BOTHELL, Wash.--(BUSINESS WIRE)--Immunome, Inc. (the “Company”) (Nasdaq: IMNM), a biotechnology company focused on developing first-in-class and best-in-class targeted cancer therapies, announced today that on August 3, 2026, the Compensation Committee of the Company’s Board of Directors (the “Compensation Committee”) granted inducement awards consisting of non-statutory stock options to purchase an aggregate of 176,500 shares of common stock to nine new employees under the Company’s 2024 Inducement Plan. The Compensation Committee approved the stock options as an inducement material to such employees’ employment in accordance with Nasdaq Listing Rule 5635(c)(4). Each stock option has an exercise price per share equal to $23.01, the Company’s closing sales price on August 3, 2026, and will vest over four years, with 25% of the underlying shares vesting on the one-year anniversary of the applicable vesting commencement date and the balance of the underlying shares vesting monthly thereafter over 36 months, subject to the new employee’s continued service relationship with the Company through the applicable vesting dates. The stock options are subject to the terms and conditions of the Company’s 2024 Inducement Plan and the terms and conditions of an applicable stock option agreement covering the grant. About Immunome, Inc. Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, supported by a leadership team with deep experience in the design, development, and commercialization of cutting-edge therapies, including antibody-drug conjugates. Our pipeline includes varegacestat, an investigational gamma secretase inhibitor for which an NDA has been accepted by the U.S. FDA; IM-1021, a clinical-stage ROR1 ADC; IM-1617, a clinical-stage solid tumor ADC; and IM-3050, a clinical-stage FAP-targeted radiotherapy. We are also advancing a broad portfolio of early-stage ADCs pursuing undisclosed solid tumor targets. For more information, visit . ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); Contacts Investor Contact Max Rosett Chief Financial Officer investors@immunome.com

