A Phase 1/2, Open-label, Multi-center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of JIN-A02 in Patients With EGFR Mutant Advanced Non-small Cell Lung Cancer

This study is a Phase I/II open-label, multi-center study to evaluate the safety, tolerability, PK, and an anti-tumor activity of JIN-A02, a 4th generation EGFR-TKI agent for oral administration, in EGFR mutant-positive, advanced NSCLC subjects who showed disease progression after receiving standard anticancer therapy, including approved EGFR-TKI therapy and/or no more than a single platinum-based anticancer chemotherapy. In Part A of the study, dose escalation is carried out where MTD is evaluated using Bayesian Optimal Interval (BOIN) design in subjects with advanced NSCLC harboring EGFR-mutation of C797S or T790M. In Part B, dose exploration is carried out to further evaluate the safety of JIN-A02 and to determine the RP2D using 2 preliminary effective dose levels and with the help of a safety review committee (SRC) in advanced NSCLC subjects harboring EGFR mutant C797S or T790M. In Part C dose expansion study, subjects with EGFR mutant who show disease progression after receiving standard anticancer therapy, including approved EGFR-TKI therapy with activity against T790M such as Osimertinib and/or no more than one platinum-based anticancer chemotherapy, are divided into 5 different cohorts based on the EGFR mutation and the anti-tumor activity of JIN-A02 is evaluated. Before enrollment in the study, the EGFR mutant profile is determined using either tumor tissue and/or plasma ctDNA. The profile is determined locally through a test method approved by the sponsor. The sponsor reviews and approves each potential subject for enrollment. Study eligibility evaluation will utilize local test(s).

开始日期2023-07-30

申办/合作机构

J INTS BIO

100 项与 JIN-A02 相关的临床结果

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100 项与 JIN-A02 相关的转化医学

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100 项与 JIN-A02 相关的专利（医药）

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项与 JIN-A02 相关的新闻（医药）

2024-10-24

·PRNewswire

J INTS BIO Presents Interim Findings from Phase 1/2 Clinical Trial of 4th-Generation EGFR-TKI 'JIN-A02' in NSCLC: A Potential Breakthrough in Overcoming Acquired Resistance to Targeted Therapy

