IDO-de rived can cer vac cine scores in com bo tri al with Keytru da; Vir teams up with WuXi on coro n avirus an ti bod ies

IDO-de 铆钉可以在 com 上与 Keytru da 的三人组比赛中控制 vac 电影得分; Vir 团队与 WuXi 一起在 coro n avirus 和 ti body 上比赛

2020-02-26 01:00:16 ENDPOINTS NEWS

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→ Copen­hagen-based IO Biotech said that its can­cer vac­cine has passed the high bar set for its in­ter­im fu­til­i­ty analy­sis in Phase II, show­ing “a sub­stan­tial­ly high­er” over­all re­sponse rate among non-small cell lung can­cer pa­tients when com­bined to Keytru­da than the PD-1 alone —which ac­cord­ing to the com­pa­ny in­duced his­tor­i­cal ORR of 39%. In­ves­ti­ga­tors will car­ry on eval­u­at­ing IO-102 plus Keytru­da, with fi­nal da­ta ex­pect­ed by the end of the year. The can­di­date is an IDO-de­rived pep­tide se­quence de­signed to stir up T cell ac­tion against IDO — the en­zyme tar­get for an ill-fat­ed class of small mol­e­cule drugs.“In that sense you have flags on the sur­face of [tu­mor cells] that our T cells can rec­og­nize and there­by ac­tu­al­ly get rid of those IDO pos­i­tive cells,” CEO Mai-Britt Zoc­ca told End­points News. “And this is ac­tu­al­ly me­di­at­ing change of the tu­mor mi­croen­vi­ron­ment.” IO Biotech is fund­ing the study while part­ner Mer­ck gets to share the re­sults. A cock­tail of IO102 and IO103 — which di­rects T cells against PD-L1 — is be­ing test­ed in com­bi­na­tion with Op­di­vo for melanoma pa­tients. → A month af­ter join­ing the hunt for an­ti­bod­ies that could treat Covid-19, Vir Biotech­nol­o­gy is en­list­ing WuXi Bi­o­log­ics to do the cell-line de­vel­op­ment, process and for­mu­la­tion de­vel­op­ment as well as ini­tial man­u­fac­tur­ing. The San Fran­cis­co-based start­up said it’s iden­ti­fied a num­ber of mon­o­clon­al an­ti­bod­ies that bind to SARS-CoV-2, iso­lat­ed from in­di­vid­u­als who had sur­vived SARS. A deal with WuXi — which gives the pow­er­ful CRO rights to com­mer­cial­ize in Chi­na — po­si­tions them for quick ad­vance­ment, CEO George Scan­gos said. → As­traZeneca has di­vest­ed an­oth­er gas­troin­testi­nal drug, col­lect­ing $52.5 mil­lion up­front from Red­Hill Bio­phar­ma for par­tial rights to Movan­tik. The drug, which was orig­i­nal­ly de­vel­oped by Nek­tar Ther­a­peu­tics to treat opi­oid-in­duced con­sti­pa­tion, gen­er­at­ed US sales of $96 mil­lion last year (Dai­ichi Sankyo shares some of the prof­its). As­traZeneca will con­tin­ue to sup­ply the drug for a while. → Parisian biotech Sci­pio bio­science, which helps re­search and clin­i­cal labs with sin­gle-cell se­quenc­ing, has se­cured €6 mil­lion in Se­ries A fund­ing. The mon­ey will fu­el the fi­nal de­vel­op­ment of its sin­gle-cell RNA-se­quenc­ing kit, as well as mar­ket­ing and busi­ness de­vel­op­ment ef­forts to pre­pare for com­mer­cial launch in 2022. By Mwango Kashoki, MD, MPH, Vice President-Technical, and Richard Macaulay, Senior Director, of Parexel Regulatory & Access In recent years, we’ve seen a significant uptake in the use of regulatory options by companies looking to accelerate the journey of life-saving drugs to market. In 2018, 73% of the novel drugs approved by the U.S. Federal Drug Administration (FDA) were designated under one or more expedited development program categories (Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval).