Ipsen agrees new oncology licensing deal

Ipsen has obtained ex-US regulatory and commercial rights to tovorafenib for most common paediatric low-grade glioma, plus any future indications developed by Day One Biopharmaceuticals.

The oral type II RAF kinase inhibitor is the first US Food and Drug Administration (FDA)-approved treatment for relapsed or refractory forms of the disease with a BRAF fusion or rearrangement, or V600 mutation. Tovorafenib is indicated for these patients aged six months and older, following the ongoing Phase II trial FIREFLY-1, Day One explained.

Gaining access to tovorafenib

Ipsen confirmed that under the agreement, it will oversee regulatory and commercial activities for tovorafenib in all regions outside of the US.

Day One will hold exclusive global development and US commercial rights for tovorafenib, the company declared. It will receive approximately $111 million upfront. This includes approximately $71 million in cash and up to approximately $350 million in additional milestone payments.

The parties also shared that tovorafenib is also being evaluated as a part of a combination treatment alongside the MEK inhibitor pimasertib, in recurrent or progressive solid tumours with MAPK pathway alterations.

“Paediatric low-grade glioma is the most common form of childhood brain cancer, and, outside the US, there are still no approved targeted treatments for people with [paediatric low-grade glioma] caused by BRAF alterations… 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,” David Loew, Chief Executive Officer, Ipsen shared. 

“We believe Ipsen’s footprint in Europe and major regions outside of the US…will be an enormous benefit to tovorafenib and to the paediatric oncology community worldwide,” Jeremy Bender, PhD, Chief Executive Officer, Day One commented.