OSE Immunotherapeutics Receives IDMC Approval to Continue “Atalante 1” Phase 3 NSCLC Clinical Trial of Tedopi®

  • Trial in Non-Small Cell Lung Cancer (NSCLC) Patients After Immune Checkpoint Inhibitor Failure
  • Checkpoint Inhibitor Failures Is an Unmet Need in Non-Small Cell Lung Cancer Patient Population

NANTES, France--()--Regulatory News:

OSE Immunotherapeutics SA (Paris:OSE) (ISIN: FR0012127173; Mnémo: OSE) received approval from the Independent Data Monitoring Committee (IDMC) to continue Atalante 1, the Company’s international pivotal Phase 3 clinical study of Tedopi® for the treatment of Non-Small Cell Lung Cancer (NSCLC) following immune checkpoint inhibitor treatment.

“ While checkpoint inhibitors are now considered as the standard of care in first- and second-line treatment of advanced NSCLC, there is a strong clinical need for patients in immune escape after such treatment. Our Tedopi® neoepitope product is well positioned to benefit NSCLC patients experiencing treatment failure after checkpoint inhibitors, as there is currently no approved treatment for these patients,” said Alexis Peyroles, CEO of OSE Immunotherapeutics.

The Tedopi® Phase 3 trial, Atalante 1, is evaluating the benefit of Tedopi® in HLA-A2 positive patients with NSCLC at invasive stage IIIB or metastatic stage IV, in 2nd or 3rd line treatment following failure of a checkpoint inhibitor, compared to current standard chemotherapy treatments in this patient population. The primary endpoint of the trial is overall survival. This international trial is being conducted in the U.S., in Europe and in Israel.

ABOUT OSE Immunotherapeutics

OSE Immunotherapeutics is a biotechnology company focused on the development of innovative immunotherapies for immune activation and regulation in the fields of immuno-oncology and autoimmune diseases. Neoepitopes innovation (Tedopi®) is today in Phase 3 in advanced lung cancers (NSCLC) after checkpoint inhibitor failure (anti-PD-1 and anti-PD-L1). A global license and collaboration agreement was signed in April 2018 with Boehringer Ingelheim to develop checkpoint inhibitor OSE-172 (anti-SIRPa monoclonal antibody), for the treatment of advanced solid tumors. An option to license was exercised in July 2016 by Janssen Biotech to continue clinical development of FR104 (an anti CD28 mAb) in auto-immune diseases after positive phase 1 results. A 2-step license option was signed in 2016 with Servier Laboratories to develop OSE-127 (monoclonal antibody targeting the CD127 receptor, the alpha chain of the interleukin-7 receptor) to develop the product up to the completion of a phase 2 clinical trial planned in autoimmune bowel disease and Sjogren’s syndrome. The company has several scientific and technological platforms: neoepitopes, agonist or antagonist monoclonal antibodies, ideally positioned to fight cancer and autoimmune diseases. Its first-in-class clinical portfolio offers a diversified risk profile.

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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 26 April 2018, including the annual financial report for the fiscal year 2017, 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.

Contacts

OSE Immunotherapeutics
Sylvie Détry
Sylvie.detry@ose-immuno.com
+33 143 297 857
or
French Media: FP2COM
Florence Portejoie
fportejoie@fp2com.fr
+33 607 768 283
or
U.S. Media: LifeSci Public Relations
Linda Phelan Dyson, MPH
linda@lifescipublicrelations.com
+1 973 986 5973
or
U.S. and European Investors
Chris Maggos
chris@lifesciadvisors.com
+41 79 367 6254

Release Summary

OSE Immunotherapeutics Receives IDMC Approval to Continue “Atalante 1” Phase 3 NSCLC Clinical Trial of Tedopi®.

Contacts

OSE Immunotherapeutics
Sylvie Détry
Sylvie.detry@ose-immuno.com
+33 143 297 857
or
French Media: FP2COM
Florence Portejoie
fportejoie@fp2com.fr
+33 607 768 283
or
U.S. Media: LifeSci Public Relations
Linda Phelan Dyson, MPH
linda@lifescipublicrelations.com
+1 973 986 5973
or
U.S. and European Investors
Chris Maggos
chris@lifesciadvisors.com
+41 79 367 6254