A Phase 2b, Prospective, Multicenter, Randomized, Double-Masked, Active-Controlled Study to Assess the Efficacy and Safety of Repeat Intravitreal Injections of Foselutoclax (UBX1325) in Patients With Diabetic Macular Edema

The goal of this clinical trial is to assess the efficacy and safety of multiple doses of foselutoclax (UBX1325) in patients with Diabetic Macular Edema. The main questions the study aims to answer are:
* Assess the efficacy of foselutoclax compared to aflibercept
* Assess the safety and tolerability of foselutoclax

开始日期2023-08-23

申办/合作机构

Unity Biotechnology, Inc.

NCT05275205 / Completed临床2期

A Phase 2, Prospective, Multicenter, Randomized, Double-Masked, Active-Controlled Study to Assess the Safety, Tolerability, and Evidence of Activity of a Repeat Intravitreal Injection of UBX1325 in Patients With Neovascular Age-Related Macular Degeneration (Wet AMD)

This study is intended to assess safety, tolerability and biological activity of a repeat IVT injection of UBX1325 in patients with wet AMD.

开始日期2022-03-02

申办/合作机构

Unity Biotechnology, Inc.

NCT04857996 / Completed临床2期

A Phase 2a, Prospective, Multicenter, Randomized, Double Masked, Sham-Controlled Study to Assess the Safety, Tolerability and Evidence of Activity of a Single Intravitreal Injection of UBX1325 in Patients With Diabetic Macular Edema

This study is intended to assess the exposure, safety, biological activity, and durability of UBX1325, a phosphate pro-drug, and its active parent molecule (UBX0601) following a single intravitreal (IVT) injection of UBX1325 in patients with diabetic macular edema (DME).

开始日期2021-06-25

申办/合作机构

Unity Biotechnology, Inc.

100 项与 Foselutoclax 相关的临床结果

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100 项与 Foselutoclax 相关的转化医学

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100 项与 Foselutoclax 相关的专利（医药）

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项与 Foselutoclax 相关的文献（医药）

2024-09-19·Journal of clinical medicine

Multifocal Electroretinography Changes after UBX1325 (Foselutoclax) Treatment in Neovascular Age-Related Macular Degeneration.

Article

作者: Sapieha, Przemyslaw ; White, Lorraine ; Macha, Nathan ; Yu, Minzhong ; Ghosh, Anirvan ; Maturi, Raj K ; Klier, Sharon

Background/Objectives: The objective of this study was to determine the treatment effect of foselutoclax in neovascular age-related macular degeneration (AMD) by multifocal electroretinography (mfERG) and evaluate mfERG as a potential clinical endpoint in AMD studies. Methods: A total of five subjects were included in the study who had active choroidal neovascularization and a history of at least two anti-vascular endothelial growth factor (VEGF) injections in the last 6 months. Subjects received a 50 µL intravitreal injection of foselutoclax at the baseline visit and Weeks 4, 24, and 28 of the study period. Results: After foselutoclax treatment, the largest improvement in the mfERG N1-P1 response density occurred at Week 8 as three of five subjects achieved a ≥20% gain. In addition, three of five subjects demonstrated a BCVA improvement of ≥5 ETDRS letters over baseline at Weeks 4, 8, and 24. The mean change in BCVA demonstrated statistical significance in Weeks 4 and 8, showing increases of 5 (p = 0.02) and 6.2 (p = 0.02) letters, respectively. Conclusions: Foselutoclax treatment was shown to have the potential to recover outer retinal function as determined by mfERG and BCVA at approximately Week 8 of treatment.

2024-02-01·Nature Medicine1区 · 医学

Therapeutic targeting of cellular senescence in diabetic macular edema: preclinical and phase 1 trial results

1区 · 医学

Article

作者: David, Nathaniel E ; Klier, Sharon ; Cagnone, Gael ; Fournier, Frédérik ; Sapieha, Przemyslaw ; Rizk, Rana ; Sullivan, Lynne ; Diaz-Marin, Roberto ; Nguyen, Alex ; Wilson, Ariel M ; Ragusa, Derek ; Tsuruda, Pamela R ; Beltran, Pedro J ; Buscarlet, Manuel ; Rezende, Flavio A ; Dananberg, Jamie ; Damiano, Jason ; Joyal, Jean-Sebastien ; Blot, Guillaume ; Masaki, Lauren ; Dejda, Agnieszka ; Mallette, Frédérick A ; Hafiane, Ikhlas ; Hata, Masayuki ; Chorfi, Sarah ; Juneau, Rachel ; Patel, Priyanka ; Ghosh, Anirvan ; Crespo-Garcia, Sergio

