BIOSKILL: Studying Vacc-4x, an HIV therapeutic vaccine, an assessment of immune-mediated anti-viral effects, when administered with adjuvant GM-CSF prior to HIV latent reservoir activation by the HDAC inhibitor, romidepsin - BIOSKILL

开始日期2016-01-13

申办/合作机构

Bionor Pharma ASA

NCT02092116 / Completed临床1/2期

An Open Phase I/IIa Study to Evaluate the Safety and Effect of Therapeutic HIV-1 Immunization Using Vacc-4x + rhuGM-CSF and HIV-1 Reactivation Using Romidepsin on the Viral Reservoir in Virologically Suppressed HIV-1 Infected Adults on cART

The REDUC trial's objective is to address one of the core issues with the treatment of HIV, which is that some HIV infected cells hide in so-called latent reservoirs. The reservoirs are unaffected by conventional HIV medication and invisible to the immune system. HDACi have the potential to activate these latently infected cells. This will make the HIV infected cells visible to the immune system; the immune response generate by Vacc-4x will be able to attack and eliminate the infected cells.

开始日期2014-03-01

申办/合作机构

Bionor Immuno AS

[+1]

EUCTR2012-002281-12-DE / Not yet recruitingN/A

Re-boosting of Subjects Previously Included in the CT BI-Vacc-4x 2007/1 Study. An Open, Multicenter, Immunogenicity, Follow-up Reboosting Study with Vacc-4x in Subjects Infected with HIV-1 Who Have Maintained an Adequate Response to ART

开始日期2013-02-01

申办/合作机构

Bionor Immuno AS

100 项与 Bionor Pharma ASA 相关的临床结果

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0 项与 Bionor Pharma ASA 相关的专利（医药）

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项与 Bionor Pharma ASA 相关的文献（医药）

2018-07-31·AIDS

Differences in antiretroviral regimens do not impact safety or level of latency reversal in persons receiving romidepsin

Letter

作者: Søgaard, Ole S ; Tolstrup, Martin ; Østergaard, Lars ; Sommerfelt, Maja ; Leth, Steffen ; Jørgensen, Sofie

2018-04-01·JAIDS Journal of Acquired Immune Deficiency Syndromes

P-C1 Development of HIV-1 Immunotherapy with Vacc4x and Vacc-C5

作者: Smith, Peter ; Stjernholm, Grete ; Dalgleish, Angus ; Kvale, Dag ; Sommerfelt, Maja ; Sorenson, Birger ; Zeldis, Jerome ; Ökvist, Mats

HIV-1 immunotherapy offers an alternative to cART or as a “functional cure” by eliminating reactivated viral reservoirs. Both cellular and antibody mediated immune responses have been identified which are capable of reducing either HIV-1 infection risk or severity of infection. We present data on both T-cell based (Vacc4x) and antibody based (vacc-C5) vaccine antigen under development for HIV-1 immunotherapy.Vacc4x has undergone phase II trials demonstrating reductions in viral load and sustained anti-HIV-1 T-cell responses. Additional immune modulation, such as that used in cancer immunotherapy, may have utility in HIV-1 Immunotherapy. For this reason we combined Vacc4x with the immune modulator Lenalidomide both in vitro and in a phase I trial of 24 subjects in order to assess the ability of this combination to enhance CD4+ T cell responses. The combination was safe, well tolerated and demonstrated increases in CD4+ T-cell counts after a 2 week vaccine protocol.We have identified that antibodies specific for a heterodimeric peptide construct comprising the C5501-512 and gp41732-744 regions of the HIV envelope protein (Vacc-C5) are correlated with slow disease progression, lower viral load and markers of immune function in HIV-1 patients and are capable of mediating antibody dependent cytotoxicity. We conducted a phase I/II trial of 36 ART treated patients vaccinated with Vacc-C5 antigen. Vacc-C5 was safe, well tolerated and increased anti-Vacc-C5 titre in a subset of patients.These data support the continued development of Vacc4x, Lenalidomide and Vacc-C5 in an HIV-1 immunotherapeutic setting.

