Phase 1 Randomised, Single-centre, Observer-blind, Placebo-controlled Trial of Safety and Immunogenicity of EN41-UGR7C HIV Vaccine Candidate Administered Intramuscularly in Healthy Female Volunteers

The purpose of the clinical trial is to evaluate the safety and immunogenicity in female volunteers of EN41-UGR7C vaccine candidate adjuvanted with Alum using IM administration. The objective of the immunisation is to induce mucosal and systemic binding and neutralizing antibodies against HIV in order to block the virus on the mucosal surface and neutralise the viral particles that may eventually succeed in crossing the mucosal barrier.
This is a Phase 1 exploratory study. EN41-UGR7C will be administered for the first time in humans.
Volunteers who are vaccinated with EN41-UGR7C may develop an immune response against HIV, but its ability to induce meaningful protection against HIV will not be known before Phase 3 efficacy trials are completed, as correlates of protection against HIV are not yet clearly defined.
Consequently, there is no direct benefit to volunteers. They will be reimbursed for their time and travel.

开始日期2013-04-01

申办/合作机构

PX Therapeutics SA

NCT01509144 / Completed临床1期

Phase 1, Randomised, Single-centre, Observer-blind Clinical Trial of Safety and Immunogenicity of Nasal-prime and Intramuscular Boost Immunisation With EN41-FPA2 HIV Vaccine in Healthy Female Volunteers

Objectives:
To assess the safety of three priming immunisations by nasal route followed by two booster immunisations by intramuscular route
To assess immunogenicity responses induced by the vaccine.

开始日期2012-01-01

申办/合作机构

PX Therapeutics SA

100 项与 HIV vaccine(PX Therapeutics SA) 相关的临床结果

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100 项与 HIV vaccine(PX Therapeutics SA) 相关的转化医学

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100 项与 HIV vaccine(PX Therapeutics SA) 相关的专利（医药）

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项与 HIV vaccine(PX Therapeutics SA) 相关的文献（医药）

RSC Advances

Adsorptive separation of para-xylene by nonporous adaptive crystals of phenanthrene[2]arene

Article

作者: Ding, Man-Hua ; Tang, Lin-Li ; Duan, Yin-Rong ; Zeng, Fei ; Hou, Ying

A new method for the preparation of phenanthrene[2]arene on a large-scale was developed. The synthetic phenanthrene[2]arene has been successfully used as nonporous adaptive crystals for the separation of para-xylene from xylene isomers.

