排名前五的靶点	数量

PDL1(程序性死亡配体1)	6
PSMA(前列腺癌特异性膜抗原)	5
ADRM1(ADRM1 26S proteasome ubiquitin receptor)	5
TRBC1(人T细胞受体β-1链C区)	3
HSP90(Heat shock 90kDa proteins)	2

关联

项与 The Johns Hopkins University 相关的药物

[18F]DCFPyL

靶点

PSMA

作用机制

PSMA抑制剂 [+1]

在研机构

Progenics Pharmaceuticals, Inc. [+4]

原研机构

Progenics Pharmaceuticals, Inc.

在研适应症

诊断试剂 [+3]

非在研适应症

复发性前列腺癌

最高研发阶段批准上市

首次获批国家/地区

美国

首次获批日期2021-05-26

Paclitaxel

紫杉醇

靶点

Tubulin

作用机制

微管蛋白抑制剂

在研机构

National Cancer Institute [+39]

原研机构

National Institutes of Health

在研适应症

转移性胰腺腺癌 [+153]

非在研适应症

腺泡细胞癌 [+178]

最高研发阶段批准上市

首次获批国家/地区

美国

首次获批日期1992-12-29

Daclatasvir/Sofosbuvir

达卡拉韦/索磷布韦

靶点

NS5A x NS5B polymerase

作用机制

NS5A抑制剂 [+1]

在研机构

The Johns Hopkins University [+1]

原研机构

RojanPharma Pharmaceutical Company

在研适应症

慢性丙型肝炎

非在研适应症

慢性丙型肝炎基因型 3

最高研发阶段批准上市

首次获批国家/地区-

首次获批日期-

2,770

项与 The Johns Hopkins University 相关的临床试验

NCT06236542 / Not yet recruitingN/AIIT

NextGen Tracheostomy Toolkit: Integrating Augmented and Virtual Reality With Robotics to Improve Tracheostomy Care

The goal of this clinical trial is to test the NextGen Tracheostomy Toolkit in people who have a tracheostomy. The main questions it aims to answer are:
What is the number of atraumatic tracheostomy suctionings before and after the use of automated robotic suctioning device divided by the total number of tracheostomy suctionings across arms experimental group 1 vs. control group?
What is the number of atraumatic tracheostomy suctionings before and after the use of Nextgen Tracheostomy Toolkit divided by the total number of tracheostomy suctionings across arms experimental group 3 vs. control group?
What is the number of successful first-time tracheostomy tube change attempts before and after the use of mixed reality tracheostomy tube change device divided by the total number of tracheostomy tube changes across arms experimental group 2 vs. control group?
What is the number of successful first-time tracheostomy tube change attempts before and after the use of Nextgen Tracheostomy Toolkit divided by the total number of tracheostomy tube changes across arms experimental group 3 vs. control group? Participants will be randomly divided into 4 groups and assigned different interventions.
Experimental group 1 will receive suctionings using automated robotic suctioning device.
Experimental group 2 will receive tracheostomy tube changes using mixed reality tracheostomy tube changing system.
Experimental group 3 will receive Nextgen Tracheostomy Toolkit that includes suctionings using automated robotic suctioning device and tracheostomy tube changes using mixed reality tracheostomy tube changing system.
Control group will receive usual tracheostomy care Researchers will compare the four groups to see the effect of Nextgen tracheostomy toolkit and its components on the number of atraumatic tracheostomy suctionings and number of successful first-time tracheostomy tube changes.

开始日期2027-10-01

申办/合作机构

The Johns Hopkins University

NCT06005662 / Suspended临床2期IIT

Inpatient Buprenorphine Induction With Psilocybin for Opioid Use Disorder: a Randomized Double-blind Trial

This study will examine the effect of a single high dose of psilocybin therapy (30 mg) versus a very low dose (1 mg) as an adjunctive therapy to individuals undergoing standard-of-care buprenorphine treatment for Opioid use disorder (OUD). Effects of adjunctive psilocybin will be determined for longitudinal outcomes of opioid abstinence, compliance with buprenorphine maintenance, quality of life, and mood.