2018-03-01·AIDS Research and Human Retroviruses4区 · 医学

Postvaccination C-Reactive Protein and C5/gp41^732–744Antibody Level Fold-Changes Over Baseline Are Independent Predictors of Therapeutic HIV Vaccine Effect in a Phase 2 Clinical Study of Vacc-4x

4区 · 医学

Article

作者: Sommerfelt, Maja A. ; Jelmert, Øyvind ; Sanchez, Brittany ; Stjernholm, Grete ; Zhang, Lily ; Huang, Yunda ; Jolliffe, Darren ; Ökvist, Mats

Therapeutic vaccination has the potential to contribute to functional HIV cure strategies. However, to show functional HIV cure, study participants must be taken off combination antiretroviral therapy (cART). The availability of suitable biomarkers that can predict viral load (VL) or CD4 count outcomes following therapeutic HIV vaccination would reduce the risks associated with cART interruption in such studies. This report sought to determine baseline and postvaccination biomarker predictors of vaccine effect (VE) on VL and CD4 counts following cART interruption in a double-blind, randomized phase 2 study of the peptide-based therapeutic HIV vaccine, Vacc-4x (n = 93), versus placebo (n = 43). Antibody responses to a novel envelope glycoprotein antigen, C5/gp41^732-744, and three safety marker measurements [C-reactive protein (CRP), white blood cell, and lactate dehydrogenase] were considered. Interaction tests in univariate and multivariate linear regression models were used to estimate the effect of biomarkers on VE, defined as the VL or CD4 count difference in Vacc-4x versus placebo groups. The reported q-values (considered significant for hypothesis-generating purposes if ≤0.2) accounted for multiple comparisons using the false discovery rate method. Data were analyzed from all available 58 Vacc-4x and 25 placebo recipients before cART resumption. Lower postvaccination fold-change over baseline of CRP concentration (interaction p- (q-) value = 0.005 (0.11) for VL) and higher fold-change of anti-C5/gp41^732-744 antibody levels (0.005 (0.11) for VL and 0.009 (0.20) for CD4) were associated with Vacc-4x benefit. These findings suggest potential roles for inflammation and immune activation markers in predicting therapeutic HIV VE.

项与 Bionor Pharma ASA 相关的新闻（医药）

2024-03-18

·药明康德

速递 | 针对体内“垃圾”降解过程，超2500万英镑助力帕金森病创新疗法进入临床

▎药明康德内容团队编辑Mission Therapeutics日前宣布已完成2520万英镑融资，用于推进其治疗帕金森病和急性肾损伤的在研疗法的临床开发。本轮融资由现有投资者辉瑞Venture Investments、Sofinnova Partners、罗氏Venture Fund、SR One、IP Group和Rosetta Capital共同领投。Mission公司计划使用这些资金加速其主打候选药物MTX325和MTX652的临床开发。MTX325和MTX652都能抑制线粒体去泛素化酶（DUB）USP30。从而增加与损伤相关的线粒体泛素化，以促进线粒体自噬——细胞用来清除功能失常线粒体的必要过程。越来越多的科学证据将细胞内功能失常线粒体的积累与一系列疾病联系起来，包括帕金森病、肾病、心力衰竭和杜氏肌营养不良症（DMD）。MTX325是一种能够渗透进入中枢神经系统的药物，有潜力成为改变帕金森病疾病进程的治疗手段，它即将进入1期临床试验。而局限于在外周起作用的MTX652目前正在进行2期临床试验，用于治疗与心脏手术相关的急性肾损伤。▲Mission公司的研发管线（图片来源：Mission公司官网）去年11月，剑桥大学、哈佛大学和Mission Therapeutics的科学家在Nature Communications上发表论文，支持MTX325通过靶向USP30可以改变帕金森病进程的论点。通过使用USP30敲除小鼠模型和MTX325药物处理，他们发现抑制USP30可防止体内由α-突触核蛋白诱导的多巴胺能神经元损失。抑制USP30还降低了包括磷酸化α-突触核蛋白和胶质细胞激活在内的帕金森病潜在生物标志物水平。Anker Lundemose博士于2015年加入Mission Therapeutics，担任首席执行官。他是一位连续创业者，创立了多家成功的生物技术公司，并拥有广泛的国际医药、生物技术和投资者人脉。他目前是Commit Biologics董事会主席。在加入Mission Therapeutics之前，Lundemose博士是Bionor Pharma的首席执行官，并且是BioTesch Advice & Consultancy的管理合伙人。大家都在看药明康德为全球生物医药行业提供一体化、端到端的新药研发和生产服务，服务范围涵盖化学药研发和生产、生物学研究、临床前测试和临床试验研发、细胞及基因疗法研发、测试和生产等领域。如您有相关业务需求，欢迎点击下方图片填写具体信息。▲如您有任何业务需求，请长按扫描上方二维码，或点击文末“阅读原文/Read more”，即可访问业务对接平台，填写业务需求信息▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放参考资料：[1] Mission Therapeutics raises £25.2 million to progress clinical candidates in the area of mitophagy. Retrieved March 15, 2024, from https://missiontherapeutics.com/mission-therapeutics-raises-25-2-million-to-progress-clinical-candidates-in-the-area-of-mitophagy/免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