项与 HIV vaccine(PX Therapeutics SA) 相关的新闻（医药）

2023-02-26

·药明康德

多款基因疗法使患者获益长达数年、HIV疫苗组合疗法展现积极疗效... | 一周盘点

▎药明康德内容团队编辑本期看点1. 用于治疗粘多糖病II型患者的基因疗法RGX-121使患者持续获益已达三年，有望明年递交上市申请。2. 疫苗组合疗法在治疗HIV的临床试验中展现积极疗效，使正在接受抗逆转录病毒治疗的HIV感染者无需接受抗逆转录病毒治疗（ART）治疗的时间延长。3. 安斯泰来用于治疗迟发型庞贝病的基因替代疗法积极数据公布，患者停用酶替代疗法51周时的功能检测结果依然保持稳定。4. 治疗法布里病的基因疗法ST-920早期临床数据公布，观察到关键生物标志物α-半乳糖苷酶A活性的持续升高，最长的已持续超过两年。药明康德内容团队整理RGX-121：公布1/2/3期临床试验数据REGENXBIO公司宣布了其候选基因疗法RGX-121用于治疗19岁以下的II型黏多糖贮积症（MPS II）患者的1/2/3期试验的积极数据。MPS II是一种罕见的神经退行性溶酶体贮积症，由溶酶体酶艾杜糖酸-2-硫酸酯（I2S）酶缺乏引起。这种关键酶活性的降低或丧失会导致糖胺聚糖（GAG）在溶酶体的积累，从而引起溶酶体功能障碍和神经退行性病变。目前该病的标准疗法为酶替代疗法。RGX-121是一种一次性的基因疗法，旨在使用AAV9载体将编码I2S酶的人艾杜糖酸-2-硫酸酯酶（IDS）基因递送至中枢神经系统（CNS）。此次公布的结果显示，RGX-121在3种剂量水平下均具有良好的耐受性，没有药物相关的严重不良事件（SAEs）。一次性给予RGX-121后，患者脑脊液（CSF）中GAGs呈剂量依赖性的减少令人鼓舞。其中，队列3（使用关键计划剂量水平）患者的CSF GAGs的降幅最大，在给药后第48周时已接近正常水平。此外，在RGX-121给药三年后，患者的神经发育和日常活动技能也获得了持续的改善。该公司表示计划在2024年递交生物制品许可申请（BLA）。HTI：公布1/2a期临床试验数据AELIX Therapeutics公司公布了其与吉利德科学（Gilead Sciences）合作开展的一项名为AELIX-003的临床研究的数据。该研究旨在评估接受ART的HIV感染者使用含有AELIX的HTI T细胞疫苗和吉利德科学的Toll样受体7（TLR7）激动剂vesatolimod治疗方案的安全性、耐受性、免疫原性和疗效。Vesatolimod是一种在研强效选择性口服TLR7激动剂，可直接激活浆细胞样树突状细胞。在这项研究中，vesatolimod会激活体内HIV的表达，增强疫苗诱导的免疫反应，从而消除病毒感染的细胞。T细胞疫苗的HTI免疫原含有特异性HIV抗原区域，那些具有“控制器表型”（controller phenotypes）的患者对于该区域有丰富的T细胞免疫反应，这意味着它们可以在不使用抗逆转录病毒药物的情况下极大程度地控制HIV。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。在这项研究中，所有受试者接受疫苗/vesatolimod治疗后将在仔细监测下暂停使用抗逆转录病毒药物，以确定干预措施是否能有效控制HIV水平。结果显示，该研究达到了安全性、耐受性和免疫原性的主要和次要终点。HTI疫苗与vesatolimod联用可诱导高水平的HTI特异性T细胞反应，使HIV感染者无需ART的时间延长。病毒库高的疫苗接种者能够在没有ART的情况下维持病毒缓解24周，而所有病毒库高的安慰剂组受试者在前12周内就需要开始ART治疗。AT845：公布1/2期临床试验数据安斯泰来（Astellas Pharma）更新了其正在进行的1/2期临床试验FORTIS的初步安全性和疗效数据，该试验评估了其在研腺相关病毒（AAV）基因替代疗法AT845在迟发型庞贝病（LOPD）成人患者中的安全性、耐受性和疗效。庞贝病是由于缺乏酸性α-葡萄糖苷酶（GAA）引起的遗传性溶酶体储存障碍，GAA的水平降低或缺失导致肌肉和其他组织溶酶体中底物糖原的积累，因此又称为2型糖原累积病。这是一种会造成骨骼肌与心肌失能、通常为致命性的罕见疾病。目前，酶替代疗法（ERT）是该病唯一的获批疗法，这是一种慢性治疗，每两周需输注一次，完全依赖于组织从血浆中摄取GAA。此次公布的数据显示，4名受试者中有3名在AT845给药后停止使用ERT，在停用ERT 19、44和51周时，他们的功能检测结果保持稳定。对接受过治疗的受试者（包括中止ERT的受试者）的持续评估显示，疾病功能终点（包括用力肺活量和6 min步行测试）持续保持稳定。所有受试者对AT845输注的耐受性良好，大多数治疗中出现的不良反应为轻度（1级），并被认为与治疗无关。ST-920：公布1/2期临床试验的新数据Sangamo Therapeutics公司于近日公布了其用于治疗法布里病（Fabry disease）患者的基因疗法ST-920的1/2期临床试验STAAR的最新初步结果。法布里病是一种溶酶体贮积症，由α-半乳糖苷酶A基因（GLA）突变引起，从而导致α-Gal A活性缺乏，无法正常代谢鞘氨醇三聚己糖苷（Gb3）。Gb3在体内的积聚可以对许多重要器官造成破坏，例如肾脏、心脏、神经、眼睛、肠道以及皮肤。