SEOUL, South Korea, Oct. 24, 2024 /PRNewswire/ -- J INTS BIO, a pioneering biopharmaceutical company, has unveiled promising interim results from the Phase 1/2 clinical trial of its novel 4th-generation EGFR Tyrosine Kinase Inhibitor (TKI), JIN-A02, aimed at EGFR-mutated non-small cell lung cancer (NSCLC) patients who developed resistance and progressive diseases despite treatments. The data was presented at this year's edition of ENA (EORTC-NCI-AACR) Symposium, held in Barcelona, Spain, from October 23-25, 2024, drawing significant attention from the global oncology community. Continue Reading Ethan Seah, Vice President of J INTS BIO, is giving a poster presentation on the Phase 1/2 study of its novel oral 4th generation EGFR-TKI ‘JIN-A02’ at the ENA (EORTC-NCI-AACR) Symposium. JIN-A02: A Next-Generation Therapeutic Targeting Resistance to 3rd-Generation EGFR-TKIs Mutations in the epidermal growth factor receptor (EGFR) is a key driver in the pathogenesis of NSCLC, with 3rd Generation EGFR-TKIs like osimertinib serving as the cornerstone of treatment. Unfortunately, eventually resistance to this treatment will occur, leading to cancer relapse and disease progression. JIN-A02, developed by J INTS BIO, is the 4th-generation EGFR-TKI specifically designed to address this. By targeting both the original mutations and those acquired subsequently as a result of cancer treatments, it offers a therapeutic solution for these patients. The ongoing Phase 1/2 clinical trial evaluates JIN-A02 in patients with advanced or metastatic NSCLC who have developed resistance and disease progression after 3rd-generation EGFR-TKIs use. The study consist of 3 parts: dose escalation (Part A), dose exploration (Part B), and dose expansion (Part C). The data generated so far in Part A has been encouraging with a good safety profile and early efficacy signals, underscoring JIN-A02's position as a novel treatment for EGFR-TKI-resistant NSCLC. J INTS BIO said, "New treatment are urgently needed for lung cancer patients whose disease has worsened or relapsed after treatment with 3rd-generation EGFR-TKI. JIN-A02 is potentially one such treatment option that can bring hope to patients world wide." Study Design and Interim Results: To date, the Part A of the study has enrolled 16 patients who received increasing doses of JIN-A02, starting with a low dose of 12.5mg daily to 150 mg daily, with the primary objective of determining the maximum tolerated dose (MTD). This Part also look at safety, pharmacokinetics, and anti-tumor activity as secondary objectives. Doses higher than 150mg are currently being studied in this Part. Key Interim Findings: Safety: JIN-A02 demonstrated a very favorable tolerability across all dose levels studied so far, with no dose-limiting toxicities (DLTs) observed up to 150mg daily. There has been no myelosuppression and more importantly, no adverse events commonly associated with EGFR TKI such as rash, diarrhea and cardiotoxicity and this despite tumor reduction already being observed. This is the reason higher doses are being studied. Efficacy: Tumor control were reported early in this study at lower doses. The first instance occurring at a relative low dose of 50mg. In this cohort, Partial Response of the lung lesions with stable disease in brain metastases was reported. Another Partial Response of the lung lesions was reported in the next cohort of 100mg, in a patient with similar primary EGFR mutation. These findings highlight JIN-A02's potency as a therapeutic agent, even in patients with progressive diseases and who were heavily treated prior to entering this study. Central Nervous System (CNS): Of interest is JIN-A02 activity against brain metastases, a potentially fatal complication of progressive lung disease. Reduction in the brain metastases was first reported with JIN-A02 in the 100mg Cohort, although stable disease was reported in the 50mg Cohort. These results points to JIN-A02 not only penetrating the tough Blood-Brain Barrier, but also exerting its anti-tumor effects. Progression to Subsequent Trial Phases: Once we have the final doses to be used in Phase 2, the dose-expansion part of the study (Part B) will begin, and two doses will be selected and studied in bigger groups of patient to verify its safety, pharmacokinetics, and anti-tumor activity. Part B is essential for the selection of the final dose level to be used in Phase 2 or Part C of this study. In this final part (Part C), we will investigate JIN-A02 in specific patient populations who are stratified by EGFR mutation subtypes and the presence of CNS metastases. Part C is critical for generating a bigger dataset on the drug's therapeutic potential across distinct NSCLC patient groups for regulatory approval purposes. Implications for Future Therapeutic Development Professor Byeong Cheol Cho of Severance Hospital's Division of Medical Oncology, South Korea, commented on the significance of these findings, stating, "JIN-A02's demonstrated efficacy against both lung and its associated CNS disease underscores its potential as a groundbreaking treatment for patients with EGFR-TKI-resistant NSCLC, including and especially those with brain metastases." JIN-A02's ability to effectively target CNS lesions represents a notable advancement and as a 4th generation EGFR-TKI, offers hope for patients with very limited options as a result of progression after 3rd-generation TKIs use. Next Steps in Clinical Development: J INTS BIO is fully committed to accelerating the clinical development of JIN-A02. And as the clinical study continues to enroll patients ahead of schedule, JIN-A02, is poised to shape the treatment landscape of NSCLC and to offer hope to lung cancer patients worldwide. SOURCE J INTS BIO WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床结果AACR会议临床2期