基因疗法临床1期临床2期

2023-01-26

·佰傲谷BioValley

艾滋病有可能治愈吗？HIV治疗的未来

自从1980年发现艾滋病，艾滋病的研究已经历经40多年，但是至今仍然没有治愈的方法。抗逆转录病毒疗法是一个重要的里程碑，改变了数百万患者的生活，现在目标仍然是找到艾滋病的治愈方法。艾滋病治愈有两个概念：一个是根除病毒，即HIV被完全从体内清除；另一个是功能性治愈，即在不进行药物治疗的情况下，病毒不复制，不发生传播。据联合国艾滋病规划署数据，目前全球范围内HIV携带者和艾滋病患者人数高达3800万人，且数量仍在快速增长中。攻克艾滋病仍然无数科研工作者和企业的目标。本文就来梳理一下目前艾滋病治疗最新的研究进展。被治愈的四例患者2008年，第一个被治愈艾滋病的蒂莫西·雷·布朗（TimothyRayBrown）被称为“柏林病人”。1995年29岁的布朗被诊断出患有艾滋病，2006年，他又被诊断患有急性骨髓性白血病。2007年，他接受骨髓移植来治疗白血病，医生在骨髓捐献者找到了一个CCR5-丁型-32基因突变的携带者，这种基因突变的基因天生免疫艾滋病毒。随后发现布朗不仅治好了白血病，体内的艾滋病毒也消失了。2020年，医学杂志《柳叶刀》发表的一项研究显示，一名艾滋病病毒携带者在两年多的时间里没有检测出活病毒，被认定为世界上第2例被治愈的HIV感染者。与“柏林病人”相似，被称为“伦敦病人”的亚当·卡斯蒂列霍（AdamCastillejo）是一名艾滋病毒携带者的同时，患有晚期淋巴瘤，同样也是接受了CCR5△32突变的骨髓移植。“柏林病人”的奇迹再次复刻。2022年2月15日，加州大学洛杉矶分校和约翰·霍普金斯大学的研究团队在逆转录病毒和机会性感染会议（CROI）上报告了一个艾滋病治疗案例：一名接受脐带血干细胞移植治疗急性髓细胞白血病的女性艾滋病患者，在停止艾滋病药物治疗后，已经长达14个月没有检测到HIV病毒了。同样又是CCR5Δ32/Δ32脐带血干细胞移植，这名患者被称为“纽约病人”。2022年7月27日，美国希望之城（CityofHope）的研究团队宣布，一名66岁的艾滋病患者被“治愈”，成为继继“柏林病人”、“伦敦病人”和“纽约病人”之后，第四位经干细胞移植实现艾滋病长期缓解的病例。这四位被治愈的患者的共同点是抖接受了CCR5基因突变的干细胞移植。揪出潜伏的HIV病毒HIV会将自己的遗传物质整合在人的DNA上并潜伏起来，这是治愈艾滋病的一大障碍。药物和免疫系统只能清除有表达的病毒和有被感染症状的细胞，整合在细胞内的HIV不能被发现形成病毒库，随时准备卷土重来。如果能有办法将“潜伏”起来的HIV揪出来，艾滋病的治疗将会有大大的改善。现在有多家企业正在探索这种治疗思路。HIV治疗领域的领导者吉利德，正在与西班牙生物技术公司AELIX合作研发这种疗法。吉利德自己的实验性抗病毒药物Vesatolimod可以将病毒从宿主DNA中踢出来，Vesatolimod是一种强效选择性口服TLR7激动剂，可直接激活浆细胞样树突状细胞，从而激活体内HIV的表达。