ST-920是一款一次性输注、肝脏靶向的基因疗法。此疗法通过AAV向患者肝脏递送功能性GLA基因拷贝，从而使细胞恢复生产α-Gal A。此次更新的数据截至2022年10月20日，在13名患者中观察到α-Gal A活性的持续升高，最长的已持续超过两年。在6个月时接受首批肾脏活检的患者中，其中1名患者的Gb3的清除率达78%，肾小球足细胞损失减少77%。所有剂量递增试验中的患者均不用再接受ERT，至今不需要恢复ERT治疗。身体健康状况SF-36评分显示，患者的平均一般健康评分在临床意义和统计学意义上均有显著增加。该公司计划将于2023年针对该疗法开展3期试验。FBX-101：公布1/2期临床试验的新数据Forge Biologics公布了其新型基因疗法FBX-101在Krabbe病患者中开展的1/2期临床试验RESKUE的初步数据。Krabbe病是由一种负责分解某类脂质（如psychosine）的溶酶体酶半乳糖甘油糖苷酶（GALC）的基因功能缺失突变引起的。如果GALC功能缺失，psychosine在细胞中的毒性积累会导致大脑和周围神经系统的髓鞘细胞死亡，进而引起患者运动功能的丧失。目前，骨髓移植是治疗中枢神经系统性Krabbe病患者的标准治疗，但患者依然会发展为周围神经系统疾病，并最终导致死亡。FBX-101是一种腺相关病毒血清型rh10（AAVrh10）基因疗法，通常在造血干细胞移植后进行。FBX-101能够向中枢和外周神经系统中的细胞递送GALC基因的功能拷贝，已被证明能在功能上纠正中枢和周围神经病变和与Krabbe病相关的行为障碍，并显著提高该病动物模型的寿命。之前公布的1/2期试验结果显示，接受FBX-101治疗6个月时，患者白细胞中GALC的活性显著提高，运动功能得到改善，且大脑正常发育。Forge公司此次公布了患者接受治疗12个月时的随访数据，研究人员在患者的血浆和CSF中观察到GALC转基因的持续高表达，且患者的运动功能和大脑发育保持正常。此外，尚未观察到与治疗相关的SAE、肝酶升高或抗AAVrh10抗体的产生。IMC-M113V：公布1期临床试验数据Immunocore公司公布了其在研TCR疗法IMC-M113V的安全性和活性数据。这是一种双特异性可溶性TCR疗法，用于治疗HIV病毒感染者。IMC-M113V建立在Immunocore公司旗下ImmTAX技术基础上，旨在消除持续被艾滋病毒感染的CD4+细胞（“储库”）。IMC-M113V的靶点是Gag蛋白的肽段，该蛋白由被HIV感染的细胞表面HLA*A02递呈。减少这些细胞的数量是在没有抗逆转录病毒药物的情况下可能达到病毒抑制状态的一种方法，有望实现功能性治愈。此次公布的是一项开放标签的1/2期临床试验，旨在确定IMC-M113V治疗HIV感染者的安全性和生物活性的剂量，这些患者的HLA-A*02:01呈阳性、接受抑制性抗逆转录病毒疗法不超过7年。结果显示，所有的3种剂量下的IMC-M113V均表现出良好的耐受性，没有严重的不良事件，没有血液学或化学方面的明显变化，也没有出现细胞因子释放综合征（CRS）或神经毒性。在整个用药和随访过程中，血浆病毒载量保持抑制。在接受15 mg剂量的患者中有一半达到了预先设定的药效学活性指标。Allocetra：获西班牙药品和医疗器械管理局批准开展1/2期临床试验Allocetra是Enlivex Therapeutics公司正在开发的一种通用的现货型细胞疗法，旨在将巨噬细胞重新编程为稳态状态。将非稳态的巨噬细胞重编程为稳态状态对于重新平衡免疫系统和解决危及生命的疾病至关重要。在临床前研究中，使用Allocetra联用免疫检查点抑制剂（PD-1抑制剂或CTLA-4抑制剂）使患有卵巢癌的小鼠及患有腹膜间皮瘤的小鼠获得了具有统计学意义的生存获益。此前，Allocetra已在美国和以色列获批开展临床试验。DNL310：公布1/2期临床试验的新数据Denali Therapeutics公司公布了其针对MPS II开展的在研酶替代疗法DNL310的1/2期临床试验的新中期数据。DNL310是一款由IDS蛋白与Denali的酶转运载体（ETV）结合的融合蛋白药物。Denali的转运载体平台含有可与天然转运受体结合的工程化Fc片段，通过与在血脑屏障上表达的天然转运受体结合，借着转胞作用（transcytosis）能够将大分子递送到大脑。DNL310被设计为可以递送IDS蛋白至包含脑部的全身细胞与组织的溶酶体中，以对GAG进行分解。此次更新的数据显示，在接受超过49周的DNL310治疗后，研究人员观察到患者在多个量表评分上的积极变化，包括Vineland适应行为量表第二版（VABS-II）、用于评估认知能力的贝利婴幼儿发展量表（BSID-III）以及总体印象量表。听觉脑干反应测试的结果显示，DNL310能够改善患者的听力。其他生物标志物数据表明，DNL310能够使脑脊液中的硫酸乙酰肝素快速并持续正常化至正常健康水平，并改善溶酶体功能相关的生物标志物。目前，使用DNL310治疗的数据已长达两年，其安全性依旧与标准护理保持一致。BXQ-350：公布1期临床试验数据Bexion Pharmaceuticals公司公布了其S1P激活剂BXQ-350在患有复发性实体瘤（包括复发性恶性脑肿瘤）的儿童和年轻人中的1期临床试验数据。