A Phase 2 Study of NC410 and FOLFIRINOX in Combination With Nivolumab With or Without Ipilimumab in Patients With Treatment-naïve, Metastatic Pancreatic Cancer

The purpose of this study is to evaluate safety of the treatment regimen and identify any novel toxicities.

开始日期2025-09-04

申办/合作机构

The Sidney Kimmel Comprehensive Cancer Center

[+2]

NCT05572684

/ Active, not recruiting临床1/2期

A Phase 1b/2, Open-Label, Safety, Tolerability and Efficacy Study of NC410 Plus Pembrolizumab for Participants with Advanced Unresectable And/or Metastatic Immune Checkpoint Inhibitor (ICI) Refractory Solid Tumors or ICI Naïve MSS/MSI-Low Solid Tumors

This is an open-label, non-randomized, Phase 1b/2 study to determine the safety and tolerability of NC410 when combined with a standard dose of pembrolizumab. This study will also assess the clinical benefit of combination therapy in participants with advanced unresectable and/or metastatic ICI refractory solid tumors OR ICI naïve MSS/MSI-low solid tumors

开始日期2022-10-06

申办/合作机构

NextCure, Inc.

[+1]

NCT04408599

/ Terminated临床1/2期

A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of NC410 in Subjects With Advanced or Metastatic Solid Tumors

This research study is studying a new drug, NC410, as a possible treatment for advanced or metastatic solid tumors.

开始日期2020-06-10

申办/合作机构

NextCure, Inc.

100 项与 NC-410 相关的临床结果

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100 项与 NC-410 相关的转化医学

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100 项与 NC-410 相关的专利（医药）

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项与 NC-410 相关的文献（医药）

2024-01-01·Cancer immunology, immunotherapy : CII

Leukocyte-associated immunoglobulin-like receptor-1 blockade in combination with programmed death-ligand 1 targeting therapy mediates increased tumour control in mice

Article

作者: Vijver, Saskia V ; Meyaard, Linde ; Boon, Louis ; Langermann, Solomon ; Leusen, Jeanette H W ; Gonder, Susanne ; Flies, Dallas ; Lebbink, Robert Jan ; Singh, Akashdip ; Pascoal Ramos, M Ines ; Jansen, J H Marco ; Farndale, Richard W ; Bihan, Dominique ; Mommers-Elshof, Eline T A M

Abstract:

Collagen expression and structure in the tumour microenvironment are associated with tumour development and therapy response. Leukocyte-associated immunoglobulin-like receptor-1 (LAIR-1) is a widely expressed inhibitory collagen receptor. LAIR-2 is a soluble homologue of LAIR-1 that competes for collagen binding. Multiple studies in mice implicate blockade of LAIR-1:collagen interaction in cancer as a promising therapeutic strategy. Here, we investigated the role of LAIR-1 in anti-tumour responses. We show that although LAIR-1 inhibits activation, proliferation, and cytokine production of mouse T cells in vitro, tumour outgrowth in LAIR-1-deficient mice did not differ from wild type mice in several in vivo tumour models. Furthermore, treatment with NC410, a LAIR-2-Fc fusion protein, did not result in increased tumour clearance in tested immunocompetent mice, which contrasts with previous data in humanized mouse models. This discrepancy may be explained by our finding that NC410 blocks human LAIR-1:collagen interaction more effectively than mouse LAIR-1:collagen interaction. Despite the lack of therapeutic impact of NC410 monotherapy, mice treated with a combination of NC410 and anti-programmed death-ligand 1 did show reduced tumour burden and increased survival. Using LAIR-1-deficient mice, we showed that this effect seemed to be dependent on the presence of LAIR-1. Taken together, our data demonstrate that the absence of LAIR-1 signalling alone is not sufficient to control tumour growth in multiple immunocompetent mouse models. However, combined targeting of LAIR-1 and PD-L1 results in increased tumour control. Thus, additional targeting of the LAIR-1:collagen pathway with NC410 is a promising approach to treating tumours where conventional immunotherapy is ineffective.

eLife1区 · 生物学

Cancer immunotherapy by NC410, a LAIR-2 Fc protein blocking human LAIR-collagen interaction