开始日期2027-04-01

申办/合作机构

The Johns Hopkins University

NCT03879161 / SuspendedN/AIIT

A Percutaneous Ultrasound Device With Needle Guide for Vascular Access

This first-in-human pilot study seeks to evaluate the feasibility and safety of using a percutaneous ultrasound device with needle guide for vascular access. Eligible participants will undergo the procedure of transcatheter arterial chemoembolization for primary or metastatic liver cancer, as part of participants' clinical care. The percutaneous ultrasound device with needle guide will be deployed in eligible participants at the beginning of the procedure for guiding a needle inside the femoral artery. Once the needle is inside the artery, then a guide wire is advanced inside the needle and vascular access is successfully obtained.
The study will identify whether this ultrasound-based device with needle guide is helpful for guiding a needle inside the femoral artery.

开始日期2026-09-01

申办/合作机构

The Johns Hopkins University

[+1]

100 项与 The Johns Hopkins University 相关的临床结果

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0 项与 The Johns Hopkins University 相关的专利（医药）

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234,131

项与 The Johns Hopkins University 相关的文献（医药）

2025-02-01·Neurology-Clinical Practice

A Systematic Review of Sleep Disturbance in Idiopathic Intracranial Hypertension

Review

作者: Shaw, Jacob S. ; Esagoff, Aaron I. ; Kosyakova, Natalia ; Young, Lisa ; Bryant, Barry R. ; Buenaver, Luis F. ; Richey, Lisa N. ; Salas, Rachel Marie E. ; Kentis, Sabrina ; Peters, Matthew E.

Purpose of Review:

Sleep disturbances, particularly obstructive sleep apnea (OSA), may have a significant impact on the outcomes of patients with idiopathic intracranial hypertension (IIH). We conducted a PRISMA-compliant systematic literature review to study sleep disturbance in adult patients with IIH.

Recent Findings:

The current literature on the relationship between IIH and sleep is quite limited. Research has found that sleep disturbances are associated with lower quality of life and may worsen several symptoms associated with IIH, such as headache, cognitive deficits, and neuropsychiatric issues.

Summary:

OSA was more prevalent in patients with IIH than in healthy controls. Several studies found that OSA was associated with worse IIH symptoms and treatment of OSA helped improve these parameters. Limitations included available literature and heterogeneity in sleep metrics and OSA diagnostic criteria between studies. Overall, further study of sleep disturbances in patients with IIH may encourage earlier screening, improved treatment options, and long-term improvements in quality of life.

2025-02-01·Neurology-Clinical Practice

Radiographic Horizontal Conjugate Gaze Deviation

Review

作者: Kattah, Jorge C. ; Badihian, Shervin ; Samaha, Elias ; Zee, David S. ; Newman-Toker, David E.

Purpose of Review:

The potential diagnostic value of radiographic, horizontal, conjugate gaze deviation (Rad h-CGD) was first recognized in 2003 by Simon et al. Thereafter, interest grew related to its potential use as a marker of different neurologic and vestibular disorders. Over the past 20 years, we have identified clinical correlates of Rad h-CGD including those caused by supratentorial and infratentorial lesions. We propose clinicians and radiologists will better diagnose and manage patients by knowing the different diagnostic possibilities for Rad h-CGD.

Findings:

We report different clinical correlates of Rad h-CGD relevant for localizing and lateralizing lesions. We measured the angle of deviation and correlated it with the clinical findings and underlying mechanisms. We then reviewed important data from the previous literature relevant to the localization of each lesion and combined it with our experience into the design of a practical algorithm to interpret Rad h-CGD.

Summary:

Using Rad h-CGD provides useful information about the diagnosis and localization and may reveal subtle ocular findings not clear on physical examination. However, Rad h-CGD alone cannot distinguish between supratentorial and infratentorial lesions, and therefore, the clinical context is critical. Moreover, although Rad h-CGD occurs with strokes due to large vessel occlusion, it could also be seen with an acute vestibular syndrome, secondary to a peripheral vestibular neuritis. Other possibilities include ischemic events in the cerebellum, brainstem, and labyrinth.

