Johnson & Johnson drops OSE’s rheumatoid arthritis drug

OSE is looking into worldwide partnering opportunities for FR104. (Raysonho/CC0)

Johnson & Johnson has dumped OSE Immunotherapeutics’ autoimmune candidate FR104. J&J picked up the rights to the CD28 antagonist for €10 million ($11 million) upfront in 2016, but clinical progress stalled following the deal. 

The potential for FR104 to improve outcomes in autoimmune disorders such as rheumatoid arthritis caught J&J’s attention in 2013. Back then, J&J secured an exclusive option the drug, which is designed to control T effector functions and thereby stop the immune system from damaging tissues. Three years later, with phase 1 data supporting FR104’s safety and pharmacokinetics, J&J took up its option. 

At the time, OSE planned to work with J&J to decide whether rheumatoid arthritis, psoriasis or another indication represented the best path through the clinic. Rheumatoid arthritis emerged as the chosen indication but the anticipated phase 2 trial never materialized.


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Now, J&J has decided to hand back the rights to FR104. At the end of the year, OSE will regain the IP, data, filings and materials related to the drug. The news sent shares in OSE, which has a market cap of little more than €50 million, down by as much as 12% shortly after the market opened. OSE sought to put a positive spin on the news, though.

“FR104 is a valuable asset, phase 2-ready for autoimmune diseases. FR104 has already demonstrated a strong clinical and biological safety profile as well as shown initial signals of clinical efficacy,” OSE CEO Alexis Peyroles said in a statement. “OSE is currently evaluating the best options for continuing a sustainable development of FR104 including worldwide partnering opportunities.”

OSE will need some form of support to get FR104 moving through the clinic again. The biotech had less than €19 million in available cash at the end of June and is currently enrolling non-small cell lung cancer patients in a phase 3 trial of its lead candidate Tedopi.

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