OSE Immunotherapeutics Announces Temporary Pause of Patient Accrual

6 July 2017

OSE Immunotherapeutics Announces Temporary Pause of Patient Accrual
While Continuing Treatment for Patients Already Enrolled

In Phase 3 Clinical Trial of Tedopi®


OSE Immunotherapeutics today announced that following the recommendation by IDMC (independent experts) on the phase 3 clinical study, Atalante 1, which is evaluating Tedopi® for the treatment of non-small cell lung cancer, the Company is temporarily pausing patient accrual while continuing treatment for patients already enrolled in order to further assess the study’s current patient profile in relation to the potential benefit of Tedopi® with more mature data.

“The Company has decided to halt temporarily patient enrolment, but to continue treatment of patients already enrolled in this clinical trial, due to an emerging benefit/risk balance of the experimental treatment” said Dominique Costantini, Chief Executive Officer of OSE Immunotherapeutics. “Patients eligible for inclusion in the Atalante 1 study are cancer patients at an advanced stage who have failed a first-line treatment with chemotherapy or failed second-line therapy with checkpoint inhibitors, and enter the trial at stage of disease progression. This cancer progression may be difficult to control for some patients in the near-term due to the generally longer-term activity observed with a combination of neoepitopes, which differs from chemotherapy’s generally near-term activity.”

Following further review of more patients’ data and additional information being available, a decision will be made for the trial continuation as such or possible amendment to include specific sub-groups of patients.

The expected safety profile was observed in both treatment groups. The safety profile observed in the experimental treatment group is consistent with the one observed in the previous clinical trials of Tedopi®.

“While further data analysis occurs here, we remain focused on advancing our other promising product candidates in the Company’s robust development pipeline,” continued Dr. Costantini.