This is an adaptive prospective, multi-center, randomized, double-blind, placebo-controlled study to evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of WAL0921 in subjects with glomerular kidney disease and proteinuria, including diabetic nephropathy and rare glomerular kidney diseases (primary focal segmental glomerulosclerosis [FSGS], treatment-resistant minimal change disease [TR MCD], primary immunoglobulin A nephropathy [IgAN], and primary membranous nephropathy [PMN]). Subjects in this study will be randomized to receive the investigational drug WAL0921 or placebo as an intravenous infusion once every 2 weeks for 7 total infusions. All subjects will be followed for 24 weeks after their last infusion.

开始日期2024-07-02

申办/合作机构

Walden Biosciences, Inc.初创企业

NCT05891366 / Completed临床1期

Safety, Pharmacokinetics, and Pharmacodynamics of a Single, Ascending Dose of WAL0921 in Healthy Subjects

This is a randomized, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, pharmacokinetics, and pharmacodynamics of WAL0921 in healthy subjects.

开始日期2023-05-31

申办/合作机构

Walden Biosciences, Inc.初创企业

100 项与 Walden Biosciences, Inc. 相关的临床结果

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0 项与 Walden Biosciences, Inc. 相关的专利（医药）

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项与 Walden Biosciences, Inc. 相关的文献（医药）

International Journal of Oncology

Targeting PIM2 by JP11646 results in significant antitumor effects in solid tumors

Article

作者: Baldino, Carmen ; Gil‑Moore, Malgorzata ; Katsuta, Eriko ; Opyrchal, Mateusz ; Adjei, Alex ; Moore, Justine ; Ding, Yi ; Caserta, Justin ; Gelman, Irwin ; Takabe, Kazuaki ; Yousif, Mohamed ; Lee, Kelvin

Proviral integration of Moloney virus 2 (PIM2) is a pro‑survival factor of cancer cells and a possible therapeutic target in hematological malignancies. However, the attempts at inhibiting PIM2 have yielded underwhelming results in early clinical trials on hematological malignancies. Recently, a novel pan‑PIM inhibitor, JP11646, was developed. The present study examined the utility of targeting PIM2 in multiple solid cancers and investigated the antitumor efficacy and the mechanisms of action of JP11646. When PIM2 expression was compared between normal and cancer tissues in publicly available datasets, PIM2 was found to be overexpressed in several types of solid cancers. PIM2 ectopic overexpression promoted tumor growth in in vivo xenograft breast cancer mouse models. The pan‑PIM inhibitor, JP11646, suppressed in vitro cancer cell proliferation in a concentration‑dependent manner in multiple types of cancers; a similar result was observed with siRNA‑mediated PIM2 knockdown, as well as an increased in cell apoptosis. By contrast, another pan‑PIM inhibitor, AZD1208, suppressed the expression of downstream PIM2 targets, but not PIM2 protein expression, corresponding to no apoptosis induction. As a mechanism of PIM2 protein degradation, it was found that the proteasome inhibitor, bortezomib, reversed the apoptosis induced by JP11646, suggesting that PIM2 degradation by JP11646 is proteasome‑dependent. JP11646 exhibited significant anticancer efficacy with minimal toxicities at the examined doses and schedules in multiple in vivo mice xenograft solid cancer models. On the whole, the present study demonstrates that PIM2 promotes cancer progression in solid tumors. JP11646 induces apoptosis at least partly by PIM2 protein degradation and suppresses cancer cell proliferation in vitro and in vivo. JP11646 may thus be a possible treatment strategy for multiple types of solid cancers.

