Servier drops GeNeuro’s multiple sclerosis drug after midphase miss

The decision leaves GeNeuro unpartnered on the cusp of phase 3. (Servier)

Servier has turned down the chance to license a multiple sclerosis drug from GeNeuro. The decision comes a year after the monoclonal antibody, GNbAC1, failed to beat placebo in a phase 2b trial.

GeNeuro and Servier continued to track patients enrolled in the six-month phase 2b in the belief the effects of the antibody, which targets the endogenous retroviral MSRV-Env protein, may only become apparent after a year. However, while GeNeuro found positives in the 12-month data, the update failed to transform analyst perceptions about the prospects of GNbAC1.

Now, six months after the 12-month readout, Servier is severing its ties to GNbAC1. In turning down the option to license GNbAC1, Servier is writing off the €37.5 million ($43.8 million) it paid to enter into the pact with GeNeuro. Servier remains tied to GeNeuro through its investments in the biotech.

The travails of GNbAC1 in the clinic provide the backdrop to the decision. But GeNeuro and Servier are both framing the move as being shaped by factors other than the phase 2b clinical data. In a statement, Servier EVP Emmanuel Canet said the change was motivated by “R&D strategic reasons.”

GeNeuro CEO Jesús Martin-Garcia, while being careful not to speak for Servier, cited certain facts to contextualize the decision. 

“If Servier had taken the decision to exercise the option and license, they would have had to fund continued development of GNbAC1 for MS, including in the U.S. ... while they don’t have U.S. rights,” Martin-Garcia said. 

Servier was evidently open to funding global development despite not owning U.S. rights when it first entered into the deal with GeNeuro. Since then, Servier has learnt more about GNbAC1 and changed as a company. Notably, following its $2.4 billion acquisition of Shire’s oncology business, Servier is far more focused on cancer and the U.S. than it was four years ago. Martin-Garcia pointed to Servier’s newly established focus on cancer and the U.S. when stating facts that may help explain the decision.

In theory, Servier’s move into North America and existing financial responsibilities for GNbAC1 could have put it among the companies interested in the U.S. rights to the asset. However, in reality, Servier decided to walk away from GNbAC1. 

The decision leaves GeNeuro unpartnered on the cusp of phase 3, but it won’t have to start its search for a new ally from scratch. As owner of the U.S. rights to GNbAC1, GeNeuro has been in talks with potential partners since shortly after posting the 12-month data in March. 

“We were approached by a number of companies to start discussing potential partnerships for U.S. rights. Now, we are going to expand the geographic scope of some of those discussions. And also, we now have all the therapeutic options including combinations open,” Martin-Garcia said. 

The level of interest in the rights will rest on how potential partners interpret the phase 2b data. GeNeuro set out to show GNbAC1 reduced the number of cerebral Gad-enhancing lesions and had a positive effect on other measures of neuroinflammation. By those yardsticks, the 270-patient trial failed. However, GeNeuro has found cause for optimism in the clinical data on neuroprotection.

“[We saw] robust and consistent effects on key markers in neuroprotection that are linked to disease progression. The unmet medical need in MS is disease progression,” Martin-Garcia said.   

Martin-Garcia thinks the neuroprotection results point to multiple paths forward for GNbAC1. In patients with remitting multiple sclerosis, GNbAC1 could be combined with anti-inflammatory drugs. Equally, GNbAC1 could be used as a monotherapy in progressive forms of the disease. Martin-Garcia’s continued interest in the monotherapeutic use of GNbAC1 reflects a belief that progressive multiple sclerosis is driven more by brain atrophy than inflammation.