ᶦ A year ago, Biogen made a big bet on a small gene therapy company. Now they have new evidence one of their therapies could work. As the world becomes increasingly dependant on Asia for the ingredients of its medicines, Sanofi sees business to be done in Europe. The French drugmaker said it’s creating the world’s second largest active pharmaceutical ingredients (API) manufacturer by spinning out its six current sites into a standalone company: Brindisi (Italy), Frankfurt Chemistry (Germany), Haverhill (UK), St Aubin les Elbeuf (France), Újpest (Hungary) and Vertolaye (France). They have mapped out €1 billion in expected sales by 2022 and 3,100 employees for the new operations headquartered in France. ICER appears to have reversed course on the fresh crop of acute migraine therapies. The cost-effectiveness watchdog in November issued a draft report suggesting that existing generic medicines are more effective and cheaper than Allergan’s December-approved CGRP ubrogepant, Biohaven rival molecule, rimegepant (which is under FDA review), and Lilly’s October-sanctioned lasmiditan, which binds to 5-HT1F receptors. Off it goes. Moderna has shipped the first batch of its mRNA vaccine against SARS-CoV-2 from its manufacturing facility in Norwood, Massachusetts, to the National Institute of Allergy and Infectious Diseases in Bethesda, Maryland, for a pioneering Phase I study. It’s a hectic race against time. In the 42 days since Moderna selected the sequence they would use to develop their vaccine — a record time, no less — the number of confirmed cases around the world has surged astronomically from a few dozen to over 80,000, per WHO and Johns Hopkins estimates. The candidate that they came up with, mRNA-1273, encodes for a prefusion stabilized form of the spike protein, which gives the virus its crown shape and plays a key role in transmission. The Coalition for Epidemic Preparedness Innovations, the Oslo-based group better known as CEPI, funded the manufacture of this batch. Bicycle Therapeutics — which is developing a new class of chemically synthesized drugs designed to be pharmacologically as active as biologics, yet manufactured as small molecules —  has scored another big partner: Roche’s Genentech. In a union of two of the hottest trends in the US biopharma world, ICER is teaming up with a high-profile company to integrate real-world evidence in their assessment of treatment value. The drug pricing watchdog — formally the Institute for Clinical and Economic Review — said it will utilize Aetion’s evidence platform in “select upcoming assessments” and their new 24-month re-evaluations of drugs granted accelerated approval by the FDA. The first US clinical trials on the novel coronavirus are scheduled to get underway next month at the University of Nebraska Medical Center, where American passengers were taken after being evacuated from the Diamond Princess cruise ship, and at the Kaiser Permanente Washington Health Research Institute. Both trials are sponsored by the NIH’s National Institute for Allergy and Infectious Diseases, which has led the US’s medical response to the outbreak. Three years after it first paid out fines for its role in the US opioid abuse epidemic, Mallinckrodt has announced an agreement-in-principle that will see the company pay out $1.6 billion and place its