抗体药物偶联物免疫疗法

2026-07-26

·药明康德

坐骨神经痛创新疗法IND获FDA许可；Nectin-4靶向ADC疗法临床试验进展公布…… | 一周盘点

本期看点： 1. Consano Bio宣布，其主打在研疗法C-1101的IND申请已获得美国FDA的许可。C-1101用于治疗慢性疼痛性腰骶神经根病（LSR，俗称慢性坐骨神经痛）。此次许可使目前正在澳大利亚开展的1期临床试验得以扩展至美国临床中心。 2. Innate Pharma宣布，其Nectin-4靶向抗体偶联药物（ADC）IPH4502治疗晚期实体瘤的1期临床试验已完成剂量递增阶段患者入组。。截至目前，该疗法展现出良好的安全性特征，血液学毒性有限。 C-1101：IND申请获得FDA许可 Consano Bio宣布，C-1101的IND申请已获美国FDA许可，该疗法拟用于治疗慢性疼痛性腰骶神经根病，即通常所称的慢性坐骨神经痛。此次IND申请获FDA许可后，Consano Bio正在澳大利亚开展的1期临床试验将扩展至美国临床中心。这项多中心、随机、对照、双盲1期临床研究正在评估C-1101治疗慢性坐骨神经痛患者的安全性。研究计划在3个依次开展的剂量递增队列中招募具有症状的患者，每名受试者将接受一次硬膜外注射。 C-1101是一款新型血小板来源的多蛋白生物制品，该疗法旨在通过调节炎症，并在损伤部位促进和增强细胞修复，从而治疗慢性坐骨神经痛。C-1101含有浓度稳定的细胞因子、生长因子和基质蛋白，旨在帮助激活人体自身的自然修复反应。通过硬膜外注射给药，C-1101拟将高于生理水平浓度的相关蛋白直接递送至神经损伤部位，以发挥局部治疗作用。 IPH4502：完成1期临床研究剂量递增阶段的患者入组 Innate Pharma日前宣布，其自主研发的Nectin-4靶向ADC疗法IPH4502已完成1期临床研究剂量递增阶段的患者入组。该研究是一项开放标签、多中心1期临床试验，旨在评估IPH4502单药治疗Nectin-4阳性晚期实体瘤患者的安全性、耐受性及初步抗肿瘤活性，涉及的瘤种包括但不限于尿路上皮癌、非小细胞肺癌、头颈部鳞状细胞癌、乳腺癌、卵巢癌、胃癌、食管癌和结直肠癌。剂量递增阶段已在法国和美国共招募76例患者，初步数据预计于今年年底公布，并将为后续在选定瘤种中开展1期剂量优化提供依据。截至目前，IPH4502继续展现出良好的安全性特征，血液学毒性较为有限。这一结果支持Innate Pharma关于其专有连接子能够减缓游离exatecan的释放，从而降低毒性的假设。与此同时，IPH4502在既往接受过多线治疗的晚期实体瘤患者中持续显示出初步抗肿瘤活性，其中，在接受过ADC疗法Padcev（enfortumab vedotin）治疗的尿路上皮癌患者以及非小细胞肺癌和头颈部鳞状细胞癌患者中，均观察到客观缓解。 IPH4502是一款由3个具有差异化特征的组成部分构建而成的ADC疗法。IPH4502的载荷为强效拓扑异构酶Ⅰ抑制剂exatecan，有望克服以MMAE载荷为基础的ADC疗法所面临的部分局限，包括多药耐药蛋白1（MDR1）介导的耐药，并且无需进行CYP2D6基因分型；其专有稳定连接子旨在减缓游离exatecan释放至循环系统，从而降低相关毒性；其抗体部分则是一种高亲和力的人源化抗Nectin-4抗体，其结合表位与Padcev所识别的表位不同且不重叠。临床前研究显示，IPH4502在对Padcev耐药的肿瘤模型，以及Nectin-4低表达或异质性表达的肿瘤中均展现出抗肿瘤活性，支持其在尿路上皮癌以外多种实体瘤中的潜在应用。 IM-3050：1期试验首例患者给药 Immunome公司宣布，其在研FAP靶向放射性配体疗法IM-3050的首次人体1期临床试验已完成首例患者给药。该研究是一项开放标签、多中心、剂量递增及扩展试验，拟在肿瘤表达FAP的晚期实体瘤患者中评估IM-3050的安全性、耐受性、剂量学、药代动力学及初步抗肿瘤活性。剂量递增阶段将评估IM-3050多次给药的不同递增剂量，以确定最大耐受剂量和/或推荐扩展剂量；剂量扩展阶段则将进一步评估候选推荐剂量下的安全性和耐受性。 IM-3050是一款靶向FAP的在研镥-177放射性配体疗法。FAP广泛表达于肿瘤微环境中的癌症相关成纤维细胞。IM-3050旨在将放射性同位素镥-177直接递送至表达FAP的细胞，其释放的β粒子有望通过旁观者效应损伤或杀伤附近的肿瘤细胞。 ITI-5000：1期试验首例患者给药 Immunomic Therapeutics（ITI）宣布，其用于治疗三阴性乳腺癌（TNBC）的在研治疗性癌症疫苗ITI-5000已在1期临床试验中完成首例受试者给药。该受试者已完成给药后的初步监测，截至目前未观察到显著不良事件或安全性问题。此次开展的VITALITI研究是一项多中心、开放标签、首次人体1期临床试验，旨在评估ITI-5000单药治疗或联合标准辅助治疗用于II-III期三阴性乳腺癌患者的安全性、耐受性和初步免疫学活性。 ITI-5000采用ITI专有的UNITE平台与下一代自扩增RNA（saRNA）技术开发，可编码CT83和HERV-K包膜蛋白两种肿瘤相关抗原。通过将靶抗原与溶酶体相关膜蛋白（LAMP）融合，该疫苗旨在诱导针对肿瘤相关抗原的靶向T细胞免疫应答，从而为患者带来持久的治疗获益。ITI计划将ITI-5000开发为一种疾病修饰性疗法，目标是降低三阴性乳腺癌患者的疾病复发风险，并为这一患者群体提供新的治疗选择。 Lu AH69593：获FDA快速通道资格灵北（Lundbeck）日前宣布，美国FDA已授予其口服食欲素2受体激动剂Lu AH69593快速通道资格。Lu AH69593由灵北自主发现，是该公司针对睡眠—觉醒障碍开发的多款在研化合物之一，目前正处于1b期临床开发阶段，用于治疗发作性睡病。发作性睡病是一种慢性神经系统疾病，会损害大脑调节睡眠与觉醒的能力。患者可能出现日间过度嗜睡、突发睡眠、夜间睡眠片段化、睡眠瘫痪及幻觉等症状；1型发作性睡病患者还可能出现猝倒，即在情绪刺激下突然丧失肌张力。这些症状可能对患者的日常活动、学习、工作、社交生活及生活质量造成广泛影响。食欲素是一种促进觉醒的神经肽，在维持睡眠与觉醒状态稳定方面发挥关键作用。食欲素通过食欲素1受体和食欲素2受体传递信号，其中食欲素2受体（OX2R）被认为是促进觉醒信号传递及调节睡眠—觉醒周期的核心受体。Lu AH69593旨在激活OX2R，并通过食欲素通路增强促觉醒信号，具有成为“best-in-class”药物的潜力。通过靶向与觉醒生物学直接相关的通路，该候选药物有望帮助发作性睡病患者恢复觉醒状态并改善睡眠—觉醒调节。