A Phase 1, First in Human, Randomized, Placebo-controlled Trial With a Controlled Gluten Challenge to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of VTP-1000 in Adults With Celiac Disease

GLU001 is a first-in-human clinical trial to assess the safety and tolerability of VTP-1000 for adults with celiac disease. This trial will assess VTP-1000 at various dose levels compared to placebo in a single ascending dose (SAD) and multiple ascending dose (MAD) format. Participants will be followed for a short period of time to assess the impact of VTP-1000 on their immune system (Adverse events, reactions in the blood, and physical exam differences). Participants enrolled in the MAD portion of the trial will undergo a gluten challenge to assess the impact exposure to gluten has on participants after administration of VTP-1000.

开始日期2024-08-01

申办/合作机构

Barinthus Biotherapeutics Plc

NCT05617040 / Active, not recruiting临床1/2期

A Phase 1/Phase 2 Trial to Evaluate Safety, Immunogenicity and PSA Response of VTP-850 Prostate Cancer Immunotherapeutic in Men With Biochemical Recurrence After Definitive Local Therapy for Prostate Cancer

This is a multi-centre, Phase 1/2, open-label clinical trial of the VTP-850 prime-boost immunotherapeutic in men with biochemical recurrence after definitive local therapy for prostate cancer.

开始日期2023-01-30

申办/合作机构

Barinthus Biotherapeutics Plc

NCT05343481 / Active, not recruiting临床2期

A Phase 2b, Open-label Study to Evaluate the Efficacy, Safety, Tolerability, Immunogenicity and Treatment Regimens of VTP-300 Combined With Low-dose Nivolumab in Chronic Hepatitis B Infection

This is an open-label study to determine the efficacy, safety, tolerability and immunogenicity of ChAdOx1-HBV and MVA-HBV, together VTP-300, in combination with low-dose nivolumab, in patients with chronic HBV who are virally suppressed with oral anti-viral therapies.

开始日期2022-09-21

申办/合作机构

Barinthus Biotherapeutics Plc

100 项与 Barinthus Biotherapeutics Plc 相关的临床结果

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0 项与 Barinthus Biotherapeutics Plc 相关的专利（医药）

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项与 Barinthus Biotherapeutics Plc 相关的文献（医药）

2019-08-01·Oncogene1区 · 医学

Oncolytic herpes simplex virus immunotherapy for brain tumors: current pitfalls and emerging strategies to overcome therapeutic resistance

1区 · 医学

Review

作者: Bernstock, Joshua D ; Beierle, Elizabeth A ; Totsch, Stacie K ; Ishizuka, Andrew S ; Friedman, Gregory K ; Gillespie, G Yancey ; Markert, James M ; Lynn, Geoffrey M ; Kang, Kyung-Don ; Schlappi, Charles ; Whitley, Richard J ; Fox, Brandon

Malignant tumors of the central nervous system (CNS) continue to be a leading cause of cancer-related mortality in both children and adults. Traditional therapies for malignant brain tumors consist of surgical resection and adjuvant chemoradiation; such approaches are often associated with extreme morbidity. Accordingly, novel, targeted therapeutics for neoplasms of the CNS, such as immunotherapy with oncolytic engineered herpes simplex virus (HSV) therapy, are urgently warranted. Herein, we discuss treatment challenges related to HSV virotherapy delivery, entry, replication, and spread, and in so doing focus on host anti-viral immune responses and the immune microenvironment. Strategies to overcome such challenges including viral re-engineering, modulation of the immunoregulatory microenvironment and combinatorial therapies with virotherapy, such as checkpoint inhibitors, radiation, and vaccination, are also examined in detail.

