MGMT

Merck & Co – known as MSD outside the US and Canada – has acquired Yale University oncology spinout Modifi Biosciences in a deal worth $1.3bn. The agreement gives Merck access to preclinical compounds designed to exploit DNA repair defects in difficult-to-treat cancers, including glioblastomas. Modifi, formed in 2021, has developed a new class of small molecules that target cancer cells lacking expression of a key DNA repair protein called MGMT. Approximately half of all glioblastomas and up to 80% of gliomas lack MGMT, which Modifi says makes these cancers a “natural first target” for its approach. Emerging research has also indicated that this MGMT deficiency is seen in many other tumour types. Merck has acquired all outstanding shares of Modifi for $30m upfront, with Modifi shareholders eligible to receive potential milestone payments totalling up to $1.3bn. David Weinstock, vice president, discovery oncology, Merck Research Laboratories, said: “DNA repair defects are a frequent hallmark of tumour cells and a major cause of resistance to cancer therapy. The… Modifi Biosciences team has developed an innovative approach that we believe has potential for treating some of the most refractory cancer types.” Also commenting on the deal, Modifi’s co-founder, Ranjit Bindra, said: “In founding Modifi Biosciences, we sought to radically change the oncology treatment paradigm for cancer patients with glioblastoma and other tumours. “We are honoured to have Merck recognise the potential of our science, and as an oncology company, [it is] perfectly positioned to advance our innovations through clinical trials and commercialisation.” Merck has made a number of acquisitions this year. In July, it completed its previously announced acquisition of EyeBio in a deal worth $3bn, giving it access to a late-stage candidate for diabetic macular oedema and neovascular age-related macular degeneration, as well as a preclinical pipeline targeting retinal diseases. The company also announced in April that it had acquired University at Buffalo laboratory spinout Abceutics in a deal worth $208m to improve antibody-drug conjugates safety, and acquired immuno-oncology company Harpoon Therapeutics and its pipeline of T-cell engagers for approximately $680m in March.

药械追踪 No.1 / 礼来阿尔茨海默病疗法多纳单抗在英国获批上市 2024年10月23日，礼来（NYS：LLY）宣布，英国药品和保健产品监管局（MHRA）已授予多纳单抗（donanemab）上市许可，每四周静注一次用于治疗英国符合条件的成年人因阿尔茨海默病引起的轻度认知障碍和轻度痴呆。 多纳单抗是继渤健和卫材的阿杜卡单抗（aducanumab）（现已撤市）以及卫材的乐意保（仑卡奈单抗）之后，第三种获得全球批准的抗淀粉样蛋白AD疗法。2024年7月，多纳单抗在美国获批上市，9月在日本获批上市。 在中国，礼来公司于2023年10月提交了多纳单抗的上市申请，并于当年11月获得优先审评资格，目前仍在审评中。 ->点击文末阅读原文，解锁完整双语新闻 No.2/ 灵北偏头痛疗法艾普奈珠单抗落地粤港澳大湾区 2024年10月23日，灵北旗下预防性治疗成人偏头痛的创新药物艾普奈珠单抗（Eptinezumab）通过“港澳药械通”正式落地粤港澳大湾区中山大学孙逸仙纪念医院。 艾普奈珠单抗已于2020年2月获美国FDA批准，适用于成人偏头痛的预防性治疗，这也是FDA批准的首个也是唯一经静脉注射使用的偏头痛预防性治疗的靶向CGRP的单克隆抗体类药物。2022年11月，艾普奈珠单抗落地海南博鳌乐城先行区。 ->点击文末阅读原文，解锁完整双语新闻 企业动态 No.1 / 默沙东斥资13.3亿美元收购新型肿瘤疗法开发商Modifi Biosciences 2024年10月23日，默沙东宣布收购Modifi Biosciences，获得其基于DNA修复缺陷治疗难治肿瘤的临床前分子。此次收购包括3000万美元的预付款和总计13亿美元的潜在分期付款。 Modifi Biosciences成立于2021年，致力于开发通过DNA修饰治疗肿瘤的新型药物。该公司基于从耶鲁大学获得的技术开发了一类新型小分子，针对缺乏关键DNA修复蛋白O6-甲基鸟嘌呤-DNA甲基转移酶（MGMT）的肿瘤细胞。 ->点击文末阅读原文，解锁完整双语新闻 全球医疗情报领导者 解锁隐藏在数据中的商业潜力  关于 G B I ” 自从2002年成立以来，GBI始终以技术为驱动，为药企、器械及行业相关服务商提供贯穿生命周期的全球药品市场竞争数据、全球行业资讯、HCPs洞察、全国医疗器械数据等商业信息与洞察，助力企业在进行战略布局和决策时，脱颖而出。历经20余年的深耕细作GBI已成为95%以上跨国药企、国内头部药企、咨询与投资机构等医疗圈灯塔用户值得信赖的长期合作伙伴。 联系我们 投稿 | 发稿 | 媒体合作 ▶ zhangxinyue13@baidu.com 数据库 | 咨询服务 | 资讯追踪 ▶ 点击左下“阅读原文”完成表单填写 点击阅读原文，解锁完整双语新闻

Modifi Biosciences, a spin out of Yale University founded in 2021, has been snapped up by Merck for $30 million paid upfront, and up to $1.3 billion in potential milestone payments. Modifi focuses on the development of small molecule drugs that target cancer cells with impaired DNA repair. “In founding Modifi Biosciences, we sought to radically change the oncology treatment paradigm for cancer patients with glioblastoma and other tumors,” said Ranjit Bindra, co-founder of Modifi Biosciences, professor of therapeutic radiology at Yale School of Medicine, and Scientific Director of the Yale Brain Tumor Center. “We are honored to have Merck recognize the potential of our science, and as an oncology company, they are perfectly positioned to advance our innovations through clinical trials and commercialization.” Modifi Biosciences has developed a new class of small molecule drugs that specifically target cancer cells that lack the expression of O6-methylguanine methyltransferase (MGMT), a protein that plays a key role in DNA repair. Mutations that affect DNA repair are common in cancer cells that can be exploited against them to treat drug-resistant forms of cancer. “DNA repair defects are a frequent hallmark of tumor cells and a major cause of resistance to cancer therapy,” said Dr. David Weinstock, vice president, discovery oncology, Merck Research Laboratories. “The talented Modifi Biosciences team has developed an innovative approach that we believe has potential for treating some of the most refractory cancer types.” googletag.cmd.push(function () { googletag.display('text-ad1'); }); Research published by Modifi’s scientific founders in 2022 showed that this approach had promising results in mouse models of drug-resistant glioma, a type of cancer that affects the brain and spinal cord. Since then, the company has been conducting preclinical trials in models of glioma and glioblastoma; It is estimated that up to 80% of gliomas and approximately half of all glioblastomas lack the MGMT protein, making these types of cancer the ideal first target for Modifi’s new drug class. “We designed our small molecules to have the ability to uniquely overcome clinical resistance mechanisms that have been known for decades but until now have been non-actionable. Additionally, we created the molecules in a manner which allows them to be rapidly progressed from bench-to-bedside,” said Seth Herzon, co-founder of Modifi Biosciences and Professor of Chemistry at Yale.