After throwing down $70 million upfront to partner on Black Diamond Therapeutics’ solid tumor candidate earlier this year, Servier is pulling out its checkbook to ink yet another oncology licensing deal, this time in a rare form of eye cancer where current treatment options are slim.
Servier is paying Ideaya Biosciences $210 million out of the gate for regulatory and commercial rights to the biotech’s experimental protein kinase C (PKC) inhibitor darovasertib outside the U.S. The potential first-in-class therapy is being developed across several primary and metastatic uveal melanoma (UM) indications, and Ideaya will retain rights to the asset stateside.
All told, the deal could net Ideaya upward of $530 million. Aside from the $210 million paid upfront, Servier could also pay out up to $100 million in approval-based milestones, plus up to $220 million more in commercial milestone payments, according to a Sept. 2 press release. Beyond the milestone payments, Ideaya is in line for double-digit royalties on sales outside the U.S.
The companies will work collaboratively on the candidate’s development and share related costs, Servier and Ideaya said Tuesday.
Darovasertib is currently working its way through several clinical trials, including a phase 2/3 study in combination with Pfizer’s Xalkori (crizotinib) in previously untreated HLA-A2-negative UM and a phase 3 study of the PKC inhibitor as a neoadjuvant monotherapy in primary UM, independent of patients’ HLA status.
Friday, Ideaya said it plans to present the first median overall survival data on darovasertib plus Xalkori from more than 40 patients with first-line metastatic UM who enrolled in a phase 1/2 trial. That presentation is slated for the 2025 Society for Melanoma Research Congress in late October.
Meanwhile, Ideaya and Servier are now planning to launch an additional phase 3 study of darovasertib next year as a potential adjuvant treatment in both HLA-A2-negative and HLA-A2-positive patients with UM, according to the companies’ joint press release.
Darovasertib currently boasts a breakthrough therapy designation from the FDA as a neoadjuvant therapy in enucleation-recommended primary UM, as well as a fast track tag in combination with Xalkori for adults with metastatic UM. The asset also carries U.S. orphan drug designation in UM, inclusive of metastatic disease.
UM is a rare and aggressive form of eye cancer that originates in the sensory organ’s uveal tract, which includes the iris, ciliary body and choroid. The disease can pose “significant risks” to patients because of its potential to metastasize to other parts of the body, in particular the liver, Servier and Ideaya noted.
Current treatment options include radiation therapy, surgical tumor removal and, in severe cases, removal of the eye.
“Our collaboration with Ideaya is a significant step to make darovasertib the potential first-in-class treatment available to uveal melanoma patients worldwide,” Arnaud Lallouette, M.D., executive vice president of global medical and patient affairs at Servier, said in a statement. “Today, there are limited treatment options and there is an urgent need to improve patient outcomes.”
This is neither Ideaya nor Servier’s first oncology tie-up this year.
Back in January, Ideaya paid Hengrui Pharmaceuticals $75 million upfront for rights to a DLL3-directed antibody-drug conjugate outside of greater China.
On Servier’s side, the nonprofit-led pharma in March laid out $70 million to license Black Diamond’s RAF inhibitor asset BDTX-4933, which the biotech had recently deprioritized over resource constraints. Under that agreement, Black Diamond could receive up to $710 million in milestone payments from Servier.