项与 Walden Biosciences, Inc. 相关的新闻（医药）

2024-09-30

·GlobeNewswire-Health Care

Walden Biosciences Fully Enrolls First Cohort in Phase 2 Basket Study of WAL0921 in Chronic Kidney Diseases

Expects Topline Results from First Multiple Ascending Dose Cohort by Year-end 2024 and to Initiate Rare Kidney Disease Cohorts in Early 2025CAMBRIDGE, Mass., Sept. 30, 2024 (GLOBE NEWSWIRE) -- Walden Biosciences, Inc. (Walden), a private, venture-backed biotechnology company advancing disease modifying therapies to transform the treatment of kidney disease, today announced that it has completed initial dosing of all subjects in the first cohort of a Phase 2 basket study evaluating WAL0921 as a treatment for chronic kidney diseases. WAL0921 is Walden’s first-in-class, proprietary, humanized monoclonal antibody that binds soluble urokinase plasminogen activator receptor (suPAR) and inhibits the pathological activity of suPAR that causes podocyte dysfunction and kidney disease. The Phase 2 basket study will evaluate WAL0921 in individuals with glomerular kidney diseases and proteinuria. This study will enroll subjects with diabetic nephropathy (DN) and rare glomerular kidney diseases, including focal segmental glomerulosclerosis (FSGS), treatment resistant minimal change disease (TR-MCD), IgA nephropathy (IgAN), and primary membranous nephropathy (PMN). “This study is unique in that it will establish safety in a multiple ascending dose (MAD) study of WAL0921 in a diseased population and will also serve as proof-of-concept for each individual kidney disease being assessed. The study initially evaluates two ascending doses in subjects with diabetic nephropathy to establish safety and confirm the pharmacodynamic effect of lowering suPAR that we saw in healthy subjects in our Phase 1+ clinical study,” stated Dr. Andrew Blair, Chief Medical Officer of Walden Biosciences. “We look forward to generating topline data from cohort 1 by year-end 2024 and to advancing this Phase 2 basket study into rare kidney disease cohorts in early 2025,” added Dr. Blair. “We are pleased to have swiftly completed initial dosing of the first cohort in the MAD portion of our Phase 2 study as it moves us one step closer to bringing this potentially disease-modifying treatment to chronic kidney disease patients," stated Blaine McKee, Ph.D., Chief Executive Officer of Walden. “Based on the data from preclinical studies and our compelling early clinical study, we believe WAL0921 has substantial therapeutic potential.” The Phase 2 clinical study is supported by positive data from the recently completed Phase 1+ clinical study of WAL0921. The Phase 1+ clinical study was a single center, double-blind, placebo-controlled, single ascending dose study of WAL0921 in five cohorts that evaluated its safety, pharmacokinetics, and pharmacodynamics in 40 healthy subjects. Data from the study showed that WAL0921 was safe, well-tolerated, and demonstrated proof-of-biology through a rapid, dose-dependent reduction in free suPAR levels. The Phase 2 Clinical Study The Phase 2 clinical study is an adaptive, prospective, multi-center, randomized, double-blind, placebo-controlled study to evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of WAL0921 in subjects with glomerular kidney diseases and proteinuria, including diabetic nephropathy (DN) and rare glomerular kidney diseases including focal segmental glomerulosclerosis (FSGS), treatment-resistant minimal change disease (TR-MCD), IgA nephropathy (IgAN) and membranous nephropathy (MN). The study will enroll up to 96 subjects, randomized three-to-one (active:placebo). Initially, 44 subjects will be enrolled, with the rare kidney disease cohorts following the DN cohorts. The study is flexible and will be adapted to reflect the emerging data from the initial 44 subjects, and up to 52 additional subjects may be adaptively enrolled to further explore safety, efficacy, PK, and PD of WAL0921 by expanding or adding cohorts of subjects (e.g., to improve statistical powering, explore alternative dosing schedules, or explore alternative dose). Subjects will be administered seven sequential IV doses of WAL0921 or placebo every 14 days over a 12-week treatment period and will be followed for an additional 24 weeks. About Walden BiosciencesWalden Biosciences is a private, venture-backed Phase 2 clinical development-stage company focused on developing breakthrough, disease-modifying medicines to treat kidney diseases. Walden is applying novel, multi-disciplinary approaches that directly target the kidney to prevent damage, slow disease progression, and restore kidney function. Walden’s programs address novel targets for therapeutic intervention, directly targeting two cell types critical for kidney function: podocytes and proximal tubular cells. Dysfunction of these cells are critical hallmarks of the majority of kidney diseases. Walden’s clinical-stage program is a humanized monoclonal antibody that inhibits suPAR, a cause of podocyte dysfunction and kidney disease, which is being evaluated in a Phase 2 Basket study. Walden’s second most advanced program is an IND-ready small molecule that is designed to stabilize and restore the function of dynamin, an enzyme responsible for the maintenance of the cytoskeletal architecture and function of podocytes and proximal tubule cells. All of Walden’s programs offer the promise to deliver disease-modifying, breakthrough therapies that are readily combinable with the standard of care to transform the treatment of kidney disease. For more information, please visit www.waldenbiosciences.com. Investor Contact:Anne Marie FieldsManaging DirectorPrecision AQ (formerly known as Stern Investor Relations)annemarie.fields@precisionaq.com Media ContactsFTI ConsultingRobert StanislaroRobert.Stanislaro@fticonsulting.com-OR-Helen O’GormanHelen.OGorman@fticonsulting.com