PLOS Biology1区 · 生物学

Star nanoparticles delivering HIV-1 peptide minimal immunogens elicit near-native envelope antibody responses in nonhuman primates

1区 · 生物学

ArticleOA

作者: Padhan, Kartika ; Walkowicz, William E ; Mužíková, Gabriela ; Tsybovsky, Yaroslav ; Seder, Robert A ; Schmidt, Stephen D ; Baharom, Faezzah ; Saunders, Kevin O ; Androvič, Ladislav ; Laga, Richard ; Lynn, Geoffrey M ; Francica, Joseph R ; Parks, Robert ; Aussedat, Baptiste ; Stewart-Jones, Guillaume B E ; Petrovas, Constantinos ; Haynes, Barton F ; Ramirez-Valdez, Ramiro Andrei ; Flynn, Barbara J

Peptide immunogens provide an approach to focus antibody responses to specific neutralizing sites on the HIV envelope protein (Env) trimer or on other pathogens. However, the physical characteristics of peptide immunogens can limit their pharmacokinetic and immunological properties. Here, we have designed synthetic "star" nanoparticles based on biocompatible N-[(2-hydroxypropyl)methacrylamide] (HPMA)-based polymer arms extending from a poly(amidoamine) (PAMAM) dendrimer core. In mice, these star nanoparticles trafficked to lymph nodes (LNs) by 4 hours following vaccination, where they were taken up by subcapsular macrophages and then resident dendritic cells (DCs). Immunogenicity optimization studies revealed a correlation of immunogen density with antibody titers. Furthermore, the co-delivery of Env variable loop 3 (V3) and T-helper peptides induced titers that were 2 logs higher than if the peptides were given in separate nanoparticles. Finally, we performed a nonhuman primate (NHP) study using a V3 glycopeptide minimal immunogen that was structurally optimized to be recognized by Env V3/glycan broadly neutralizing antibodies (bnAbs). When administered with a potent Toll-like receptor (TLR) 7/8 agonist adjuvant, these nanoparticles elicited high antibody binding titers to the V3 site. Similar to human V3/glycan bnAbs, certain monoclonal antibodies (mAbs) elicited by this vaccine were glycan dependent or targeted the GDIR peptide motif. To improve affinity to native Env trimer affinity, nonhuman primates (NHPs) were boosted with various SOSIP Env proteins; however, significant neutralization was not observed. Taken together, this study provides a new vaccine platform for administration of glycopeptide immunogens for focusing immune responses to specific bnAb epitopes.

Personalized cancer vaccines based on peptide amphiphiles ensure consistent formulations for inducing anticancer immunity

作者: Ramirez-Valdez, Andrei ; Lynn, Geoffrey ; Tobin, Kennedy ; Nichols, Sarah ; Coble, Vincent ; Zhu, Yaling ; Seder, Robert A. ; Ishizuka, Andrew S. ; Baharom, Faezzah

Personalized cancer vaccines (PCVs) consisting of tumor-specific peptide antigens combined with immunostimulatory drugs can be used to induce anticancer immunity associated with tumor regression.However, each patient requires a unique set of tumor-specific peptide antigens that often have diverse phys. (e.g., hydrodynamic behavior, charge) and chem. (e.g., hydrophilic/hydrophobic) characteristics.The variability of peptide antigen properties poses a major challenge to ensuring formulation consistency, which is required by regulatory authorities and needed for achieving reliable activity in patients.To address this challenge, we developed PCVs based on peptide antigens linked to amphiphilic di-block copolymers that are designed to self-assemble into nanoparticle micelles.To evaluate how different parameters of the peptide antigen and amphiphile (e.g., block length, composition, net charge, etc.) impact formulation characteristics and in vivo activity, we produced a combinatorial library of unique amphiphiles with diverse properties and evaluated their hydrodynamic behavior (e.g., particle size by light scattering) as well as in vivo activity as vaccines for inducing anticancer immunity.Our results reveal how different properties of the amphiphile, including net charge, dictate the size and stability of resulting micelles and how such parameters impact in vivo activity.Based on these findings, we developed a lead PCV approach based on peptide amphiphiles that induced higher magnitude anticancer immunity and led to improved tumor regression as compared with conventional vaccine formulations that do not account for peptide antigen variability.Overall, PCVs based on peptide amphiphiles ensure consistent formulations that reliably induce anticancer immunity.