2024-06-16

·药明康德

显著延长肝癌患者生存期的细胞疗法；可同时减重并降低心血管风险的小分子疗法…… | 一周盘点

▎药明康德内容团队编辑本期看点 1. 既能减重又能降低心血管风险的小分子疗法NT-0796在早期临床试验中表现积极。 2. T细胞受体（TCR）T细胞疗法SCG101在晚期乙型肝炎病毒（HBV）相关肝细胞癌（HCC）患者中展现出抗病毒和抗肿瘤双重活性，显著延长患者的生存期。 3. 白血病患者在接受造血干细胞移植后接受一剂INB-100治疗，100%可评估的患者于今年5月31日时仍然存活，并且维持完全缓解（CR）达到1年。药明康德内容团队整理 NT-0796：公布1b/2a期临床试验数据 NodThera宣布其在炎症性肥胖受试者中进行的临床1b/2a期心血管风险研究取得了积极数据，该研究旨在评估其在研口服、可穿透血脑屏障的NLRP3炎性小体抑制剂NT-0796，对患者的炎症、心血管和代谢风险参数的影响。NLRP3炎症小体是一种经过高度验证的抗炎药物靶点。分析显示，NT-0796可有效减少患者体内C反应蛋白（CRP）水平，并使患者的体重显著减少。此外，接受NT-0796治疗患者的其他促炎和心脏代谢生物标志物也有所减少，这是该研究的次要终点。与以往的试验一致，NT-0796总体上安全且耐受性良好，不良事件主要是轻度和短暂的，未观察到严重不良事件。NodThera目前正在为针对肥胖症，以及包括其他心脏代谢疾病和帕金森病在内的临床2期研究做准备。 SCG101：公布首次人体临床试验结果星汉德生物（SCG Cell Therapy）宣布，其自主研发的HBV特异性TCR-T细胞疗法SCG101入选了2024年度欧洲肝脏研究协会年会（EASL Congress 2024）的焦点精选报告。SCG101是一种针对乙型肝炎病毒表面抗原（HBsAg）的特异性自体TCR-T细胞疗法。星汉德生物依托自主研发的独有GianT技术平台，筛选高亲力且高活性的天然TCR，可以有效靶向实体肿瘤中通过主要组织相容性复合体（MHC）表达的细胞内抗原。临床前和临床研究数据显示，SCG101具有肿瘤抑制和HBV cccDNA根除作用，可实现抗肿瘤和抗病毒功能。此次公布的研究结果显示，SCG101在晚期HBV相关HCC患者中展现出抗病毒和抗肿瘤双重活性，显著延长了患者的生存期。至稿件截止日，客观缓解率（ORR）为33%，获得部分缓解（PR）的患者均维持缓解超过6个月，其中1例实现了靶病灶完全缓解（pCR），且持续缓解超过27个月。此外，患者的肿瘤应答与SCG101的抗病毒活性高度相关。4例血清HBsAg显著下降并维持在低水平的患者的肿瘤缩小，且无进展生存期和总生存期显著延长至5.9个月和19.0个月。 INB-100 IN8bio：公布1期临床试验的新数据 IN8bio公司公布了其在研现货型γδ T细胞疗法INB-100的最新1期临床试验结果。INB-100是一款来自健康供体的同种异体γδ T细胞，在体外经过扩增和激活后，被输注到白血病患者体内。在这项研究者发起的1期临床试验中，白血病患者在接受造血干细胞移植后，接受一剂INB-100的治疗。这些患者包括高风险和复发急性髓系白血病（AML）患者，他们此前已接受过多种疗法治疗，包括嵌合抗原受体（CAR）T细胞疗法。截至2024年5月31日的数据，100%可评估的白血病患者仍然存活并且维持CR达到1年。此前发表的历史数据显示，高达50%的血液癌症患者在接受造血干细胞移植和减轻强度预处理（reduced intensity conditioning）的情况下会出现复发，并且在复发后不久去世。在这10名患者中，两名接受INB-100治疗的患者已经无癌三年半，另一名患者接近3年无癌。数据同时显示，接受单次治疗后的365天里，同种异体γδ T细胞能够长期持久地在体内扩增。新闻稿指出，这是首次同种异体细胞疗法表现出持续的扩增和持久性。安全性方面，INB-100没有出现剂量限制性毒性，未发现细胞因子释放综合征（CRS），神经毒性或免疫效应细胞相关神经毒性综合征（ICANS），未发现严重感染。 Delpacibart braxlosiran （AOC 1020）：公布1/2期临床试验的初步数据 Avidity Biosciences宣布其用于治疗面肩肱型肌营养不良症（FSHD）的在研抗体寡核苷酸偶联物（AOC）delpacibart braxlosiran（del-brax，AOC 1020）在临床1/2期试验FORTITUDE中的初步积极数据。FSHD是由于DUX4基因异常表达所引起。DUX4蛋白的异常表达导致肌肉细胞基因表达的变化，造成FSHD患者肌肉功能的终身、渐进性丧失。根据新闻稿，del-brax是首个旨在治疗FSHD根本原因的在研AOC疗法，由一种专有的转铁蛋白受体1（TfR1）靶向单克隆抗体，与靶向DUX4 mRNA的siRNA偶联所组成。 ▲Del-brax下调患者受DUX4调控的基因表达（图片来源：参考资料[2]）此次公布的结果显示，FSHD患者接受该疗法后，其受DUX4调控的基因一致性地下调超过50%，并且患者的肌肉功能有改善的趋势。根据此积极结果，Avidity计划加速FORTITUDE研究中注册队列的启动。 Bexicaserin（LP352）：公布1b/2a期临床试验的新数据 Longboard Pharmaceuticals公司公布了PACIFIC研究的开放标签扩展（OLE）研究的积极数据。PACIFIC研究旨在评估其在研疗法bexicaserin（LP352）用于治疗与广泛发育性和癫痫性脑病相关癫痫发作的疗效与安全性。