1区 · 生物学

ArticleOA

作者: M Ines Pascoal Ramos ; Zachary Cusumano ; Jason Bosiacki ; Christina Jensen ; Sol Langermann ; Linde Meyaard ; Ana Paucarmayta ; Dallas Flies ; Linjie Tian ; Akashdip Singh ; Morten A Karsdal ; Linda Liu ; Jahangheer Shaik ; Stefan Willems ; Chang Song ; Emma J de Ruiter ; Nicholas Willumsen ; Saskia V Vijver ; Eline Elshof

Collagens are a primary component of the extracellular matrix and are functional ligands for the inhibitory immune receptor leukocyte-associated immunoglobulin-like receptor (LAIR)-1. LAIR-2 is a secreted protein that can act as a decoy receptor by binding collagen with higher affinity than LAIR-1. We propose that collagens promote immune evasion by interacting with LAIR-1 expressed on immune cells, and that LAIR-2 releases LAIR-1-mediated immune suppression. Analysis of public human datasets shows that collagens, LAIR-1 and LAIR-2 have unique and overlapping associations with survival in certain tumors. We designed a dimeric LAIR-2 with a functional IgG1 Fc tail, NC410, and showed that NC410 increases human T cell expansion and effector function in vivo in a mouse xenogeneic-graft versus-host disease model. In humanized mouse tumor models, NC410 reduces tumor growth that is dependent on T cells. Immunohistochemical analysis of human tumors shows that NC410 binds to collagen-rich areas where LAIR-1+ immune cells are localized. Our findings show that NC410 might be a novel strategy for cancer immunotherapy for immune-excluded tumors.

项与 NC-410 相关的新闻（医药）

2025-09-16

·PRNewswire

The Lustgarten Foundation Announces Landmark Year of Fueling Cutting-Edge Pancreatic Cancer Research