项与 Barinthus Biotherapeutics Plc 相关的新闻（医药）

2024-10-04

·GlobeNewswire-Health Care

Barinthus Bio Completes Enrollment for Phase 2b HBV003 Clinical Trial in Chronic Hepatitis B and Phase 1 PCA001 Clinical Trial in Prostate Cancer

Investigational immunotherapy, VTP-300, is being evaluated as part of a potential functional cure regimen for chronic Hepatitis B. Interim data update for HBV003 anticipated in Q4 2024. Data update for PCA001 anticipated in H1 2025. Oct. 01, 2024 -- Barinthus Biotherapeutics plc (NASDAQ: BRNS), a clinical-stage biopharmaceutical company developing novel immunotherapeutic candidates that guide T cells to control disease, announced the completion of enrollment for two clinical trials: HBV003, a Phase 2b clinical trial of VTP-300 in adults with chronic hepatitis B (CHB); and PCA001, a Phase 1 clinical trial of VTP-850 in men with rising prostate-specific antigen (PSA) after definitive local therapy for prostate cancer (i.e., biochemical recurrence). “We continue to execute our strategy and are pleased to complete the enrollment in two different trials in CHB and prostate cancer, two diseases where recruitment can be a real challenge,” said Bill Enright, Chief Executive Officer of Barinthus Bio. “These two fantastic milestones keep us on track for anticipated data readouts from HBV003 in Q4 of 2024 and from PCA001 in the first half of 2025.” The Phase 2b HBV003 trial (NCT05343481) has enrolled 121 participants and is designed to obtain critical dosing information for a potential functional cure regimen for CHB, with participants receiving VTP-300 and low-dose (LD) nivolumab. This trial design builds on positive monotherapy results from the clinical study HBV002, which included an evaluation of VTP-300 given alone and in combination with LD nivolumab. Earlier this year, interim data from the HBV003 trial was presented at the European Association for the Study of the Liver (EASL) Congress and demonstrated that treatment with VTP-300 and LD nivolumab is generally well-tolerated and led to a sustained decline in Hepatitis B surface antigen (HBsAg) levels. Participants reaching Day 169 were assessed for NUC therapy discontinuation eligibility in line with the study criteria, with 76% of participants meeting the criteria (n=16/21). 19% of the eligible participants (n=4/21) reached undetectable levels of HBsAg, with 2 of these patients maintaining undetectable levels for over 16 weeks. The PCA001 Phase 1 trial (NCT05617040) has enrolled 22 participants and is designed to determine the recommended Phase 2 dosing regimen of VTP-850 as well as evaluate safety and efficacy, as measured by PSA and T cell response. VTP-850 is a next-generation prostate cancer immunotherapeutic candidate which utilizes Barinthus Bio’s ChAdOx/MVA platform of two proprietary nonreplicating viral vectors in a sequential dosing approach. Globally it is estimated that there are approximately 254 million people living with CHB infection. This includes up to 2.4 million in the U.S. and 10.6 million in Europe, with the highest prevalence in East Asia and Africa. Approximately 1.1 million people died from hepatitis B virus infection and related complications in 2022, such as liver cirrhosis and hepatocellular carcinoma. Due to low diagnosis rates, only 13% of people living with CHB are aware of their infection and less than 3% had received antiviral treatment at the end of 2022. In 2020, prostate cancer was the fourth most common cancer worldwide, with 1.4 million new cases diagnosed. In the US, out of every 100 American men, an estimated 13 will get prostate cancer during their lifetime. In the UK, prostate cancer is the most common cancer in men, with more than 52,000 people diagnosed with the disease on average each year. 20-30% of patients experience rising levels of PSA after local therapy (e.g. prostatectomy), indicating that disease was not cured by local therapy. Of men who do experience biochemical recurrence, there is a 1 in 9 chance of developing metastases. Barinthus Bio is a clinical-stage biopharmaceutical company developing novel immunotherapeutic candidates designed to guide the immune system to overcome chronic infectious diseases and autoimmunity. Helping people living with serious diseases and their families is the guiding principle at the heart of Barinthus Bio. With a focused pipeline built around our proprietary platform technologies, Barinthus Bio is advancing immunotherapeutic product candidates in infectious diseases and autoimmunity, including: VTP-300, that utilizing our ChAdOx/MVA platform designed as a potential component of a functional cure for chronic HBV infection and VTP-1000, utilizing our SNAP-Tolerance Immunotherapy (SNAP-TI) platform and is designed to treat people with celiac disease. Barinthus Bio is also conducting a Phase 1 clinical trial for VTP-850, a second-generation immunotherapeutic candidate designed to treat recurrent prostate cancer. Barinthus Bio’s differentiated technology platforms and therapeutic approach, coupled with deep scientific expertise and focus on clinical development, uniquely positions the company to navigate towards delivering treatments that improve the lives of people with chronic infectious diseases and autoimmunity. For more information, visit www.barinthusbio.com. The content above comes from the network. if any infringement, please contact us to modify.