临床2期临床结果临床1期

2024-05-14

·GlobeNewswire-Health Care

Walden Biosciences Announces Research Collaboration with World Renowned Genetic Epidemiologist to Advance Work on Causal Role of suPAR in Chronic Kidney Disease

May 13, 2024 -- Walden Biosciences, Inc. (Walden), a private, venture-backed biotechnology company advancing disease-modifying therapies to transform the treatment of kidney disease, today announced that it has entered into a research collaboration with Primula Group to lever a large body of genetic data on patients living with chronic kidney disease (CKD), including insights from close to 500,000 individuals in the UK Biobank. The study will be led by Dipender Gill, M.D. Ph.D., who is based at Imperial College London and has over 200 research papers on Mendelian randomization methods and application. “We are delighted to collaborate with one of the world’s leading experts in Mendelian randomization to advance suPAR science and better understand the causative role of elevated suPAR levels in kidney diseases,” said Alex Duncan, Ph.D., Chief Scientific Officer of Walden. “Elevated levels of suPAR are known to injure kidney tissues, leading to podocyte dysfunction, kidney disease, and the associated proteinuria. The compromised kidney structure and function often leads to end-stage kidney disease, which can result in the need for dialysis or kidney transplant. Data from this study is expected to further support the clinical advancement of Walden’s anti-suPAR antibody, WAL0921, which is currently in Phase 2 clinical studies in CKD and expand the mechanistic insight into how elevated suPAR causes CKD.” The study will investigate established variants from genetic analysis of the human PLAUR gene that encodes uPAR and affects circulating levels of soluble uPAR (suPAR), thereby affecting kidney function (Hindy et al., JCI, 2022). This study will elucidate the common and distinct effects of PLAUR variants on the circulating proteome, metabolome, and their potential clinical implications. The genetic variants will also be used as proxies to study the effect of pharmacological modulation of suPAR. “The collaboration with Walden will build on earlier data supporting a causal role of suPAR in kidney disease and gives us a unique opportunity to help guide and transform the treatment of these patients, as well as identify other outcomes where targeting suPAR may be beneficial,” noted Dr. Gill. Earlier this year, Walden completed a Phase 1+ clinical study of WAL0921, a first-in-class, proprietary, humanized monoclonal antibody that binds suPAR and inhibits its pro-inflammatory action on podocytes causing kidney dysfunction and disease. The Phase 1+ clinical study was a single center, placebo-controlled, single ascending dose study of WAL0921 in five cohorts that evaluated its safety, pharmacokinetics, and pharmacodynamics in 40 healthy subjects. Data from the study showed that WAL0921 was safe, well-tolerated, and demonstrated proof-of-biology through a rapid, dose-dependent reduction in free suPAR levels. “We are pleased to be working with Dr. Gill to support this important work, as data from this collaboration will add to our growing understanding of the role that elevated suPAR plays in kidney disease and will support our ongoing Phase 2 study of WAL0921 in kidney disease,” stated Blaine McKee, Ph.D., Chief Executive Officer of Walden. Walden Biosciences is a private, venture-backed clinical development-stage company focused on developing breakthrough, disease-modifying medicines to treat kidney diseases. Walden is applying novel, multi-disciplinary approaches that directly target the kidney to prevent damage, slow disease progression, and restore kidney function. Walden’s programs address novel targets for therapeutic intervention, directly targeting two cell types critical for kidney function: podocytes and proximal tubular cells. Dysfunction of these cells are critical hallmarks of the majority of kidney diseases. Walden’s clinical-stage program is a humanized monoclonal antibody that inhibits suPAR, a pro-inflammatory mediator that causes podocyte dysfunction and kidney disease. Walden’s second most advanced program is a small molecule that is designed to restore the function of dynamin, an enzyme responsible for the maintenance of the cytoskeletal architecture and function of podocytes and proximal tubule cells. All of Walden’s programs offer the promise to deliver disease-modifying, breakthrough therapies that are readily combinable with the standard of care to transform the treatment of kidney disease. For more information, please visit www.waldenbiosciences.com. The content above comes from the network. if any infringement, please contact us to modify.

