A Phase 1 Randomized, A Phase 1 Randomized, Placebo Controlled, Double Blind, Two Part, Single- and Multiple-Ascending-Dose Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenously Administered ABL301 in Healthy Adult Participants

This is a Phase 1, FIH, randomized, double-blind, placebo-controlled study designed to assess the safety, tolerability, PK and PD after SAD and MAD in healthy adult participants.

开始日期2022-12-31

申办/合作机构

ABL Bio, Inc.

100 项与 ABL-301 相关的临床结果

登录后查看更多信息

100 项与 ABL-301 相关的转化医学

登录后查看更多信息

100 项与 ABL-301 相关的专利（医药）

登录后查看更多信息

项与 ABL-301 相关的新闻（医药）

2024-10-04

·PipelineReview

ABL Bio Announces Clinical Collaboration to Evaluate ABL103 in Combination with KEYTRUDA® (pembrolizumab) in Patients with Solid Tumors

– MSD will supply KEYTRUDA to be evaluated in combination with ABL Bio’s ABL103 in a Phase 1b/2 clinical trial SEONGNAM, South Korea I October 4, 2024 I ABL Bio (CEO Sang Hoon Lee), a company specializing in bispecific antibodies, today announced that it has entered into a clinical trial collaboration and supply agreement with MSD (a subsidiary of Merck & Co., Inc., Rahway, NJ, USA), to evaluate ABL103 in combination with MSD’s anti-PD-1 therapy, KEYTRUDA ® (pembrolizumab) in patients with advanced or metastatic solid tumors. Under the terms of the agreement, ABL Bio will conduct a phase 1b/2 clinical trial to evaluate the safety and efficacy of ABL103 in combination with KEYTRUDA. In this combination study, MSD will supply KEYTRUDA. ABL103 is bispecific antibody that simultaneously targets B7-H4 and 4-1BB. ABL103 is one of the pipeline programs in which ABL Bio’s 4-1BB based bispecific antibody platform ‘Grabody-T’ has been applied. Grabody-T is designed to activate T cells only in the tumor microenvironment, reducing the liver toxicity of conventional 4-1BB monoclonal antibody and enhancing the antitumor activity. ABL103 also has mechanism to activate the 4-1BB signaling pathways in the tumor microenvironments where the B7-H4 antigens exist, allowing T cells to selectively attack tumor cells while sparing normal cells. Currently, the dose escalation part of the phase 1 clinical trial for ABL103 is ongoing in South Korea. Sang Hoon Lee, CEO of ABL Bio said “we are pleased to enter into this clinical collaboration agreement with MSD. With this agreement, we are ready to move on to the next stage of ABL103 clinical development. We hope that the combination of ABL103 and KEYTRUDA contributes to a better life for patients with advanced or metastatic solid tumors. To date, the phase 1 study for ABL103 monotherapy is progressing smoothly, and we will do our best in clinical development to achieve meaningful results from ABL103.” Meanwhile, ABL Bio is developing various clinical and non-clinical assets based on its bispecific antibody platform ‘Grabody’. More than 15 clinical projects for more than 7 assets, including ABL001, ABL111, ABL503, ABL105, ABL202, ABL301, and ABL103, are underway for different indications in various countries, including the United States, China, Australia, and Korea. In the case of ABL001, the U.S. Food and Drug Administration (FDA) recently granted Fast Track designation to support the rapid development of this new drug candidate. Meanwhile, ABL Bio is preparing to initiate clinical trials for ABL104. In addition, ABL Bio is continuously researching and developing several other product candidates, including bispecific antibody-drug conjugates (ADCs). KEYTRUDA ® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. SOURCE: ABL Bio

临床1期引进/卖出快速通道抗体药物偶联物

2024-10-04

·PRNewswire

ABL Bio Announces Clinical Collaboration to Evaluate ABL103 in Combination with KEYTRUDA® (pembrolizumab) in Patients with Solid Tumors