generics unit in bankruptcy. The tentative deal would settle hundreds of lawsuits from state and local governments over Mallinckrodt’s role in the epidemic, while also helping address the company’s increasingly mountainous debt. Although Purdue Pharma has drawn the bulk of both public and legal acrimony for opioid sales, documents made public earlier this year showed that Mallinckrodt subsidiary SpecGx, along with the generic subsidiaries of Teva and Endo Pharmaceuticals, accounted for the vast majority of the 76 billion opioid pills distributed from 2006 to 2012. Mallinckrodt was at the top of that list.
总部位于哥本哈根的 IO 生物技术公司表示,其癌症疫苗已经通过了第二阶段中期无效分析的高标准。非小细胞肺癌患者与可瑞达(Keytruda)联合使用时的整体反应率“显著高于” PD-1单独使用时的整体反应率,根据该公司诱导的历史 ORR 为39%。 调查人员将对 IO-102和可瑞达(Keytruda)进行评估,预计年底会有最终数据。该候选人是一个 IDO 衍生的肽序列,旨在激发 T 细胞对 IDO 的作用-酶目标的一类低脂肪小分子药物。“从这个意义上说,我们的 T 细胞可以识别肿瘤细胞的表面,从而真正摆脱这些 IDO 阳性细胞,”首席执行官 Mai-Britt Zocca 告诉 Endpoints News 。“这实际上是在调节肿瘤微环境的变化。” IO 生物技术公司正在资助这项研究,而合作伙伴默克(Merck)公司将分享研究结果。一种 IO102和 IO103的鸡尾酒——它引导 T 细胞对抗 PD-L1——正在与 Opdivo 联合检测黑色素瘤患者。 →在加入可治疗 Covid-19抗体的搜寻工作一个月后, Vir Biotechnology 正在招募 WuXi Biologics 做细胞线开发、工艺和配方开发以及初期制造。这家总部位于旧金山的初创公司表示,他们发现了一些与 SARS 病毒-CoV-2结合的单克隆抗体,这些抗体是从 SARS 患者中分离出来的。该公司首席执行官乔治•斯堪戈斯( George Scanggos )表示,与药明康德( WuXi )达成的一项协议,将使它们处于快速发展的地位。 →阿斯利康(AstraZeneca)剥离了另一种胃肠道药物,从红山生物制药公司获得了5250万美元的预付款,以获得 Movantik 的部分权利。该药物最初由 Nektar Therapeutics 研发,用于治疗阿片引起的便秘,去年在美国的销售额为9600万美元(第一三共(Daiichi Sankyo)分享了部分利润)。阿斯利康(AstraZeneca)将继续供应这种药物一段时间。 →巴黎生物科技公司 Scipio Bioscience ,帮助研究和临床实验室进行单细胞测序,已经获得了600万欧元的 A 系列资金。这笔资金将推动其单细胞 RNA 测序工具的最终开发,以及营销和业务开发工作,为2022年的商业发射做准备。 由 Mwango Kashoki 、 MD 、 MPH 、技术副总裁和 Parexel Regulatory & Access 高级总监 Richard Macaulay 担任 近年来,我们看到,寻求加快拯救生命药物上市进程的公司在使用监管选择方面取得了显著进展。2018年,73%经美国联邦药物管理局( FDA )批准的新药被指定为一个或多个快速发展计划类别(快速通道、突破性治疗、优先审评、加速审批)。\7590; 一年前,百健(Biogen)在一家小型基因治疗公司上下了大赌注。现在他们有了新的证据,他们的一种疗法可以奏效。 随着世界对其药品成分越来越依赖亚洲,赛诺菲(Sanofi)预计欧洲的业务将会开展。 这家法国制药商表示,将目前的6个生产基地分拆为一家独立的公司,从而创建了全球第二大原料药(API)制造商:布林迪西(意大利)、法兰克福化学(德国)、哈弗希尔(英国)、圣奥宾·埃尔比夫(法国)、 jpest (匈牙利)和 Vertorolaye (法国)。他们计划到2022年实现10亿欧元的预期销售额,并为总部位于法国的新业务安排3100名员工。 ICER 似乎已经逆转了新的急性偏头痛治疗作物的进程。 成本效益监管机构去年11月发布了一份报告草案,建议现有的仿制药比艾尔建(Allergan)去年12月批准的 CGRP 受体、 Biohaven 竞争对手分子、 Rimegap (正在接受 FDA 审查)和礼来(Lilly)10月份批准的与5-HT1F 受体结合的 lasmitan 更有效、更便宜。 它走了。 Moderna 已将第一批针对 SARS-CoV-2的 mRNA 疫苗从位于马萨诸塞州诺伍德的生产工厂运往马里兰州贝塞斯达的国家过敏和传染病研究所,进行第一阶段的开创性研究。 这是一场与时间竞争的激烈竞赛。根据世卫组织和约翰霍普金斯的估计,自 Moderna 选择用于开发疫苗的序列以来的42天里,世界各地确诊病例的数量从几十例猛增到8万多例。 他们提出的候选人, mRNA-1273编码的预灌注稳定形式的尖峰蛋白,使病毒的冠状,并发挥关键作用的传播。位于奥斯陆的组织“流行病防备创新联盟”资助了这批产品的生产。 Bicycle Therapeutics 正在开发一种新型的化学合成药物,其设计的药理活性与生物制剂一样,但却是小分子药物。该公司已获得另一个大合作伙伴:罗氏(Roche)的基因技术公司( Genentech )。 在美国生物制药领域两大最热门趋势的结合中, ICER 正与一家知名公司合作,将真实世界的证据纳入其治疗价值评估。 药品定价监管机构——正式的临床和经济评估协会( Institute for Clinical and Economic Review )表示,将利用 Aeion 的证据平台“选择即将进行的评估”,并对 FDA 批准加速审批的药品进行为期24个月的重新评估。 美国对新型冠状病毒的首次临床试验计划于下月在内布拉斯加州大学医学中心进行。在该中心,美国乘客在从钻石公主游轮撤离后被带走,在凯撒永久居民华盛顿健康研究所。这两项试验都是由美国国立卫生研究院( NIH )国家过敏和传染病研究所( National Institute for Allergy and Infective Diseases )赞助的,该研究所领导着美国对疫情的医疗反应。 三年前, Mallinkrodt 首次因在美国阿片类药物滥用流行病中扮演的角色而被罚款后,该公司宣布了一项原则上的协议,将支付16亿美元,并将旗下仿制药部门破产。 这一初步协议将解决州和地方政府对 Mallinkrodt 在疫情中的角色提出的数百起诉讼,同时也有助于解决该公司日益沉重的债务问题。尽管普渡制药公司已经吸引了大部分的公共和法律上的鸦片类药物销售,但今年早些时候公开的文件显示, Malinckrodt 子公司 SpecGx ,连同梯瓦(Teva)和远藤(Endo)制药的仿制药子公司,在2006年至2012年分配的760亿个阿片类药物中占了绝大多数。Mallinkrodt 在这份名单上名列前茅。

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