Darovasertib

Servier and Ideaya Biosciences will work collaboratively on darovasertib\'s development and share related costs, the companies said Tuesday.\n 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. 

Plus, news about Zenas BioPharma, OMass Therapeutics, Merck, Bayer, Convalife Pharmaceuticals, Mabwell Bioscience, CapVest, Stada and vTv Therapeutics: 💰 Servier licenses Ideaya Biosciences’ cancer drug: The French pharma is getting the ex-US rights to Ideaya’s experimental uveal melanoma drug for $200 million upfront. Servier could fork over another $320 million in biobucks for the Phase 2/3 candidate, which is named darovasertib. — Kyle LaHucik 🧪 Zymeworks discontinues work on T cell engager: The biotech determined that its additional dose evaluation in a Phase 1 trial of ZW171 wouldn’t yield the benefit-risk profile it wanted. Zymeworks had planned to test the TCE in cancers with high levels of mesothelin. — Jaimy Lee 🧾 Zenas BioPharma makes a royalty deal: Royalty Pharma is paying $75 million upfront and up to $300 million total in exchange for the royalties on sales of obexelimab, Zenas’ experimental bifunctional monoclonal antibody that’s being tested in several autoimmune diseases. An increasing number of biotechs are inking royalty deals to bolster their balance sheets. — Jaimy Lee 🇨🇭 OMass Therapeutics, Roche ink deal: The Swiss drugmaker is paying $20 million upfront for the rights to develop and commercialize OMass’ preclinical oral inflammatory bowel disease program. There are also more than $400 million in milestones and tiered royalties on the table. — Jaimy Lee 🫀 Merck and Bayer’s Verquvo fails a Phase 3 study in heart failure: The companies have been testing the drug in adults with stable chronic heart failure and reduced ejection fraction. Verquvo is already approved to treat a different subset of patients with heart failure. — Jaimy Lee 🇨🇳 Two Chinese biotechs file for IPOs in Hong Kong: This includes Convalife Pharmaceuticals , a decade-old cancer drug developer with one approved medicine and 16 others in development, and Mabwell Bioscience , a cancer and age-related diseases biotech founded eight years ago. Mabwell is already listed on the Shanghai Stock Exchange STAR Market. It tried for an HKEX listing in January but let its filing lapse. The companies are the latest to file to go public in the still active IPO market in Hong Kong. — Kyle LaHucik 🇩🇪 CapVest Partners takes a majority stake in Stada: Sources told The Financial Times that Stada has a valuation of roughly €10 billion, including debt. Bain Capital and Cinven acquired Stada in 2017 and then took the German pharma company private. Stada was known as a generics maker but has since broadened its business into consumer healthcare and specialty drugs. The deal is expected to close in the first half of next year — Jaimy Lee 💊 vTv Therapeutics’ $80M private placement: The company plans to use the funding to advance cadisegliatin, its Phase 3 adjunctive therapy to insulin for patients with type 1 diabetes. The PIPE’s investors include several institutional investors and the T1D Fund. — Jaimy Lee