参考资料： [1] Lundbeck receives FDA Fast Track designation for Lu AH69593, an investigational orexin 2 receptor agonist for narcolepsy. Retrieved July 23, 2026 from https://www.prnewswire.com/news-releases/lundbeck-receives-fda-fast-track-designation-for-lu-ah69593-an-investigational-orexin-2-receptor-agonist-for-narcolepsy-302833103.html [2] AbelZeta Receives EMA PRIME Designation for C-CAR168 in Lupus Nephritis and Systemic Lupus Erythematosus. Retrieved July 23, 2026 from https://www.prnewswire.com/news-releases/abelzeta-receives-ema-prime-designation-for-c-car168-in-lupus-nephritis-and-systemic-lupus-erythematosus-302829668.html [3] Consano Bio Receives FDA Investigational New Drug Clearance to Expand the C-1101 Chronic Sciatica Clinical Development Program into the United States. Retrieved July 23, 2026 from https://www.prnewswire.com/news-releases/consano-bio-receives-fda-investigational-new-drug-clearance-to-expand-the-c-1101-chronic-sciatica-clinical-development-program-into-the-united-states-302828924.html [4] FDA Grants Orphan Drug Designation to Affinia Therapeutics’ AFTX-201 for the Treatment of BAG3-Associated Dilated Cardiomyopathy (DCM). Retrieved July 23, 2026 from https://www.businesswire.com/news/home/20260722771473/en/FDA-Grants-Orphan-Drug-Designation-to-Affinia-Therapeutics-AFTX-201-for-the-Treatment-of-BAG3-Associated-Dilated-Cardiomyopathy-DCM [5] Healx Announces First Patient Dosed in Phase 1/2 Trial to Evaluate the Effect of HLX-4310 on Metastatic Recurrence and Progression in Sarcomas with a Focus on Osteosarcoma. Retrieved July 23, 2026 from https://www.globenewswire.com/news-release/2026/07/22/3331213/0/en/healx-announces-first-patient-dosed-in-phase-1-2-trial-to-evaluate-the-effect-of-hlx-4310-on-metastatic-recurrence-and-progression-in-sarcomas-with-a-focus-on-osteosarcoma.html [6] Innate Pharma announces Completion of Enrollment in Phase 1 Dose Escalation Study of IPH4502, a Novel Nectin-4 Exatecan Antibody-Drug Conjugate (ADC). Retrieved July 23, 2026 from https://www.innate-pharma.com/media/all-press-releases/innate-pharma-announces-completion-enrollment-phase-1-dose-escalation-study-iph4502-novel-nectin-4-exatecan-antibody-drug-conjugate-adc [7] Immunome Announces First Patient Dosed in Phase 1 Trial Evaluating IM-3050, an FAP-Targeted Radioligand Therapy, in Patients with FAP-Expressing Advanced Solid Tumors. Retrieved July 23, 2026 from https://investors.immunome.com/immunome-announces-first-patient-dosed-in-phase-1-trial-evaluating-im-3050-an-fap-targeted-radioligand-therapy-in-patients-with-fap-expressing-advanced-solid-tumors/ [8] Immunomic Therapeutics Announces First Patient Dosed in Phase 1 Trial of Cancer Vaccine Candidate ITI-5000. Retrieved July 23, 2026 from https://immunomix.com/immunomic-therapeutics-announces-first-patient-dosed-in-phase-1-trial-of-cancer-vaccine-candidate-iti-5000/ [9] Prime Medicine Announces U.S. FDA Clearance of Investigational New Drug Application for PM577a in H1069Q-mutated Wilson Disease. Retrieved July 24, 2026 from https://investors.primemedicine.com/news-releases/news-release-details/prime-medicine-announces-us-fda-clearance-investigational-new [10] Enveda’s Positive Phase 1B Results for ENV-294, a Potential First-in-Class Oral Therapy for Moderate-to-Severe Atopic Dermatitis, Were Presented at AAD Innovation Academy; Additional Details to Be Shared at EADV. Retrieved July 24, 2026 from https://www.businesswire.com/news/home/20260723966929/en/Envedas-Positive-Phase-1B-Results-for-ENV-294-a-Potential-First-in-Class-Oral-Therapy-for-Moderate-to-Severe-Atopic-Dermatitis-Were-Presented-at-AAD-Innovation-Academy-Additional-Details-to-Be-Shared-at-EADV 免责声明：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：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

