Givastomig

– ABL Bio and GSK enter into a multi-program agreement to develop novel medicines for neurodegenerative diseases – Programs will leverage ABL Bio’s Grabody-B platform technology to effectively deliver molecules across the blood-brain barrier – ABL Bio to receive up to £77 million in upfront and near-term payments SEONGNAM, South Korea I April 7, 2025 I ABL Bio Inc. (KOSDAQ: 298380), a clinical-stage biotech company developing bispecific antibody technology for immuno-oncology and neurodegenerative diseases, announced a worldwide licensing agreement enabling GSK to develop novel medicines for neurodegenerative diseases by utilizing ABL Bio’s blood-brain barrier (BBB) shuttle platform, Grabody-B. The agreement aims to develop multiple programs for novel targets across therapeutic modalities including antibody, polynucleotide or oligonucleotides, such as siRNA and ASOs, to address significant unmet medical needs of patients suffering from neurodegenerative conditions. The blood-brain barrier (BBB) serves as a protective barrier that restricts the entry of harmful substances and agents into the brain and is considered a significant obstacle in the development of treatments for neurological diseases. ABL Bio’s Grabody-B was developed to overcome the limitations of existing drugs that have difficulty crossing the BBB by targeting the Insulin-like Growth Factor 1 Receptor (IGF1R), facilitating drug penetration across the BBB and enabling efficient delivery into the brain. Under the terms of the agreement, ABL Bio will receive up to £77.1 million in upfront and near-term payments, including an immediate upfront payment of £38.5 million, research milestones and potential program expansion. In total, ABL Bio is eligible to receive up to £2.075 billion in research, development, regulatory and commercialization milestone payments across multiple potential programs. ABL Bio will receive tiered royalties on net sales if products are successfully commercialized. As part of the agreement, ABL Bio will transfer Grabody-B-related technology and know-how to GSK, while GSK will assume responsibility for preclinical and clinical development, manufacturing, and commercialization. Christopher Austin, SVP of Research Technologies, GSK, said “There is a critical need for new therapeutics to treat neurodegenerative brain diseases, which are rapidly increasing in prevalence due to the aging of the population. Many of the most promising new therapies are antibodies, which cannot efficiently reach the brain without a shuttle to get them across the BBB. This agreement reflects our commitment to innovative platform technologies to overcome the BBB and thus open entirely new opportunities for treating these devastating diseases, an important component of our emerging pipeline.” Sang Hoon Lee, CEO of ABL Bio said “This agreement underscores ABL Bio’s leadership in BBB technology and its commitment to advancing transformative therapeutics in neurodegenerative diseases