Compromised vascular endothelial barrier function is a salient feature of diabetic complications such as sight-threatening diabetic macular edema (DME). Current standards of care for DME manage aspects of the disease, but require frequent intravitreal administration and are poorly effective in large subsets of patients. Here we provide evidence that an elevated burden of senescent cells in the retina triggers cardinal features of DME pathology and conduct an initial test of senolytic therapy in patients with DME. In cell culture models, sustained hyperglycemia provoked cellular senescence in subsets of vascular endothelial cells displaying perturbed transendothelial junctions associated with poor barrier function and leading to micro-inflammation. Pharmacological elimination of senescent cells in a mouse model of DME reduces diabetes-induced retinal vascular leakage and preserves retinal function. We then conducted a phase 1 single ascending dose safety study of UBX1325 (foselutoclax), a senolytic small-molecule inhibitor of BCL-xL, in patients with advanced DME for whom anti-vascular endothelial growth factor therapy was no longer considered beneficial. The primary objective of assessment of safety and tolerability of UBX1325 was achieved. Collectively, our data suggest that therapeutic targeting of senescent cells in the diabetic retina with a BCL-xL inhibitor may provide a long-lasting, disease-modifying intervention for DME. This hypothesis will need to be verified in larger clinical trials. ClinicalTrials.gov identifier: NCT04537884 .

Eye

Exploring new horizons in neovascular age-related macular degeneration: novel mechanisms of action and future therapeutic avenues

Review

作者: Singh, Rishi P. ; Shirian, Jonathan D. ; Shirian, Jonathan D ; Shukla, Priya ; Singh, Rishi P

AbstractNeovascular age-related macular degeneration (nAMD) can lead to significant vision impairment through the growth of abnormal neovascular membranes in the choroid. Despite advancements with current anti-vascular endothelial growth factor (VEGF) therapies, challenges such as frequent injections, inadequate response, and patient-related concerns persist. Emerging therapeutics aim to reduce vision-loss through a variety of mechanisms. Gene therapies, including RGX-314 and Ixo-vec, express an anti-VEGF protein, and 4D-150, expresses an anti-VEGF protein and a VEGF-C inhibitory miRNA. Anti-VEGF associated therapeutics include OPT-302, targeting VEGF-C and VEGF-D, BI 836880, which inhibits VEGF-A and Ang-2 activity, and Tarcocimab tedromer, inhibiting all VEGF-A isoforms. Agents with novel mechanisms of action include UBX1325, which inhibits an anti-apoptotic protein, Restoret (EYE103), a Wnt agonist, and the tyrosine kinase inhibitors, EYP-1901, OTX-TKI, CLS-AX, and KHK4951.

项与 Foselutoclax 相关的新闻（医药）

2024-09-24

·GlobeNewswire-Health Care

UNITY Biotechnology to Host In-Person Ophthalmology Day in New York on Tuesday, October 15, 2024

