2 November 2018 - - French biotechnology company OSE Immunotherapeutics SA will regain the worldwide rights to FR104, its first-in-class CD28 antagonist, from Janssen Biotech, Inc., effective December 31, 2018, the company said.

Following the termination of the license agreement, OSE Immunotherapetics will recover its FR104 intellectual property rights that had been licensed to Janssen.

The agreement also provides that OSE Immunotherapeutics will for its continued development of FR104 have exclusive access to all intellectual property, data, filings and materials developed by Janssen relating to the FR104 programme.

Janssen has been pursuing the development of FR104 pursuant to an exclusive license from OSE Immunotherapeutics*. Janssen's decision to return the program to OSE Immunotherapeutics is based on its own internal strategic review and prioritization of its portfolio.

CD28 blockade by FR104 controls T effector functions while potentiating regulatory T cells. This novel means of controlling immune synapses potentially offers new therapeutic options in multiple inflammatory and autoimmune diseases where T cells are involved and there are important unmet medical needs. 

Positive safety and biological activity results from FR104's Phase 1 proof of clinical concept study taken together with the preclinical safety profile and efficacy data in multiple preclinical models of autoimmune/inflammatory diseases further support continued clinical development.

OSE Immunotherapeutics is a clinical-stage biotechnology company focused on developing and partnering therapies to control the immune system for immuno-oncology and autoimmmune diseases.

The company has a diversified first-in-class clinical portfolio consisting of several scientific and technological platforms including neoepitopes and agonist or antagonist monoclonal antibodies, all ideally positioned to fight cancer and autoimmune diseases.

Its most advanced asset, Tedopi, is a proprietary combination of 10 neo-epitopes aimed at stimulating T-lymphocytes and is currently in Phase 3 development in non-small cell lung cancer (NSCLC) after checkpoint inhibitor failure (anti PD-1 and anti PD-L1).

In April 2018, Boehringer Ingelheim and OSE signed a global license and collaboration agreement to develop checkpoint inhibitor OSE-172 (anti-SIRPa monoclonal antibody) in multiple cancer indications.

In July 2016, Janssen Biotech, Inc. exercised a licensing option to continue clinical development of FR104 (an anti-CD28 mAb) in auto-immune diseases after positive Phase 1 results; termination of licence agreement effective Dec. 31, 2018 due to strategic portfolio prioritization and OSE regained all worldwide rights on this asset.

In 2016, Servier Laboratories signed a two-step license option 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.