BXQ-350是一种由多功能、溶酶体激活蛋白Saposin C和磷脂酰丝氨酸组成的制剂，在体外和体内显示出临床前抗肿瘤作用，特别是在结直肠、脑和其他实体瘤中。Bexion公司已完成两个针对成人和儿科人群的单药1期试验。BXQ-350在这些项目中表现出强大的安全性，并证明了BXQ-350单药在一系列肿瘤中具有活性，包括多形性胶质母细胞瘤（GBM），结直肠癌和阑尾癌。此外，其他临床和非临床数据表明，BXQ-350在化疗诱导的周围神经病变中同样具有活性。BXQ-350在此次公布数据的研究中达到了安全性和最大计划剂量的目标，支持Bexion公司在新诊断的弥漫性内源性脑桥胶质瘤（DIPG）和弥漫性中线胶质瘤（DMG）中开展儿科1期研究。BA3182：IND申请获得FDA许可BA3182是BioAtla公司开发的条件激活的生物（CAB）EpCAM/CD3双特异性T细胞接合抗体，包含两个EpCAM结合位点和两个CD3ε结合位点，用于治疗晚期腺癌。EpCAM在实体瘤中的高水平表达使其成为抗体分子治疗上皮癌，特别是腺癌的有吸引力的靶标。然而，EpCAM在正常细胞中也非常普遍，传统的EpCAM/CD3双特异性抗体的使用会面临剂量限制毒性问题。体外研究表明，CAB双特异性抗体BA3182与靶蛋白人EpCAM和人CD3结合，在肿瘤微环境（TME）的特征性酸性条件下具有高特异性和亲和力，而在正常细胞的碱性生理条件下（pH 7.4）的结合力大大降低。体内研究表明，BA3182相比于非CAB变体的治疗指数提高了100倍以上。在获得了FDA的IND批准后，BioAtla公司将进行一项首次人体1期研究，以评估BA3182在晚期腺癌患者中的安全性、药代动力学（PK）和有效性。AL01211：公布1期临床试验的初步数据AceLink Therapeutics公司公布了其用于治疗法布里病的新型GCS抑制剂在健康受试者中的1期试验的初步数据。AL01211具有优秀的效力（个位数纳摩尔半抑制浓度IC50）、高选择性和其他良好的、可支持每日一次口服的药物特性，为目前需频繁静脉注射ERT的法布里病患者提供了口服小分子疗法的潜在选择。此次公布的结果显示，AL01211在健康受试者中的安全性和耐受性良好，并能使血浆药效学生物标志物呈剂量依赖性的降低。BX004：公布1b/2a期临床试验数据BiomX公司公布了其噬菌体鸡尾酒疗法BX004用于治疗铜绿假单胞菌引起慢性肺部感染的囊性纤维化（CF）患者的安全性和有效性数据。铜绿假单胞菌是引起CF患者肺部感染和死亡的主要因素。BX004旨在靶向和破坏铜绿假单胞菌。研究结果显示，BX004治疗在所有患者和剂量水平上均安全且耐受性良好。研究人员还观察到了初步的疗效信号，相比于安慰剂组，接受BX004治疗的CF患者的细菌负荷显著减少。CDX-7108：公布1期临床试验数据Codexis公司与Nestlé Health Science公司共同公布了一项1期临床试验的数据，该试验旨在评估其候选产品CDX-7108的安全性，耐受性，PK和药效学。CDX-7108是一种脂肪酶变体，专门设计用于克服现有胰酶替代疗法（PERT）的局限性。PERT是胰腺外分泌功能不全（EPI）的主要治疗方法，这是一种使人衰弱的胃肠道疾病，由损害胰腺功能的疾病引起，例如胰腺炎、胰腺癌、克罗恩病、乳糜泻和囊性纤维化。CDX-7108对胃中的酸性条件高度稳定，并对上肠中的蛋白酶具有抗性。此次公布的初步数据显示，与安慰剂相比，接受CDX-7108的患者的脂质吸收有所改善。此外，在参与单次剂量递增和多次剂量递增研究的48名受试者中没有发现安全问题。Sevuparin：公布1b期临床试验数据Modus Therapeutics公司公布了其创新专有多糖药物sevuparin用于治疗败血症的早期临床试验的积极数据。Sevuparin具有多模式的作用机制，包括抗炎，抗粘附和抗聚集作用，是一种具有明显减弱的抗凝血特征的类肝素，与常规类肝素相比，可以给予高几倍的剂量，而没有相关的出血副作用风险。此次公布的试验结果显示，在脂多糖（LPS）诱导产生短暂炎症反应的健康受试者中，所有3种剂量水平下的sevuparin都是安全的，且耐受性良好。此外，sevuparin治疗使受试者的某些白细胞群水平呈剂量依赖性增加，在统计学上具有显著性，并能使LPS诱导的呼吸频率增加呈剂量依赖性的抑制。这些发现表明sevuparin有潜力作为全身炎症（包括败血症和感染性休克）的治疗方法。CD40.HIVRI.Env：公布1期临床试验的中期数据LinKinVax公司公布了其靶向树突状细胞的候选疫苗CD40.HIVRI.Env在健康受试者中的1期安全性和免疫原性结果。树突状细胞是免疫系统的关键激活剂，CD40.HIVRI.Env是一种将HIV包膜蛋白与特异性靶向树突状细胞表面CD40受体的单克隆抗体结合而成的候选疫苗，旨在预防艾滋病毒感染。此次公布的数据显示，该候选疫苗的安全性和耐受性良好，且能够诱导早期、显著和持续的免疫反应。