through strategic partnership with global pharmaceutical leaders like GSK. Additionally, this agreement will serve as a great opportunity to strengthen ABL Bio’s position in the neurodegenerative disease treatment market through the potential commercialization of Grabody-B and to expand the modality areas where Grabody-B can be utilized. Given the increasing number of patients suffering from neurodegenerative diseases such as Alzheimer’s and Parkinson’s diseases, we hope this partnership will accelerate the development of innovative treatments and bring renewed hope to patients worldwide.” About ABL Bio ABL Bio is developing various clinical and non-clinical assets based on its bispecific antibody platform ‘Grabody’. Clinical projects for 7 pipelines, including ABL301, ABL001 (tovecimig), ABL111 (givastomig), ABL503 (ragistomig), ABL105, ABL202, and ABL103, are underway for different indications in various countries, including the United States, China, Australia, and Korea. In case of ABL001 (tovecimig), has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) to support the rapid development of this new drug candidate. In addition, ABL111 (givastomig), co-developed with I-Mab, is expected to disclose the top-line data from the Phase 1b clinical trial in 2025, evaluating the triple combination therapy with nivolumab and chemotherapy. 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). SOURCE: ABL Bio

ABL Bio与葛兰素史克达成多项目协议，共同开发神经退行性疾病创新药物 项目将利用ABL Bio的Grabody-B平台技术，有效实现分子跨越血脑屏障 ABL Bio将获得高达7700万英镑的预付款及短期付款 韩国城南 2025年4月7日 /美通社/ -- ABL Bio Inc. (KOSDAQ: 298380)是一家专注于开发用于免疫肿瘤学和神经退行性疾病的双特异性抗体技术的临床阶段生物技术公司。该公司宣布与葛兰素史克(GSK)达成一项全球许可协议，允许葛兰素史克利用ABL Bio的血脑屏障(BBB)递送平台Grabody-B开发神经退行性疾病创新药物。该协议旨在开发针对多种新型靶点的项目，涵盖多种治疗模式，包括抗体、多核苷酸或寡核苷酸（如siRNA和ASO），以满足神经退行性疾病患者尚未满足的重大医疗需求。 血脑屏障(BBB)是一道保护屏障，可阻止有害物质和病原体进入大脑，被认为是开发神经系统疾病治疗方法的一大障碍。ABL Bio开发的Grabody-B平台旨在克服现有药物难以跨越血脑屏障的局限性，通过靶向胰岛素样生长因子1受体(IGF1R)，促进药物穿透血脑屏障，实现高效递送至大脑。 根据协议条款，ABL Bio将获得高达7710万英镑的预付款及短期付款，包括3850万英镑的即时预付款、研究里程碑付款及潜在项目扩展费用。总体而言，ABL Bio有资格在多个潜在项目中获得高达20.75亿英镑的研究、开发、监管和商业化里程碑付款。若产品成功商业化，ABL Bio还将获得净销售额的分级特许权使用费。作为协议的一部分，ABL Bio将向葛兰素史克转让Grabody-B相关技术和专有技术，而葛兰素史克将负责临床前和临床开发、生产及商业化。 葛兰素史克研究技术高级副总裁Christopher Austin表示："治疗神经退行性脑部疾病的新疗法存在迫切需求，由于人口老龄化，这类疾病的患病率正在迅速上升。许多最有前景的新疗法是抗体，但如果没有递送平台帮助其跨越血脑屏障，抗体就无法有效地到达大脑。这项协议体现了我们对创新平台技术的不懈追求，旨在克服血脑屏障障碍，从而为治疗这些毁灭性疾病开辟全新的机会，这也是我们新兴产品线的重要组成部分。" ABL生物首席执行官Sang Hoon Lee表示："该协议彰显了ABL生物在BBB技术领域的领导地位，以及我们通过与葛兰素史克等全球制药领军企业的战略合作伙伴关系，推动神经退行性疾病变革性疗法发展的决心。此外，该协议还将是一个绝佳机会，通过Grabody-B的潜在商业化，巩固ABL Bio在神经退行性疾病治疗市场的地位，并拓展Grabody-B的应用模式领域。鉴于阿尔茨海默病和帕金森病等神经退行性疾病患者数量的不断增加，我们希望此次合作能够加速创新疗法的开发，为全球患者带来新的希望。" 关于ABL Bio ABL Bio基于其双特异性抗体平台"Grabody"，正在开发各种临床和非临床项目。包括ABL301、ABL001 (tovecimig)、ABL111 (givastomig)、ABL503 (ragistomig)、ABL105、ABL202 和 ABL103 在内的7条产品线的临床项目，正在美国、中国、澳大利亚和韩国等不同国家针对不同适应症开展。ABL001 (tovecimig)已获得美国食品药品监督管理局(FDA)的快速通道认定，以支持这一新候选药物的快速开发。此外，与I-Mab共同开发的ABL111 (givastomig)，预计将于2025年披露1b期临床试验的主要数据，评估其与纳武单抗和化疗的三联疗法。与此同时，ABL Bio正准备启动ABL104的临床试验。此外，ABL Bio还在持续研发其他多个候选产品，包括双特异性抗体偶联药物(ADC)。