UNIONDALE, N.Y., Sept. 15, 2025 /PRNewswire/ -- The Lustgarten Foundation, the nation's largest private funder of pancreatic cancer research, today announced a landmark year of funding, awarding ten new grants to researchers at eight leading institutions. These new grants, totaling $13.85 million, support Lustgarten's unique patient-centered mission which drives outcomes across three research pillars—early detection and interception, new drug development, and personalized medicine. With the addition of these new grants, the Lustgarten Foundation supports 51 active grants across 29 institutions. The Foundation concentrates on translating its understanding of the underlying biology of pancreatic cancer into clinical applications to change, extend, and ultimately save patients' lives. "Despite devastating federal cuts to cancer research, the Lustgarten Foundation remains the driving force behind pancreatic cancer science," said Linda Tantawi, CEO of the Lustgarten Foundation. "We are advancing critical research with urgency and purpose—because patients don't have the luxury of time. Through significant financial investment and thought leadership, we are empowering researchers and propelling science forward, toward a future where people with pancreatic cancer have more treatment options, better outcomes, and more precious time with their loved ones. There has never been a more hopeful time in pancreatic cancer research—and we are determined to turn that hope into real breakthroughs." Of the $13.85 million in new awards: 14% supports early detection and interception efforts, aiming to develop and deliver tools enabling early diagnosis of pancreatic cancer; develop and optimize biomarkers enabling early detection in the general population; develop approaches for risk assessment and management of high-risk groups. 66% supports new drug development projects, aiming to accelerate the development of therapies; identify novel drug targets based on an understanding of the biology of pancreatic cancer initiation and progression; accelerate preclinical and clinical testing of novel drugs and combinations in pancreatic cancer. 20% supports personalized medicine studies, aiming to implement a personalized medicine program; better characterize and understand the heterogeneity of pancreatic cancer; develop tools to guide treatment decisions matching the right treatment to the right patient at the right time. These ten new grant commitments bring the Lustgarten Foundation's total support in fiscal year 2025 to nearly $20 million to fuel cutting-edge pancreatic cancer research. Advancing the Lustgarten Foundation's commitment to funding early detection projects, Marcia Canto, MD, Director of Clinical Research, Division of Gastroenterology at Johns Hopkins University School of Medicine was awarded a grant for her study "Artificial Intelligence-Augmented Early Detection and Prevention of Pancreatic Cancer." Funding the development and delivery of tools to enable early diagnosis of pancreatic cancer, including screening in the general population and approaches for risk assessment, management, and interception in high-risk groups will ultimately give patients and their families more help—and more hope—than ever before. Lustgarten Foundation-AACR Career Development Awards Honoring Ruth Bader Ginsburg and John Robert Lewis awarded to Anupriya Singhal, MD, PhD, Memorial Sloan Kettering Cancer Center, for her study "Interrogating vulnerabilities of a KRAS inhibitor-resistant cell state in pancreatic cancer," and Vincent Bernard Pagan, MD, PhD, The University of Texas MD Anderson Cancer Center, for his study "Targeting oncogenic metabolic adaptations to overcome therapy resistance in pancreatic cancer." The awards support trailblazing investigators committed to increasing the understanding and treatment of pancreatic cancer. These awards support career advancement and the development of promising talent in pancreatic cancer research, in honor of the lives and legacies of two iconic Americans lost to pancreatic cancer. Dr. Robert F. Vizza Lustgarten Clinical Accelerator Initiative (CAI) grants awarded to Gregory Beatty, MD, PhD, Associate Professor of Medicine (Hematology-Oncology) at the University of Pennsylvania Perelman School of Medicine for his study "Combinatorial myeloid activation as immunotherapy for metastatic pancreatic cancer," Dung Le, MD, Professor of Oncology at Johns Hopkins University School of Medicine for her study "NC410 and FOLFIRINOX in Combination with Anti-PD-1 with and without Anti-CTLA-4 for Treatment Naive Metastatic Pancreatic Cancer," Kevin C. Soares, MD, Assistant Attending Surgeon of Hepatopancreatobiliary Surgery at Memorial Sloan Kettering Cancer Center (MSK) for his study "A Pilot Study of Neoadjuvant mFOLFIRINOX and ELI-002 7P with or without Anti-PD-1 Checkpoint Blockade in Borderline and Resectable Pancreatic Ductal Adenocarcinoma," and Briane Boone, MD, assistant professor in the Department of Surgical Oncology and an adjunct assistant professor in the Department of Microbiology, Immunology, and Cell Biology at West Virginia University for his study "Targeting myeloperoxidase