融资临床2期

2024-04-21

·药明康德

100%抑制关键标志物的脑渗透性疗法；持久降低发作率超95%的细胞疗法…… | 一周盘点

▎药明康德内容团队编辑本期看点1. 再生细胞疗法NRTX-1001用于治疗癫痫能够持久减少患者的癫痫发作，2名患者分别在接受治疗后的16个月和21个月内，癫痫发作较基线减少＞95。2. 新型口服脑渗透性NLRP3抑制剂VENT-02的早期临床数据积极，对血液中导致炎症反应的关键因素IL-1ß有100%的抑制作用。3. 治疗天使综合征（Angelman syndrome）的反义寡核苷酸疗法GTX-102在早期临床试验中表现积极，在第170天显示出快速且具有临床意义的多领域功能改善。图片来源：123RFNRTX-1001：公布1/2期临床试验的新数据Neurona Therapeutics公司公布了其候选再生细胞疗法NRTX-1001的1/2期临床试验的新数据。NRTX-1001是一种来源于人类多能干细胞的再生神经细胞治疗候选药物，用于治疗癫痫。这些完全分化的中间神经元分泌抑制性神经递质γ-氨基丁酸（GABA）。一次给药之后，这些人类中间神经元可在大脑的癫痫区域实现靶向整合并持久地抑制癫痫活动。接受NRTX-1001一次性治疗后患者需在第一年接受免疫抑制，目的是促进NRTX-1001的整合和长期持久性。此次公布的结果显示，队列1接受低剂量NRTX-1001治疗的5名受试者癫痫发作的中位数比基线减少了75%，在治疗后的六个月内，5名受试者中有4名报告癫痫发作比基线减少>50%。两名受试者在接受NRTX-1001治疗后分别接受了16个月和21个月的随访，结果显示，癫痫发作较基线持续减少＞95%，生活质量测试评分也有所提高。截至目前，所有接受治疗的受试者对NRTX-1001的耐受性都很好，神经心理学测试表明没有发现神经认知障碍。该试验中队列2的前两名受试者接受了更高剂量的NRTX-1001，目前尚未报告任何严重不良事件。VENT-02：公布1期临床试验数据Ventus Therapeutics公司公布了其新型口服脑渗透性NLRP3抑制剂VENT-02的1期临床试验结果。该1期临床试验评估了VENT-02在成年健康受试者中的药效学、药代动力学、安全性和耐受性。NLRP3炎症小体的异常激活与纤维化、皮肤病和风湿病等全身性疾病有关，也是帕金森病、阿尔茨海默病和难治性癫痫等多种神经系统疾病病理变化的关键驱动因素。VENT-02对NLRP3的治疗性抑制可阻止NLRP3炎症小体的形成，进而抑制IL-1β和IL-18的产生和细胞焦亡。此次公布的结果显示，VENT-02对血液中的IL-1ß有100%的抑制作用，24小时内脑脊液中的药物含量显著降低，炎症生物标志物（如高敏C反应蛋白[hsCRP]）也明显减少，从而证明了VENT-02对靶点的全面作用。根据试验中观察到的半衰期和靶点覆盖率，VENT-02已被证明具有每日给药一次的潜力。在这项1期临床试验中，VENT-02的耐受性良好，没有报告剂量限制性毒性或严重不良反应，仅观察到轻度或中度与治疗相关的不良反应。中度不良反应包括头痛和恶心，只有在剂量高于预期治疗剂量数倍时才会出现。该公司预计将于2024年下半年开展针对中枢神经系统疾病的临床试验。GTX-102：公布1/2期临床试验的中期数据Ultragenyx Pharmaceutical公司公布了其用于治疗天使综合征的在研疗法GTX-102在1/2期临床试验中获得的最新数据。天使综合征是一种由UBE3A基因缺失或突变所造成的神经系统发育障碍疾病，主要疾病特征包括发育迟缓、智力残疾、言语及平衡障碍。GTX-102是一种反义寡核苷酸疗法，可以促进神经元细胞中父系UBE3A的等位基因表达，产生患者体内所缺失的关键蛋白产物。此次公布的数据分析显示，接受GTX-102治疗的扩展队列A和B的患者，在第170天显示出快速且具有临床意义的多领域功能改善。此外，部分剂量递增队列患者在第758天显示出长期和持续的临床益处，远超过自然历史数据。基于这些数据，该公司计划启动关键性3期临床试验。AB-1005（AAV2-GDNF）：公布1b期临床试验的新数据拜耳（Bayer）公司旗下Asklepios BioPharmaceutical（AskBio）公司公布了其治疗帕金森病的在研基因疗法AB-1005的1b期临床试验结果。AB-1005是一种基于腺相关病毒血清型2（AAV2）载体的在研基因疗法，含有编码人胶质细胞源性神经营养因子（GDNF）的转基因。通过磁共振成像（MRI）监测的对流增强给药方式直接进行神经外科注射后，GDNF可以在大脑局部区域实现稳定和连续的表达。此次公布的结果显示，接受AB-1005治疗后的第18个月时，所有11名患者均耐受良好，未发生严重不良事件，达到试验的主要目标。基于这一结果，两家公司已经启动了一项2期临床试验，预计将于今年晚些时候开始在美国、欧盟和英国招募患者。BB-301：公布1b/2a期临床试验中首位患者的数据Benitec Biopharma公司公布了其开发的用于治疗眼咽肌营养不良（Oculopharyngeal Muscular Dystrophy）的沉默和取代基因疗法BB-301在早期临床试验中的首位患者的数据。该疗法利用一种新型的、经过改良的AAV9载体，表达一种独特的、单一的双功能构建体，从而能够促进密码子优化的PABPN1基因和两个针对PABPN1突变体的siRNA的共同表达。这两个siRNA被塑造成microRNA骨架，以抑制有缺陷的PABPN1突变体的表达，同时允许表达经过密码子优化的PABPN1基因，用PABPN1蛋白的功能性版本取代突变体。