SAN FRANCISCO, Sept. 24, 2024 (GLOBE NEWSWIRE) -- UNITY Biotechnology, Inc. (“UNITY”) [NASDAQ: UBX], a biotechnology company developing therapeutics to slow, halt or reverse diseases of aging, today announced that it will host an in-person and virtual event for investors and analysts on Tuesday, October 15, 2024, at 8:00 a.m. ET in New York, NY. The event will feature presentations from prominent ophthalmology key opinion leaders (KOLs) and company management. UNITY Biotechnology Ophthalmology Day Agenda Date: Tuesday, October 15, 2024Time: 8:00 a.m. until 9:30 a.m. ETLocation: Park Terrace Hotel, New York, NY (with simultaneous webcast)Registration and Webcast Link: https://lifescievents.com/event/unitybiotechnology/ Welcome and Introductions: Anirvan Ghosh, Ph.D., Chief Executive Officer, UNITY BiotechnologySenolytic Therapeutic Hypothesis: Mike Sapieha, Ph.D., Chief Scientist, UNITY BiotechnologyUBX1325 Clinical Development Plan – BEHOLD and ASPIRE studies in DME: Robert Bhisitkul, M.D., Ph.D., UCSF School of MedicineRetina Expert Roundtable: Arshad Khanani, M.D., MA, FASRS, Sierra Eye Associates, University of Nevada Reno School of MedicineDante Pieramici, M.D., California Retina ConsultantsAlicia Tozier, Chief Strategy Officer, UNITY Biotechnology Live Q&A The event will focus on UNITY’s ongoing Phase 2b ASPIRE study evaluating foselutoclax (UBX1325) head-to-head against aflibercept in diabetic macular edema (DME). Twenty-four-week safety and efficacy data are expected in the first quarter of 2025, and 36-week data are expected in the second quarter of 2025. Retina experts will address the evolving therapeutic landscape and the potential of UBX1325 to address unmet needs in DME. For virtual attendees, the live webcasts of the presentations will be accessible through the “Investors & Media” section of the company’s website, www.unitybiotechnology.com, under “Events & Presentations.” Archived replays will be available for 90 days. Featured Retina Experts Robert Bhisitkul, M.D., Ph.D.Robert Bhisitkul, M.D., Ph.D., is an ophthalmologist and retina specialist at UCSF Health who provides medical and laser treatments for macular degeneration, diabetic retinopathy and other retinal diseases. He also performs macular hole and macular pucker surgeries (conditions that cause blurred or distorted vision), retinal detachment and complications of diabetic eye disease. Dr. Bhisitkul recruits patients to participate in UCSF clinical trials of novel therapies for macular degeneration and diabetic retinopathy, and also for studies on long-term outcomes for treatments such as surgically implantable devices that deliver medication. He has published more than 60 papers in clinical and scientific journals. Arshad M. Khanani, M.D., MA, FASRSArshad M. Khanani, M.D., MA, FASRS, is a Managing Partner, Director of Clinical Research, and Director of Fellowship at Sierra Eye Associates and Clinical Associate Professor at the University of Nevada, Reno School of Medicine. Dr. Khanani founded the clinical research department at Sierra Eye Associates, which is now one of the leading clinical research centers in the country. He has served as a principal investigator for over 100 clinical trials and has been a top enroller in the country for multiple Phase 1-3 trials. In addition, Dr. Khanani was the first to perform surgical procedures in multiple surgical clinical trials dealing with sustained delivery and gene therapy. He has published over 75 scientific publications and is a frequent guest speaker at national and international meetings. Dante Pieramici, M.D.Dante Pieramici, M.D. is currently a managing partner of the California Retina Consultants and a member of the Medical Leadership Board of the Retina Consultants of America. As the Medical Director of Clinical Research at California Retina Consultants, Dr. Pieramici has served as the principal or sub investigator, reading center investigator or advisor for over 100 clinical trials. His research has focused primarily on new surgical and pharmacologic treatments for age-related macular degeneration and diabetic related eye diseases. He has served as a consultant for numerous biotech companies, helping to design, monitor and evaluate clinical trial results for retinal diseases. He has authored over 150 peer-reviewed research papers and book chapters on retinal diseases and has served as editor for the text, Ocular Trauma: Principles and Practice. Dr. Pieramici currently serves as President of the California Retina Research Foundation and serves as a long-time board member at S.E.E International. About UBX1325UBX1325 is an investigational compound being studied in retinal diseases, including DME, and is not approved for any use in any country. UBX1325 is a potent small molecule inhibitor of BCL-xL, a member of the BCL-2 family of apoptosis regulating proteins. UBX1325 is designed to inhibit the function of proteins that senescent cells rely on for survival. The Phase 2 BEHOLD study in patients with DME demonstrated that a single injection of UBX1325 resulted in a statistically significant and clinically meaningful improvement in mean BCVA through 48 weeks compared to sham treatment. In preclinical studies, UNITY has demonstrated that targeting BCL-xL with UBX1325 preferentially eliminated senescent cells from diseased tissue while sparing cells in healthy tissue. UNITY’s goal with UBX1325 is to transformationally improve real-world outcomes for patients with retinal disease. About UNITYUNITY is developing a new class of therapeutics to slow, halt, or reverse diseases of aging. UNITY’s current focus is on creating medicines to selectively eliminate or modulate senescent cells and thereby provide transformative benefit in age-related ophthalmologic and neurologic diseases. More information is available at www.unitybiotechnology.com or follow us on X and LinkedIn. Media ContactInizio Evoke CommsKatherine SmithKatherine.Smith@inizioevoke.com Investor ContactLifeSci Advisors, LLCJoyce Allairejallaire@lifesciadvisors.com Source: Unity Biotechnology, Inc.

