensed to J&J to pursue clinical development
? Effi-7, interleukin receptor 7 antagonist - in preclinical development for inflammatory bowel diseases and other autoimmune diseases
? Effi-DEM, new generation checkpoint inhibitor targeting the SIRP-a receptor on the strategic CD47/SIRP- a pathway - in preclinical development for immuno-oncology
? R&D: candidates targeting new receptors in immuno-oncology
The portfolio’s blockbuster potential gives OSE Immunotherapeutics the ability to enter into global agreements at different stages of development with major pharmaceutical players, such as the one signed for FR104 with the J&J Group. Immunotherapy is a highly promising and growing market. By 2023 Immunotherapy of cancer could represent nearly 60% of treatments against less than 3% at present * and the projected market is estimated at $67 billion in 2018 **.
There are more than 80 autoimmune diseases that represent a significant market including major players in the pharmaceutical industry with sales upper $10 billion for the main products. The medical need is largely unmet and requires the provision of new innovative products involved in the regulation of the immune system.
Nantes, Paris, September 20, 2016 - OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnémo: OSE), a biotechnology company developing immunotherapies of activation and regulation in immuno-oncology, auto-immune diseases and transplantation, will present a poster describing the updated design of the registration clinical trial Atalante 1, at the next World Conference on Lung Cancer taking place in Vienna (Austria) from December 4th to December 7th, 2016. This trial with Tedopi® is ongoing internationally in Non-Small Cell Cancer (NSCLC).
The Atalante 1 study with Tedopi® is open in nine countries, in the United States and in Europe, where patient enrollment is being actively pursued.
« This pivotal trial triggers strong interest from clinicians. This is a major asset in our strategic plan to create value that determines the registration of Tedopi® and its potential turnover. The company is also planning to develop combinations with checkpoint inhibitors and is exploring other potential indications », commented Dominique Costantini, CEO of OSE Immunotherapeutics.
The clinical trial includes patients with NSCLC expressing HLA-A2, a key receptor for cytotoxic T- immune response (representing 45% of NSCLC population). The HLA-A2 serum test is regularly used at hospital and its result aims to select HLA-A2 positive patients, the population responding to Tedopi®. Quest Diagnostics in the U.S. and Viapath in Europe are conducting this biologic test for Atalante 1.
The World Conference on Lung Cancer is organized by the International Association for the Study of Lung Cancer, the World Conference on Lung Cancer (WCLC) is the world's largest meeting dedicated to lung cancer. The event brings together the world’s lead physicians and researchers to present the latest breakthroughs and findings in the field.
ABOUT OSE IMMUNOTHERAPEUTICS
Our ambition is to become a world leader in activation and regulation immunotherapies
OSE Immunotherapeutics is a biotechnology company led by world-class immunologists and focused on the development of innovative immunotherapies for immune activation and regulation in the fields of immuno-oncology, auto-immune diseases and transplantation.
The company has a balanced portfolio of first-in-class products with a diversified risk profile ranging from clinical phase 3 registration trials to R&D:
? Tedopi®, a combination of 10 optimized neo-epitopes to induce specific T activation in immuno-oncology - currently in registration Phase 3 trial advanced NSCLC HLA A2+ patients EU /US - Orphan Status in the US - registration expected in 2019 - a Phase 2 with Tedopi® in combination with a checkpoint inhibitor in NSCLC is considered in 2017 - the product is also considered in other cancer indications.
? FR104, CD28-antagonist in immunotherapy - Phase 1 trial completed - targets autoimmune diseases and transplantation - licensed to J&J to pursue clinical development
? Effi-7, interleukin receptor 7 antagonist - in preclinical development for inflammatory bowel diseases and other autoimmune diseases
? Effi-DEM, new generation checkpoint inhibitor targeting the SIRP-a receptor on the strategic CD47/SIRP- a pathway - in preclinical development for immuno-oncology
? R&D: candidates targeting new receptors in immuno-oncology
The portfolio’s blockbuster potential gives OSE Immunotherapeutics the ability to enter into global agreements at different stages of development with major pharmaceutical players, such as the one signed for FR104 with the J&J Group. Immunotherapy is a highly promising and growing market. By 2023 Immunotherapy of cancer could represent nearly 60% of treatments against less than 3% at present * and the projected market is estimated at $67 billion in 2018 **.
There are more than 80 autoimmune diseases that represent a significant market including major players in the pharmaceutical industry with sales upper $10 billion for the main products. The medical need is largely unmet and requires the provision of new innovative products involved in the regulation of the immune system.