此次公布的数据显示，与该研究在自然史观察导入期进行的治疗前评估相比，接受BB-301治疗后第90天时，该研究中首个患者的多种吞咽功能指标均获得了改善。安全性方面，未在接受BB-301治疗的两名受试者中观察到严重不良事件。两名受试者出现了短暂的2级胃食管反流病（即“反酸”或“烧心”）。这两名受试者在短期服用了经批准用于治疗胃食管反流病的普通处方药后，胃食管反流病都得到了缓解。▲接受BB-301治疗后第90天时，患者在所有临床结局上都有改善（图片来源：参考资料[16]）Botensilimab：公布1期临床试验的新数据Agenus公司公布了其在微卫星稳定性（MSS）或错配修复缺陷型（dMMR）转移性结直肠癌（CRC）患者中开展的1期临床试验的积极结果。Botensilimab是一种在研新型多功能CTLA-4抗体，旨在将临床获益扩展到既往对标准治疗或在研疗法无反应的“冷”肿瘤。除与CTLA-4受体结合外，其Fc增强的结构能够诱导记忆免疫反应，下调调节性T细胞，并使T细胞更好地启动和活化，从而放大免疫反应。在一项超过300例患者的1b期临床研究中，botensilimab已经在9种实体肿瘤中证明了其临床应答，无论是单独使用还是与巴替利单抗联合使用。截至2024年3月1日的数据，在对77例无活动性肝转移的难治性MSS-CRC患者进行的1期试验中，中位随访时长为13.6个月，观察到的总缓解率为23%。18例获得缓解患者的中位缓解持续时间尚未达到。预计12个月和18个月的总生存率分别为71%和62%，中位总生存期为21.2个月。目前，botensilimab的2期试验已完成注册，该公司计划于2024年下半年展示详细的2期临床试验的疗效结果。WAL0921：公布1+期临床试验数据Walden Biosciences公司公布了其人源化单克隆抗体WAL0921针对健康受试者的1+期临床试验的结果。WAL0921能够结合循环游离可溶性尿激酶纤溶酶原激活受体（suPAR）及其膜结合形式uPAR，并抑制其导致肾脏疾病的病理活性。此次公布的结果显示，在40名健康受试者中，WAL0921的安全性和耐受性良好。此外，WAL0921能够快速、剂量依赖性地降低循环游离的suPAR水平。VTP-200：公布1b/2期临床试验数据Barinthus Biotherapeutics公司公布了其在研免疫治疗联合方案VTP-200用于治疗持续性高危HPV感染和产生相关癌前病变的患者的早期临床试验数据。VTP-200是一种需要接种两次的HPV疫苗，首次接种使用ChAdOx载体，第二次接种使用MVA载体，两者都编码相同的HPV抗原，旨在激发针对HPV的抗原特异性T细胞免疫反应。此次公布的结果显示，该研究达到了主要安全性终点。VTP-200总体耐受性良好，没有发生治疗相关的≥3级的不良事件或严重不良事件。在最高剂量的ChAdOx-HPV给药组（第2组）中观察到，高危（hr）HPV清除率为60%，宫颈病变清除率为67%，呈积极趋势。不过，来自五个活性剂量组的汇总数据显示，治疗组在hrHPV清除率或宫颈病变清除率上与安慰剂组相比，差异无统计学意义。SLATEv1：公布1/2期临床试验的中期数据Gritstone bio公司公布了其“现货型”新抗原疫苗SLATEv1联合免疫检查点抑制剂晚期转移性实体瘤的1期临床试验的中期结果。SLATEv1能够提供一组癌症患者共享的20种新抗原，包括多种癌基因（KRAS、TP53、BRAF和CTNNB1）中的多个复发突变，有望驱动T细胞反应。此次公布的结果显示，该联合疗法具有良好的耐受性，观察到的治疗相关不良事件大多数为1/2级，与基于病毒载体的疫苗和免疫检查点抑制剂的预期急性炎症一致。2例患者出现3/4级严重治疗相关不良事件，这些不良事件也是剂量限制性毒性。患者的总缓解率为0%，中位无进展生存期和总生存期分别为1.9个月和7.9个月。相对于患者肿瘤表达的KRAS新抗原，T细胞反应偏向于疫苗中编码的人类白细胞抗原匹配的TP53新抗原，这表明以前未知的新抗原免疫显性层次结构可能会影响多表位共享新抗原疫苗的治疗效果。基于这些结果，Gritstone bio公司开发了一种专门针对KRAS衍生的新抗原的优化疫苗，该疫苗正在2期临床研究中进行评估。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] AskBio presents 18-month Phase Ib trial results of AB-1005 gene therapy for patients with Parkinson’s disease. Retrieved April 17, 2024, from https://www.globenewswire.com/news-release/2024/04/16/2863581/0/en/AskBio-presents-18-month-Phase-Ib-trial-results-of-AB-1005-gene-therapy-for-patients-with-Parkinson-s-disease.html[2] TransCode Therapeutics Announces FDA Clearance To Initiate Phase 1/2 Clinical Trial with TTX-MC138 in Patients with Advanced Solid Tumors. Retrieved April 17, 2024, from