临床2期临床结果

2024-08-23

·药时代

全球创新拓展国际化版图，这家18A头部创新药企2024上半年收入大涨477%

原创新药研发向来被视为一个风险较高的行业，一款药物需要10年以上的时间，投入数亿美元的研发费用，经历从立项研发到后续多个环节的临床验证，任何一个失误都可能导致功亏一篑。在过去十年，中国创新药行业从无到有，并经历了从高峰到低谷的周期。在数年的寒冬里，行业不断分化。大浪淘沙后，今年行业发展的步伐明显加快，一批国内创新药企交出了亮眼的中报成绩单，创新药价值回归的曙光已然显现。日前，亚盛医药（6855.HK）公布2024年中期业绩。报告期内，公司在“全球创新”战略引导下，在对外合作、商业化、临床开发等方面均取得突破性进展。值得一提的是，2024年上半年公司总收入创新高，并首次实现盈利。报告期内，亚盛医药收入创新高，实现收入人民币8.24亿元，较去年同比增长477%，主要来源于产品销售收入和对外合作授权收入等。公司首次实现扭亏为盈，净利润达人民币1.63亿元。报告期内，公司首个上市品种奥雷巴替尼（商品名：耐立克®）的商业化快速推进，实现销售收入人民币1.13亿元，较去年下半年环比增长120%，较去年上半年同比增长5%。公司与跨国制药企业武田就耐立克®签署了一项独家选择权协议。一旦选择权被行使，武田将获得开发及商业化耐立克®的全球权利许可，惟中国大陆、中国香港特别行政区、中国澳门特别行政区、中国台湾等地区除外。亚盛医药已收到选择权付款人民币7.2亿元和股权投资款项人民币5.4亿元。公司现金流持续获得改善，保持稳健充沛：截至2024年6月30日，货币资金余额为人民币11亿元；截至2024年7月初，货币资金余额为人民币18亿元。 01 开启重磅全球合作达成中国小分子肿瘤药最大BD 亚盛医药一直积极寻求全球合作伙伴，在报告期内与跨国制药企业武田就耐立克®达成独家选择权协议。该合作总交易额达人民币93.6亿元，包含7.2亿元的选择权付款，和共计86.4亿元的选择权行使费及额外的潜在里程碑付款。同时，公司还将获得基于年度销售额双位数的递增销售分成。截至目前，此项合作为国内小分子肿瘤药领域的最大的对外权益许可。此外，亚盛医药还获得武田的股权投资。该合作充分彰显了耐立克®在全球的临床和商业化价值，也为其将来的全球商业化进程奠定了基石。目前，亚盛医药已收到武田人民币7.2亿元的选择权付款和人民币5.4亿元的股权投资款项。 02 耐立克®商业化快速推进造血能力不断增强随着公司原创1类新药耐立克®的首个适应症于2023年1月获纳入医保；新适应症于2023年11月获批，耐立克®正不断释放增长空间，亚盛医药的商业化造血能力也在逐步增强。报告期内，耐立克®实现销售收入人民币1.13亿元，环比增长120%，同比增长5%。亚盛医药正快速推进上市品种的商业化。截至2024年6月30日，耐立克®的全国准入医院和DTP药房共达到670家，其中准入医院数量较去年底增长达79%。继去年11月新适应症获批至今年6月30日，耐立克®已获20个省83个城市114个项目的重特大疾病补充保险或惠民保报销，其中在河北省、海南省、内蒙古自治区、无锡、湖州、深圳、烟台等20个省级或者地市被纳入惠民保特殊药品目录，大大减轻患者就医负担，提高用药可及性。作为中国首个获批上市的第三代BCR-ABL抑制剂，耐立克®的临床价值和潜力在报告期内不断得到国内外肿瘤领域的权威认可。2024年1月，该药物获纳入美国国家综合癌症网络（NCCN）慢性髓细胞白血病（CML）治疗指南；此外，耐立克®于报告期内获2024 CSCO恶性血液病诊疗指南升级推荐，涉及CML、费城染色体阳性急性淋巴细胞白血病（Ph+ ALL）领域的治疗，并新增多项I级推荐。今年7月，耐立克®在中国澳门获批上市，获批的适应症分别为治疗任何酪氨酸激酶抑制剂（TKI）耐药、并伴有T315I突变的CML慢性期（-CP）和加速期（-AP）的成年患者；以及治疗对一代和二代TKI耐药和/或不耐受的CML-CP成年患者。这是该药物继在中国内地获批上市后的又一重大里程碑。 03 全球创新成果斐然 8项注册临床全面推进在"全球创新"的战略引导下，亚盛医药于报告期内在临床开发方面取得多项里程碑进展，全球临床布局持续高速推进。截至目前，公司两大核心品种，耐立克®及Bcl-2抑制剂APG-2575（Lisaftoclax）共斩获11项注册临床试验许可，其中3项已经完成，其他8项正全力推进。 2024年2月，耐立克®获美国食品药品监督管理局（FDA）许可开展一项全球注册III期临床研究，用于治疗既往接受过治疗的CML-CP成年患者。这是耐立克®获美国FDA许可的首个注册III期临床研究，也是亚盛医药全球血液肿瘤布局的重要一步。而在血液肿瘤之外，耐立克®于今年6月获国家药品监督管理局（NMPA）药物审评中心（CDE）临床试验许可，开展其针对系统性全身治疗失败的琥珀酸脱氢酶（SDH）缺陷型胃肠间质瘤（GIST）患者的全球注册III期临床研究，这是公司在实体瘤领域临床开发的重大里程碑。