2025-02-01·BIOMATERIALS

Ligand-free biodegradable poly(beta-amino ester) nanoparticles for targeted systemic delivery of mRNA to the lungs

Article

作者: Cutting, Garry R ; Green, Jordan J. ; Tzeng, Stephany Y. ; Sharma, Neeraj ; Cutting, Garry R. ; Kavanagh, Erin W. ; Kavanagh, Erin W ; Green, Jordan J ; Tzeng, Stephany Y

Non-viral nanoparticles (NPs) have seen heightened interest as a delivery method for a variety of clinically relevant nucleic acid cargoes in recent years. While much of the focus has been on lipid NPs, non-lipid NPs, including polymeric NPs, have the possibility of improved efficacy, safety, and targeting, especially to non-liver organs following systemic administration. A safe and effective systemic approach for intracellular delivery to the lungs could overcome limitations to intratracheal/intranasal delivery of NPs and improve clinical benefit for a range of diseases including cystic fibrosis. Here, engineered biodegradable poly (beta-amino ester) (PBAE) NPs are shown to facilitate efficient delivery of mRNA to primary human airway epithelial cells from both healthy donors and individuals with cystic fibrosis. Optimized NP formulations made with differentially endcapped PBAEs and systemically administered in vivo lead to high expression of mRNA within the lungs in BALB/c and C57 B/L mice without requiring a complex targeting ligand. High levels of mRNA-based gene editing were achieved in an Ai9 mouse model across bronchial, epithelial, and endothelial cell populations. No toxicity was observed either acutely or over time, including after multiple systemic administrations of the NPs. The non-lipid biodegradable PBAE NPs demonstrate high levels of transfection in both primary human airway epithelial cells and in vivo editing of lung cell types that are targets for numerous life-limiting diseases particularly single gene disorders such as cystic fibrosis and surfactant deficiencies.