2026-07-24

·BioSpace

Immunome Announces First Patient Dosed in Phase 1 Trial Evaluating IM-3050, an FAP-Targeted Radioligand Therapy, in Patients with FAP-Expressing Advanced Solid Tumors

IM-3050 is a fibroblast activation protein (FAP)-targeted radioligand therapy designed to deliver radioactive lutetium-177 directly to FAP-expressing cells. The Phase 1 trial is designed to evaluate the safety, tolerability, dosimetry, pharmacokinetics, and preliminary anti-tumor activity of IM-3050 in participants with FAP-expressing advanced solid tumors. Immunome, Inc. (Nasdaq: IMNM), a biotechnology company committed to developing first-in-class and best-in-class targeted cancer therapies, today announced that the first patient has been dosed in the Phase 1, first-in-human trial of IM-3050, an investigational FAP-targeted radioligand therapy being evaluated in patients with FAP-expressing advanced solid tumors. “FAP is a high-potential target with expression in 75% of solid tumors,” said Bob Lechleider, M.D., Chief Medical Officer of Immunome. “We believe an optimized radioligand therapy is well-suited to FAP’s intriguing biology. IM-3050 is designed to deliver radioactive lutetium-177 directly to FAP-expressing cells, and we look forward to evaluating its potential in patients with advanced solid tumors.” The Phase 1 trial is an open-label, multicenter dose escalation and expansion study designed to determine the safety, tolerability, dosimetry, pharmacokinetics, and preliminary anti-tumor activity of IM-3050 in participants with FAP-expressing advanced solid tumors. The dose escalation portion of the study will evaluate escalating repeated doses of IM-3050 to determine the maximum tolerated dose and/or recommended expansion dose; the expansion portion is designed to further evaluate safety and tolerability at the candidate recommended dose. IM-3050 is an investigational lutetium-177 radioligand therapy targeting fibroblast activation protein (FAP), which is broadly expressed on cancer-associated fibroblasts in the tumor microenvironment. IM-3050 is designed to deliver radioactive lutetium-177 directly to FAP-expressing cells, where emitted beta particles may damage or kill nearby tumor cells through a bystander effect. Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, supported by a leadership team with deep experience in the design, development, and commercialization of cutting-edge therapies, including antibody-drug conjugates. Our pipeline includes varegacestat, an investigational gamma secretase inhibitor for which an NDA has been submitted to the U.S. FDA; IM-1021, a clinical-stage ROR1 ADC; IM-1617, a clinical-stage solid tumor ADC; and IM-3050, a clinical-stage FAP-targeted radioligand therapy. We are also advancing a broad portfolio of early-stage ADCs pursuing undisclosed solid tumor targets. The content above comes from the network. if any infringement, please contact us to modify.