Johnson & Johnson ($JNJ) has exercised its option to license FR104 from OSE Immunotherapeutics (EPA:OSE). The agreement, which follows shortly after the conclusion of a Phase I trial of FR104, sees J&J commit to pay up to €155 million ($173 million) for the global rights to the CD28 antagonist in autoimmune diseases and transplantations.
J&J, through its Janssen Biotech subsidiary, is paying €10 million up front and signing up to pay the rest as FR104 hits certain development, regulatory and commercial milestones. In return, Janssen will take over global development and commercialization of FR104, a monoclonal antibody fragment that is designed to induce immune tolerance in transplant patients and those suffering from autoimmune diseases.
The idea is that FR104 acts as an antagonist of CD28. Through this mechanism of action, Nantes, France-based OSE thinks FR104 can inhibit the proliferation of T cells, the destructive actions of effector memory T cells and the synthesis of cytokines.
"[CD28] is involved in the activation of the T lymphocytes,” OSE CEO Dominique Costantini told FierceBiotech. “Due to the fact that we have a pure antagonist, we are blocking the effector action of the lymphocyte. We block the capability of these lymphocytes to destroy the tissue."
The concept is underpinned by two decades of academic research. OSE has added to this with preclinical data on FR104 in disease models including rheumatoid arthritis, multiple sclerosis and psoriasis. More recently, OSE has added Phase I data to its case for FR104.
“We have seen that ... the safety is good, [as are] the pharmacokinetics,” Costantini said.
J&J’s Janssen has kept tabs on FR104 as OSE has gone about generating these data. The Big Pharma formalized its interest in 2013 when it picked up an exclusive option to license FR104. At that time, FR104 was being developed by Effimune, a French biotech that merged with OSE Pharma earlier this year. With OSE having now brought FR104 through a Phase I trial successfully, Janssen has stepped in and exercised its option on the asset.
The next steps, inlcuding the choice of indication, are still being decided. "We'll think about rheumatoid arthritis, psoriasis, but it is not defined at this stage,” Costantini said. “We have to organize different steering committees in order to understand the next [steps].”
Shares in OSE climbed more than 15% in early trading in Paris, before falling slightly from these peaks later in the day. The cash injection from the deal has extended OSE’s financial runway from 18 months to out beyond two years.
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