Ipsen has announced that it has entered into a global partnership worth over $460m with Day One to commercialise its monotherapy to treat common paediatric brain tumours.
As part of the deal, Ipsen will obtain all ex-US global regulatory and commercial rights to tovorafenib for patients living with paediatric low-grade gliomas (pLGG) and any future indications, while Day One maintains exclusive global development and US commercial rights.
Under the terms of the agreement, Day One will receive an upfront payment of approximately $111m, including $71m in cash and a $40m equity investment at a premium, along with up to $350m in additional launch and sales milestones, plus tiered royalties.
The oral, once-weekly type 2 RAF kinase inhibitor mutant BRAF V600, wild-type BRAF and wild-type CRAF kinases, is indicated in the US under the brand name Ojemda to treat certain patients aged six months and older with relapsed or refractory pLGG.
Recognised as the most common brain tumour diagnosed in children, pLGG is a group of slow-growing tumours that can occur in numerous locations throughout the brain and spinal cord.
Commenting on the partnership, David Loew, chief executive officer, Ipsen, said: “We are delighted to partner with the team at Day One as we work to bring tovorafenib to every eligible patient around the world who may benefit from this important new treatment option.”
Day One’s chief executive officer, Jeremy Bender, said: “Our collaboration with Ipsen… highlights our shared commitment to bring novel therapeutics to patients who have limited treatment options.”
Previously granted Orphan Drug Designation by the US Food and Drug Administration, Ojemda recently received approval from the US regulator for patients six months and older with relapsed or refractory pLGG harbouring a BRAF fusion or rearrangement, or BRAF V600 mutation, which accounts for more than 50% of pLGG cases globally.
The monotherapy is also currently being evaluated as a therapy for patients aged six months to 25 years with pLGG harbouring BRAF fusion or rearrangement or BRAF V600 mutation requiring front-line treatment as part of the phase 3 FIREFLY-2/LOGGIC study, as well as the FIRELIGHT-1 study, which is investigating tovorafenib in combination with MEK inhibitor pimasertib for adolescent and adult patients with recurrent or progressive solid tumours with MAPK pathway alterations.