AELIX的HTIT细胞疫苗则开始攻击病毒，HTI疫苗旨在将免疫反应重新聚集于HIV中特别易受攻击的部位，包括从潜伏病毒库中激活的病毒。美国的ViiVHealthcare也在进行临床前研究，以采取类似的方法将病毒推出宿主。其被称为IAP抑制剂的药物，可以激活细胞中的信号通路，可以诱导隐藏的HIV重新激活并变得可见，且不会对其他健康细胞产生任何重大影响。这项研究被《自然》杂志评为“2020年十大科学发现之一”。去年，一项研究发现，癌症药物PD-1单抗pembrolizumab（一种用于治疗黑色素瘤和其他癌症的免疫检查点抑制剂）可以将HIV从免疫细胞中的储库中清除出来。抗PD-1单抗与抗逆转录病毒协同作用，有助于艾滋病的治疗甚至治愈。挪威的一家公司Bionor正在测试三种不同的治疗策略。该公司正在开发一种阻止病毒复制的抗体疫苗，一种用来杀死病毒库的T细胞疫苗，以及一种干扰HIV病毒进入人体细胞能力的候选肽药物。免疫疗法艾滋病毒之所以如此危险，是因为它会攻击免疫系统，使人们无法抵御其他病毒、病菌的感染。免疫疗法旨在增强免疫细胞对抗病毒的能力。对于免疫疗法来说，疫苗是最受关注的。HIV疫苗的研发方向包括两种：一种是预防性疫苗，即接种疫苗可以预防感染HIV或者防止疾病进展；另一种是治疗性的疫苗，这是给已经感染HIV的患者使用，目的是增强免疫系统，使身体能够减少或根除病毒。同样是和吉利德合作，AELIX正在进行其治疗性HTI疫苗的1期临床试验。去年最新的临床研究结果发表在《自然医学》上。接受该疗法的患者停止了抗逆转录病毒治疗。首次证明了T细胞疫苗可以帮助控制艾滋病毒。欧洲艾滋病疫苗倡议正在临床试验中测试多种疫苗，使免疫系统更好地对抗艾滋病毒。这些疫苗包括：T细胞、B细胞疫苗和mRNA疫苗，可以在患者无药的情况下实现HIV缓解。牛津的Immunocore公司设计了一种T细胞受体，可以寻找并结合HIV，并指示免疫T细胞杀死任何HIV感染的细胞，包括HIV潜伏的细胞，即使是在HIV水平非常低的情况下。该疗法于2022年7月进行了首位患者给药。HIV逃避免疫系统的方法之一是通过快速，随机的突变。为了靶向变异的病毒，ViiVHealthcare的研究人员开发了广泛中和抗体（bNAb），可以靶向和中和许多不同的HIV变体。去年10月，ViiVHealthcare发布了其bNAb的2a期试验结果，表明单次输注具有很强的抗病毒功效。阻止病毒复制功能性治愈HIV的另一种方法是阻止病毒复制。虽然不能完全摆脱病毒，但是可以让病毒量维持在一个较低的水平，并阻止它传播。目前主流的HIV治疗方法“鸡尾酒”就是多种抗逆转录药物联用来最大限度地抑制病毒的复制。德国Bicoll公司与亥姆霍兹慕尼黑中心合作，开发了一类新型HIV抑制剂，该抑制剂基于聚酮金氨酸的全合成衍生物，聚酮金氨酸是一种在链霉菌中发现的分子。虽然仍处于开发的早期阶段，但这些化合物被发现对HIV-1和HIV-2具有活性。“天然产品是灵感的重要来源，”Bicoll董事会主席MariaLamottke说。“凭借Bicoll在药物化学和天然产物方面的专业知识，我们可以将其从想法推进到临床前潜在药物。