Bexicaserin是一款高选择性、口服、新型5-HT2C受体超激动剂，为潜在的“best-in-class”疗法。所有41例完成PACIFIC研究的患者均选择参加OLE研究。结果显示，在OLE研究中接受bexicaserin治疗约6个月的可评估受试者（n=40）的中位可数运动性癫痫发作频率较进入PACIFIC研究时的基线水平降低56.1%。其中，在PACIFIC研究中被随机分配到接受bexicaserin治疗组的受试者（n=31）减少了54.9%，在PACIFIC研究中被随机分配到安慰剂组的受试者在OLE研究中过渡到bexicaserin治疗，这类患者（n=9）减少了57.3%。安全性方面，观察到的最常见的治疗伴发不良事件为上呼吸道感染、COVID-19、肺炎、鼻窦炎、癫痫发作和食欲下降。一名受试者因嗜睡而停药，一名受试者因撤回同意而停药。 JIN-A02：公布1/2期临床试验的新数据 J INTS BIO公司公布了其进行中的用于治疗非小细胞肺癌（NSCLC）的新型第4代口服EGFR酪氨酸激酶抑制剂（TKI）JIN-A02的1期临床研究的最新情况。JIN-A02具有高度的选择性，可有效对抗携带EGFR C797S双突变或三突变的NSCLC，并具有高脑渗透率和体内疗效。截至目前，已有两名患者达到了确认的PR，还有3名患者达到了疾病稳定（SD）。此外，研究人员还在1例达到SD的患者中观察到脑转移灶缩小28.6%。安全性方面，未报告剂量限制性毒性，也没有发现皮疹、腹泻或心脏毒性这类通常与EGFR TKI的使用相关的副作用。 PCS6422：公布1b期临床试验的初步数据 Processa Pharmaceuticals公司公布了其下一代卡培他滨组合疗法（NGC-Cap）治疗III/IV期胃肠道癌症患者的1b期临床试验的初步结果。口服卡培他滨在体内代谢后会变成5-氟尿嘧啶（5-FU），进而代谢成两种分子，一种能主动杀死癌细胞，一种只会产生副作用。二氢嘧啶脱氢酶（DPD）在5-FU转化为引起副作用的分子方面起着重要作用。PCS6422能够不可逆地抑制DPD。在相当剂量水平下，PCS6422单药在动物中既没有毒性也不具有活性。而当与卡培他滨或5-FU联合给药时，PCS6422降低了5-FU向仅引起副作用的分子的代谢，从而使更多的5-FU到达癌细胞。Processa Pharmaceuticals公司将PCS6422与低剂量的卡培他滨结合使用，组成了NGC-Cap。此次公布的结果显示，在所有接受一剂PCS6422后再接受7天卡培他滨治疗的可评估患者中，12例可评估患者的疾病控制率为66.7%（8/12），包括2例PR和6例SD。这些患者的无进展生存期约为5-11个月。相比之下，在卡培他滨产品说明书中，301例接受卡培他滨单药治疗的转移性结直肠癌患者的总缓解率约为21%，患者发生进展的时间约为4.5个月。安全性方面，与卡培他滨单药治疗相比，在所有NGC-Cap剂量组中，5-FU的暴露量更高，副作用的发生情况相似或更少。 ▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放参考资料（可上下滑动查看） [1] NodThera’s NLRP3 Inhibitor NT-0796 Meets Primary Endpoint of Inflammation Reversal in Phase Ib/IIa Trial in Obese Subjects with Cardiovascular Risk. Retrieved June 14, 2024 from https://www.nodthera.com/news/nodtheras-nlrp3-inhibitor-nt-0796-meets-primary-endpoint-of-inflammation-reversal-in-phase-ib-iia-trial-in-obese-subjects-with-cardiovascular-risk/ [2] 重磅｜EASL 最新突破性数据：星汉德生物TCR-T细胞治疗晚期肝癌患者总生存期显著延长并伴随乙肝表面抗原清除，获选最佳精选报告. Retrieved June 14, 2024 from https://www.prnasia.com/story/450060-1.shtml [3] Avidity Announces Unprecedented AOC 1020 Data from Phase 1/2 FORTITUDE™ Trial Demonstrating Greater Than 50 Percent Reduction in DUX4 Regulated Genes and Trends of Functional Improvement in People Living with Facioscapulohumeral Muscular Dystrophy. Retrieved June 14, 2024 from https://www.prnewswire.com/news-releases/avidity-announces-unprecedented-aoc-1020-data-from-phase-12-fortitude-trial-demonstrating-greater-than-50-percent-reduction-in-dux4-regulated-genes-and-trends-of-functional-improvement-in-people-living-with-facioscapulohumeral-m-302170099.html [4] Avidity Biosciences Investor & Analyst Event Series – Vol. 9: Preliminary Data from Phase 1/2 FORTITUDE™ trial of AOC 1020 in people living with FSHD. Retrieved June 14, 2024 from https://aviditybiosciences.investorroom.com/events-and-presentations#:~:text=Avidity%20Biosciences%20Investor%20%26%20Analyst%20Event%20Series%20%E2%80%93%20Vol.%209%3A%20Preliminary%20Data%20from%20Phase%201/2%20FORTITUDE%E2%84%A2%20trial%20of%20AOC%201020%20in%20people%20living%20with%20FSHD [5] IN8bio Presents Positive Data Demonstrating Durable 1-year Complete Remission in 100% of Evaluable Patients in Phase 1 Trial of INB-100. Retrieved June 14, 2024, from https://www.globenewswire.com/news-release/2024/06/13/2898625/0/en/IN8bio-Presents-Positive-Data-Demonstrating-Durable-1-year-Complete-Remission-in-100-of-Evaluable-Patients-in-Phase-1-Trial-of-INB-100.html [6] Longboard Pharmaceuticals Announces Positive Interim Results from the Open-Label Extension (OLE) of the Phase 1b/2a PACIFIC Study Evaluating Bexicaserin in Participants with Developmental and Epileptic Encephalopathies (DEEs). Retrieved June 14, 2024, from [7] Processa Pharmaceuticals Announces Positive Efficacy Results from Preliminary Evaluation of Phase 1b Dose-escalating Trial with NGC-Cap in Gastrointestinal Cancer. Retrieved June 14, 2024, from https://www.globenewswire.com/news-release/2024/06/11/2896777/0/en/Processa-Pharmaceuticals-Announces-Positive-Efficacy-Results-from-Preliminary-Evaluation-of-Phase-1b-Dose-escalating-Trial-with-NGC-Cap-in-Gastrointestinal-Cancer.html [8] J INTS BIO, ASCO 2024 - JIN-A02 showed tumor reductions including brain metastasis in the ongoing first-in-human, dose-finding Phase 1 clinical study. Retrieved June 14, 2024, from https://www.prnewswire.com/news-releases/j-ints-bio-asco-2024--jin-a02-showed-tumor-reductions-including-brain-metastasis-in-the-ongoing-first-in-human-dose-finding-phase-1-clinical-study-302168022.html [9] Surrozen Presents Preliminary Results from Phase 1a Study of SZN-043 in Healthy Volunteers and Patients with a History of Liver Cirrhosis at the 2024 European Association for the Study of the Liver (EASL) in Milan. Retrieved June 14, 2024, from