1,406

项与 The Johns Hopkins University 相关的新闻（医药）

2024-11-13

·合全药业

议程更新 | 药明康德科学论坛广州站

在医药研发领域，创新的浪潮不断席卷而来。根据全球权威机构Citeline发布的《Pharma R&D Annual Review 2024》报告，2024年全球在研药物总数达到了22,825种，相比去年增长了7.20%。其中，肿瘤学依然是研发的热点领域，占比达38%。除了肿瘤领域，其他治疗领域也显示出了积极增长，神经学领域以7.5%的增长率略高于平均水平，而消化/代谢领域的增长尤为显著，增长率高达13.1%。尽管新药研发的数量达到了历史新高，但行业依然面临着一系列挑战和不确定性。针对各种不同疾病领域的创新药物，如何加速药物的早期发现？如何应对早期药物合成的挑战？如何选择合适的临床前研发策略？如何通过CMC工作将候选化合物快速推进至临床阶段？如何选择合适的临床试验终点？ 11月29日，药明康德将在广州举办“药明康德科学论坛”。特邀新药领域的先锋企业代表，以及药明康德技术负责人，分别从早期发现、生物学评价、化学合成、生物分析、DMPK、非临床研究、工艺及制剂开发、临床研究等角度，通过案例分享，全方位地与您共同探讨肿瘤学、神经学、代谢、抗感染、心血管领域以及复杂分子等药物的研发及生产策略，为该领域的新药研发企业揭示最新趋势与技术进展，共同加速创新药的研发。 01 会议信息时间 2024年11月29日09:00-17:00 地点广州翡翠希尔顿酒店 B1F明珠8号厅 02 特邀嘉宾刘利平博士君圣泰医药创始人、CEO 刘洋洋博士知易生物联合创始人、副总经理廖慧博士药明康德化学业务平台主任，WuXi TIDES药物发现项目管理团队陆愈博士合全药业执行主任，API业务部毛亮先生合全药业执行主任，可开发性和制剂研究部负责人王勇博士药明康德副总裁，康德弘翼数据管理与统计分析团队负责人杨赟博士药明康德化学业务平台高级主任，WuXi TIDES寡核苷酸药物化学团队负责人张志翔博士药明康德生物学业务平台执行主任 * 按嘉宾姓氏拼音排序更多重磅嘉宾，陆续揭晓中 03 会议议程 9:30-12:00 以临床价值为导向的肿瘤疾病模型及其药理学张志翔博士药明康德生物学业务平台执行主任肿瘤免疫疗法的新靶点及毒性分析——靶向CD47肿瘤免疫治疗的研究进展白亦君药明康德测试事业部项目管理和申报服务部活体生物药开发刘洋洋博士知易生物联合创始人，副总经理 ADC药物的生物分析策略于婷婷药明康德测试事业部生物分析部副主任临床阶段原料药的工艺开发与质量控制陆愈博士合全药业执行主任，API业务部加速推进IND的早期制剂开发策略毛亮合全药业执行主任，可开发性和制剂研究部负责人肿瘤关键试验中终点的选择王勇博士药明康德副总裁，康德弘翼数据管理与统计分析团队负责人 13:00-17:00 从实验室到病床：神经药理学中的临床前动物模型优化策略宿靓博士药明康德生物学业务平台主任 “漏斗”模型助力中枢神经药物的体外渗透性研究熊涛药明康德测试事业部药性评价部主任，渗透性与转运体组负责人早期发现平台加速代谢病领域药物研发郭蔚晖博士药明康德生物学业务平台高级主任多肽药物的早期合成挑战和应对策略廖慧博士药明康德化学业务平台主任，WuXi TIDES药物发现项目管理团队抗呼吸道病毒药物的药效学研究策略林付森药明康德生物学业务平台主任靶向HBV病毒药物及毒性研究王智慧药明康德测试事业部项目管理和申报服务部主任大自然的馈赠：治疗代谢疾病的多功能药物开发刘利平博士君圣泰医药创始人、CEO 生物标志物的临床生物分析策略和自身免疫类疾病的案例分享陈文笔药明康德测试事业部生物分析部一体化平台加速寡核苷酸新药开发杨赟博士药明康德化学业务平台高级主任，WuXi TIDES寡核苷酸药物化学团队负责人 04 注册报名本次活动免费开放，主要面向生物科技、制药企业、高校及研究机构负责人等，扫描下方二维码立即报名。温馨提示 ◆　本次活动采用线上免费注册的方式，席位有限。 ◆　入场券需经过主办方审核通过方可获得，请预参加嘉宾尽快报名。报名截止时间：11月27日中午12:00。 