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. 

9月2日，施维雅和领先的精准医学肿瘤学公司IDEAYA Biosciences宣布了一项独家许可协议，为全球患者提供治疗罕见癌症的有前景的药物darovasterib。根据该协议，施维雅在美国以外的所有地区获得了darovasterib的监管和商业权利。IDEAYA保留其在美国的darovasterib权利。Darovasertib是一种强效且选择性的蛋白激酶C（PKC）抑制剂，正在开发中以广泛治疗原发性和转移性葡萄膜黑色素瘤（UM）。 根据协议条款，IDEAYA将获得2.1亿美元的预付款，并有资格获得高达1亿美元的监管批准里程碑付款和高达2.2亿美元的商业里程碑付款，以及美国以外所有地区净销售额的两位数特许权使用费。施维雅将负责darovasterib在美国以外所有地区的监管和商业活动。IDEAYA和施维雅将合作开发darovasterib并分担相关费用。 施维雅全球医疗与患者事务执行副总裁Arnaud Lallouette表示：“在施维雅，我们的使命是为有重大需求的患者提供变革性疗法。我们与IDEAYA的合作是使darovasterib成为全球葡萄膜黑色素瘤患者可获得的潜在一流治疗的重要一步。如今，治疗选择有限，迫切需要改善患者的预后。我们期待利用我们的全球肿瘤学网络和开发肿瘤靶向疗法的专业知识，使全球患者都能获得这种突破性的治疗。” IDEAYA Biosciences首席执行官Yujiro S.Hata表示：“Darovasertib解决了一个尚未满足的重大需求，我们很高兴与施维雅合作，在全球范围内将其开发为全球葡萄膜黑色素瘤患者的潜在护理标准。这一合作伙伴关系使IDEAYA和施维雅能够在三个3期注册试验中加速Darovassertib的全球开发，旨在改善新佐剂、佐剂和转移环境中的患者预后。” IDEAYA Biosciences首席业务官Daniel Simon表示：“我们相信，施维雅的全球足迹和在为欧洲和美国以外其他主要地区的患者带来新疗法方面的良好记录，将确保这种可能改变生活的治疗能够惠及尽可能多的患者。” Darovasertib目前正在多个全球临床试验中进行评估。其中包括一项2/3期随机试验，该试验评估了Darovasterib与克里唑替尼联合治疗HLA-A2阴性转移性葡萄膜黑色素瘤（UM）一线患者的疗效，预计该患者的中位无进展生存期读数将从2025年底到2026年第1季度，以及一项3期随机试验评估了新辅助Darovasterbi作为原发性UM的单一疗法，与HLA状态无关。IDEAYA和施维雅的目标是在2026年启动一项全球3期随机临床试验，以评估佐剂darovasterib在原发性UM中的疗效，包括HLA-A2阴性和阳性患者。 葡萄膜黑色素瘤（UM）是一种罕见的侵袭性癌症，起源于葡萄膜束，包括虹膜、睫状体和脉络膜。尽管罕见，但由于其可能转移到身体的其他部位，特别是肝脏，因此存在重大风险。目前的治疗选择包括放射治疗、手术切除肿瘤，或在严重情况下切除眼睛（眼球摘除）。 Darovasertib已获得美国FDA的突破性治疗指定，作为眼球摘除术的新辅助疗法，推荐用于原发性UM，Darovasertib与克里唑替尼联合用于成年转移性UM患者的快速通道指定。Darovasertib还被美国FDA指定为UM的孤儿药，包括转移性UM。 关注下方公众号，带你看世界!