https://www.globenewswire.com/news-release/2024/06/10/2896001/0/en/Surrozen-Presents-Preliminary-Results-from-Phase-1a-Study-of-SZN-043-in-Healthy-Volunteers-and-Patients-with-a-History-of-Liver-Cirrhosis-at-the-2024-European-Association-for-the-S.html [10] Eilean Therapeutics Announces FDA Clearance of Investigational New Drug (IND) Application for Lomonitinib for the Treatment of Acute Myeloid Leukemia (AML). Retrieved June 14, 2024, from https://www.prnewswire.com/news-releases/eilean-therapeutics-announces-fda-clearance-of-investigational-new-drug-ind-application-for-lomonitinib-for-the-treatment-of-acute-myeloid-leukemia-aml-302167897.html [11] Ensem Therapeutics Announces Achievement of Milestone Following Entry of Small Molecule CDK2 Inhibitor into Clinical Trials for Solid Tumors. Retrieved June 14, 2024, from https://www.businesswire.com/news/home/20240612661711/en/ [12] Zumutor Biologics Announces Dosing of First Patient with ZM008, a First-in-Class Anti LLT1 Antibody. Retrieved June 14, 2024, from https://www.prnewswire.com/news-releases/zumutor-biologics-announces-dosing-of-first-patient-with-zm008-a-first-in-class-anti-llt1-antibody-302170537.html [13] KSQ Therapeutics Announces First Patient Dosed in Clinical Development Program for KSQ-001EX, a CRISPR/Cas9 Engineered Tumor Infiltrating Lymphocyte (eTIL®) Therapy. Retrieved June 14, 2024, from https://ksqtx.com/news-events/ksq-therapeutics-announces-first-patient-dosed-in-clinical-development-program-for-ksq-001ex-a-crispr-cas9-engineered-tumor-infiltrating-lymphocyte-etil-therapy/ [14] City of Hope CAR T Cell Therapy for Advanced Prostate Cancer Demonstrates Positive Results in Phase 1 Clinical Trial. Retrieved June 14, 2024, from https://www.businesswire.com/news/home/20240612751963/en [15] Assembly Biosciences Doses First Participant in Phase 1a/b Clinical Trial of Herpes Simplex Virus Helicase-Primase Inhibitor Candidate ABI-5366. Retrieved June 14, 2024, from https://investor.assemblybio.com/news-releases/news-release-details/assembly-biosciences-doses-first-participant-phase-1ab-clinical [16] VYNE Therapeutics Announces Dosing of First Participants in Phase 1a Trial of Novel BD2-Selective BET Inhibitor VYN202. Retrieved June 14, 2024, from https://vynetherapeutics.com/press-releases/vyne-therapeutics-announces-dosing-of-first-participants-in-phase-1a-trial-of-novel-bd2-selective-bet-inhibitor-vyn202/ 免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