临床结果免疫疗法

2024-10-02

·PipelineReview

Barinthus Bio Completes Enrollment for Phase 2b HBV003 Clinical Trial in Chronic Hepatitis B and Phase 1 PCA001 Clinical Trial in Prostate Cancer

OXFORD, UK I October 01, 2024 I Barinthus Biotherapeutics plc (NASDAQ: BRNS), a clinical-stage biopharmaceutical company developing novel immunotherapeutic candidates that guide T cells to control disease, announced the completion of enrollment for two clinical trials: HBV003, a Phase 2b clinical trial of VTP-300 in adults with chronic hepatitis B (CHB); and PCA001, a Phase 1 clinical trial of VTP-850 in men with rising prostate-specific antigen (PSA) after definitive local therapy for prostate cancer (i.e., biochemical recurrence). “We continue to execute our strategy and are pleased to complete the enrollment in two different trials in CHB and prostate cancer, two diseases where recruitment can be a real challenge,” said Bill Enright, Chief Executive Officer of Barinthus Bio. “These two fantastic milestones keep us on track for anticipated data readouts from HBV003 in Q4 of 2024 and from PCA001 in the first half of 2025.” The Phase 2b HBV003 trial ( NCT05343481 ) has enrolled 121 participants and is designed to obtain critical dosing information for a potential functional cure regimen for CHB, with participants receiving VTP-300 and low-dose (LD) nivolumab. This trial design builds on positive monotherapy results from the clinical study HBV002, which included an evaluation of VTP-300 given alone and in combination with LD nivolumab. Earlier this year, interim data from the HBV003 trial was presented at the European Association for the Study of the Liver (EASL) Congress and demonstrated that treatment with VTP-300 and LD nivolumab is generally well-tolerated and led to a sustained decline in Hepatitis B surface antigen (HBsAg) levels. Participants reaching Day 169 were assessed for NUC therapy discontinuation eligibility in line with the study criteria, with 76% of participants meeting the criteria (n=16/21). 19% of the eligible participants (n=4/21) reached undetectable levels of HBsAg, with 2 of these patients maintaining undetectable levels for over 16 weeks. The PCA001 Phase 1 trial ( NCT05617040 ) has enrolled 22 participants and is designed to determine the recommended Phase 2 dosing regimen of VTP-850 as well as evaluate safety and efficacy, as measured by PSA and T cell response. VTP-850 is a next-generation prostate cancer immunotherapeutic candidate which utilizes Barinthus Bio’s ChAdOx/MVA platform of two proprietary nonreplicating viral vectors in a sequential dosing approach. About Chronic Hepatitis B Globally it is estimated that there are approximately 254 million people living with CHB infection. This includes up to 2.4 million in the U.S. and 10.6 million in Europe, with the highest prevalence in East Asia and Africa. Approximately 1.1 million people died from hepatitis B virus infection and related complications in 2022, such as liver cirrhosis and hepatocellular carcinoma. Due to low diagnosis rates, only 13% of people living with CHB are aware of their infection and less than 3% had received antiviral treatment at the end of 2022. About Prostate Cancer In 2020, prostate cancer was the fourth most common cancer worldwide, with 1.4 million new cases diagnosed. In the US, out of every 100 American men, an estimated 13 will get prostate cancer during their lifetime. In the UK, prostate cancer is the most common cancer in men, with more than 52,000 people diagnosed with the disease on average each year. 20-30% of patients experience rising levels of PSA after local therapy (e.g. prostatectomy), indicating that disease was not cured by local therapy. Of men who do experience biochemical recurrence, there is a 1 in 9 chance of developing metastases. About Barinthus Bio Barinthus Bio is a clinical-stage biopharmaceutical company developing novel immunotherapeutic candidates designed to guide the immune system to overcome chronic infectious diseases and autoimmunity. Helping people living with serious diseases and their families is the guiding principle at the heart of Barinthus Bio. With a focused pipeline built around our proprietary platform technologies, Barinthus Bio is advancing immunotherapeutic product candidates in infectious diseases and autoimmunity, including: VTP-300, that utilizing our ChAdOx/MVA platform designed as a potential component of a functional cure for chronic HBV infection and VTP-1000, utilizing our SNAP-Tolerance Immunotherapy (SNAP-TI) platform and is designed to treat people with celiac disease. Barinthus Bio is also conducting a Phase 1 clinical trial for VTP-850, a second-generation immunotherapeutic candidate designed to treat recurrent prostate cancer. Barinthus Bio’s differentiated technology platforms and therapeutic approach, coupled with deep scientific expertise and focus on clinical development, uniquely positions the company to navigate towards delivering treatments that improve the lives of people with chronic infectious diseases and autoimmunity. For more information, visit www.barinthusbio.com . SOURCE: Barinthus Bio