https://www.globenewswire.com/news-release/2024/04/15/2862824/0/en/TransCode-Therapeutics-Announces-FDA-Clearance-To-Initiate-Phase-1-2-Clinical-Trial-with-TTX-MC138-in-Patients-with-Advanced-Solid-Tumors.html[3] Ultragenyx Announces Positive Interim Phase 1/2 Data in Patients with Angelman Syndrome After Treatment with GTX-102. Retrieved April 17, 2024, from https://www.globenewswire.com/news-release/2024/04/15/2862638/20739/en/Ultragenyx-Announces-Positive-Interim-Phase-1-2-Data-in-Patients-with-Angelman-Syndrome-After-Treatment-with-GTX-102.html[4] Nature Medicine Publishes Interim Results from Gritstone bio’s Phase 1/2 Study of “Off-the-Shelf” Neoantigen Vaccine Platform (SLATE). Retrieved April 17, 2024, from https://www.globenewswire.com/news-release/2024/04/15/2862633/0/en/Nature-Medicine-Publishes-Interim-Results-from-Gritstone-bio-s-Phase-1-2-Study-of-Off-the-Shelf-Neoantigen-Vaccine-Platform-SLATE.html[5] Agenus Announces Updated Phase 1 Data and Progress on BOT/BAL Development in Metastatic MSS Colorectal Cancer. Retrieved April 17, 2024, from https://www.businesswire.com/news/home/20240412973954/en[6] Walden Biosciences Announces Positive Topline Data from Phase 1+ Clinical Study of WAL0921 in Development for Treatment of Kidney Diseases. Retrieved April 17, 2024, from https://www.globenewswire.com/news-release/2024/04/15/2862634/0/en/Walden-Biosciences-Announces-Positive-Topline-Data-from-Phase-1-Clinical-Study-of-WAL0921-in-Development-for-Treatment-of-Kidney-Diseases.html[7] NiKang Therapeutics Doses First Patient in a Phase 1/1b Study of NKT3447, an Oral, Selective Inhibitor of CDK2 Which Reduces Cyclin E Expression. Retrieved April 17, 2024, from https://www.businesswire.com/news/home/20240415891824/en/[8] Volastra Therapeutics Announces First Patient Dosed in Phase Ib Clinical Trial of Sovilnesib. Retrieved April 17, 2024, from https://www.businesswire.com/news/home/20240416246457/en[9] Compass Therapeutics Announces First Patient Dosed in the Phase 1 Study of CTX-8371 in Patients with Solid Tumors. Retrieved April 17, 2024, from https://investors.compasstherapeutics.com/news-releases/news-release-details/compass-therapeutics-announces-first-patient-dosed-phase-1-study[10] Neurona Therapeutics Presents Positive Clinical Update from NRTX-1001 Cell Therapy Trial in Adults with Drug-resistant Focal Epilepsy at American Academy of Neurology (AAN) 2024 Annual Meeting. Retrieved April 17, 2024, from https://www.neuronatherapeutics.com/news/press-releases/041524/[11] Acumen