to enhance chemotherapy response in pancreatic adenocarcinoma." The CAI speeds the translation of basic research into the clinic by supporting novel, science-driven clinical trials. With three new trials added this year, there are now 12 trials supported through this innovative program. All the data from CAI trials will also be integrated into Lustgarten's United Clinical Information Database (LUCID), improving the data's collective potential while making it accessible to the broader research community. Innovation and Collaboration Program grants awarded to Ronald Parchem, PhD, Baylor College of Medicine For his study, "Mechanisms Driving Tumor Innervation in Pancreatic Cancer," and Massimiliano Mazzone, PhD , Group Leader at the VIB-KU Leuven Center for Cancer Biology and Professor in the Department of Oncology at KU Leuven for his study "Unraveling the role of P2Y6+ macrophages in PDAC liver Metastasis." Lustgarten Equity, Accessibility, and Diversity (LEAD) Grant Program supports efforts to increase the participation of underrepresented groups in pancreatic cancer clinical trials. When clinical trials lack diversity, it can lead to inaccurate results, less effective—or even harmful—treatments for some populations, and a loss of trust in the medical system. It also hinders innovation and can cost billions in failed trials or limited market access. The supported projects are designed to identify and address barriers to participation and develop and implement specific tools to expand community outreach, patient education, and/or clinical recruitment staff. The 2025 LEAD grant ($426,975) was awarded to Nina Steele, PhD, University of Cincinnati, and Howard Crawford, PhD, Henry Ford Pancreatic Cancer Center, for their project "Racial Disparities in Pancreatic Cancer." This project will enable Drs. Steele and Crawford to develop tools that will allow researchers to better understand the complexity and heterogeneity of pancreatic cancer. Black African Americans are 20% more likely to develop pancreatic cancer and have worse survival outcomes compared to White patients, yet available research tools and databases typically do not include, or massively under-represent, Black African American patients. To advance the Lustgarten Foundation's personalized medicine efforts, a grant was awarded to Howard Crawford, PhD, Scientific Director of the Henry Ford Pancreatic Cancer Center for his study "Mapping stromal evolution and immune suppression in the first racially diverse human pancreatic cancer spatial genome atlas." Personalized (or precision) medicine is an important and evolving research area for pancreatic cancer, focusing on creating custom treatment strategies based on a patient's unique genetic and tumor markers and mutations. Through partnerships, the Lustgarten Foundation brings focus and strategy to pancreatic cancer research and maximizes our collective financial investment so we can fund the most high-risk, high-reward science. This year, leading cancer research experts convened for a workshop focused on Solving the Early Detection and Diagnosis of Recalcitrant Cancers. The event, jointly hosted by the Lustgarten Foundation, the Mark Foundation for Cancer Research, and the American Association for Cancer Research (AACR), showcased how partnership drives progress in addressing critical gaps in cancer research, particularly in early detection—a frontier that holds promising life-saving potential. As a direct outcome of the workshop, a new request for applications (RFA) was released, with funding for selected grants expected in fiscal year 2026. "By breaking down silos and driving collaboration and information sharing, we are creating a culture of innovation and dedication to scientific rigor that is critical to solving the complexities of pancreatic cancer," said Andrew Rakeman, Vice President of Research at the Lustgarten Foundation. "At the Lustgarten Foundation, and collaborative and science-driven strategy is fueling discoveries and advancing breakthroughs faster than ever before." To date, the Lustgarten Foundation has funded more than $301 million in research grants and has been a driving force in every major advancement in pancreatic cancer research since its inception in 1998. About Lustgarten Foundation The Lustgarten Foundation is the largest private funder of pancreatic cancer research in the world, funding preeminent pancreatic cancer researchers, driving the pursuit of bold and innovative science toward earlier detection and better treatments, and transforming pancreatic cancer into a curable disease. The Foundation funds research where creative risks yield high rewards to accelerate and expand life-saving treatment options. We believe time is everything to patients and their families, and that community is power. Lustgarten programs and events provide people affected by pancreatic cancer a voice and a place to create hope, together. For more information about the Lustgarten Foundation, visit lustgarten.org and follow us on Facebook, Instagram, Bluesky, LinkedIn, and YouTube . SOURCE Lustgarten Foundation WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