基因编辑从前面提到的4位被治愈的艾滋病感染者，可以得知一个关键的基因突变——CCR5，拥有这个基因突变的人天生免疫艾滋病毒，但是这个世界上只有不到1%的人才会拥有这个突变。其原理是CCR5是HIV病毒用来进入并感染免疫细胞表面的一种蛋白质。CCR5相关基因突变的人缺少CCR5蛋白的组分，使得HIV不能与之结合。理论上可以通过基因编辑来人工制造这种突变。美国的Sangamo公司十年前就通过从患者体内提取T细胞，并编辑这些细胞，然后重新注回患者体内，从而实现免疫HIV。但是这种结果并不理性，不仅没有治愈，还出现了很多严重的副作用。2019年，贺建奎使用基因编辑创造的“基因编辑婴儿”轰动科学界。他是对生殖细胞进行了基因编辑，使得一对婴儿从出生就携带CCR5突变。但是后续研究表明，携带这些突变的人可能会发生某些感染导致英年早逝。贺建奎也因为违法科学伦理，被判入刑。前路仍然困难重重治愈艾滋病仍然面临着多重挑战，阻碍HIV治疗最大的障碍就是HIV病毒的快速变异和产生耐药能力，前面介绍的这些治疗方法，仍没有关于病毒是否会产生耐药性的证据。虽然不同的研发思路都有很多疗法，但是这些疗法极少数能到达后期临床试验，过去几年里有几家企业放弃了他们的艾滋病研究项目。2021年，强生公司撤回了一项2B期疫苗研究，该研究显示保护有限。强生正在美国和欧洲进行3期试验中继续使用不同的疫苗方案测试这种方法。Moderna是COVID-19mRNA疫苗的早期开发商之一，于2022年1月开始了两项2期试验，测试一种针对HIV的mRNA疫苗。Covid-19疫苗的急速进展为其他疫苗的开发也带来了好处，但是艾滋病mRNA疫苗能否从中获益仍然是扑朔迷离。总结目前艾滋病的治疗研究仍然是围绕几个主要思路，如何把整合在DNA上的HIV激活，清除病毒库；借助免疫系统来应对病毒；组织病毒的复制；使用基因编辑技术。这些研究路径都不断有着最新进展，但是大部分都是处在理论阶段，实际实践中，往往会更加复杂。关于艾滋病的研究仍然是道阻且艰。参考来源：1.https://www.labiotech.eu/in-depth/hiv-cure-research/2.https://mp.weixin.qq.com/s?__biz=MzIxMDM4NzA3NQ==&mid=2247490362&idx=1&sn=40f7d4a550d862b19f7e1f0de7886e48&chksm=976432d6a013bbc0edb3044cb30990d46f73c8a4a99ac973abd1fd1aefb52def3490406c94c7&scene=273.https://www.sohu.com/na/455245231_1210266464.https://news.antpedia.com/p/250375104.html5.https://www.vodjk.com/news/181022/1515701.shtml6.https://new.qq.com/rain/a/20210628A089TA00近期热门视频更多精彩视频，尽在佰傲谷视频号，欢迎关注~本周好文推荐如需转载请联系佰傲谷并在醒目位置注明出处﹀‍ 点亮在看，传递信息♥