05 特邀嘉宾简介刘利平博士君圣泰医药创始人、CEO 刘利平博士是港股上市公司君圣泰医药的创始人及首席执行官；君圣泰医药目前正在全球推进多项中、后期临床试验，开发非酒精性脂肪性肝炎（NASH）、2 型糖尿病（T2DM）、原发性硬化性胆管炎（PSC）等适应症。作为同类首创的多靶点新分子实体，HTD1801被美国FDA授予2项“快速通道资格认定”、1项“孤儿药资格认定”，并获得国家“十三五” “重大新药创制”科技重大专项支持。刘博士拥有近30年新药开发经验，在国际刊物上发表了20多篇论文，并获得60多项国际授权专利。刘博士于1994年获得南开大学博士学位，并在加拿大多伦多大学完成博士后研究，于2009年获得约翰霍普金斯大学MBA学位。此外，刘博士还获得科技部授予的科技创新创业人才，获证券时报授予的十大药物创新科学家、安永亚太区成功女性企业家等多项殊荣。刘洋洋博士知易生物联合创始人、副总经理刘洋洋，医学博士，知易生物联合创始人、副总经理。“珠江科技新星”获得者，广东省活体生物药工程技术研究中心副主任，“广州市创新领军团队”核心成员。2013年联合创办知易生物，目前负责公司新药的早期发现以及临床研究。主持省级科技课题2项，作为骨干研究人员参与国家“863”计划，以及其他省市级科技课题5项。申请专利40多件，PCT14件，已授权19件。发表SCI论文14篇。廖慧博士药明康德化学业务平台主任，WuXi TIDES药物发现项目管理团队廖慧博士于2018年获得美国俄亥俄州立大学博士学位，在博士期间主攻环肽库的构建、特殊肽合成、蛋白-多肽相互作用研究。同年九月，她加入药明康德化学服务部，主要负责管理各类定制化多肽合成项目，至今已参与100+项目管理，支持超过50家客户，多次获得客户嘉奖与好评。陆愈博士合全药业执行主任，API业务部陆愈博士于2022年加入合全药业，现任API业务部执行主任，负责毒理和临床阶段小分子原料药的路线筛选、工艺研发及优化、工业化技术转移及生产等业务。加入合全药业之前，陆愈博士先后在美国陶氏益农以及礼来制药任职，有10多年的工艺研发和项目管理经验，曾获2021年美国化学协会颁发的杰出青年研究者奖项。陆愈博士毕业于复旦大学化学系，于美国德克萨斯大学奥斯汀分校获得有机化学博士学位。毛亮先生合全药业执行主任，可开发性和制剂研究部负责人毛亮先生于2017年加入药明康德合全药业，担任可开发性和制剂研究部的负责人。该团队服务于合全药业CMC一体化平台，专注于先导化合物的成药性评价，早期的固态化学研究，临床前制剂开发以及针对于难溶化合物的特殊制剂（给药途径）研究。加入合全之前，毛亮先生在早期药物研发领域有十多年的丰富经验，涉及的领域主要包括固态表征，晶型盐型筛选，结晶工艺开发，临床前制剂研究和生物利用度增强剂型的开发。曾在诺华制药（Novartis）担任高级研究员，并拥有多项发明专利；在和记黄埔医药以及上海医药工业研究院也有数年药物研发经历。毛亮先生毕业于南京工业大学，获得生物化工专业学士和硕士学历。王勇博士药明康德副总裁，康德弘翼数据管理与统计分析团队负责人王勇博士，药明康德副总裁，康德弘翼数据管理与统计分析团队负责人。他拥有超过25年临床开发和商业化实现的经验，曾在美国任雅培、艾尔建高管；PAREXEL亚太区生物统计负责人；CDE三方协调委员会成员。杨赟博士药明康德化学业务平台高级主任，WuXi TIDES寡核苷酸药物化学团队负责人杨赟博士于2008年加入天津药明康德。目前担任药明康德高级主任、WuXi TIDES寡核苷酸药物化学团队二部负责人。杨博士拥有十多年化学制药行业的经验，聚焦在核苷、糖、核苷酸等特殊化学合成能力。他已带领寡核苷酸固相合成、液相合成团队为超过全球100多个客户的早期项目提供重要的支持，并带领团队支持多个一体化项目推进。杨赟于南开大学元素所获得有机化学博士学位。张志翔博士药明康德生物学业务平台执行主任张志翔博士现任药明康德生物学业务平台体内药理学部启东分部负责人。他于复旦大学生物科学部获得了学士学位，并于中国科学院上海药物研究所获得了药理学博士学位。在加入药明康德之前，他曾就职于和记黄埔医药及罗氏研发中国有限公司，主要从事抗癌药物的体内药效评估、靶点验证和生物标志物研究。

