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Fresenius Medical Care's Third-Party Clinical Research Organization Frenova Announces Strategic Collaboration Advancing Genomics-Driven, Precision Kidney Disease Care
Prnewswire· 2025-07-31 20:30
合作公告 - Fresenius Medical Care旗下Frenova与Nephronomics、GENEWIZ达成合作,共同推进My Reason®基因组研究计划,旨在利用前沿技术提升对肾脏、心血管和代谢疾病的理解[1] - 合作将整合三方资源:Frenova提供肾病临床数据网络,Nephronomics贡献肾脏精准医学技术,GENEWIZ提供DNA测序技术[4][5] - 目标是通过基因组分析开发个性化肾脏疾病诊疗方案,重新定义以患者为中心的医疗模式[3] My Reason®研究计划 - 该项目是全球最大的肾脏疾病基因组数据注册库,已收录35,000名参与者生物样本,计划两年内扩展至50,000人[3] - 数据集包含全基因组测序和纵向临床数据,涵盖实验室检测结果、诊断历史、治疗方案及原始放射影像[11] - Nephronomics拥有该数据集的独家商业权利,将用于构建Nephronomics Atlas知识库[4] 技术应用 - GENEWIZ将运用其25年经验的DNA测序技术处理生物样本,Azenta全球生物样本库网络提供长期存储服务[5] - Nephronomics采用专有人工智能/机器学习模型分析数据,识别新型疾病亚型、保护性基因变异和治疗靶点[4] - 合作将产生大规模全基因组测序数据,建立最全面的心血管-肾脏-代谢疾病基因型-表型数据库[4] 参与方背景 - Fresenius Medical Care是全球领先的肾脏疾病服务商,运营3,675家透析诊所,为29.9万患者提供服务,覆盖全球420万透析患者[7] - Frenova作为其临床研究子公司,拥有肾病领域最大的纵向患者数据库[9] - Nephronomics是Fresenius与Mechanica Partners的合资企业,专注于肾脏精准医疗[11] - Azenta生命科学(Nasdaq: AZTA)提供全流程生命科学解决方案,旗下GENEWIZ在基因组学领域具有领先地位[13]
Apellis(APLS) - 2025 Q2 - Earnings Call Presentation
2025-07-31 20:30
Second Quarter 2025 Financial Results Conference Call C E D R I C F R AN C O I S , M . D . , P h . D . Co-Founder, President & Chief Executive Officer T I M O T H Y S U L L I VAN July 31, 2025 Forward-looking statements Statements in this presentation about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements" within the meaning of The Private Securities Litigation Reform Act of 1995. The words " ...
Vericel (VCEL) - 2025 Q2 - Earnings Call Presentation
2025-07-31 20:30
Vericel cautions you that all statements other than statements of historical fact included in this presentation that address activities, events or developments that we expect, believe or anticipate will or may occur in the future are forward-looking statements. Although we believe that we have a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting us and are subject to risks, assumptions, uncertainties and factors relating ...
CERo Therapeutics Doses Second Acute Myeloid Leukemia Patient with CER-1236
Globenewswire· 2025-07-31 20:10
临床试验进展 - CERo Therapeutics已在第一阶段CER-1236临床试验中完成第二例急性髓系白血病(AML)患者的给药 该试验在科罗拉多州丹佛市的Sarah Cannon研究所进行 由Yazan Migdady博士担任首席研究员[1] - 第二例患者给药后已超过7天 目前持续监测安全性、耐受性和疗效等关键终点[1] - 第一例患者在28天剂量限制毒性(DLT)观察期内未出现剂量限制性毒性 药代动力学分析显示输注细胞在第14天达到峰值 扩增20.8倍[2] 产品技术特点 - CER-1236是一种靶向TIM 4L的新型自体CAR-T候选疗法 采用吞噬机制 可能成为癌症免疫治疗的重要进展[2] - 公司专有技术平台将先天性和适应性免疫特性整合到单一治疗结构中 通过构建吞噬途径消除肿瘤细胞 称为嵌合吞噬受体T细胞(CER-T)[5] - CER-T技术相比现有CAR-T疗法具有更广的治疗应用潜力 可能覆盖血液系统恶性肿瘤和实体瘤[5] 试验设计细节 - 第一阶段1/1b期研究为多中心开放标签设计 评估CER-1236在复发/难治性AML等患者中的安全性和初步疗效[3] - 研究分为两部分:剂量递增阶段确定最大耐受剂量 扩展阶段评估安全性和疗效 主要终点包括不良事件发生率、总体缓解率等[3] - 次要终点包括药代动力学参数 公司预计将在研究过程中持续通报进展[2][3] 公司管理层观点 - CEO Chris Ehrlich表示首例患者输注后CER-1236细胞快速显著扩增 验证了临床前科学工作的正确性[4] - 公司对CER-1236作为新型癌症治疗方法的前景保持信心 并感谢临床团队和患者的贡献[4] - 研究团队正在进行方案规定的安全性、药效学、药代动力学和疗效终点评估[2]
Vericel Reports Second Quarter 2025 Financial Results
Globenewswire· 2025-07-31 20:08
Total Revenue Growth of 20% to $63.2 Million, with MACI Revenue Growth of 21% to $53.5 Million Gross Margin Increased More than 400 Basis Points to 74% Adjusted EBITDA Growth of 112% to $13.4 Million, with Adjusted EBITDA Margin Increase of More than 900 Basis Points to 21% Approximately 600 MACI Arthro Surgeons Trained to Date Received FDA IND Clearance for Phase 3 MACI Ankle Clinical Study Conference Call Today at 8:30am Eastern Time CAMBRIDGE, Mass., July 31, 2025 (GLOBE NEWSWIRE) -- Vericel Corporatio ...