临床研究

2012-01-23

·BioSpace

With Final Documentation Submitted for International Patent Applications, Bionor Pharma ASA Sees Promise of Two Core Platform Technologies

OSLO, NORWAY--(Marketwire - January 23, 2012) - Highlighted Links Bionor Pharma corp site News Summary Bionor Pharma ASA has previously submitted two international patent applications for the Company's core platform technologies, supporting all products in the pipeline. Bionor today announces that final additional data have been submitted for both applications, within the deadline of 12 months. Bionor Pharma ASA (OSLO: BIONOR) today announced that its submission has been completed for two applications of Intellectual Property that will provide general platform protection for the Company's development of peptide vaccines for cellular immunity (such as the HIV therapeutic vaccine Vacc-4x) and humoral immunity (such as the HIV therapeutic / preventive vaccine Vacc-C5). About the platform patent technologies The immune system induces cellular immunity to kill virus infected cells, and humoral immunity to generate antibodies that can bind virus particles and aid in their elimination. The submitted data complete the international patent applications of the two platform technologies that were made on December 2nd, 2010 and January 6th, 2011 respectively. Bionor Pharma's technology is based on identification of conserved peptide regions on proteins important for viral propagation, followed by modifications of these peptides to enhance immune responses. The data submitted supports properties to be protected by the platform patents involving general means to enhance these immune responses. These common properties have been used in the development of current and future specific vaccines, such as for HIV (Vacc-4x and Vacc-C5), Influenza A (Vacc-Flu) and Hepatitis C (Vacc-HCV). "The submission of these new additional data creates a solid foundation for Bionor's current and future IP," said Steen Krøyer, CEO of Bionor Pharma. "Since an essential part of our company's assets are intellectual property, we therefore believe this will strongly benefit the funding of our clinical programs and bring value to the partnering processes." About the vaccine products, developed from the two platform technologies HIV/AIDS The therapeutic HIV vaccine Vacc-4x is the Company's lead investigational product, and has completed a Phase IIb multinational, placebo controlled double-blind trial, which found a statistically significant reduction in viral load in treated subjects. Patients given the vaccine were 70 percent more likely to remain off ART (conventional medicine) two years after being injected with the vaccine. Vacc-C5 is developed to induce antibodies to HIV that can reduce immune hyper activation associated with HIV infection. Bionor intends to bring Vacc-C5 into the clinic in 2Q 2012. Because researchers have already found that patients with antibodies to the C5 region on HIV have little virus in their blood and slow disease progression, Bionor anticipates that Vacc-C5 will offer an important weapon towards finding a functional cure for HIV. Vacc-4x in combination with Vacc-C5 can potentially revolutionize the management of HIV infection and could form the basis for a preventive HIV vaccine. Influenza A Vacc-Flu is in preclinical research, which is expected to finish by the end of 2012. Vacc-Flu will then be prepared for clinical development and partnering process. Vacc-Flu is a universal Influenza vaccine that researchers hope will be effective against all variations of the Influenza A virus, and lasting for several years before revaccination is necessary. Hepatitis C Vacc-HCV is also in preclinical phase which is expected to be finalized during 2012. Vacc-HCV will then be prepared for clinical development and partnering process. "Because Vacc-Flu and Vacc-HCV are based on peptides with similar vaccine design as for Bionor's other vaccines, which have shown no serious side effects in human trials, we are optimistic that also these candidates will be continued into human trials," said Mr. Krøyer. About Bionor Pharma Bionor Pharma ASA is a Norwegian biopharmaceutical company based in Oslo, Norway. The Company's innovative peptide vaccine technology platforms are well suited to the development of vaccines for a wide range of viral diseases, such as HIV/AIDS, Influenza, HCV (Hepatitis C) and HPV (Human Papilloma Virus). Bionor's proprietary technology platforms are developed following more than ten years of research on peptides. The vaccines are designed to safely activate each person's immune system to combat a specific viral disease. Bionor seeks to create positive cash flow at an early stage of development by signing partnering deals with biotech and pharmaceutical companies. This includes short-term out-licensing of products with royalty payments or direct funding of clinical trials, such as Bionor's agreement signed in August 2011 with one of the world's largest biotech companies. The collaboration includes a clinical trial on patients with HIV using a combination of Vacc-4x, and the cancer drug Revlimid® (Lenalidomide). More information about Bionor Pharma, its research and products, is available at . Contacts Bionor Pharma ASA Oslo: +47 23 01 09 60 Skien: +47 35 90 85 00 Steen Kroyer CEO Birger Sorensen EVP Head of Vaccines USA Contact: David Sheon 202 422-6999 Email Contact Digg this Bookmark with del.icio.us Add to Newsvine Technorati: HIV vaccine AIDS new drug Bionor Bionor Pharma

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药物(靶点)	适应症	全球最高研发状态

Vacc-C5 ( HIV envelope protein gp120 )	HIV感染更多	临床2期
CRX (Bionor Pharma)	HIV感染更多	临床前
HIV vaccine(Bionor Pharma ASA)	HIV感染更多	终止
Vacc-4s	HIV感染更多	无进展
罗米地辛 ( HDACs )	HIV感染更多	无进展