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November 2, 2018

Janssen returns FR104 global rights to OSE Immunotherapeutics

Janssen Biotech has returned the global rights to its autoimmune disease asset, FR104, to French pharmaceutical company OSE Immunotherapeutics.

Janssen Biotech has returned the global rights to its autoimmune disease asset, FR104, to French pharmaceutical company OSE Immunotherapeutics.

Effective 31 December 2018, the termination of the licence agreement will provide OSE Immunotherapetics with the intellectual property rights that it previously licensed to Janssen.

In addition, OSE will have exclusive access to the FR104-related intellectual property, data, filings and materials developed by Janssen, which will support further development of the asset.

Janssen’s decision to return the programme is said to be a result of its internal strategic review and prioritisation of product portfolio.

OSE Immunotherapeutics CEO Alexis Peyroles said: “FR104 is a valuable asset, Phase II-ready for autoimmune diseases, as we have all the necessary preclinical and clinical data required to conduct Phase II trials.

“FR104 has already demonstrated a strong clinical and biological safety profile as well as shown initial signals of clinical efficacy.”

“FR104 has already demonstrated a strong clinical and biological safety profile as well as shown initial signals of clinical efficacy. OSE is currently evaluating the best options for continuing a sustainable development of FR104 including worldwide partnering opportunities.”

FR104 is a monoclonal antibody fragment being developed to block CD28, which is known to be an important receptor in effector T lymphocytes. The inhibition of CD28 allows T effector functions regulation and stimulation of regulatory T cells.

The control of immune synapses is expected to facilitate new drugs for inflammatory and autoimmune diseases with unmet clinical need.

Janssen exercised an option to licence the asset in July 2016, under a global option and licence agreement signed between the companies in September 2013 with FR104 at a preclinical stage.

The licence agreement provided Janssen with rights for all international clinical development, registration and commercialisation activities.

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