抗体药物偶联物临床申请核酸药物

2024-11-12

·合全药业

议程揭晓 | 药明康德科学论坛广州站

在医药研发领域，创新的浪潮不断席卷而来。根据全球权威机构Citeline发布的《Pharma R&D Annual Review 2024》报告，2024年全球在研药物总数达到了22,825种，相比去年增长了7.20%。其中，肿瘤学依然是研发的热点领域，占比达38%。除了肿瘤领域，其他治疗领域也显示出了积极增长，神经学领域以7.5%的增长率略高于平均水平，而消化/代谢领域的增长尤为显著，增长率高达13.1%。尽管新药研发的数量达到了历史新高，但行业依然面临着一系列挑战和不确定性。针对各种不同疾病领域的创新药物，如何加速药物的早期发现？如何应对早期药物合成的挑战？如何选择合适的临床前研发策略？如何通过CMC工作将候选化合物快速推进至临床阶段？如何选择合适的临床试验终点？ 11月29日，药明康德将在广州举办“药明康德科学论坛”。特邀新药领域的先锋企业代表，以及药明康德技术负责人，分别从早期发现、生物学评价、化学合成、生物分析、DMPK、非临床研究、工艺及制剂开发、临床研究等角度，通过案例分享，全方位地与您共同探讨肿瘤学、神经学、代谢、抗感染、心血管领域以及复杂分子等药物的研发及生产策略，为该领域的新药研发企业揭示最新趋势与技术进展，共同加速创新药的研发。 01 会议信息时间 2024年11月29日09:30-17:00 地点广州翡翠希尔顿酒店 B1F明珠8号厅 02 特邀嘉宾刘利平博士君圣泰医药创始人、CEO 刘洋洋博士知易生物联合创始人、副总经理王勇博士药明康德副总裁，康德弘翼数统团队负责人陆愈博士合全药业执行主任，API业务部毛亮先生合全药业执行主任，可开发性和制剂研究部负责人张志翔博士药明康德生物学业务平台执行主任更多重磅嘉宾，陆续揭晓中 03 会议议程 9:30-12:00 以临床价值为导向的肿瘤疾病模型及其药理学张志翔博士药明康德生物学业务平台执行主任肿瘤免疫疗法的新靶点及毒性分析——靶向CD47肿瘤免疫治疗的研究进展白亦君药明康德测试事业部项目管理和申报服务部活体生物药开发刘洋洋博士知易生物联合创始人，副总经理 ADC药物的生物分析策略于婷婷药明康德测试事业部生物分析部副主任临床阶段原料药的工艺开发与质量控制陆愈博士合全药业执行主任，API业务部加速推进IND的早期制剂开发策略毛亮合全药业执行主任，可开发性和制剂研究部负责人肿瘤关键试验中终点的选择王勇博士药明康德副总裁，康德弘翼数统团队负责人 13:00-17:00 从实验室到病床：神经药理学中的临床前动物模型优化策略宿靓博士药明康德生物学业务平台主任 “漏斗”模型助力中枢神经药物的体外渗透性研究熊涛药明康德测试事业部药性评价部主任，渗透性与转运体组负责人早期发现平台加速代谢病领域药物研发郭蔚晖博士药明康德生物学业务平台高级主任多肽药物的早期合成挑战和应对策略廖慧博士药明康德化学业务平台主任，WuXi TIDES药物发现项目管理团队抗呼吸道病毒药物的药效学研究策略林付森药明康德生物学业务平台主任靶向HBV病毒药物及毒性研究王智慧药明康德测试事业部项目管理和申报服务部主任大自然的馈赠：治疗代谢疾病的多功能药物开发刘利平博士君圣泰医药创始人、CEO 生物标志物的临床生物分析策略和自身免疫类疾病的案例分享陈文笔药明康德测试事业部生物分析部一体化平台加速寡核苷酸新药开发杨赟博士药明康德化学业务平台高级主任，WuXi TIDES寡核苷酸药物化学团队负责人 04 注册报名本次活动免费开放，主要面向生物科技、制药企业、高校及研究机构负责人等，扫描下方二维码立即报名。