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（可上下滑动查看）[1] LinKinVax Welcomes Interim Results of the ANRS VRI06 Phase I Trial Evaluating a Novel HIV Vaccine Candidate. Retrieved February 24, 2023, from https://www.businesswire.com/news/home/20230222005313/en/[2] BiomX Announces Positive Results from Part 1 of the Phase 1b/2a Study Evaluating BX004 for Treatment of Chronic Pulmonary Infections in Patients with Cystic Fibrosis. Retrieved February 24, 2023, from https://www.globenewswire.com/news-release/2023/02/22/2612975/0/en/BiomX-Announces-Positive-Results-from-Part-1-of-the-Phase-1b-2a-Study-Evaluating-BX004-for-Treatment-of-Chronic-Pulmonary-Infections-in-Patients-with-Cystic-Fibrosis.html[3] AELIX has presented promising top-line results from the clinical study AELIX-003 at the 2023 Conference on Retroviruses and Opportunistic Infections (CROI). Retrieved February 24, 2023, from https://www.aelixtherapeutics.com/aelix-therapeutics-presents-positive-results-from-randomized-placebo-controlled-phase-iia-therapeutic-hiv-vaccine-and-immune-modulator-combination-clinical-trial/[4] Immunocore announces initial Phase 1 safety and pharmacodynamic activity data with first soluble TCR therapy for people living with HIV，Retrieved February 2rd, 2023 from https://ir.immunocore.com/news-releases/news-release-details/immunocore-announces-initial-phase-1-safety-and-pharmacodynamic[5] Modus Therapeutics announces positive topline data from its Phase 1b LPS provocation study evaluating the potential of sevuparin for treatment of sepsis. Retrieved February 2rd, 2023 from https://www.modustx.com/press-release?releaseIdentifier=bef7616d-cdc3-4eae-830e-01a83e23f4af[6] Astellas Announces Update on Preliminary Safety and Efficacy Data from FORTIS Study of Investigational AT845 in Adults with Late-Onset Pompe Disease. Retrieved February 24, 2023, from https://www.prnewswire.com/news-releases/astellas-announces-update-on-preliminary-safety-and-efficacy-data-from-fortis-study-of-investigational-at845-in-adults-with-late-onset-pompe-disease-301750884.html[7] Additional Positive Interim Data from Phase I/II/III CAMPSIITE™ Trial of REGENXBIO's RGX-121 for the Treatment of MPS II (Hunter Syndrome) Presented at 19th Annual WORLDSymposiumTM. Retrieved February 24, 2023, from https://www.prnewswire.com/news-releases/additional-positive-interim-data-from-phase-iiiiii-campsiite-trial-of-regenxbios-rgx-121-for-the-treatment-of-mps-ii-hunter-syndrome-presented-at-19th-annual-worldsymposiumtm-301753564.html[8] Sangamo