OSE Immunotherapeutics to Present Atalante 1, the Registration Clinical Trial of Tedopi®, Ongoing in the U.S. and in Europe, at the World Conference on Lung Cancer (WCLC)

Dienstag, 20.09.2016 17:50


Regulatory News:

OSE Immunotherapeutics SA (Paris:OSE) (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.

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 diseasesand other autoimmune diseases
  • Effi-DEM, new generation checkpoint inhibitor targeting the SIRP-α receptor on the strategic CD47/SIRP- α 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.

*Citi Research Equity
**BCC Research
Since September 1st, 2016, the new company’s headquarters are located on: 22, boulevard Benoni Goullin, 44200 Nantes, France

Forward-looking statements
This press release contains express or implied information and statements that might be deemed forward-looking information and statements in respect of OSE Immunotherapeutics. They do not constitute historical facts. These information and statements include financial projections that are based upon certain assumptions and assessments made by OSE Immunotherapeutics’ management in light of its experience and its perception of historical trends, current economic and industry conditions, expected future developments and other factors they believe to be appropriate.
These forward-looking statements include statements typically using conditional and containing verbs such as “expect”, “anticipate”, “believe”, “target”, “plan”, or “estimate”, their declensions and conjugations and words of similar import.
Although the OSE Immunotherapeutics management believes that the forward-looking statements and information are reasonable, the OSE Immunotherapeutics’ shareholders and other investors are cautioned that the completion of such expectations is by nature subject to various risks, known or not, and uncertainties which are difficult to predict and generally beyond the control of OSE Immunotherapeutics. These risks could cause actual results and developments to differ materially from those expressed in or implied or projected by the forward-looking statements. These risks include those discussed or identified in the public filings made by OSE Immunotherapeutics with the AMF. Such forward-looking statements are not guarantees of future performance.
This press release includes only summary information and should be read with the OSE Immunotherapeutics Reference Document filed with the AMF on 8 June 2016 under the number R.16-052, the consolidated financial statements and the management report for the fiscal year 2015, as well as the Merger Document registered with the AMF on 26 April 2016 under number E.16-026, all available on the OSE Immunotherapeutics’ website.
Other than as required by applicable law, OSE Immunotherapeutics issues this press release at the date hereof and does not undertake any obligation to update or revise the forward-looking information or statements.

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