温馨提示 ◆　本次活动采用线上免费注册的方式，席位有限。 ◆　入场券需经过主办方审核通过方可获得，请预参加嘉宾尽快报名。报名截止时间：11月27日中午12:00。 05 特邀嘉宾简介刘利平博士君圣泰医药创始人、CEO 刘利平博士是港股上市公司君圣泰医药的创始人及首席执行官；君圣泰医药目前正在全球推进多项中、后期临床试验，开发非酒精性脂肪性肝炎（NASH）、2 型糖尿病（T2DM）、原发性硬化性胆管炎（PSC）等适应症。作为同类首创的多靶点新分子实体，HTD1801被美国FDA授予2项“快速通道资格认定”、1项“孤儿药资格认定”，并获得国家“十三五” “重大新药创制”科技重大专项支持。刘博士拥有近30年新药开发经验，在国际刊物上发表了20多篇论文，并获得60多项国际授权专利。刘博士于1994年获得南开大学博士学位，并在加拿大多伦多大学完成博士后研究，于2009年获得约翰霍普金斯大学MBA学位。此外，刘博士还获得科技部授予的科技创新创业人才，获证券时报授予的十大药物创新科学家、安永亚太区成功女性企业家等多项殊荣。刘洋洋博士知易生物联合创始人、副总经理刘洋洋，医学博士，知易生物联合创始人、副总经理。“珠江科技新星”获得者，广东省活体生物药工程技术研究中心副主任，“广州市创新领军团队”核心成员。2013年联合创办知易生物，目前负责公司新药的早期发现以及临床研究。主持省级科技课题2项，作为骨干研究人员参与国家“863”计划，以及其他省市级科技课题5项。申请专利40多件，PCT14件，已授权19件。发表SCI论文14篇。王勇博士药明康德副总裁，康德弘翼数统团队负责人王勇博士，药明康德副总裁，康德弘翼数据管理与统计分析团队负责人。他拥有超过25年临床开发和商业化实现的经验，曾在美国任雅培、艾尔建高管；PAREXEL亚太区生物统计负责人；CDE三方协调委员会成员。陆愈博士合全药业执行主任，API业务部陆愈博士于2022年加入药明康德合全药业，现任API业务部执行主任，负责毒理和临床阶段小分子原料药的路线筛选、工艺研发及优化、工业化技术转移及生产等业务。加入合全药业之前，陆愈博士先后在美国陶氏益农以及礼来制药任职，有10多年的工艺研发和项目管理经验，曾获2021年美国化学协会颁发的杰出青年研究者奖项。陆愈博士毕业于复旦大学化学系，于美国德克萨斯大学奥斯汀分校获得有机化学博士学位。毛亮先生合全药业执行主任，可开发性和制剂研究部负责人毛亮先生于2017年加入药明康德合全药业，担任可开发性和制剂研究部的负责人。该团队服务于合全药业CMC一体化平台，专注于先导化合物的成药性评价，早期的固态化学研究，临床前制剂开发以及针对于难溶化合物的特殊制剂（给药途径）研究。加入合全之前，毛亮先生在早期药物研发领域有十多年的丰富经验，涉及的领域主要包括固态表征，晶型盐型筛选，结晶工艺开发，临床前制剂研究和生物利用度增强剂型的开发。曾在诺华制药（Novartis）担任高级研究员，并拥有多项发明专利；在和记黄埔医药以及上海医药工业研究院也有数年药物研发经历。毛亮先生毕业于南京工业大学，获得生物化工专业学士和硕士学历。张志翔博士药明康德生物学业务平台执行主任张志翔博士现任药明康德生物学业务平台体内药理学部启东分部负责人。他于复旦大学生物科学部获得了学士学位，并于中国科学院上海药物研究所获得了药理学博士学位。在加入药明康德之前，他曾就职于和记黄埔医药及罗氏研发中国有限公司，主要从事抗癌药物的体内药效评估、靶点验证和生物标志物研究。