Therapeutics Announces Evidence of Clinical Benefit in Phase 1/2 STAAR Study in Fabry Disease. Retrieved February 24, 2023, from https://www.businesswire.com/news/home/20230222005671/en[9] Denali Therapeutics Announces New Interim Data from DNL310 Phase 1/2 Study for MPS II and DNL126 Preclinical Data for MPS IIIA at WORLDSymposium™. Retrieved February 24, 2023, from https://www.denalitherapeutics.com/investors/press-release?id=9226&type=api[10] Codexis and Nestlé Health Science Announce Interim Results from Phase 1 Clinical Trial of CDX-7108 for Exocrine Pancreatic Insufficiency. Retrieved February 25, 2023, from https://www.globenewswire.com/news-release/2023/02/23/2614809/24825/en/Codexis-and-Nestl%C3%A9-Health-Science-Announce-Interim-Results-from-Phase-1-Clinical-Trial-of-CDX-7108-for-Exocrine-Pancreatic-Insufficiency.html[11] Bexion Pharmaceuticals, Inc. Announces Publication of Pediatric Phase 1 (KOURAGE) Results. Retrieved February 25, 2023, from https://www.prnewswire.com/news-releases/bexion-pharmaceuticals-inc-announces-publication-of-pediatric-phase-1-kourage-results-301754621.html[12] BioAtla Announces FDA Clearance of Investigational New Drug Application for BA3182, a CAB-EpCAMxCAB-CD3 Bispecific T-Cell Engager for the Treatment of Advanced Adenocarcinoma. Retrieved February 25, 2023, from https://ir.bioatla.com/news-releases/news-release-details/bioatla-announces-fda-clearance-investigational-new-drug-0[13] AceLink Presents Phase 1 Study of AL01211 to Treat Fabry Disease at WORLD Symposium. Retrieved February 25, 2023, from https://www.businesswire.com/news/home/20230223005278/en/[14] Enlivex Receives Clearance From Spanish Agency of Medicines and Medical Devices For Treatment of Patients with Advanced Solid Malignancies in the Ongoing Allocetra Phase I/II Clinical Trial. Retrieved February 25, 2023, from https://enlivex.com/investor-relations/#latest-news[15] Forge Biologics Reports Positive FBX-101 Clinical Updates for Patients with Krabbe Disease at WORLDSymposium. Retrieved February 25, 2023, from https://www.businesswire.com/news/home/20230223005450/en/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2期疫苗临床结果临床1期

