A Phase I/Ib Dose Escalation and Cohort Expansion Study of OMX-0407 a Salt-inducible Kinase Inhibitor in Patients With Previously Treated Unresectable Solid Tumours

The main purpose of the dose escalation phase of the study is to determine the safety of different doses of OMX-0407.
The dose expansion (phase Ib) part of the study will evaluate efficacy, safety and tolerability at a dose determined in the dose escalation,

开始日期2023-03-30

申办/合作机构

iOmx Therapeutics AG初创企业

100 项与 OMX-0407 相关的临床结果

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100 项与 OMX-0407 相关的转化医学

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100 项与 OMX-0407 相关的专利（医药）

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项与 OMX-0407 相关的新闻（医药）

2024-09-02

·药明康德

穿越血脑屏障的变构小分子疗法早期结果积极；使化疗耐药患者肿瘤完全消失的靶向疗法将启动新研究…… | 一周盘点

▎药明康德内容团队编辑本期看点 1. 盐诱导激酶（SIK）抑制剂OMX-0407在1a期临床试验中使1名对多种化疗药物耐药的晚期实体瘤患者的肿瘤完全消失。 2. 治疗帕金森病的变构小分子疗法GT-02287的早期临床结果积极，它能够穿越血脑屏障并与靶标结合，同时展现良好的安全性与耐受性。药明康德内容团队整理 OMX-0407：公布1a期临床试验数据 iOmx Therapeutics公司宣布，其潜在“first-in-class”的选择性SIK抑制剂OMX-0407的1a期临床试验已顺利完成，即将启动1b期临床试验。OMX-0407能够通过调控酪氨酸激酶信号直接干扰肿瘤细胞增殖。除了这种直接作用方式外，OMX-0407还能通过增强肿瘤坏死因子等死亡受体配体引发的肿瘤细胞凋亡，重塑肿瘤微环境。初步数据显示，OMX-0407单药治疗是安全且耐受性良好的。OMX-0407对经过多次治疗的晚期实体瘤患者有抗癌活性。其中，一名对多种化疗药物耐药的患者达到了持久的完全缓解（CR），所有肿瘤病灶均消失。此外，生物标志物分析表明，循环血细胞中存在确凿的药理活性证据。 GT-02287：公布1期临床试验数据 Gain Therapeutics宣布其用于治疗帕金森病的在研变构小分子GT-02287在1期试验中获得积极结果。GT-02287是一种口服变构蛋白调节剂，具有可穿越血脑屏障的小分子量。该药物可恢复溶酶体蛋白酶葡萄糖脑苷脂酶（GCase）的功能，该酶由于GBA1基因突变（与帕金森病相关的最常见遗传异常）或其他与年龄相关的压力因素而发生错误折叠和受损。在帕金森病的临床前模型中，GT-02287恢复了GCase酶功能，减少了聚集的α突触核蛋白、神经炎症和神经元死亡，提高了多巴胺水平，改善动物的运动功能和认知能力，可能具有减缓帕金森病进展的潜力。此外，GT-02287显著降低了血浆神经丝轻链（NfL）水平，这是一种神经退行性疾病的生物标志物。此次公布的结果显示，GT-02287存在于受试者的脑脊液中，并与外周靶标相结合。在具良好安全性与耐受性的口服剂量下，该药物的血浆水平达到治疗性水平，并可抵达中枢神经系统并与靶标相结合，显示GT-02287是潜在的帕金森病疗法，无论患者是否具有GBA1突变。Gain Therapeutics预计在今年第四季度启动该疗法的1b期临床试验。 Exidavnemab：公布1期临床试验数据 BioArctic公司公布了其靶向聚集的α突触核蛋白的单克隆抗体exidavnemab的两项与艾伯维合作开展的1期研究的积极结果。该候选药物旨在治疗帕金森病等神经退行性疾病。结果显示，85名接受了exidavnemab静脉注射或皮下注射的受试者对治疗的总体耐受性良好。Exidavnemab的半衰期约30天，对聚集的α突触核蛋白具有高亲和力和选择性，这是其在大脑中保持高靶点结合力的关键。 OCU410ST：1/2期临床试验完成第三个队列的给药 Ocugen公司宣布，其针对Stargardt病开发的候选基因疗法OCU410ST的1/2期临床试验已完成第三个队列的给药。OCU410ST利用腺相关病毒（AAV）递送平台在视网膜递送RORA基因，可调节与Stargardt病相关的通路，例如脂褐素形成、氧化应激、炎症、细胞存活网络等。 