- MSD will supply KEYTRUDA to be evaluated in combination with ABL Bio's ABL103 in a Phase 1b/2 clinical trial SEONGNAM, South Korea, Oct. 4, 2024 /PRNewswire/ -- ABL Bio (CEO Sang Hoon Lee), a company specializing in bispecific antibodies, today announced that it has entered into a clinical trial collaboration and supply agreement with MSD (a subsidiary of Merck & Co., Inc., Rahway, NJ, USA), to evaluate ABL103 in combination with MSD's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) in patients with advanced or metastatic solid tumors. Under the terms of the agreement, ABL Bio will conduct a phase 1b/2 clinical trial to evaluate the safety and efficacy of ABL103 in combination with KEYTRUDA. In this combination study, MSD will supply KEYTRUDA. ABL103 is bispecific antibody that simultaneously targets B7-H4 and 4-1BB. ABL103 is one of the pipeline programs in which ABL Bio's 4-1BB based bispecific antibody platform 'Grabody-T' has been applied. Grabody-T is designed to activate T cells only in the tumor microenvironment, reducing the liver toxicity of conventional 4-1BB monoclonal antibody and enhancing the antitumor activity. ABL103 also has mechanism to activate the 4-1BB signaling pathways in the tumor microenvironments where the B7-H4 antigens exist, allowing T cells to selectively attack tumor cells while sparing normal cells. Currently, the dose escalation part of the phase 1 clinical trial for ABL103 is ongoing in South Korea. Sang Hoon Lee, CEO of ABL Bio said "we are pleased to enter into this clinical collaboration agreement with MSD. With this agreement, we are ready to move on to the next stage of ABL103 clinical development. We hope that the combination of ABL103 and KEYTRUDA contributes to a better life for patients with advanced or metastatic solid tumors. To date, the phase 1 study for ABL103 monotherapy is progressing smoothly, and we will do our best in clinical development to achieve meaningful results from ABL103." Meanwhile, ABL Bio is developing various clinical and non-clinical assets based on its bispecific antibody platform 'Grabody'. More than 15 clinical projects for more than 7 assets, including ABL001, ABL111, ABL503, ABL105, ABL202, ABL301, and ABL103, are underway for different indications in various countries, including the United States, China, Australia, and Korea. In the case of ABL001, the U.S. Food and Drug Administration (FDA) recently granted Fast Track designation to support the rapid development of this new drug candidate. Meanwhile, ABL Bio is preparing to initiate clinical trials for ABL104. In addition, ABL Bio is continuously researching and developing several other product candidates, including bispecific antibody-drug conjugates (ADCs). KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. SOURCE ABL Bio, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床1期引进/卖出快速通道