2023-02-22

·Business Wire

LinKinVax Welcomes Interim Results of the ANRS VRI06 Phase I Trial Evaluating a Novel HIV Vaccine Candidate

PARIS--( BUSINESS WIRE )-- LinKinVax, a clinical-stage biotechnology company, welcomes the interim results of the ANRS VRI06 Phase I trial evaluating a preventive HIV vaccine and conducted by the sponsor INSERM-ANRS and the Vaccine Research Institute (ANRS and Université Paris-Est Créteil, France). These results show that the vaccine candidate is safe and induces an early, significant and sustained immune response. The CD40.HIVRI.Env vaccine candidate is developed by the VRI with a technology whose exclusive worldwide license is held by LinKinVax. It is the first vaccine based on this technology, that targets an immune response binding HIV envelope protein to monoclonal antibodies specifically targeting CD40 receptors on the surface of dendritic cells. Once injected, the Env protein is thus delivered directly to the dendritic cells that play a key role in the education and activation of the immune system. André-Jacques Auberton-Hervé , Co-founder and CEO of LinKinVax declared : “We are pleased with these very promising immunogenicity results, which demonstrate the robustness of our DC Targeting vaccine platform and confirm its safety. This important milestone paves the way for the upcoming Phase II/III clinical studies that we will conduct once the final Phase I results have been obtained. These studies will aim to demonstrate the efficacy of the vaccine, the “Everest of vaccine strategies”, which has been the elusive goal of HIV research for the past 40 years.” “ The CD40.HIVRI.Env vaccine candidate has demonstrated both its safety and ability to induce early, potent and sustained responses ,” explained Prof. Yves Lévy, Executive Director of the VRI and CMSO of LinKinVax . “ The immune response profile generated by this vaccine (antibody response and activation of polyfunctional CD4 + T cells) was the one associated with a reduced risk of HIV infection in the RV144 trial. However, at this early stage of vaccine development, it is important to remember that volunteers should continue to protect themselves from any risk of HIV infection, as the efficacy of the vaccine will only be evaluated in the Phase II/III studies .” ANRS VRI06 clinical study This Phase I study conducted in France and Switzerland included 72 healthy volunteers by the end of its recruitment period in October 2022. An interim analysis of the results was carried out on 36 subjects. This dose escalation study included three groups: a first group of 12 subjects received a subcutaneous dose of 0.3 mg of vaccine at inclusion and at Weeks 4 and 24; the second and third groups then received doses of 1 or 3 mg, respectively, according to the same schedule. The vaccine is combined with the Hiltonol® adjuvant, designed to enhance its potential action. This is a double-blind trial and some volunteers are injected with a placebo. The safety and immunogenicity were assessed at Weeks 6, 26 and 48. Safety and tolerance The results observed at Week 26 in the first 36 volunteers included (average age 34 years, 64% male), show that the vaccine candidate is safe and well tolerated . Promising induction of an effective immune response to HIV The vaccine yielded high levels of antibodies directed against HIV envelope : 80-100% at Week 6, 100% at Week 26 in all groups (0.3, 1 and 3 mg). These levels remained stable or dropped slightly until Week 48. Antibodies targeting a specific area of the HIV envelope (V1/V2 region) were also produced. Furthermore, at Week 26, neutralising antibodies were detected in 50% of subjects in the 0.3 mg group and 100% of subjects in the other two groups. The observed counts of CD4 + T cells targeting specifically the HIV envelope protein produced after the vaccination remained stable until Week 48. About LinKinVax technology : LinKinVax’s vaccine platform is built around a humanized monoclonal antibody, which is merged with regions of pathogens of interest, targeting the CD40 molecule expressed by dendritic cells, DC, which play a key role in stimulating the immune system. The results obtained demonstrate the benefits of this strategy owing to the small quantity of antigens required to activate the immune system, with or without an adjuvant, and its ability to trigger a lasting cellular and humoral and immune response. The platform also benefits from the experience and safety profile of the protein-based vaccines that have been widely used for over 30 years now. Three products are in or about to enter clinical trials: a prophylactic vaccine for HIV, (currently in phase I led by Inserm/ANRS), a SARS-CoV-2 vaccine covering variants of interest, and a therapeutic vaccine for human papillomavirus-related cancers. About LinKinVax LinKinVax was founded in 2020 and is led by two internationally renowned personalities in the worlds of medicine, industry and business, namely André-Jacques Auberton-Hervé, Honorary Chairman and founder of SOITEC, and Prof. Yves Levy, MD, PhD, immunologist, and Director of the Vaccine Research Institute (VRI/ANRS/UPEC). LinKinVax is developing an innovative protein-based vaccine platform that can accelerate availability of vaccines by leveraging the research conducted at the Vaccine Research Institute (VRI). This DC Targeting-based protein vaccine platform can adapt to changes and mutations in the target pathogens. For further information, please visit www.linkinvax.com

疫苗临床结果临床1期免疫疗法

2023-02-15

·Business Wire

Wellbeing Subsidiary KGK Science Announces Publication of Safety Studies on Paraxanthine and Comparison to Caffeine Toxicity.

