DB-959Na

New cognition/function and extensive plasma biomarker results of T3D-959 treatment from the Phase 2 PIONEER trial, in a modified intent-to treat population of mild to moderate Alzheimer's patients will be presented at the upcoming Alzheimer's Association International Conference (AAIC) in Philadelphia, PA from July 28 to August 1. T3D-959 is a novel, orally delivered, once-a-day, small molecule drug candidate, designed to activate two nuclear receptors regulating brain glucose energy and lipid metabolism to improve brain health and function. RESEARCH TRIANGLE PARK, N.C., July 24, 2024 /PRNewswire/ -- T3D Therapeutics, Inc., a clinical stage drug development company engaged in the development of a new orally administered treatment for Alzheimer's disease (AD), today announced that CEO, John Didsbury, will be presenting new Phase 2 results in a modified intent-to-treat population of mild to moderate Alzheimer's patients at AAIC. The poster presentation will take place on Sunday, July 28th in Philadelphia, PA. Presentation Details: Continue Reading A Novel Way to Reduce Alzheimer's Amyloid Plaque Burden, Phase 2 Clinical Trial Results of T3D-959 Presented at AAIC Post this Title: Phase 2 PIONEER Trial of Oral T3D-959 for the Treatment of Patients Diagnosed with Mild-to-Moderate Alzheimer's Disease: New Results in a Modified Intent-to-Treat Population Session: Developing Topics: Drug Development Poster Number: Sunday-798 Abstract Number: 95625 Date/Time: July 28, 2024, 8:00am-4:15pm (ET) Location: Pennsylvania Convention Center, Exhibit Hall (Hall BC) Presenter, John Didsbury states, "AD is a disease that encompasses a plethora of neurodegenerative 'triggers' including beta amyloid plaques, tau neurofibrillary bundles, oxidative stress, neuroinflammation and neurotransmitter deficits. Altered glucose and lipid brain metabolism is at its core. Improving brain metabolism can impact these neurodegenerative triggers, including reducing amyloid plaque burden. Current AD drug development is highly focused on plaque reduction, but recently-marketed therapies are not ideal in terms of safety and delivery. The novel mechanism of action, oral once-a-day administration, and safety profile of T3D-959 offers the potential to address the deficiencies of anti-plaque antibodies." About T3D-959: T3D-959, a small molecule, delivered orally once daily, is a brain-penetrating PPAR delta/gamma dual nuclear receptor agonist designed to improve both glucose and lipid metabolism dysfunctions present in AD and other neurodegenerative disorders. About the Study: The Phase 2 PIONEER study (Prospective therapy to Inhibit and Overcome Alzheimer's Disease Neurodegeneration via Brain EnErgetics and Metabolism Restoration) was a double-blind, placebo-controlled, parallel-group Phase 2 safety and efficacy study that enrolled 250 adults with mild-to-moderate Alzheimer's disease (MMSE 14-26). PIONEER was designed to assess the safety, tolerability, and effectiveness of T3D-959 in the treatment of Alzheimer's disease. T3D-959 was administered orally once daily over a 24-week dosing period. Subjects received one of three different doses of T3D-959 (15mg, 30mg, or 45mg) or a placebo. To learn more about this study please visit and reference study number NCT04251182. PIONEER is supported by the National Institute on Aging, part of the National Institutes of Health, under award number R01AG061122 and by the Alzheimer's Association's Part the Cloud Gates Partnership Grant Program. About T3D Therapeutics, Inc.: T3D Therapeutics, Inc. is a privately held, Research Triangle Park, NC-based company. The Company has an exclusive license to T3D-959, its lead product candidate, and a platform of structurally related molecules. T3D Therapeutics' mission is to develop and commercialize T3D-959 for the treatment of Alzheimer's disease. Forward-Looking Statements: Statements contained in this release that are not statements of historical fact are forward-looking statements, including those statements relating to the Company's expectations regarding clinical studies and developments, and the future potential of its product candidates, including T3D-959, and other statements that are predictive in nature or that depend upon or refer to future events or conditions. Without limiting the generality of the foregoing, words such as "may," "will," "expect," "believe," "anticipate," "intend," "could," "estimate" or "continue" are intended to identify forward-looking statements. Readers are cautioned that certain important risks and uncertainties, and assumptions, which if they do not materialize or prove incorrect, may affect the Company's actual results and could cause such results to differ materially from any forward-looking statements which may be made in this release or which are otherwise made by or on behalf of the Company. Factors which may affect the Company's results include, but are not limited to, uncertainties and/or unexpected results related to research and development and clinical testing, the timing, costs and uncertainty of obtaining any required regulatory approvals, changes in the regulatory landscape, uncertainties related to obtaining additional capital as needed to meet the Company's needs on acceptable terms, or at all, the absence of any guarantee of product demand, market acceptance or competitive advantage for any of the Company's product candidates, if approved, and certain trade, legal, social and economic risks. Any forward-looking statement in this release speaks only as of the date on which it is made, and the Company assumes no obligation to update or revise any such forward-looking statement. For more information visit . CONTACT: John Didsbury, Ph.D., CEO T3D Therapeutics, Inc. 1-919-237-4897 Email: info (at) t3dtherapeutics (dot) com SOURCE T3D Therapeutics, Inc.

