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By email : Alexis Peyroles

OSE Immunotherapeutics: An increased scale and a capacity to enhance the value of its assets through industrial partnerships, to ensure its development and cover cash-flow needs.

OSE Immunotherapeutics’ growth strategy includes leveraging the work of the company’s highly-skilled R&D teams to secure key strategic partnerships and out-licensing opportunities at the most appropriate stage of clinical development (either early- or later-stage).

Thanks to its advanced clinical programs and innovative drug candidates immuno-oncology, autoimmune diseases and transplantation, OSE Immunotherapeutics is in a strong position to achieve this goal.

Through such partnerships, OSE Immunotherapeutics aims to develop and/or commercialize its drug candidates and expand development to other potential applications and specific geographies. Partnerships will also help to generate mid- and long-term revenues through royalties and milestones. These will contributesignificantly to the company’s cash-flow needs.

In the longer-term, OSE Immunotherapeutics will consider commercializing some of its R&D products in-house, provided that such efforts show they can be highly profitable and achievable and that they allow the Company to retain maximum value+

Tedopi®, seeking partnerships for alternate indications ; first license agreement signed for NSCLC

Tedopi®, a specific immunotherapy activating t-lymphocytes, addresses hla-a2 positive patients with non-small cell lung cancer (NSCLC).

  • Tedopi® is currently in a Phase 3 registration clinical trial for lung cancer in Europe and the USA; trial completion is expected in 2018.
  • A Phase 2 clinical trial of Tedopi® combined with a checkpoint inhibitor is expected for lung cancer in 2017, in partnership with a European research organization.
  • New cancer indications involving a strong medical need will be considered with appropriate partners in the areas of: ovarian, colon, triple negative breast cancer, mesothelioma or treatment of brain metastasis. Based on the clinical data already generated [link to Clinical trials, Phase 2 Results Tedopi®], these programs could start directly from Phase 2.

Signature of a first agreement with rafa laboratories
A first license and distribution agreement for Israel was signed in May 2015 with Rafa Laboratories, a pharmaceutical company specializing in oncology and rare lung diseases.

FR104 : a license and commercialization agreement with Janssen Biotech Inc., affiliate of Johnson & Johnson Group

Clinical phase 1 trial with positive results, targeting indications in autoimmune diseases and transplantation (Press release)

  • FR104, a CD28-antagonist, is an optimized monoclonal antibody fragment targeting the CD28 receptor, a key receptor in effector T lymphocytes. These effector T lymphocytes are harmful in the case of autoimmune diseases and transplantation.
  • At the end of 2013, with FR104 at a preclinical stage, a global option and license agreement was signed with Janssen Biotech, owned by Johnson & Johnson (a global leading pharmaceutical group), which has allowed the development of the product to the current stage. This option has been exercised by Janssen in July 2016 to continue Phase 2 clinical development, with expected payments of milestones and royalties (Press release).


OSE-127 (Effi-7), a license option agreement with Servier for the product’s development and commercialization

A 2-steps license option to develop OSE-127 (Effi-7) to enable the development of the product up to the completion of a phase 2 clinical trial planned in ulcerative colitis an autoimmune bowel disease (Press release)

  • OSE-127  is a monoclonal immunomodulatory antibody targeting the alpha chain of the interleukin-7 receptor (IL-7R-alpha or CD127 receptor). Effi-7 has an innovative mechanism of action: it blocks both the IL-7 and the internalization of the receptor, thus inducing a powerful antagonist effect on the pathogenic T lymphocytes involved in autoimmune diseases. This mechanism has been confirmed recently through multiple in vitro and in vivo studies.
  • Currently in preclinical stage for ulcerative colitis, the development of OSE-127 will also be pursued until the clinical phase 2 as part of the EFFIMab [Link to scientific collaborations] consortium, led by OSE Immunotherapeutics and including the University Hospital of Nantes and the company PxTherapeutics.

New collaboration and license agreements on other programs will be considered with industry partners involved in activation or regulation immunology, and in therapeutic combinations of high clinical interest.