VANCOUVER, British Columbia--( BUSINESS WIRE )--Wellbeing Digital Sciences Inc. (“ Wellbeing” or the “ Company ”) (NEO: MEDI ) (OTC: KONEF ) (FRA: SQ2 ), an evidence-based mental healthcare company focused on the development and implementation of innovative clinical solutions, including psychedelic medicine and digital therapeutics as supported by clinical research, announced today that its wholly owned subsidiary KGK Science Inc. (“KGK”), completed preclinical safety studies for Rarebird Coffee (“Rarebird”), a manufacturer and own label distributor of coffee crafted with paraxanthine (Px), a caffeine replacement. KGK has authored a manuscript entitled “Paraxanthine safety and comparison to caffeine,” which was published in the journal “Frontiers in Toxicology on February 2, 2023. Paraxanthine, the predominant metabolite of caffeine, is found in small amounts in coffee and other plants. Our bodies routinely convert caffeine into Px, but the pharmacological effects resulting from this metabolism, have not been well characterized. Preclinical studies of safety, using Rarebird Coffee’s Px ingredients, were conducted as a first step prior to market entry. Px has been proposed as a safer alternative to caffeine for use in foods and beverages, and the comparison study to caffeine lends support this premise. The extensive battery of safety tests suggested a lack of genetic toxicity and mutagenicity. Repeat-dose safety studies indicated a larger No-Observed-Adverse-Effect-Level (NOAEL) for Px in comparison to caffeine, suggesting an improved safety profile for Px. These findings further the scientific understanding of the safety profile for Px, a subject that has largely been ignored despite the prevalence of caffeine-containing food products in the marketplace. “This study represents an important first step to both further our understanding of caffeine safety and highlight the use of Px as a potential caffeine replacement” says Najla Guthrie, CEO of Wellbeing Digital and KGK. “The safety profile of Px, in comparison to caffeine, is apparent in this study. It is imperative that consumers understand how caffeine is metabolized and to know whether those metabolites are more or less safe than caffeine. The head-to-head comparison in this study suggests paraxanthine Px has an improved safety profile over caffeine, and one of our goals is to increase consumer awareness of Px as an innovative caffeine replacement,” says Jeffrey Dietrich, founder and CEO of Rarebird, Inc. ABOUT Rarebird, Inc Rarebird is a coffee company whose goal is to turn people’s coffee routines into wellness rituals. Founded in 2020, Rarebird produces Px coffee, a ground coffee that contains paraxanthine instead of caffeine. ABOUT KGK SCIENCE Subsidiary of Wellbeing Digital Sciences, KGK is a leading North American contract research organization based in London, Ontario that primarily provides high-quality clinical research trials with a focus on nutraceutical and emerging health care products. Founded in 1997, the business has successfully helped hundreds of companies with custom designed clinical trials and claim substantiation strategies to move products into global markets. KGK’s other existing service lines include expert regulatory support and compliance solutions, participant recruitment, research support services and consulting services. Furthermore, the company has produced over 150 publications, executed over 400 clinical trials across more than 40 indications, amassed 25,000 participants in its database and collected 10 million data points. For additional information, please visit kgkscience.com . ABOUT WELLBEING DIGITAL SCIENCES Wellbeing Digital Sciences Inc. is an evidence-based mental healthcare company focused on the development and implementation of innovative clinical treatment solutions, including psychedelic medicine and digital therapeutics, as supported by clinical research. Its mission is supported by a network of North American clinics that provide forward-thinking therapies and other types of treatment to patients as well as through a contract research organization that offers clinical trials services to clients pursuing drug development. For additional information, please visit wellbeingdigital.co . On behalf of: Najla Guthrie Chief Executive Officer WELLBEING DIGITAL SCIENCES Notice Regarding Forward-Looking Information: This news release contains forward-looking statements including but not limited to statements regarding the Company’s business, assets or investments, as well other statements that are not historical facts. Readers are cautioned not to place undue reliance on forward-looking statements, as there can be no assurance that the plans, intentions or expectations upon which they are based will occur. By their nature, forward-looking statements involve numerous assumptions, known and unknown risks and uncertainties, both general and specific, that contribute to the possibility that the predictions, forecasts, projections and other forward-looking statements will not occur, which may cause actual performance and results in future periods to differ materially from any estimates or projections of future performance or results expressed or implied by such forward-looking statements. These assumptions, risks and uncertainties include, among other things, the state of the economy in general and capital markets in particular, investor interest in the business and prospects of the Company. The forward-looking statements contained in this news release are made as of the date of this news release. Except as required by law, the Company disclaims any intention and assumes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable securities law. Additionally, the Company undertakes no obligation to comment on the expectations of, or statements made, by third parties in respect of the matters discussed above.

临床研究

100 项与 HIV vaccine(PX Therapeutics SA) 相关的药物交易

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