此外，亚盛医药也在同步深耕Bcl-2选择性抑制剂APG-2575（Lisaftoclax）在血液肿瘤领域的临床布局。报告期内，APG-2575（Lisaftoclax）获CDE临床试验许可，开展一项该品种联合阿扎胞苷（AZA）一线治疗新诊断的中高危骨髓增生异常综合征（MDS）患者的注册III期临床研究，此为APG-2575（Lisaftoclax）获批开展的第四个注册III期临床研究。 04 临床数据持续强劲多领域进展不断获全球认可作为始终聚焦全球创新的创新医药企业，亚盛医药打造了一条具有"First-in-class"与"Best-in-class"潜力的高价值产品管线，已在中国、美国、澳大利亚、欧洲及加拿大开展40多项临床试验。多管线品种在多领域的治疗潜力不断得到探索和验证，多项临床进展接连在各大国际学术会议上获得披露，进一步展现公司的产品研发优势与全球临床开发实力。报告期内，亚盛医药三个重点品种耐立克®、APG-2575（Lisaftoclax）和APG-2449的四项临床进展入选2024美国临床肿瘤学会（ASCO）年会，这也是公司连续第七年在ASCO年会亮相。其中，耐立克®治疗TKI耐药的SDH-缺陷型GIST患者的最新数据获口头报告。数据表明，耐立克®在SDH-缺陷型GIST这一目前尚无标准治疗方案的疾病领域显示出良好的治疗前景，患者的临床获益率（CBR）达92.3%，中位无进展生存期（PFS）为 25.7个月。FAK/ALK/ROS1三联TKI APG-2449在非小细胞肺癌（NSCLC）患者中的最新数据也获ASCO年会展示，再次体现了该品种在NSCLC领域的治疗潜力。而在今年6月举办的2024年欧洲血液学协会年会（EHA 2024）上，亚盛医药展示了五项研究的最新进展，涉及耐立克®、APG-2575（Lisaftoclax）和APG-5918三个重点品种，充分展现公司在血液肿瘤的竞争实力。耐立克®有三项研究入选EHA 2024，其中一项在2023年美国血液学会（ASH）年会公布的数据基础上，更新了耐立克®治疗CML和Ph+ ALL患者的中位1年随访数据。数据显示，耐立克®在经过多个TKI治疗（包括对ponatinib或/和asciminib耐药），伴有或不伴有T315I突变的患者中，都表现出优异持续的临床疗效，且长期药物耐受性良好。 APG-2575（Lisaftoclax）在今年的ASCO年会和EHA年会上也有多项临床进展入选，均展现了该品种在多个血液肿瘤领域的治疗潜力。在本届ASCO年会上，亚盛医药展示了APG-2575（Lisaftoclax）联合AZA治疗初治（TN）或复发/难治性（R/R）急性髓性白血病（AML）患者的Ib/II期临床研究的最新积极数据、APG-2575（Lisaftoclax）单药或联合治疗华氏巨球蛋白血症（WM）患者的全球多中心Ib/II期研究最新积极数据。而在EHA 2024上，APG-2575（Lisaftoclax）治疗 R/R多发性骨髓瘤（MM）或免疫球蛋白轻链（AL）淀粉样变性患者的最新积极数据获展示。此外，耐立克®、APG-115、APG-2449和APG-5918四个品种在今年美国癌症研究协会年会（2024AACR）上公布了三项临床前研究最新成果，为进一步临床探索提供了重要支持。 05 深化全球创新战略布局迈向全新发展阶段为配合公司长期战略及发展，报告期内，亚盛医药已向美国证券交易委员会保密递交一份关于建议首次公开发售代表公司的普通股的美国存托股份的F-1表格登记草案。亚盛医药始终坚守"全球创新"战略，并坚持全球范围内的知识产权布局。截至2024年6月30日，公司在全球拥有520项授权专利，其中367项专利为海外授权。 “ 亚盛医药董事长、CEO杨大俊博士表示：2024年上半年，亚盛医药在全球BD、产品商业化及全球临床开发方面均取得了多项里程碑式进展，充分展现了公司的全球创新实力、在血液肿瘤领域的竞争优势。 ” 报告期内，我们就耐立克®与跨国制药企业武田达成高达逾人民币90亿元的全球合作，并将获得基于年度销售额双位数的递增销售分成。这是目前为止国内小分子肿瘤药的最大BD。此外，公司还获得武田5.4亿元人民币的股权投资。这一合作再次验证公司在行业的领先地位以及耐立克的全球实力，并有望在更多无药可医的领域释放临床价值。今年2月，耐立克®获美国FDA许可，开展全球注册III期临床，也是该产品的全球化进程的重大里程碑。特别值得关注的是，公司在报告期内首次实现盈利。随着耐立克®被纳入国家医保目录并获新适应症上市批准，公司商业化能力持续提升。同时，公司全球临床开发全面推进，管线重点品种的适应症获得不断拓展，进一步筑牢了公司在血液肿瘤领域的坚实竞争壁垒。未来我们将继续秉承以患者为中心、“全球创新”的理念，进一步提升商业化能力，并加速在研品种在全球范围内的临床开发。