细胞疗法临床结果临床1期

2024-06-10

·PRNewswire

J INTS BIO, ASCO 2024 - JIN-A02 showed tumor reductions including brain metastasis in the ongoing first-in-human, dose-finding Phase 1 clinical study

SEOUL, South Korea, June 10, 2024 /PRNewswire/ -- J INTS BIO provided an update of its ongoing Phase 1 clinical study of JIN-A02, a 4th generation EGFR-TKI for NSCLC treatment, during the 3rd of June poster session of the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting held at McCormick Place in Chicago, USA, from May 31 to June 4. Continue Reading Professor Cho, Byoung Chul posing with the JIN-A02 poster at the 2024 ASCO Chicago USA Lung CT image of PR patient in Cohort 4. Tumor lesions reduced by 35.3% Lung CT image of PR patient in Cohort 3. Tumor lesions reduced by 77.3% This latest study update of JIN-A02 reported another tumor Partial Response (PR) in a patient in Cohort 4 (100mg daily). The first tumor Partial Response (PR) recorded in this study, was a patient in the earlier Cohort at a lower dose of 50mg daily. In addition, the first instance of brain tumor activity was recorded in Cohort 4, with a 28.6% reduction of the brain metastasis. To-date, Partial Response (PR) has been confirmed in two patients and Stable Diseases in three other, including the patient with reduction of brain metastasis in Cohort 4 and two patients from the lower Cohorts at a lower dose. The final patient in Cohort 4 (100mg) is expected to complete the dose-limiting toxicity (DLT) assessment period soon and thus far, no DLT has been detected. In addition, no rash, diarrhea, or cardiac toxicity (side effects commonly associated with EGFR TKIs use), has been reported in this study despite the positive efficacy signals and clinical benefits already observed. The next Cohort at 150mg daily will begin end of June. J INTS BIO said, "It is very meaningful to be able to share key clinical results in large-scale global conferences attended by global anticancer experts and research and development officials." and "JIN-A02 is expected to be a game changer to improve the life of patients with EGFR C797S positive NSCLC, for which there is currently no approved treatment," they added. According to the company, JIN-A02 is scheduled to enter phase 2 clinical trial by the end of this year. About J INTS BIO J INTS BIO is a bio company specialized in developing innovative anti-cancer and orphan drugs to realize the goal of changing lives and improving health for patients around the world. J INTS BIO's teams have prior multi-year experience in multinational pharmaceutical companies and CROs and track records in medical, regulatory affairs, drug discovery and development. About 'JIN-A02' 'JIN-A02' is a novel orally administered 4th Generation EGFR TKI targeting C797S mutations in NSCLC. Although 1st, 2nd, and 3rd Generation EGFR TKIs have been used with some success, recurrence occurs in most patients including 3rd Generation TKIs such as Osimertinib. Currently, there are no approved therapies for patients who developed EGFR C797S mutations due to the use of 3rd Generation EGFR TKIs and with the high propensity of these cancers to metastasize to the brain, there is an urgent need to develop an effective drug with high blood-brain barrier permeability. 'JIN-A02', a novel oral EGFR TKI, which is effective against C797S mutations and have a high brain penetrance, is therefore expected to become the most promising Best-in-Class 4th-generation EGFR TKI in NSCLC patients with limited or no viable treatment options. SOURCE J INTS BIO

ASCO会议临床结果临床1期临床2期孤儿药

100 项与 JIN-A02 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
EGFR突变的非小细胞肺癌	临床2期	泰国	J INTS BIO	2023-07-30
EGFR突变的非小细胞肺癌	临床2期	韩国	J INTS BIO	2023-07-30
EGFR突变的非小细胞肺癌	临床2期	美国	J INTS BIO	2023-07-30

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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


NCT05394831 (PRNewswire) 人工标引	临床1期	EGFR C797S 突变非小细胞肺癌 EGFR C797S positive	-	JIN-A02	(顧憲鹽獵衊餘醖憲艱鏇) = 夢範顧遞鬱憲憲醖膚選鹹醖鹹艱顧鹹獵積餘糧 (鏇鏇製襯夢繭衊構憲觸 ) 更多	积极	2024-06-10
JIN-A02 (ESMO2022)	N/A	非小细胞肺癌	-	JIN-A02	鬱廠繭糧鹽襯鏇顧壓獵(淵淵顧淵鹽築鬱衊願糧) = 齋襯齋窪簾網繭醖膚衊窪鹹壓醖窪願鏇製鹽積 (築蓋餘範艱齋範願顧憲 ) 更多	-	2022-09-10