Lenacapavir Sodium

The 25th International AIDS conference will take place in Munich, Germany, between 22 and 26 July. Image credit: Shutterstock / wavebreakmedia. Researchers will present data from a ‘first-of-its-kind HIV cure’ stem cell transplant at the upcoming AIDS 2024 Conference. Experts will share information about the “next Berlin Patient”, who appears to be the world’s seventh person cured of HIV following a stem cell transplant- but the first HIV cure case in which the donor had a single, rather than double, CCR5-delta32 mutation, which could have promising implications for future research. The 25th International AIDS Conference will be held between 22 and 26 July in Munich, Germany. The “next Berlin Patient” had both leukaemia and HIV and received a stem cell transplant for the former in late 2015. In late 2018, he stopped taking antiretroviral treatment for HIV and most recent investigations show he remains in HIV remission. “A healthy person has many wishes, a sick person only one,” said the next Berlin Patient, who has chosen to remain anonymous. See Also: Conflict means millions of children are missing vaccinations, UN says Moderna and Mitsubishi Tanabe link on mRNA vaccines in Japan The research, led by Christian Gaebler, professor at Charité, Universitätsmedizin, Berlin, explains that donors who provide the double mutation, one from each parent, are essentially immune to HIV, which is why the transplant has been effective. A stem cell transfer of the double mutation led to the first patient, being ‘cured’ of HIV. Meanwhile, donors with one copy of the mutation can acquire HIV, but the virus generally progresses slowly if they do not receive antiretroviral treatment. The reason this is such a notable result is that significantly more people have the single mutation than the double mutation, meaning it would make it easier to access the transplant. IAS president Sharon Lewin said: “We’re seeing impressive innovation across the entire spectrum of HIV research . For these advances to have a real-world impact, we must put people first and keep delivery and access concerns front and centre.” There will also be a poster presentation of UNAIDS-led projections showing that without bold action, there could be nearly 35 million new HIV acquisitions and nearly 18 million AIDS-related deaths between 2021 and 2050. AIDS 2024 will also include a presentation with late-breaking full results from Gilead’s PURPOSE 1 trial of long-acting injectable lenacapavir for HIV prevention. Last month, topline results from an interim analysis of the trial indicated that injectable lenacapavir demonstrated a 100% efficacy for HIV prevention in cisgender women. Research suggests that doxycycline pre-exposure prophylaxis (DoxyPrEP) is a promising strategy for preventing sexually transmitted infections (STIs), with a Phase IV trial (NCT03980223) by the University of California showing a 79% reduction in syphilis, a 92% reduction in chlamydia and a 68% reduction in gonorrhoea in the doxycycline arm compared with the placebo arm. Another presentation will look at real-world evidence showing that long-acting injectable cabotegravir (CAB-LA) is a popular and feasible HIV prevention option for women and men in Africa.

