Immuno-Oncology

OSE Immunotherapeutics’ immuno-oncology area is comprised of three programs currently in clinical status.

Tedopi®, a T-specific immunotherapy based on highly selected neoepitopes and most advanced Company’s asset, is being developed in a Phase 3 clinical trial. The product activates T lymphocytes capable of killing tumor cells that they have learned to recognize. This product has obtained significant results versus chemotherapy in “Non-Small Cell Lung Cancer” in patients with secondary resistance after failure of checkpoint inhibitors [Anti PD-(L) 1] where therapeutic need is very important.

Based on positive recommendations from the US Food and Drug Administration (FDA) “Type C” meeting following the European Medicines Agency (EMA) scientific advice, OSE Immunotherapeutics is preparing a new pivotal Phase 3 clinical study to support the regulatory registration of Tedopi® in second line. This confirmatory trial will evaluate Tedopi® versus the standard treatment in second line in HLA-A2 positive patients with advanced non-small cell lung cancer.

Patients can benefit from Tedopi® through compassionate use programs in third or further lines of treatment (post chemotherapy and immunotherapy) currently approved in France, Italy and Spain, confirming thereby the significant medical need for new therapeutic alternatives.

Other Phase 2 clinical trials of Tedopi® in combination are ongoing with international clinical research groups. The Company will capitalize on the clinical results to discuss with the regulatory authorities and to actively prepare the continuation of this development.

OSE-279 is an anti-PD1 antibody that blocks a T lymphocyte brake enabling activation of non-specific T cells in oncology. It is currently in Phase 1/2 clinical trial in advanced solid tumors and lymphomas. It is also the “backbone” component of a platform called BiCKI® for new original bispecific or bifunctional therapies.

BI 765063 (OSE-172), an anti-SIRPα monoclonal antibody, a target expressed on myeloid cells on the SIRPα/CD-47 axis, is developed in partnership with Boehringer Ingelheim in advanced solid tumors. The positive results of the Phase 1 dose escalation clinical trial as a single agent and then in combination with ezabenlimab (Boerhinger’s PD1 antagonist) have enabled the initiation of two ongoing Phase 1 cohort expansion trials.