我们期待能早日将多个全球创新药物推入国际市场，真正践行“解决中国乃至全球患者尚未满足的临床需求”的使命，惠及全球患者，并为社会和股东创造更多价值。推荐阅读全球创新实力再验证！亚盛医药耐立克®与APG-2575斩获四项口头报告，五连冠成绩全球瞩目！【2022 EHA】最具BIC潜力的Bcl-2选择性抑制剂！亚盛医药公布APG-2575最新积极临床数据亚盛医药公布2021年全年业绩：耐立克®上市销售开局不俗首个新药正式上市，全球总部、研发中心盛大启用，亚盛医药迈入新阶段！ 2021 ASH亚盛医药携核心品种耐立克®与Bcl-2抑制剂APG-2575多项重磅进展亮相，展现best-in-class潜力最具BIC潜力的Bcl-2选择性抑制剂APG-2575获批一项关键注册II期研究，亚盛医药加速细胞凋亡核心品种临床开发斩获欧盟孤儿药认证！亚盛医药奥雷巴替尼中国获批前夕又传佳讯亚盛医药与辉瑞达成临床合作协议，将携手推进APG-2575联合爱博新®用于治疗转移性ER阳性HER2阴性乳腺癌的临床开发彰显全球创新能力！亚盛医药将第四次亮相美国血液学会（ASH）年会亚盛医药EED抑制剂APG-5918研究结果荣登药化顶级期刊JMC，有望通过调节表观遗传学实现肿瘤完全消退再次提速！亚盛医药MDM2-p53抑制剂APG-115获得美国FDA快速通道资格，治疗复发/难治性不可切除/转移性黑色素瘤杨大俊博士：聚焦全球创新，临床导向很重要！——看亚盛医药的国际化之路【服贸会收官巡礼】亚盛医药公布2021年中期业绩：重要品种临床优势突出，对外合作实现重大突破亚盛医药再获合作伙伴UNITY Biotechnology里程碑付款，抗衰老药物UBX1325临床开发迅速推进第12项！亚盛医药FDA孤儿药认定再创新高，MDM2-p53抑制剂APG-115获ODD治疗IIB-IV期黑色素瘤全球TOP20占一席！亚盛医药荣登“2019ASCO表现突出企业”榜单 2021 ASCO口头报告数据惊艳，亚盛医药实力验证全球创新潜力亚盛医药杨大俊：中国创新药企业的征途是全球市场喜讯！亚盛医药核心在研品种HQP1351获美国FDA审评快速通道资格，再迎里程碑【我们在一起】亚盛医药捐赠100万款物，助力疫情抗击中国原创闪“药”ASH舞台亚盛团队尽显风采！亚盛的故事 | 写在亚盛医药香港上市之际亚盛医药抗耐药CML新药HQP1351获美国FDA临床试验许可，将直接进入Ib期临床研究亚盛医药在研1类新药APG-2575中国I期临床完成首例患者给药，为首个进入临床的国产Bcl-2选择性抑制剂【2019ASCO现场】亚盛医药公布细胞凋亡系列临床产品APG-115、APG-1387最新临床数据亚盛医药将在2019 ASCO年会上公布MDM2-p53抑制剂和IAP抑制剂的临床试验进亚盛医药宣布与君实生物达成临床合作，将探索IAP抑制剂与抗PD-1单抗联合用药亚盛医药将在2019年美国癌症研究协会（AACR）年会上展示9项研究进展亚盛医药宣布任命Thomas J. Knapp为高级副总裁兼首席法律顾问亚盛医药宣布任命Jeff Kmetz为首席商务官亚盛医药多个核心品种获“十三五”国家“重大新药创制”科技重大专项支持亚盛医药宣布与UNITY Biotechnology达成授权许可协议亚盛医药宣布与MD Anderson癌症中心达成肿瘤药物开发战略合作亚盛医药宣布与嘉和生物开展战略合作直击2018ASH现场，亚盛医药公布抗格列卫耐药原创新药HQP1351临床数据亚盛医药抗格列卫耐药新药HQP1351临床进展入选2018年美国血液学会年会口头报告亚盛医药原创双靶点Bcl-2/Bcl-xL 抑制剂APG-1252临床新数据亮相2018年亚洲肺癌大会（ACLC）秋风渐起，多方创新力量共议“2018资本市场新形势下的新药研发” 重大创新团队亚盛医药：与时间赛跑首批原创药有望三年内上市亚盛医药成功完成10亿人民币C轮融资亚盛医药将在ASCO2018年会上展示两项临床研究的中期结果亚盛医药将在2018美国癌症研究协会（AACR）年会上展示5项研究进展年会集锦：创新，一路同行——亚盛医药2018新年晚会盛大召开亚盛医药宣布成立临床顾问委员会亚盛医药全面助力第二届药促会创投会，路演尤受热捧亚盛医药宣布任命黄英杰先生为临床开发高级副总经理亚盛医药抗肿瘤1类新药MDM2-p53抑制剂APG-115获批进入中国临床，将填补国内空白亚盛医药宣布任命李含中博士为首席财务官亚盛医药原创新靶点抗肿瘤药物Bcl-2/Bcl-XL抑制剂APG-1252获CFDA临床批件亚盛医药全球研发中心在苏州落成开业，迈入创新3.0时代现场|亚盛医药2017创新与投资论坛在纽约成功举办，中美大咖共议新药投资趋势亚盛医药原创新靶点抗肿瘤药物Bcl-2/Bcl-XL抑制剂APG-1252获得美国FDA批准进入临床试验亚盛医药获5亿元B轮融资，中美澳三地6款原创新药进入临床研发【重磅】亚盛医药成功布局细胞凋亡与自噬双通路的新药开发中国原创再登全球舞台！耐立克®临床研究结果斩获国际权威期刊了解更多亚盛医药！