Pharmaceuticals Presents First Comprehensive Clinical and Biomarker Data for Sabirnetug (ACU193) at American Academy of Neurology 2024 Annual Meeting. Retrieved April 17, 2024, from https://investors.acumenpharm.com/news-releases/news-release-details/acumen-pharmaceuticals-presents-first-comprehensive-clinical-and[12] Ventus Therapeutics Announces Results from Phase 1 Clinical Trial of VENT-02, a Novel, Orally Administered, Brain-Penetrant NLRP3 Inhibitor. Retrieved April 17, 2024, from https://www.businesswire.com/news/home/20240416382118/en[13] Artiva Biotherapeutics Announces First Patient Dosed in Phase 1 Trial of AlloNK® Cell Therapy Candidate in Lupus Nephritis. Retrieved April 17, 2024, from https://www.businesswire.com/news/home/20240417656558/en/[14] NeuroBo Pharmaceuticals Doses First Patient in Its Phase 1 Clinical Trial Evaluating DA-1726 for the Treatment of Obesity. Retrieved April 17, 2024, from https://www.prnewswire.com/news-releases/neurobo-pharmaceuticals-doses-first-patient-in-its-phase-1-clinical-trial-evaluating-da-1726-for-the-treatment-of-obesity-302118491.html[15] atai Life Sciences Announces the Publication of Beckley Psytech’s Phase 1 Study of BPL-003 in the Journal of Psychopharmacology. Retrieved April 17, 2024, from https://www.globenewswire.com/news-release/2024/04/17/2864385/0/en/atai-Life-Sciences-Announces-the-Publication-of-Beckley-Psytech-s-Phase-1-Study-of-BPL-003-in-the-Journal-of-Psychopharmacology.html[16] Benitec Biopharma Reports Positive Interim Clinical Trial Data for First OPMD Subject Treated with BB-301 in Phase 1b/2a Study. Retrieved April 19, 2024, from https://www.globenewswire.com/news-release/2024/04/18/2865286/0/en/Benitec-Biopharma-Reports-Positive-Interim-Clinical-Trial-Data-for-First-OPMD-Subject-Treated-with-BB-301-in-Phase-1b-2a-Study.html[17] YS Biopharma Granted Phase I Clinical Trial License of Therapeutic Chronic Hepatitis B Virus Vaccine. Retrieved April 19, 2024, from https://www.prnewswire.com/news-releases/ys-biopharma-granted-phase-i-clinical-trial-license-of-therapeutic-chronic-hepatitis-b-virus-vaccine-302120805.html[18] Barinthus Bio Announces Topline Data from Phase 1b/2 APOLLO Trial of VTP-200 in Persistent High-Risk Human Papillomavirus (HPV) Infections. Retrieved April 19, 2024, from