临床2期免疫疗法临床1期临床结果

2024-09-29

·药明康德

总缓解率超90%的CAR-T疗法；有望一月一针的超长效GLP-1受体激动剂…… | 一周盘点

▎药明康德内容团队编辑本期看点 1. 嵌合抗原受体T（CAR-T）细胞疗法P-BCMA-ALLO1治疗复发/难治性多发性骨髓瘤患者的早期临床数据亮眼，优化淋巴细胞清除队列患者的总缓解率（ORR）达91%。 2. Metsera公司的超长效减肥疗法MET-097在临床1期试验中实现了显著且持久的减肥效果，受试者在接受治疗第36天后，体重下降达7.5%，并有望达到每月一次的给药频率。 3. 大环MEK抑制剂PAS-004在1期临床试验中使1名既往接受过多线治疗的3期结直肠癌患者获得长期疾病稳定。药明康德内容团队整理 P-BCMA-ALLO1：公布1期临床试验的新数据 Poseida Therapeutics公司公布了其与罗氏（Roche）共同开发的同种异体B细胞成熟抗原（BCMA）靶向CAR-T疗法P-BCMA-ALLO1治疗复发/难治性多发性骨髓瘤患者的1期临床试验的新中期数据。截至2024年9月6日，72名患者被纳入意向治疗（ITT）人群，并在四个队列（S、A、B和C）中接受治疗，治疗包括不同的P-BCMA-ALLO1剂量和淋巴细胞清除方案组合。这些患者既往接受过三种或三种以上的治疗，包括蛋白酶体抑制剂、免疫调节药物和抗CD38单克隆抗体。此次公布的结果显示，所有四个队列的ORR为54%，11%的患者获得了完全缓解（CR）或严格完全缓解（sCR），33%的患者获得了非常好的部分缓解或更佳（VGPR+）。值得一提的是，在优化淋巴清除组（队列C）中，患者的ORR为91%，此前未接受过BCMA靶向治疗患者的ORR达100%，既往接受过至少一种BCMA和/或GPRC5D靶向治疗方法的患者的ORR为86%。22%的患者达到CR或sCR，48%的患者实现了VGPR+。安全性方面，未发现剂量限制性毒性反应，细胞因子释放综合征（CRS）和免疫效应细胞相关神经毒性综合征（ICANS）的发生率低，均为2级或2级以下，无移植物抗宿主病或帕金森病。 MET-097：公布1期临床试验数据 Metsera公司宣布，其超长效减肥疗法MET-097在临床1期试验中实现了显著且持久的减肥效果。MET-097是一款在研超长效皮下注射GLP-1受体激动剂。MET-097通过Metsera专有的HALO新型肽脂化平台所开发，具有超长的体内清除时间。此次公布的结果显示，MET-097具有剂量线性药代动力学特征，具有380小时的半衰期，且在各受试者之间表现出一致性。受试者的体重相对于基线变化呈现剂量依赖性，接受1.2 mg剂量的受试者，在第36天（最后一次给药后的一周）时体重下降达7.5%，这一结果与现有获批和临床阶段GLP-1/GIP药物相当或更佳。在最后一次给药后四周（第57天），1.2 mg剂量组受试者的累计减重幅度达8.1%，显示药效持续性与观察到的380小时半衰期一致。安全性方面，患者的胃肠道不良事件与剂量相关，大多数为轻度且短暂。未观察到与治疗相关的严重不良事件，且无因治疗相关原因而中止研究药物的病例。 ISP-001：公布1期临床试验数据 Immusoft公司公布了其工程化B细胞疗法ISP-001用于治疗1型黏多糖贮积症（MPS I）的1期临床试验中首例患者的积极结果。MPS I是一种罕见且致命的儿童遗传病，会影响身体产生α-L-艾杜糖苷酸酶（IDUA，一种有助于分解细胞内长链糖的必需酶）的能力。糖链若无法分解会在细胞中积聚并造成渐进性损伤，这种积聚会发生在包括大脑的组织中。ISP-001细胞使用“睡美人”转座子系统（Sleeping Beauty transposon system）表达α-L-艾杜糖苷酶，从而改善MPS I症状。分析显示，该名成年患者展现药效学和身体功能上的改善，并且在生活质量和日常生活活动上获得了显著的进步。患者与MPS I相关的疼痛也获得减轻。安全性方面，ISP-001的耐受性良好。截至2024年9月19日，尚未报告任何不良事件。ISP-001已获得FDA的孤儿药资格和MPS I的罕见儿科疾病认定。根据新闻稿，ISP-001是首个进入人体临床试验的工程化B细胞疗法。 PAS-004：公布1期临床试验的初步数据 Pasithea Therapeutics公司公布了其大环MEK抑制剂PAS-004治疗MAPK通路驱动的晚期实体肿瘤患者的1期临床研究中前两个队列的数据。与目前FDA批准的MEK抑制剂不同，PAS-004是大环化合物，环化可增强药物与靶受体的结合，被认为有望改善药代动力学和安全性。该研究中的患者携带RAS、RAF或NF1突变，或有BRAF/MEK抑制剂治疗失败的经历。此次公布的结果显示，PAS-004的半衰期约为70小时，支持每日一次或更少频率的口服给药。该候选疗法还能够在稳态下实现恒定的靶点抑制，同时避免峰值血浆毒性。过往经验表明，结直肠癌患者接受MEK抑制剂单药治疗时的疗效有限，但观察到1例既往接受过4线治疗的BRAF K601E突变结直肠癌患者在接受PAS-004治疗后表现出长期稳定的疾病。