抗体药物偶联物免疫疗法临床申请

2024-11-08

·PRNewswire

Intensity Therapeutics Selected for Oral Podium Presentation in a Late-Breaking Session at the 2024 Annual Connective Tissue Oncology Society (Sarcomas) Meeting

SHELTON, Conn., Nov. 8, 2024 /PRNewswire/ -- Intensity Therapeutics, Inc. (Nasdaq: INTS), ("Intensity" or "the Company") a late-stage clinical biotechnology company focused on the discovery and development of proprietary, novel immune-based intratumorally injected cancer therapies intended to kill tumors directly and increase immune system recognition of cancers, today announced that its Phase 3 trial has been selected for an oral podium presentation at the 2024 Connective Tissue Oncology Society (CTOS) on November 16, 2024. Dr. Christian F. Meyer MD, Ph.D will be making the oral presentation highlighting completed Phase 2 results and the INVINCIBLE-3 (Phase 3) randomized soft tissue sarcoma trial design and important study criteria. The annual CTOS conference runs from November 13 to 16, 2024 in San Diego at the Grand Hyatt. Presentation Details Session 11: Trials in Progress/Late Breaking Trials Moderator: Palma Dileo, MD (she/her/hers) – University College London Hospitals NHS Foundation Trust Moderator: Steven I. Robinson, M.B.B.S. (he/him/his) – Mayo Clinic Paper 78 - A MULTICENTER, RANDOMIZED, PHASE 3 STUDY OF INTRATUMORAL INT230-6 (SHAO, VINBLASTINE, CISPLATIN) COMPARED TO STANDARD OF CARE THERAPY IN SELECTED METASTATIC SOFT TISSUE SARCOMAS: INVINCIBLE-3 TRIAL. Date: Saturday, November 16, 2024 Time: 9:00 AM PST Location: Harbor Ballroom Author: Albiruni Abdul Razak, MB BCh, BAO, LRCP & SI – Toronto Sarcoma Program, Princess Margaret Cancer Center Presenter: Christian F. Meyer, MD PhD (he/him/his) – Johns Hopkins University About Intensity Therapeutics Intensity Therapeutics is a late-stage clinical biotechnology company that applies novel engineered chemistry by enabling its aqueous cytotoxic-containing drug product, INT230-6, to mix and saturate the tumor's dense, high-fat pressurized environment. As a result of the saturation, Intensity's clinical trials have demonstrated the ability of INT230-6 to kill tumors and elicit an adaptive immune response within days of injection, representing a novel approach to cancer cell death that holds the potential to shift the treatment paradigm and turn many deadly cancers into chronic diseases even for cancers that do not respond to immunotherapy. Intensity complete two large clinical studies using INT230-6 that enrolled over 200 patients: a Phase 1/2 dose escalation trial (NCT03058289) and a Phase 2 randomized control clinical trial in breast cancer (the INVINCIBLE-2 study) (NCT04781725). Intensity Therapeutics initiated a Phase 3 trial in soft tissue sarcoma (the INVINCIBLE-3 study) (NCT06263231), testing INT230-6 as second or third-line monotherapy compared to the standard of care with overall survival as an endpoint. The Company is also conducting a Phase 2 study in collaboration with The Swiss Group for Clinical Cancer Research SAKK as part of a Phase 2/3 program evaluating INT230-6 followed by SOC and SOC alone for patients with presurgical triple-negative breast cancer. Information on the Phase 2 portion of the program (INVINCIBLE-4 Study) is listed under (NCT06358573). For more information about the Company, including publications, papers and posters about its novel approach to cancer therapeutics, visit . About the Connective Tissue Oncology Society and Sarcoma The Connective Tissue Oncology Society was formed in 1995 and incorporated in 1997. CTOS is an international group comprised of physicians and scientists with a primary interest in the tumors of connective tissues such as soft tissue sarcomas, which are a rare type of cancer that develops in the soft tissues of the body, such as muscle, fat, blood vessels, and nerves: The goal of the society is to advance the care of patients with connective tissue tumors and to increase knowledge of all aspects of the biology of these tumors, including basic and clinical research. Forward-Looking Statements Certain statements in this press release may constitute "forward-looking statements" within the meaning of the United States Private Securities Litigation Reform Act of 1995, as amended to date. These statements include but are not limited to, statements relating to the development of the Company's clinical programs. When or if used in this communication, the words "may," "could," "should," "anticipate," "believe," "estimate," "expect," "intend," "plan," "predict" and similar expressions and their variants, as they relate to the Company or its management, may identify forward-looking statements. The forward-looking statements contained in this press release are based on management's current expectations and projections about future events. Nevertheless, actual results or events could differ materially from the plans, intentions, and expectations disclosed in, or implied by, the forward-looking statements. These risks and uncertainties, many of which are beyond our control, include: the initiation, timing, progress and results of future preclinical studies and clinical trials and research and development programs; the need to raise additional funding before the Company can expect to generate any revenues from product sales; plans to develop and commercialize product candidates; the timing or likelihood of regulatory filings and approvals; the ability of the Company's research to generate and advance additional product candidates; the implementation of the Company's business model, strategic plans for the Company's business, product candidates and technology; commercialization, marketing and manufacturing capabilities and strategy; the rate and degree of market acceptance and clinical utility of the Company's system; the Company's competitive position; the Company's intellectual property position; developments and projections relating to the Company's competitors and its industry; the Company's ability to maintain and establish collaborations or obtain additional funding; expectations related to the use of cash and cash equivalents and investments; estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and other risks described in the section entitled "Risk Factors" in the Company's SEC filings, which can be obtained on the SEC website at . Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date on which they are made and reflect management's current estimates, projections, expectations and beliefs. The Company does not plan to update any such forward-looking statements and expressly disclaims any duty to update the information contained in this press release except as required by law. Investor Relations Contact: Justin Kulik [email protected] CORE IR (516) 222-2560 Media Contact: Jules Abraham CORE IR [email protected] SOURCE Intensity Therapeutics Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

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