FTX-101：IND申请获得FDA许可 Find Therapeutics公司宣布，美国FDA已经批准了FTX-101的IND申请，该公司计划在2024年第四季度启动FTX-101在健康志愿者中的1期临床研究。FTX-101是一种潜在“first-in-class”的髓鞘再生剂，旨在恢复慢性视神经病变患者的视力。FTX-101是一种经过合理设计的治疗肽，靶向Plexin A1和Neuropilin 1。Plexin A1和Neuropilin 1是大脑中存在的一种受体复合物，已被证明参与了少突胶质细胞前体细胞迁移和分化成髓鞘化少突胶质细胞的过程。临床前数据显示，FTX-101在脱髓鞘模型中具有很强的髓鞘修复活性。 ID110521156：IND申请获得韩国食品药品安全部许可 Yunovia公司宣布，韩国食品药品安全部（MFDS）已批准其口服的小分子GLP-1受体激动剂ID110521156用于治疗糖尿病和肥胖的IND申请，可启动1期多剂量递增（MAD）研究。ID110521156具有与GLP-1激素相同的作用，包括促进体内胰岛素的合成和分泌、降低血糖水平、调节胃肠道运动以及抑制食欲。作为一款小分子疗法，ID110521156与当前的标准治疗肽类注射剂相比，具有制造方便和使用简便等差异化特性。 Yunovia已于2024年7月完成了ID110521156的1期单剂量递增研究，包括食物效应研究。结果显示，ID110521156的耐受性良好，有望作为一种每日一次疗法。 MB097、MB310：获批在欧盟和英国启动1b期临床试验 Microbiotica公司宣布，其开发的两款活体生物治疗产品（LBP）MB097和MB310已获得监管部门的批准，可以在选定的欧盟国家和英国启动临床研究。MB097是一种每日一次的口服LBP，由九种细菌菌株组成，能够提供免疫检查点抑制剂（ICI）反应所需的微生物组信号，旨在提高ICI的疗效。临床前研究表明，MB097能够刺激免疫系统的核心途径，激活细胞毒性T淋巴细胞和自然杀伤细胞，使其能够杀死肿瘤细胞。此次开展的1b期研究将评估MB097联用PD-1抑制剂pembrolizumab治疗晚期黑色素瘤的安全性和疗效。 MB310是从健康供体中鉴定出的一个明确的微生物群落。临床前研究表明，MB310能够通过至少三种独立的机制发挥对溃疡性结肠炎的治疗作用，包括促进受损肠道上皮屏障的愈合，调节炎症和免疫调节细胞因子的平衡，以及诱导调节性T细胞反应。此次开展的1b期研究将评估MB310治疗溃疡性结肠炎的安全性和疗效。 ▲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] Ocugen Announces Completion of Dosing in Subjects with Stargardt Disease in High Dose Cohort of Phase 1/2 GARDian Clinical Trial of OCU410ST—A Modifier Gene Therapy. Retrieved August 30, 2024, from https://ir.ocugen.com/news-releases/news-release-details/ocugen-announces-completion-dosing-subjects-stargardt-disease [2] Study results from phase 1 studies with exidavnemab published in The Journal of Clinical Pharmacology. Retrieved August 30, 2024, from https://www.prnewswire.com/news-releases/study-results-from-phase-1-studies-with-exidavnemab-published-in-the-journal-of-clinical-pharmacology-302231302.html [3] Find Therapeutics Announces FDA Clearance of IND Application for a Phase 1 Study of FTX-101 for the Treatment of Chronic Optic Neuropathy. Retrieved August 30, 2024, from https://www.prnewswire.com/news-releases/find-therapeutics-announces-fda-clearance-of-ind-application-for-a-phase-1-study-of-ftx-101-for-the-treatment-of-chronic-optic-neuropathy-302229869.html [4] Gain Therapeutics Announces Positive Topline Results from the Phase 1 Clinical Trial of GT-02287, a Novel GCase-Targeting Small Molecule Therapy