目前，尚无针对BRAF K601E突变癌症的获批疗法。安全性方面，PAS-004的安全性和耐受性良好，没有与药物相关的剂量中断、减少或停药，迄今为止尚未观察到皮疹或皮肤毒性、胃肠道毒性或眼毒性。研究人员认为，PAS-004具有独特的MEK抑制谱，有望用于治疗NF1相关的丛状神经纤维瘤和皮肤神经纤维瘤、癌症和其他疾病。 ARO-INHBE：申请启动1/2a期临床试验 Arrowhead Pharmaceuticals公司宣布，已向新西兰的监管部门提交了启动RNAi疗法ARO-INHBE用于治疗肥胖症的1/2a期临床试验的申请。ARO-INHBE旨在降低INHBE基因在肝脏的表达并调节Activin E信号通路。INHBE是一个潜在的基因验证靶点，人类INHBE的功能丧失变异与较低的肥胖和代谢性疾病（如2型糖尿病）风险有关。Activin E在调节脂肪组织能量稳态的途径中起着配体的作用，利用ARO-INHBE干预这一途径有可能增加脂肪分解，减少脂肪过度生长和功能障碍、内脏脂肪过多和胰岛素抵抗。 IPH4502：IND申请获得FDA许可 Innate Pharma公司宣布，美国FDA已批准其抗体偶联药物（ADC）IPH4502用于治疗表达Nectin-4的晚期实体瘤的IND申请，该公司预计将在未来几个月内启动1期临床研究。IPH4502靶向Nectin-4，以拓扑异构酶I抑制剂exatecan为载荷。Nectin-4是一种细胞膜粘附蛋白，在多种实体瘤中过表达，包括尿路上皮癌、乳腺癌、食管癌、肺癌、卵巢癌和胰腺癌，在正常组织中的表达有限。在非临床模型中，IPH4502具有良好的耐受性，并在体外和体内显示出抗肿瘤活性。 VTP-1000：启动1期临床试验 Barinthus Biotherapeutics公司宣布启动其候选免疫疗法VTP-1000在成人乳糜泻患者中的首次人体1期试验。这项随机、安慰剂对照临床试验包括受控麸质挑战，将评估VTP-1000的安全性、耐受性、药代动力学和药效学。VTP-1000是一种在研注射用抗原特异性耐受免疫疗法，它利用该公司专有的SNAP-TI平台，将多种麸质肽抗原（来自小麦、大麦和黑麦蛋白）和免疫调节剂雷帕霉素包裹在纳米颗粒中同时递送至人体，以促进对麸质的免疫耐受。 ENA-001：IND申请获得FDA许可 Enalare Therapeutic公司宣布，其在研呼吸兴奋剂ENA-001的IND申请已获得美国FDA的批准，可针对与药物过量相关的呼吸抑制开展1期临床研究。该研究将包括Enalare的肌肉内制剂（IM）和静脉注射（IV）制剂。ENA-001具有新颖的作用机制，可通过颈动脉体内的外周化学感受器通路影响通气。此前，欧洲已经成功完成了5项使用ENA-001的IV制剂的1期研究，证明了其有效性和良好的耐受性。ENA-001新颖的作用机制和迄今为止的研究结果显示，该疗法有潜力改善多种致命疾病患者的生活，包括药物过量、术后呼吸抑制和早产儿呼吸暂停。 ▲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] Immusoft to Announce Positive Phase 1 Data for First Engineered B Cell Therapy in a Clinical Trial. Retrieved September 23, 2024 from https://www.prnewswire.com/news-releases/immusoft-to-announce-positive-phase-1-data-for-first-engineered-b-cell-therapy-in-a-clinical-trial-302255551.html [2] Arrowhead Pharmaceuticals Files for Regulatory Clearance to Initiate Phase 1/2a Study of ARO-INHBE for the Treatment of Obesity. Retrieved September 23, 2024 from https://ir.arrowheadpharma.com/news-releases/news-release-details/arrowhead-pharmaceuticals-files-regulatory-clearance-initiate-3 [3] Innate Pharma Announces FDA Clearance of the IND for IPH4502, a Nectin-4 ADC to Be Developed in Solid Tumors. Retrieved September 23, 2024 from https://pipelinereview.com/innate-pharma-announces-fda-clearance-of-the-ind-for-iph4502-a-nectin-4-adc-to-be-developed-in-solid-tumors/ [4] Metsera Reports Highly Competitive Results from Ongoing Trial of Novel, Potential Once-Monthly Injectable GLP-1 Receptor Agonist MET-097. Retrieved September 24, 2024 from https://www.businesswire.com/news/home/20240924023447/en/Metsera-Reports-Highly-Competitive-Results-from-Ongoing-Trial-of-Novel-Potential-Once-Monthly-Injectable-GLP-1-Receptor-Agonist-MET-097 [5] Barinthus Bio Initiates Phase 1 Clinical Trial of VTP-1000 for the Treatment of Celiac Disease. Retrieved September 24, 2024 from https://investors.barinthusbio.com/news-releases/news-release-details/barinthus-bio-initiates-phase-1-clinical-trial-vtp-1000#:~:text=Investigational%20immunotherapy%20candidate,%20VTP-1000,%20seeks%20to [6] Pasithea Therapeutics Announces Positive Initial Safety, Tolerability, Pharmacokinetic (PK), and Preliminary Efficacy Data from its Phase 1 Clinical Trial of PAS-004 in Advanced Cancer. Retrieved September 27, 2024 from https://www.globenewswire.com/news-release/2024/09/26/2953686/0/en/Pasithea-Therapeutics-Announces-Positive-Initial-Safety-Tolerability-Pharmacokinetic-PK-and-Preliminary-Efficacy-Data-from-its-Phase-1-Clinical-Trial-of-PAS-004-in-Advanced-Cancer.html [7] Enalare Receives FDA Clearance to Initiate the First Phase 1 Clinical Study of ENA-001 to Be Conducted in the United States. Retrieved September 27, 2024 from https://www.newswire.com/news/enalare-receives-fda-clearance-to-initiate-the-first-phase-1-clinical-22429358 [8] KSQ Therapeutics Announces FDA Clearance of IND Application for KSQ-004EX, a CRISPR/Cas9 Engineered Tumor-Infiltrating Lymphocyte (eTIL®) Therapy. Retrieved September 27, 2024, from https://www.globenewswire.com/news-release/2024/09/24/2952011/0/en/KSQ-Therapeutics-Announces-FDA-Clearance-of-IND-Application-for-KSQ-004EX-a-CRISPR-Cas9-Engineered-Tumor-Infiltrating-Lymphocyte-eTIL-Therapy.html#:~:text=KSQ-004EX,%20an%20eTIL%20%C2%AE%20cell%20therapy [9] Minovia Therapeutics Announces FDA Clearance of IND Application for a Phase Ib Clinical Trial of MNV-201 in Low Risk Myelodysplastic Syndrome. Retrieved September 27, 2024, from