MaxCyte Announces Strategic Platform Licensing Agreement with Anocca AB to Advance TCR-T Cell Therapy Pipeline
Globenewswire· 2025-07-31 20:05
MaxCyte’s Flow Electroporation® Technology will support non-viral gene editing in the manufacture of Anocca’s TCR-T cell therapiesROCKVILLE, Md., July 31, 2025 (GLOBE NEWSWIRE) -- MaxCyte, Inc., (Nasdaq: MXCT), a leading, cell-engineering focused company providing enabling platform technologies to advance the discovery, development and commercialization of next-generation cell-based therapeutics, today announced the signing of a Strategic Platform License Agreement (SPL) with Anocca AB, a leading, clinical ...
Crescent Biopharma Reports Second Quarter 2025 Financial Results and Recent Business Highlights
GlobeNewswire News Room· 2025-07-31 19:34
Completed Merger with GlycoMimetics and Previously Announced $200 Million Private Financing Supporting Pipeline of Next Generation Therapeutics for Solid Tumors Recent Leadership Appointments Bring Deep Experience in Oncology Drug Development, Clinical Operations and Building Biotechnology Companies On Track to Submit IND Application for CR-001, a PD-1 x VEGF Bispecific Antibody, in Fourth Quarter of 2025, with Proof-of-Concept Clinical Data Expected in Second Half of 2026 WALTHAM, Mass., July 31, 2025 (GL ...
BriaCell Adds UCLA Health as Key Site in Pivotal Phase 3 Breast Cancer Study
Globenewswire· 2025-07-31 19:30
PHILADELPHIA and VANCOUVER, British Columbia, July 31, 2025 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW, BCTXZ) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care, announces the addition of UCLA Health Jonsson Comprehensive Cancer Center, a leading cancer center in California, to its ongoing pivotal Phase 3 clinical study (Bria-ABC, NCT06072612) evaluating Bria-IMT™ in combination with a checkpoi ...
Intellia Therapeutics to Hold Conference Call to Discuss Second Quarter 2025 Earnings and Company Updates
GlobeNewswire News Room· 2025-07-31 19:30
公司财务与运营更新 - 公司将于2025年8月7日美国东部时间上午8点召开电话会议,公布2025年第二季度财务业绩和运营亮点 [1] - 电话会议的重播将于同日下午12点通过公司官网的"投资者与媒体"栏目中的"活动与演示"页面提供 [1] 公司背景与业务聚焦 - 公司是一家处于临床阶段的基因编辑领域领先企业,专注于利用CRISPR技术革新医学疗法 [2] - 公司致力于开发首创类药物,解决未满足的医疗需求并推动患者治疗范式的进步 [2] - 公司通过持续拓展CRISPR平台的编辑和递送技术能力,充分释放基因编辑潜力 [2] 投资者关系信息 - 投资者可拨打电话833-316-0545(美国)或412-317-5726(国际)接入会议,需提前5分钟拨号 [3] - 会议提供同步网络直播,链接可通过公司官网获取 [3]
FOXO TECHNOLOGIES INC. ANNOUNCES LICENSE RENEWAL AND PROVIDES OPERATIONAL UPDATE FOR MYRTLE RECOVERY CENTERS, INC.
Globenewswire· 2025-07-31 19:23
公司动态 - FOXO Technologies旗下行为健康子公司Myrtle Recovery Centers成功续签田纳西州Oneida地区酒精和药物住院治疗设施的运营许可证[1] - 该设施目前处于满负荷运营状态并管理候补名单 公司正积极考虑通过开设第二家机构或行业并购实现扩张[2] - Myrtle Recovery Centers拥有30张床位 提供戒毒住院治疗及门诊药物辅助治疗(MAT)和鸦片依赖治疗(OBOT)服务[3] 业务架构 - FOXO Technologies旗下运营三大业务板块:Rennova Community Health(经营田纳西州关键访问医院Big South Fork Medical Center)、Myrtle Recovery Centers(行为健康治疗)、FOXO Labs(生物技术研发)[3][4] - FOXO Labs专注于通过尖端生物技术开发改善人类健康和寿命的产品解决方案[4] 运营数据 - 田纳西州行为健康治疗设施续签一年期运营许可 该州心理健康与药物滥用服务部在完成年度检查后批准[1] - 公司首席执行官透露现有治疗中心处于100%入住率状态 需求超过当前容量[2]