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Friday, November 2, 2018

J&J dumps Phase 2-ready autoimmune asset, returns rights to French partner


J&J’s 5-year acquaintanceship with OSE Immunotherapeutics has come to an end as the pharma giant decided it doesn’t want the CD28 antagonist FR104 after all.
The deal termination means that Nantes, France-based OSE will once again hold worldwide rights to the asset — including any new data, IP and regulatory filings generated by J&J’s biotech unit Janssen — which is now ready for Phase II testing.

Janssen first laid its hands on the autoimmune asset in 2013, back when the drug was still being developed by Effimune, which later merged with OSE. Three years later, it exercised the option to take over global development and commercialization with an €10 million upfront and a promise of €145 million more, though the majority of that likely never materialized.
Saying everything they can to paint the news in a positive light, OSE said Janssen’s decision to return the program “is based on its own internal strategic review and prioritization of its portfolio.” A J&J spokesperson confirmed as much in response to my query.
“(W)e have all the necessary preclinical and clinical data required to conduct phase 2 trials,” said OSE CEO Alexis Peyroles in a statement. “OSE is currently evaluating the best options for continuing a sustainable development of FR104 including worldwide partnering opportunities.”
The T cell molecule CD28 is well-known in the CAR-T sphere as one of two commonly used costimulatory domains. OSE’s theory is that blocking it using a monoclonal antibody can offer immune control in a number of inflammatory and autoimmune diseases.
Aside from FR104, OSE is also developing a Phase III therapy for non-small cell lung cancer, as well as an SIRPĪ± antagonist dubbed OSE-172, partnered with Boehringer Ingelheim and Servier in oncology and autoimmune indications, respectively.

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