https://www.globenewswire.com/news-release/2024/09/26/2954055/0/en/Minovia-Therapeutics-Announces-FDA-Clearance-of-IND-Application-for-a-Phase-Ib-Clinical-Trial-of-MNV-201-in-Low-Risk-Myelodysplastic-Syndrome.html [10] Assembly Biosciences Reports Positive Interim Phase 1a Results from Clinical Trial Evaluating Long-Acting Helicase-Primase Inhibitor Candidate ABI-5366. Retrieved September 27, 2024, from https://investor.assemblybio.com/news-releases/news-release-details/assembly-biosciences-reports-positive-interim-phase-1a-results [11] Alkermes to Present Positive Clinical Data From Phase 1b Study of ALKS 2680 in Patients With Narcolepsy Type 2 and Idiopathic Hypersomnia at Sleep Europe 2024. Retrieved September 27, 2024, from https://www.prnewswire.com/news-releases/alkermes-to-present-positive-clinical-data-from-phase-1b-study-of-alks-2680-in-patients-with-narcolepsy-type-2-and-idiopathic-hypersomnia-at-sleep-europe-2024-302254991.html [12] Carrick Therapeutics Announces First Patient Dosed in Phase 1 Clinical Trial of CT7439 (CDK12/13 Inhibitor). Retrieved September 27, 2024, from https://www.carricktherapeutics.com/news-media/press-releases/detail/25/carrick-therapeutics-announces-first-patient-dosed-in-phase [13] Georgiamune Announces First Participant Dosed in First-In-Class Phase 1 Healthy Volunteers Trial of GIM-407. Retrieved September 27, 2024, from https://www.globenewswire.com/news-release/2024/09/24/2952226/0/en/Georgiamune-Announces-First-Participant-Dosed-in-First-In-Class-Phase-1-Healthy-Volunteers-Trial-of-GIM-407.html#:~:text=The%20company%20has%20initiated%20three%20first-in-class [14] Poseida Therapeutics Reports Positive Interim Phase 1 Results for Allogeneic CAR-T Therapy P-BCMA-ALLO1 with High Overall Response Rates in Heavily Pretreated Relapsed/Refractory Multiple Myeloma Patients. Retrieved September 27, 2024, from https://www.prnewswire.com/news-releases/poseida-therapeutics-reports-positive-interim-phase-1-results-for-allogeneic-car-t-therapy-p-bcma-allo1-with-high-overall-response-rates-in-heavily-pretreated-relapsedrefractory-multiple-myeloma-patients-302261471.html 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

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