引进/卖出财报医药出海

2024-08-12

·GlobeNewswire-Health Care

UNITY Biotechnology to Participate in Upcoming Investor Conferences

SAN FRANCISCO, Aug. 12, 2024 (GLOBE NEWSWIRE) -- UNITY Biotechnology, Inc. (“UNITY”) [NASDAQ: UBX], a biotechnology company developing therapeutics to slow, halt or reverse diseases of aging, today announced that members of its senior management team will provide a corporate update and participate in one-on-one meetings at the following investor conferences. H.C. Wainwright 4th Annual Ophthalmology Virtual ConferencePresentation Date and Time: Thursday, August 15, 2024 at 7:00 a.m. ETLocation: Virtual Webcast Link: Webcast H.C. Wainwright 26th Annual Global Investment ConferencePresentation Date and Time: Monday, September 9, 2024 at 7:00 a.m. ETLocation: New York, NY Webcast Link: Webcast The live webcasts of the presentations will be accessible through the “Investors & Media” section of our website, www.unitybiotechnology.com, under “Events & Presentations.” Archived replays will be available for 90 days following the events. About UBX1325UBX1325 is an investigational compound being studied in retinal diseases, including DME, and is not approved for any use in any country. UBX1325 is a potent small molecule inhibitor of Bcl-xL, a member of the BCL-2 family of apoptosis regulating proteins. UBX1325 is designed to inhibit the function of proteins that senescent cells rely on for survival. The Phase 2 BEHOLD study in patients with DME demonstrated that a single injection of UBX1325 resulted in a statistically significant and clinically meaningful improvement in mean BCVA through 48 weeks compared to sham treatment. In preclinical studies, UNITY has demonstrated that targeting Bcl-xL with UBX1325 preferentially eliminated senescent cells from diseased tissue while sparing cells in healthy tissue. UNITY’s goal with UBX1325 is to transformationally improve real-world outcomes for patients with retinal disease. About UNITYUNITY is developing a new class of therapeutics to slow, halt, or reverse diseases of aging. UNITY’s current focus is on creating medicines to selectively eliminate or modulate senescent cells and thereby provide transformative benefit in age-related ophthalmologic and neurologic diseases. More information is available at www.unitybiotechnology.com or follow us on X and LinkedIn. Media ContactInizio Evoke CommsKatherine SmithKatherine.Smith@inizioevoke.com Investor ContactLifeSci Advisors, LLCJoyce Allairejallaire@lifesciadvisors.com