for Parkinson’s Disease. Retrieved August 29, 2024, from https://www.gaintherapeutics.com/newsroom/press-releases/press-releases-2024/ainherapeuticsnnouncesositiveoplineesultsfromth20240829043502 [5] iOmx Therapeutics Initiates Phase Ib with OMX-0407. Retrieved August 30, 2024, from https://www.globenewswire.com/en/news-release/2024/08/22/2933999/0/en/iOmx-Therapeutics-Initiates-Phase-Ib-with-OMX-0407.html [6] AiViva Biopharma Completes Enrollment in a Phase 1 Clinical Trial of AIV007 for Age-Related Macular Degeneration and Diabetic Macular Edema. Retrieved August 30, 2024, from https://aiviva.com/2024/08/aiviva-biopharma-completes-enrollment-in-a-phase-1-clinical-trial-of-aiv007-for-age-related-macular-degeneration-and-diabetic-macular-edema/ [7] First Patient Dosed with LIXTE’s LB-100 in New Clinical Trial to Treat Colorectal Cancer, Collaborating with NKI, Supported by Major Pharma Company. Retrieved August 30, 2024, from https://ir.lixte.com/news-events/press-releases/detail/115/first-patient-dosed-with-lixtes-lb-100-in-new-clinical-trial-to-treat-colorectal-cancer-collaborating-with-nki-supported-by-major-pharma-company [8] ENA Respiratory Progresses Phase Ib Study of its Dry Powder Formulation of Intranasal Innate Immunomodulator INNA-051. Retrieved August 30, 2024, from https://www.globenewswire.com/news-release/2024/08/27/2935974/0/en/ENA-Respiratory-Progresses-Phase-Ib-Study-of-its-Dry-Powder-Formulation-of-Intranasal-Innate-Immunomodulator-INNA-051.html [9] Yunovia Announces IND Approval by the MFDS to Initiate Phase 1 MAD Study for the Small Molecule GLP-1 Agonist. Retrieved August 30, 2024, from https://www.prnewswire.com/news-releases/yunovia-announces-ind-approval-by-the-mfds-to-initiate-phase-1-mad-study-for-the-small-molecule-glp-1-agonist-302232393.html [10] Microbiotica’s Microbiome Medicines in Melanoma and Ulcerative Colitis Gain Regulatory Approvals in EU and UK for Phase 1b Studies. Retrieved August 30, 2024, from https://www.globenewswire.com/news-release/2024/08/27/2935969/0/en/Microbiotica-s-Microbiome-Medicines-in-Melanoma-and-Ulcerative-Colitis-Gain-Regulatory-Approvals-in-EU-and-UK-for-Phase-1b-Studies.html 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