「  本文共：15条资讯，阅读时长约：3分钟 」今日头条信达VEGF/C3补体双抗眼科Ⅱ期临床积极。信达生物在AAO2023年会上公布VEGF/C3补体双靶点药物IBI302治疗新生血管性年龄相关性黄斑变性的Ⅱ期临床最新数据。第36周时，与阿柏西普(2mg)相比，IBI302（2mg/4mg）治疗改善研究眼最佳矫正视力（BCVA）的效果达到非劣效标准，两组患者BCVA较基线变化均值分别为+10.6、+11.4和+12.0个字母；临床中，IBI302组无眼内炎或视网膜血管炎发生。该产品目前已处于Ⅲ期临床开发。国内药讯1.绿叶紫杉醇脂质体肺癌真实世界研究积极。绿叶制药自研紫杉醇脂质体（力扑素®）联合免疫一线治疗晚期非小细胞肺癌（NSCLC）的真实世界研究结果公布于SITC2023年会上。研究目前纳入100例至少接受2周期含紫杉醇脂质体联合免疫药物一线治疗的患者。中位随访时间为8.6个月。中位PFS为11个月（95% CI：8.9-16.8）。总体ORR为60.2%，疾病控制率（DCR）为91.5%。任意级别的不良事件发生率为91%，≥3级不良事件的发生率为34%。2.科越C5/FH1-5补体抑制剂II期临床积极。科越医药C5/FH1-5双靶点补体抑制剂KP104将在ASH2023年会上公布用于治疗阵发性睡眠性血红蛋白尿症(PNH)的II期试验积极结果。KP104旨在同时选择性抑制补体旁路和末端途径，具有协同治疗补体介导的疾病的潜力。科越医药计划在中国、美国和澳大利亚开展II期临床，适应症包括PNH、 IgA肾病、C3肾小球病和继发于系统性红斑狼疮的血栓性微血管病(SLE-TMA)。3.君实PD-1抑制剂联合治疗HNSCC早期临床积极。君实生物PD-1抑制剂特瑞普利单抗在SITC2023年会上公布与EGFR单抗西妥昔单抗联合治疗复发或转移性头颈部鳞状细胞癌（R/M-HNSCC）的Ⅰb/Ⅱ期临床积极结果。中位随访为10.0个月时，IRC评估的经确认的ORR为60%；DCR为80%，中位DOR为17.9个月；中位PFS为9.9个月，1年PFS率为40.7%。中位OS达15.4个月，1年OS率为54.4%。临床中，未报告与研究治疗相关的致死性AE。4.仁景mRNA疫苗获批HPV临床。仁景生物自主研发的HPV相关肿瘤治疗性mRNA疫苗RG002获FDA批准开展临床研究，用于治疗人乳头瘤病毒（HPV）16型和/或18型相关的2级或3级宫颈上皮内瘤变（CIN2/3）。RG002采用仁景生物自主知识产权的mRNA序列和脂质纳米颗粒（LNP）递送系统开发，已在临床前研究中显示出单药能诱导较强的特异性细胞免疫和肿瘤细胞杀伤作用。5.华夏英泰LILRB4靶向细胞疗法报IND。华夏英泰1类生物制品YTS104细胞注射液的临床试验申请获CDE受理。这是一款靶向LILRB4的自体型细胞治疗药物，通过慢病毒基因转导，将特定STAR基因导入自体T细胞内并经体外细胞扩增制备。该产品申报适应症包括复发/难治急性髓系白血病（AML）、慢性粒-单核细胞白血病（CMML）等。2022年年底，FDA已授予YTS104用于治疗R/R AML的孤儿药资格。国际药讯1.K药辅助治疗肾癌Ⅲ期临床成功。默沙东PD-1抑制剂Keytruda用于辅助治疗肾细胞癌（RCC）的Ⅲ期试验KEYNOTE-564达到主要终点和关键次要终点。与安慰剂相比，Keytruda辅助治疗显著改善患者的无病生存期，使疾病复发或死亡风险降低32%（HR=0.68，p=0.0010）；患者总生存期的统计也具有临床显著的改善。Keytruda的安全性与既往试验一致，没有出现新的安全性问题。2.细胞免疫疗法预防肾移植风险Ⅲ期临床积极。Medeor公司创新细胞疗法MDR-101在国际Ⅲ期临床中获积极中期结果。MDR-101由活体供肾者的血液和外周干细胞开发而来，旨在诱导供体特异性免疫耐受，预防肾移植肾的排斥反应。试验结果显示，接受HLA匹配活体捐献者肾移植的患者有63%的比例完成试验，并在两年内维持不使用免疫抑制药物状态。详细结果将公布于ASN2023年会上。3.体内CRISPR基因编辑疗法将启动Ⅲ期临床。Intellia公司CRISPR/Cas9基因编辑疗法NTLA-2001用于治疗转甲状腺素蛋白（ATTR）淀粉样变性的Ⅰ期试验最新结果积极。