7月17日，吉利德宣布，首席医学官Merdad Parsey博士将于明年初离开公司。而此时吉利德的产品线已经停滞不前，在癌症药物开发方面也面临着几次重大挫折。在继任者就位前，Parsey 博士将留任至2025年第一季度。 今年以来，吉利德的股票下跌了10%，但在周三宣布这一消息后上涨了2.39%。 Jefferies 分析师 Michael Yee 在给投资者的一份报告中写道：“过去几年，围绕新药研发成功和失败，重大争议一直持续不断。期望值的不断降低是导致Gilead股价表现不佳的主要驱动因素。不管是否属实，市场都将此次领导层的变动视为研发领域发生新变革的机会。” 2019年11月，就在Covid-19 大爆发之前，Parsey博士加入吉利德，负责监督公司的全球临床开发和医学事务组织。任职期间，他领导了开发组织的发展，特别是推进了市场领先的病毒学治疗方法，并建立了吉利德的肿瘤学管线和治疗药物。 在他领导下，该公司开发了第一种 Covid 治疗药物，最终以 Veklury 的名称上市。 Merdad Parsey，吉利德首席营销官 2020 年，吉利德达成了两项重大交易，旨在将其业务扩展到病毒学之外。 2020年4月，以 49 亿美元收购了斯坦福大学干细胞研究员Irv Weissman的初创公司Forty Seven，获得 CD47 抗体 magrolimab ，认为Magrolimab可以为公司在广泛的血液类癌症和实体瘤打开新机会。 2020年9月，以 210 亿美元收购了肿瘤学公司 Immunomedics，获得主要药物靶向TROP-2 ADC药物Trodelvy。 然而，这两次大手笔收购的药物临床试验可谓是“全军覆没”。 2024年2月，吉利德终止了CD47 抗体 magrolimab在所有血癌中的研发，并在4月底完全放弃这款单抗，magrolimab在3期临床试验失败，其中一项试验中死亡人数增加，FDA也要求部分临床试验暂停。 雪上加霜的是，Trodelvy在今年1月的非小细胞肺癌三期试验失败后，在膀胱癌研究中也未能取得进展，这是一个重大打击。Trodelvy的接连失败让吉利德扩大肿瘤业务的计划泡汤。尽管如此，Gilead仍未放弃该药物，表示将继续致力于在其他癌症类型中的应用。此前，Trodelvy还被成功批准用于治疗HR阳性/HER2阴性乳腺癌。 虽然吉利德的肿瘤业务面临几次重大挫折，但在吉利德成名领域—艾滋病毒治疗方面传来了好消息。 长期以来，艾滋病毒治疗一直是吉利德研究的重点。6月20日，吉利德宣布，每年2次的暴露前预防注射剂lenacapavir在一项 3 期研究中取得了成功。关键的3期PURPOSE 1临床试验中期分析顶线结果显示，注射用HIV-1衣壳抑制剂lenacapavir在针对顺性别女性的HIV预防研究中展示出100%的有效性。 目前，Gilead正在进军热门的肥胖症治疗领域，投资了一些肥胖和代谢疾病治疗的早期研究项目。 上个月，Gilead在美国糖尿病协会会议上分享口服GLP-1类药物GS-4571的最新临床前数据。临床前肥胖症项目证明，在28到30天内能够让非人灵长类动物体重减轻了5%-8%，并在减少食物摄入的同时提高了葡萄糖耐量，这与其他口服版GLP-1类药物的效果相当，这使吉利德的股价直接上涨了几个百分点。 Gilead董事长兼首席执行官Daniel O'Day表示：“我谨代表吉利德的每个人，感谢Merdad在过去五年中作为我们的首席医疗官做出的重大贡献。对于公司来说，这是关键的几年，我们努力加强和多样化产品组合，Merdad在我们的成功中发挥了重要作用，在Merdad的领导下，我们的产品组合增加了一倍多，并且在病毒学、肿瘤学和炎症学方面进行了54项正在进行的临床试验，我们有能力在未来取得成功的基础上再接再厉。” Parsey 博士说：“很荣幸能够领导开发团队，尤其是在我们努力为 HIV、COVID-19 和癌症患者提供变革性药物的情况下，我对我们为建立强大、多样化的临床管线所做的工作深感兴奋，该管线具有巨大的潜力，可以兑现我们改善世界各地人民健康的承诺。” 参考资料： 1.https://endpts.com 2.https://www.gilead.com/ End 声明：本公众号所有发文章(包括原创及转载文章)系出于传递更多信息之目的，且注明来源和作者。本公众号欢迎分享朋友圈或大群，谢绝媒体或机构未经授权以任何形式转载至其他平台。 转载/商务/投稿 | 联系微信 wfj_GM 商务合作 稿件征集 点击了解详情 往期回顾 1 5月| 20家药企裁员（附名单） 2 18亿美元，ADC又出海! 宜联生物宣布新授权 3 2024 ASCO| 默沙东/科伦TROP2 ADC、信达、礼新CLDN18.2 ADC数据公布