临床1期临床结果临床2期

2024-08-22

·GlobeNewswire-Health Care

iOmx Therapeutics Initiates Phase Ib with OMX-0407

Data from the successful Phase Ia dose escalation study showed that OMX-0407 monotherapy demonstrated a favorable safety profile and signs of anti-tumor activity, with one durable complete response in a high-medical-need indicationPhase Ib expansion phase in two priority indications opened MARTINSRIED, Germany and MUNICH, Aug. 22, 2024 (GLOBE NEWSWIRE) -- iOmx Therapeutics AG (iOmx), a clinical-stage biopharmaceutical company translating unexplored immune evasion biology into a growing pipeline of biomarker-enabled drug programs, today announced successful completion of the dose escalation segment of the Phase Ia/Ib clinical trial (NCT05826600) investigating OMX-0407, a first-in-class, spectrum-selective SIK (salt-inducible kinase) inhibitor, in patients with advanced solid tumors and opening of the expansion phase in kidney cancer and angiosarcoma. Murray Yule, M.D., Chief Medical Officer of iOmx, said: “The completion of the dose escalation segment of our Phase Ia/Ib clinical trial is a significant step forward in the development of our lead candidate OMX-0407. I look forward to observing the positive effects OMX-0407 will have on larger patient populations in kidney cancer and angiosarcoma.” Topline data from the 20-patient dose escalation segment showed that OMX-0407 monotherapy was safe and well-tolerated. Evidence of anti-cancer activity was observed in this heavily pretreated population of patients, suffering from a variety of solid tumors. Notably, one patient who was resistant to multiple previous chemotherapies achieved a durable complete response (CR) with disappearance of all tumor lesions. Furthermore, biomarker analyses showed evidence of substantial pharmacological activity in circulating blood cells. Hannes Loferer, Ph.D., Chief Operations Officer of iOmx, said: “We are now focusing on generating efficacy data in the dose expansion segment of the study. The first two indications, kidney cancer and angiosarcoma, amongst other prioritized key solid tumor indications, have a high potential for objective response to OMX-0407 based on the results of the dose escalation and the preclinical data package.” The expansion cohorts will be run in major oncology centers with expertise in kidney cancer and angiosarcoma. The study aims to further evaluate the single agent activity and the safety profile of OMX-0407 at the recommended dose as determined in the completed dose escalation segment. Backed by a robust translational data package the study will enroll patients with previously treated renal cell carcinoma and angiosarcoma. The primary endpoint is objective response rate, with secondary objectives including duration of response and patient survival. Apollon Papadimitriou, Ph.D., Chief Executive Officer of iOmx, concluded: “Kicking-off the Phase Ib segment of the OMX-0407 trial is a key development milestone for iOmx. The dose escalation data, including one long-lasting complete response in an indication of high medical need and additional signs of anti-tumor activity in other patients is very strong. We are confident that we are progressing towards providing a clinically meaningful, differentiated therapy for patients failing current cancer treatments and expect to report topline clinical proof-of-concept data by early 2026.” About the Phase Ia/Ib Clinical TrialThe Phase Ia/Ib clinical trial is investigating the effects of OMX-0407 monotherapy in patients with previously treated unresectable solid tumors. The dose escalation scheme utilized 3+3 design to characterize the safety profile of OMX-0407 and determine the maximum tolerated dose (MTD). The dose expansion phase will evaluate OMX-0407 in two tumor-specific cohorts, enrolling up to 86 patients with previously treated renal cell carcinoma or angiosarcoma. About OMX-0407OMX-0407 is an orally available and first-in-class spectrum-selective kinase inhibitor targeting key oncology-relevant tyrosine kinases and salt-inducible kinases (SIKs). OMX-0407 directly interferes with tumor cell proliferation through modulation of tyrosine kinase signaling. Complementary to this direct mode of action, OMX-0407 potentiates tumor cell apoptosis in response to death receptor ligands like tumor necrosis factor, reshaping the tumor micro-environment. About iOmx TherapeuticsiOmx Therapeutics (www.iomx.com) is a clinical-stage company that harnesses deep tumor and myeloid biology insights, along with its proprietary iOTarg™ target screening platform, to generate novel treatments for the most prevalent solid tumor indications. The company is translating unexplored immune evasion biology into a growing pipeline of biomarker-enabled drug programs. Focused on developing drugs with single agent activity, iOmx is creating potential new backbone therapies in a modality-open fashion. By applying its comprehensive drug discovery & development expertise iOmx is committed to shaping the future of cancer therapy. The company’s lead program, OMX-0407, is a proprietary first-in-class spectrum-selective kinase inhibitor targeting key oncology-relevant tyrosine kinases and salt-inducible kinases (SIKs) and is currently being investigated in a Phase Ia/Ib clinical trial in multiple solid tumors. The second program, IOMX-0675, a highly differentiated, LILRB1&2 cross-specific antibody is on track for CTA submission in Q4 2024. iOmx is backed by international venture capital investors, such as Athos, Sofinnova Partners, Wellington Partners, MIG Capital and M Ventures. The Company is based in Martinsried/Munich, Germany. Media contactMC Services AGKatja Arnold, Julia von Hummel, Catherine FeatherstonT: +49(0)89 2102280iomx@mc-services.eu

