Day One’s Ojemda received accelerated approval from the US FDA to treat low-grade glioma in paediatric patients aged six months and older. Image Credit: Lightspring / Shutterstock.

Ipsen is looking to expand its paediatric medication portfolio and has signed a licensing agreement potentially worth $461m with Day One Biopharmaceuticals for its paediatric glioma therapy Ojemda (tovorafenib).

Ipsen will make an upfront payment of $111m, of which $71m will be in cash and the rest will be an equity investment. Day One will also be in line to receive up to $350m in milestone-based milestones and ‘double-digit’ royalties on sales.

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As part of the agreement, the French pharmaceutical will gain global commercial rights, excluding the US, for Ojemda. Day One will retain global development and the US commercial rights for the therapy.

Ojemda inhibits type II rapidly accelerated fibrosarcoma (RAF) kinases and is being developed to treat paediatric low-grade glioma with BRAF rearrangements.

Low-grade gliomas are a group of slow-growing tumours that can occur in the brain and spinal cord. It is the most common central nervous system tumour type in children and adolescents, accounting for approximately a third of brain and spinal cord tumours in this population, as per the American Brain Tumor Association.

In April, Ojemda received accelerated approval by the US Food and Drug Administration (FDA) to treat patients six months of age and older with relapsed or refractory paediatric low-grade glioma harbouring a BRAF fusion or rearrangement, or BRAF V600 mutation. The therapy is expected to generate approximately $797m in sales in 2030, as per GlobalData analysis.

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Ojemda is being evaluated in patients with low-grade gliomas in a Phase III FIREFLY-2 trial (NCT05566795). The study will investigate the therapy against standard chemotherapy in approximately 400 patients. The trial’s primary endpoint is the objective response rate based on response assessment in neuro-oncology (RANO) criteria, as determined by an independent review.

Another therapy area in which both Ipsen and Day One have individually invested is antibody-drug conjugates (ADCs). Last month, Day One signed a licensing agreement with MabCare Therapeutics for its ADC worth up to $1.2bn. Ipsen signed two ADC licensing agreements this year—with Sutro Biopharma in April and Foreseen Biotechnology this month. Phase I trials investigating both ADCs are expected to start in the coming months.