12个月随访分析显示，在接受≥0.3mg/kg剂量NTLA-2001单次给药的患者（n=62）中，其血清TTR中位降低91%，治疗后第28天的中位绝对残留血清TTR浓度为17 µg/mL；药物在总研究队列（包括多发性神经病和心肌病患者）中耐受性良好。该公司计划在今年年底启动NTLA-2001的Ⅲ期临床研究。4.创新APRIL单抗肾病Ⅱ期研究见刊NEJM。大冢制药和Visterra公司开发的APRIL单抗sibeprenlimab（VIS649）在ASN2023年会上公布用于治疗IgA肾病的Ⅱ期临床积极结果。与安慰剂相比，sibeprenlimab（2mg、4mg和8mg）治疗12个月时患者的蛋白尿水平显著减少，两组患者24小时尿蛋白/肌酐比值（UPCR）的几何平均比值降幅分别为47.2%、58.8%、62.0%和20.0%；两组治疗伴发不良事件（TEAE）的发生率也相似。详细结果同时发表于《新英格兰医学杂志》上。5.PPARδ/γ核受体激动剂老年痴呆Ⅱ期临床积极。T3D Therapeutics公司口服小分子PPARδ/γ核受体双重激动剂T3D-959治疗轻中度阿尔茨海默病（AD）的Ⅱ期PIONEER试验结果积极。在ITT人群中，与安慰剂相比， T3D-959（30mg）治疗24周时显著降低患者血浆Ab42/40比值（评估淀粉样斑块负荷的生物标志物）；患者认知水平量表ADAS-Cog11的评分改善了2分；药物总体安全性良好，未发生与卒中有关的药物相关不良事件。6.吉利德将开发血癌新一代CAR-T疗法。吉利德旗下Kite公司与Epic Bio公司将利用后者的基因调控平台（GEMS），针对Kite所选择靶向血癌的靶标开发载体，应用于新一代CAR-T细胞疗法。GEMS是一种表观遗传编辑的模块化平台，是一种允许通过单独AAV载体进行体内递送的CRISPR系统。根据协议，Epic Bio将获得预付款，开发、监管和销售里程碑潜在款项。医药热点。1.西湖大学启动创建医学院。近日，西湖大学董事会研究决定设立医学院，经校长施一公提名，医学院首任院长由中国科学院院士、著名免疫学家董晨教授担任。新成立的医学院将以培养顶尖医师科学家（Physician scientists）为目标，致力于医学创新和临床转化，重点聚焦微生物学与疫苗、免疫学与炎症、生理学与代谢、肿瘤生物学与治疗、医学遗传与罕见病、药物研发、公共健康等研究领域。2.南昌大学附一院乳腺专病中心成立。11月3日，南昌大学第一附属医院象湖院区“乳腺专病中心”成立。该中心是江西省首个由省级综合医院成立的乳腺专病中心，中心聚焦乳腺疾病，致力于为患者提供全流程、一站式的就诊服务。该中心除开展乳腺癌改良根治术、保乳术、前哨淋巴结活检术等常规手术之外，也开展了乳腺良恶性肿瘤的腔镜手术、乳腺癌保乳整形手术、乳房重建术（包括假体及自体皮瓣等）等。3.上海市外卖购药可刷医保。近日，上海相关部门已与饿了么、美团平台联系，试点互联网药店医保支付工作，有几十家药店纳入范畴。在上海通过美团外卖或饿了么 App下单带有“医保支付”字样的药品，页面显示可从个人电子医保卡账户付款，目前只有部分带有“医保支付”字样的药店才可使用医保。评审动态  1. CDE新药受理情况（11月06日) 2. FDA新药获批情况（北美11月03日）股市资讯上个交易日 A 股医药板块 +1.25%涨幅前三     跌幅前三维康药业+19.99%  *ST 太安-4.55%康为世纪+10.29%  奥泰生物-3.95%诺思兰德 +9.77%  珍 宝 岛 -3.85%【舒泰神]取得关于注射用STSP-0601的Ib/I期临床试验临床研究总结报告。剂型为注射用无菌冻干粉末，适应症为伴抑制物的血友病A或B患者出血按需治疗。【广济药业]收到国家药品监督管理局下发的化学原料药恩替卡韦《化学原料药上市申请批准通知书》，获批，登记号:Y20170000288。【华神科技]看展15000吨/年高端新材料和原料药(含医药中间体)绿色生产基地项目，在控股子公司山东凌凯药业有限公司进行项目一期建设，项目一期计划分阶段建设，其中第一阶段项目建设投资不超过4.8亿元，建设工期约12个月。- The End -戳“阅读原文”，了解更多医药研发及股市资讯。