临床1期免疫疗法临床结果

2023-09-05

·BioSpace

iOmx Therapeutics appoints Dr. Nils Peter Debus as Chief Business Officer

Martinsried / Munich, Germany, September 5, 2023 - iOmx Therapeutics AG (iOmx), a clinical stage biopharmaceutical company developing cancer therapeutics based on next generation immune checkpoint targets, today announced the appointment of Dr. Nils Peter Debus as Chief Business Officer (CBO) to drive the company’s new stage of growth. Dr. Debus is an accomplished life science leader with 27 years of industry experience and an outstanding track record in Business Development & Licensing. Dr. Apollon Papadimitriou, CEO of iOmx, said: “Nils brings us significant strategic business expertise with a proven success in building partnerships and executing transformative collaborations and acquisitions. His broad industry experience, will be invaluable as we further grow our global business development activities.” Dr. Nils Debus, CBO of iOmx, added: “iOmx has made impressive progress in a brief time, leveraging its iOTarg platform to address novel immune checkpoints on myeloid cells and advancing its first novel immune checkpoint inhibitor into the clinic. By identifying novel tumor evasion biology, we will further unlock the immune system's potential to combat cancer and tackle tumors, which currently show resistance to existing immunotherapies. I look forward to working with Apollon and the entire iOmx team to build strong partnerships with pharma to maximize our strategic options. We invite the biopharma community to explore our exciting platform and advanced programs for collaboration opportunities.” Before joining iOmx Dr. Debus held the CBO position at OSE Immunotherapeutics (Paris, France), a company focusing on innovative treatments for immuno-oncology and autoimmune disorders. At Boehringer Ingelheim (Ingelheim, Germany), he spent nine years in senior BD&L roles with a focus on biosimilars, strategic transactions and alliance management, handling R&D pipeline and commercialization deals, as well as patent negotiations. At Merz Pharmaceuticals (Frankfurt, Germany) he served as VP of BD. He started his BD&L career at Schering AG (now Bayer) in Berlin, Germany. Dr. Debus is a microbiologist by training and holds a PhD in embryonic stem cell research from Humboldt University (Berlin, Germany). In addition, he received training in corporate finance from Duke University (Durham, USA). About iOmx Therapeutics iOmx Therapeutics ( ) is a biopharmaceutical company focused on developing first-in-class cancer immuno-therapeutics addressing novel immune checkpoints hijacked by cancer cells. Utilizing its iOTarg™ high-throughput screening platform, iOmx has identified a number of proprietary tumor-associated next-generation immune checkpoints and is advancing a clinical stage pipeline of promising drug candidates that have the potential to address cancers, which are resistant to current immunotherapies. The company’s lead candidate OMX-0407 targets SIK, an immune protective kinase family in multiple solid tumors, and is currently being investigated in Phase I clinical trials. Founded in 2016, based on the work of its scientific founders Philipp Beckhove MD, and Nisit Khandelwal Ph.D., conducted at the German Cancer Research Center, iOmx is today backed by international venture capital investors, such as Wellington Partners, Sofinnova Partners, M Ventures, MIG Capital and Athos Biopharma. iOmx is based in Martinsried/Munich, Germany. Media contact MC Services AG Katja Arnold, Julia von Hummel, Shaun Brown T: +49(0)89 2102280 iomx@mc-services.eu

临床1期高管变更免疫疗法

100 项与 OMX-0407 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
不可切除的实体瘤	临床2期	比利时	iOmx Therapeutics AG初创企业	2023-03-30
不可切除的实体瘤	临床2期	西班牙	iOmx Therapeutics AG初创企业	2023-03-30
血管肉瘤	临床1期	比利时	iOmx Therapeutics AG初创企业	2024-08-22
血管肉瘤	临床1期	西班牙	iOmx Therapeutics AG初创企业	2024-08-22
肾肿瘤	临床1期	比利时	iOmx Therapeutics AG初创企业	2024-08-22
肾肿瘤	临床1期	西班牙	iOmx Therapeutics AG初创企业	2024-08-22
肿瘤	临床前	-	iOmx Therapeutics AG初创企业	2022-04-07

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临床结果

适应症

分期

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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


NCT05826600 (NEWS) 人工标引	临床1期	实体瘤	-	OMX-0407	廠衊淵繭襯鏇淵壓餘鹽(範鏇繭廠襯糧簾鹹鹹艱) = OMX-0407单药治疗是安全且耐受性良好的。醖餘鏇衊艱餘積鏇蓋鑰 (齋簾齋構窪淵鬱艱膚簾 )	积极	2024-09-02