2022-10-11

·IQVIA艾昆纬

面对资本寒冬，突破性技术持续推动CNS交易热潮

导读近年来，尽管药物研发面临着研发成本高昂和后期临床试验成功率较低等多重挑战，CNS（中枢神经系统）领域的药物交易仍快速上升，在生命科学领域交易市场占据了一席之地。值得注意的是，随着神经科学候选药物成为驱动交易的关键，2020-2021年CNS领域的交易量大幅增加，尤其是新型治疗形式和给药方法。1早期研发合作推动2021年CNS交易的发展2017-2019年，神经科学领域的交易数量稳步增长，直至2020年略有下降。这一变化可能是由于COVID-19大流行期间，资源更多地转移到传染病领域。随着疫苗的成功推广和COVID-19病例的减少，CNS领域交易在2021年开始恢复，交易量激增，共达成了277项交易。突破性技术和模式的快速发展（如新型给药方法和基于核苷酸的疗法）对此功不可没。尽管所涉及的技术仍处于早期研发阶段，但它们能够使疗法穿过血脑屏障，更顺利地进入中枢神经系统。就具体适应症而言，涉及治疗多发性硬化症和阿尔茨海默症的药物交易在2021年激增，这是由于受影响的人口众多且医疗需求高。2近期主要CNS交易2021年有许多高价并购交易与神经系统疾病相关，如Jazz Pharmaceuticals以72亿美元收购了GW Pharmaceuticals；Horizon Therapeutics以30.5亿美元收购Viela Bio，但这些交易并非特定集中在某一个CNS领域。相反，只专注于CNS适应症的最大并购交易是Angelini Pharma对Arvelle Therapeutics的收购，总估值高达9.6亿美元。通过该交易，Angelini获得了塞诺氨酯，一种用于成人局灶性（部分发作）癫痫发作的抗癫痫药物，该药物最近在欧洲以Ontozry®的品牌名上市。同样受抗癫痫治疗的推动，uniQure以2.5亿欧元收购了Corlieve Therapeutics，获得了Corlieve主导的AMT-260项目，这是一种利用miRNA沉默技术治疗颞叶癫痫（最常见的局灶性癫痫形式）的基因疗法。Supernus Pharmaceuticals在2021年以4.5亿美元收购了Adamas Pharmaceuticals，获得了两种获批用于帕金森病患者的药物。该交易为Supernus获得了Gocovri（金刚烷胺）缓释胶囊，该产品在美国被批准用于治疗接受左旋多巴治疗的帕金森病患者的“关闭期”发作和运动障碍。Supernus还将获得Osmolex ER（金刚烷胺）缓释片的权利，该药在美国被批准用于治疗帕金森病和药物引起的成人锥体外系反应。尽管2021年的并购交易活动有所上升，但制药公司仍然倾向于与EBP（新兴制药公司）进行大量合作交易，依靠他们进行早期研发，在有一定进展后再接管。表1显示了IQVIA Pharma Deals平台选出的值得注意的高价值CNS合作交易。由于分析中包括了许可和合作交易，总交易价值取决于实现特定的研发和临床里程碑付款。所有公开的预付费用都已列在表中，帮助企业更好地衡量交易条款。按潜在交易总额计算，2021年最大的交易是罗氏与Shape Therapeutics为阿尔茨海默病、帕金森病和罕见疾病领域研发基因疗法而达成的合作，总金额超30亿美元。通过合作，两家公司计划利用Shape Therapeutics的新型RNA编辑平台RNAfix™和AAVid™技术平台进行临床研究，研发下一代组织特异性腺相关病毒（AAVs）。另一项就核苷酸技术达成高价交易的是武田与Anima Biotech，总金额可达24亿美元。两家公司达成合作，利用后者的翻译控制治疗平台，研发用于遗传性神经疾病的mRNA转化调节剂。临床前的研究合作将首先包括Anima针对HTT（亨廷顿）靶点的早期亨廷顿病项目。2021年，预付金额最大的许可权交易是葛兰素史克出资7亿美元与Alector合作，共同研发两种临床阶段的单克隆抗体，用于治疗神经退行性疾病。这笔交易的重点关注于“免疫神经学”这一新研究领域，探索利用人体的先天免疫系统治疗神经退行性疾病的方法。诺华与优时比就神经科学领域达成1.5亿美元预付交易的合作，共同研发UCB0599，一种小分子α-突触核蛋白错误折叠抑制剂，目前已处于帕金森病临床Ⅱ期研究阶段。辉瑞在与Biohaven Pharmaceutical的交易中也承诺提供1.5亿美元的预付款，以获得CGRP（降钙素基因相关肽）受体拮抗剂、偏头痛药物rimegepant和zavegepant的商业化权利。rimegepant于2022年4月获得欧盟委员会的上市许可，用于偏头痛的急性和预防性治疗，成为同类产品中的首个获批药物。2022年5月，辉瑞以116亿美元的交易总额收购Biohaven，获得了偏头痛药物的全球权利。该交易也成为了2022年迄今为止最大的生物制药并购案。除此之外，艾伯维斥资10亿美元收购Syndesi以获得SDI-118，一项用于治疗认知障碍的Ⅰb期管线。此外，一些备受瞩目的合作交易也已宣布，包括赛诺菲与ABL Bio达成全球合作许可协议，推进ABL301治疗帕金森病研究。3CNS发展前景尽管CNS疗法面临着许多挑战，医药公司仍继续大力投资该领域的新技术和模式。2021年交易数量的上升反映了神经科学领域日益增多的需求，这反过来又推动了交易结构中的风险分配。随着对疾病与人脑机制的了解更为深入，治疗市场将不断扩大，交易数量和交易额也将继续增长。可以预见，2022年CNS的交易活动或将继续保持去年的规模。

合作并购免疫疗法信使RNA寡核苷酸

100 项与 ABL-301 相关的药物交易

登录后查看更多信息