https://www.globenewswire.com/news-release/2024/04/18/2865826/0/en/Barinthus-Bio-Announces-Topline-Data-from-Phase-1b-2-APOLLO-Trial-of-VTP-200-in-Persistent-High-Risk-Human-Papillomavirus-HPV-Infections.html[19] Immutep Appoints Leading Research Institute to Conduct First-in-Human Phase I Study of IMP761. Retrieved April 19, 2024, from https://www.globenewswire.com/news-release/2024/04/18/2865336/0/en/Immutep-Appoints-Leading-Research-Institute-to-Conduct-First-in-Human-Phase-I-Study-of-IMP761.html[20] D2M Biotherapeutics Announces First Patient Dosed in A Phase 1 Study Evaluating DM919, a Novel MICA/B Antibody for Treating Patients with Advanced Solid Tumors. Retrieved April 19, 2024, from https://www.prnewswire.com/news-releases/d2m-biotherapeutics-announces-first-patient-dosed-in-a-phase-1-study-evaluating-302120400.html[21] Oncternal Announces First Patient Dosed in Fourth Cohort of Phase 1/2 Study of ONCT-534 for the Treatment of R/R Metastatic Castration-Resistant Prostate Cancer. Retrieved April 19, 2024, from https://www.globenewswire.com/news-release/2024/04/18/2865429/0/en/Oncternal-Announces-First-Patient-Dosed-in-Fourth-Cohort-of-Phase-1-2-Study-of-ONCT-534-for-the-Treatment-of-R-R-Metastatic-Castration-Resistant-Prostate-Cancer.html[22] Bio-Path Holdings Announces Successful Completion of Higher Dose Second Cohort in Phase 1/1b Clinical Trial of BP1002 in Refractory/Relapsed Acute Myeloid Leukemia (AML) Patients. Retrieved April 19, 2024, from https://www.globenewswire.com/news-release/2024/04/18/2865259/0/en/Bio-Path-Holdings-Announces-Successful-Completion-of-Higher-Dose-Second-Cohort-in-Phase-1-1b-Clinical-Trial-of-BP1002-in-Refractory-Relapsed-Acute-Myeloid-Leukemia-AML-Patients.html[23] Aspen Neuroscience Announces First Patient Dosed in First-in-Human Phase 1/2a Clinical Trial of Autologous Neuronal Cell Replacement Therapy for Parkinson's Disease. Retrieved April 19, 2024, from https://www.prnewswire.com/news-releases/aspen-neuroscience-announces-first-patient-dosed-in-first-in-human-phase-12a-clinical-trial-of-autologous-neuronal-cell-replacement-therapy-for-parkinsons-disease-302119216.html[24] AviadoBio Announces First Patient Treated in ASPIRE-FTD Clinical Trial Evaluating AVB-101 for Frontotemporal Dementia with GRN Mutations. Retrieved April 19, 2024, from https://www.businesswire.com/news/home/20240415509017/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

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