Takeda has paid $50 million (€44 million) upfront to co-develop Enterome’s early-phase Crohn’s disease candidate EB8018. The deal gives Takeda a stake in a small molecule designed to disarm virulent bacteria and thereby treat gastrointestinal disorders.
EB8018 blocks the activity of FimH, a lectin expressed by enterobacteriaceae such as Escherichia coli. Research suggests the lectin activates TLR4 and thereby encourages the production of TNF-alpha, a cytokine that is the target of Crohn’s drugs such as Humira and Remicade. Enterome hopes EB8018 will prevent production of the cytokine by blocking the local inflammatory cascade.
Backed by preclinical evidence to justify those hopes, Enterome has landed a deal with Takeda. The French biotech will co-develop EB8018 with Takeda and, if approved, co-promote it in the U.S. That ongoing involvement in EB8018 was part of the attraction for Enterome.
“We are not losing the ability to develop this molecule on the Enterome side. And we are very happy to have the support of this company that we know very well [through an agreement struck in 2016],” Enterome CEO Pierre Belichard said.
EB8018 is now in an eight-patient phase 1b trial in Crohn’s patients. Regulators asked Enterome to run the trial to confirm the findings of an earlier, larger phase 1 trial in healthy volunteers. If the safety and PK data are comparable to the results of the earlier trial, Enterome and Takeda will move into a phase 2a.
The phase 2a will enroll patients who have undergone surgery to treat their Crohn’s. Enterome hopes to show the drug postpones the recurrence of the disease. As it stands, the disease recurs in many patients in the first year after surgery. Success in the subpopulation will lead to phase 2b and phase 3 trials that enroll regular Crohn’s patients.
If EB8018 clears those late-phase tests, Takeda will sell the drug outside the U.S., paying royalties to Enterome, and co-promote it in the U.S. To bag those rights to EB8018, Takeda is handing over $50 million upfront and committing to pay up to $640 million in milestones. Enterome, which raised cash in January, has also signed Takeda up to contribute to its next financing.
“We get … a $15 million commitment to participate in an upcoming fundraising or capital raising or whatever structure of buying shares in the near future,” Belichard said.
The planned financing and $50 million upfront received from Takeda will support Enterome’s efforts to evolve into a platform biotech with multiple candidates that act on the gut microbiome. Next up is a microbiome-derived cancer therapeutic vaccine that is closing in on the start of human testing.
Oct 23, 2018