临床2期临床结果

100 项与 Foselutoclax 相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
湿性年龄相关性黄斑变性	临床2期	美国	Unity Biotechnology, Inc.	2022-03-02
糖尿病性黄斑水肿	临床2期	美国	Unity Biotechnology, Inc.	2021-06-25
糖尿病性黄斑水肿	临床2期	加拿大	Unity Biotechnology, Inc.	2021-06-25

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05275205 (CTgov)	临床2期	湿性年龄相关性黄斑变性	51	UBX1325 injection 50 μL (UBX1325)	構餘醖餘簾醖鹽獵鏇衊(網獵壓觸選願餘鑰鏇築) = 糧壓獵餘夢艱顧鑰範積鹽選顧構襯膚艱餘鬱糧 (願鏇範窪鹹觸衊遞顧窪, 獵鏇醖構願膚積夢構廠 ~ 廠艱壓獵衊遞餘製廠範) 更多	-	2024-08-07
				EYLEA® (aflibercept) Injection 2 mg (0.05mL) (Aflibercept (EYLEA ®))	構餘醖餘簾醖鹽獵鏇衊(網獵壓觸選願餘鑰鏇築) = 艱艱獵蓋衊鹹齋齋鹹築鹽選顧構襯膚艱餘鬱糧 (願鏇範窪鹹觸衊遞顧窪, 衊鹽醖選製顧構顧壓遞 ~ 觸築餘願鏇願網範鹽淵) 更多
NCT04857996 (BEHOLD Phase 2 \| BEHOLD, CTgov)	临床2期	糖尿病性黄斑水肿	65	Sham (Sham Control)	膚齋鹽淵積夢壓壓繭鹽(蓋製憲鹹獵積網遞鏇鏇) = 製鏇窪範衊遞鑰膚簾醖觸獵構醖糧夢積淵衊膚 (憲廠鏇齋鑰鹽鹹膚窪鹹, 觸遞遞襯繭鬱憲鑰艱襯 ~ 獵繭蓋鏇製夢蓋願鹽鏇) 更多	-	2024-05-16
				UBX1325 (UBX1325)	膚齋鹽淵積夢壓壓繭鹽(蓋製憲鹹獵積網遞鏇鏇) = 鹹範顧襯衊齋築衊製餘觸獵構醖糧夢積淵衊膚 (憲廠鏇齋鑰鹽鹹膚窪鹹, 鬱構繭衊糧夢鹽獵網衊 ~ 糧鹽遞選觸獵齋鑰廠製) 更多
NCT04857996 (BEHOLD, Corporate Publications) 人工标引	临床2期	糖尿病性黄斑水肿	65	UBX-1325	(構淵獵衊範衊蓋選遞繭) = 醖構築蓋壓壓蓋築網壓壓廠繭蓋襯觸選鬱鬱餘 (觸顧膚齋積蓋遞淵繭積 ) 更多	积极	2022-11-01
				Sham	(構淵獵衊範衊蓋選遞繭) = 製鹹齋鏇淵齋鹽齋觸淵壓廠繭蓋襯觸選鬱鬱餘 (觸顧膚齋積蓋遞淵繭積 )
NCT04857996 (BEHOLD, Corporate Publications) 人工标引	临床2期	糖尿病性黄斑水肿	65	UBX1325	(艱鹹鏇衊醖簾顧構選窪) = 範蓋願鹽廠築鑰糧構憲壓廠顧簾醖選艱範蓋膚 (願遞構積製糧衊衊壓廠 ) 更多	积极	2022-08-12
				Sham	(艱鹹鏇衊醖簾顧構選窪) = 鏇遞憲網壓餘襯廠艱衊壓廠顧簾醖選艱範蓋膚 (願遞構積製糧衊衊壓廠 ) 更多
NCT04857996 (BEHOLD, Corporate Publications) 人工标引	临床2期	糖尿病性黄斑水肿	54	UBX1325	(衊築製艱構鹹鏇鬱廠壓) = 艱醖範願觸鑰鬱簾觸鹽選鏇鏇夢醖襯範蓋鑰膚 (壓構積獵淵衊醖簾觸鹹 ) 更多	积极	2022-08-12
				Sham	(衊築製艱構鹹鏇鬱廠壓) = 網願選襯壓構繭醖簾襯選鏇鏇夢醖襯範蓋鑰膚 (壓構積獵淵衊醖簾觸鹹 ) 更多