免疫疗法

2025-08-07

·ir.nextcure.com

NextCure Provides Business Update and Reports Second Quarter 2025 Financial Results

Announced strategic partnership with Simcere Zaiming for Phase 1 program SIM0505 (CDH6 ADC) with plans to dose the first SIM0505 patient in the United States this quarter Currently in cohort 4 of the Phase 1 trial of LNCB74 (B7-H4 ADC) in multiple cancers Plan to provide SIM0505 and LNCB74 program updates by the fourth quarter of 2025, along with proof of concept data readouts in the first half of 2026 BELTSVILLE, Md., Aug. 07, 2025 (GLOBE NEWSWIRE) -- NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class, and best-in-class therapies to treat cancer, today provided a business update and reported second quarter 2025 financial results. “Our recent strategic acquisition of the global rights, excluding greater China, for SIM0505 targeting CDH6 (cadherin-6 or K-cadherin) positions us uniquely within the antibody-drug conjugate (“ADC”) field. We now are developing ADCs against two clinically validated targets leveraging two distinct payloads, a Topoisomerase 1 Inhibitor (SIM0505) and a Tubulin Inhibitor (LNCB74),” said Michael Richman, NextCure’s president and CEO. “We are on track to dose our first SIM0505 patient in the United States this quarter and plan to provide program updates on both SIM0505 and LNCB74 by the fourth quarter of 2025, along with proof of concept data readouts in the first half of 2026.” Business Highlights and Near-Term Milestones LNCB74 (B7-H4 ADC) First patient dosed in January 2025 in the Phase 1 trial, cleared cohort 3 in June 2025. Currently treating patients in cohort 4. Plan to initiate backfill cohorts in the second half of 2025. Plan to provide a program update by the fourth quarter of 2025 and proof of concept data readout in the first half of 2026. SIM0505 (CDH6 ADC) Acquired global rights, excluding greater China, where Simcere Zaiming will retain rights. Phase 1 clinical trial ongoing in China with initial data as of April 16, 2025 reporting clinical activity in cohort 1 with a partial response based on a six-week assessment. Investigational New Drug application transferred to NextCure in June 2025, with anticipated first patient dosed in the US within the third quarter of 2025. Plan to provide a program update by the fourth quarter of 2025 and a proof of concept data readout, including data from Simcere Zaiming’s ongoing Phase 1 trial, in the first half of 2026. Assets For Which We Are Seeking Partners Clinical programs NC410 (LAIR-2 fusion) and NC525 (LAIR-1 antibody). Preclinical data for NC181 (ApoE4), a humanized antibody for the treatment of Alzheimer’s disease, have demonstrated amyloid clearance, prevention of amyloid deposition, plaque clearance and reduced neuroinflammation. Preclinical data for NC605 (Siglec-15), a humanized antibody for the treatment of osteogenesis Imperfecta (OI), have demonstrated that NC605 treatment reduced bone loss and enhanced bone quality in mice with OI. Other Simcere Zaiming US affiliate $2.0 million equity investment in NextCure in June 2025. Regained compliance with the minimum bid price requirement under Nasdaq Listing Rule 5550(a)(2) for continued listing. Financial Results for Quarter Ended June 30, 2025 Cash, cash equivalents, and marketable securities as of June 30, 2025 were $35.3 million as compared to $68.6 million as of December 31, 2024. The decrease of $33.3 million was primarily due to cash used to fund operations. We expect current financial resources to be sufficient to fund operating expenses and capital expenditures into mid-2026. Research and development expenses were $24.1 million for the three months ended June 30, 2025, as compared to $12.4 million for the three months ended June 30, 2024. The increase of $11.7 million was due to $17.0 million of up-front license fees incurred in connection with the licensing agreement announced June 16, 2025. This fee was partially offset by lower costs related to other programs, lower preclinical development costs and lower personnel-related costs. General and administrative expenses were $3.2 million for the three months ended June 30, 2025, as compared to $4.1 million for the three months ended June 30, 2024. The decrease of $0.9 million was primarily related to lower personnel costs and lower insurance costs. Net loss was $26.8 million for the three months ended June 30, 2025, as compared to a net loss of $15.4 million for the three months ended June 30, 2024 as the $17.0 million up-front license fee was partially offset by lower other research and development costs and lower general and administrative costs as described above. About NextCure, Inc. NextCure is a clinical-stage biopharmaceutical company that is focused on advancing innovative medicines that treat cancer patients that do not respond to, or have disease progression on, current therapies, through the use of targeted therapies including antibody-drug conjugates. We focus on advancing therapies that leverage our core strengths in understanding biological pathways and biomarkers, the interactions of cells, including in the tumor microenvironment, and the role each interaction plays in a biologic response. Please visit www.nextcure.com for more information. Forward-Looking Statements Some of the statements contained in this press release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including with respect to funding for our operations, objectives and expectations for our business, operations and financial performance and condition, including the progress and results of clinical trials, development plans and upcoming milestones regarding our therapies. Any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “continue,” “could,” “should,” “due,” “estimate,” “expect,” “intend,” “hope,” “may,” “objective,” “plan,” “predict,” “potential,” “positioned,” “seek,” “target,” “towards,” “forward,” “later,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or similar language. Forward-looking statements involve substantial risks and uncertainties that could cause actual results to differ materially from those projected in any forward-looking statement. Such risks and uncertainties include, among others: positive results in preclinical studies may not be predictive of the results of clinical trials; NextCure’s limited operating history and not having any products approved for commercial sale; NextCure’s history of significant losses; NextCure’s need and ability to obtain additional financing on acceptable terms or at all; risks related to clinical development, marketing approval and commercialization; NextCure’s ability to maintain listing of its common stock on the Nasdaq Global Select Market; and NextCure’s dependence on key personnel. More detailed information on these and additional factors that could affect NextCure’s actual results are described under the heading “Risk Factors” in NextCure’s most recent Annual Report on Form 10-K and in NextCure’s other filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. Forward-looking statements speak only as of the date of this press release, and NextCure assumes no obligation to update any forward-looking statements, even if expectations change. Investor Inquiries Timothy Mayer, Ph.D. NextCure, Inc. Chief Operating Officer (240) 762-6486 IR@nextcure.com Source: NextCure

临床1期财报抗体药物偶联物引进/卖出

2025-06-17

·贝壳社

引进先声ADC，NextCure能否抓住救命稻草？

▲点击图片，了解详情作者：贝壳社6月16日，先声药业集团旗下的抗肿瘤创新药公司先声再明与美国生物制药公司NextCure, Inc.（以下简称NextCure）宣布，双方已建立战略合作伙伴关系，共同开发针对CDH6靶点的新型抗体药物偶联物（ADC）新药SIM0505，用于治疗实体瘤。在SIM0505项目的潜在开发阶段，先声再明将有权获得最高7.45亿美元的相关款项，这些款项涵盖首付款、开发及销售里程碑付款，并且还将根据该产品在大中华区以外地区的净销售额，额外获得高达双位数的分级特许权使用费。01NextCure：战略转型与ADC布局ADC药物的成功依赖于靶点、抗体、有效载荷三大核心组成部分的协同作用。据悉，SIM0505是由先声再明研发的一款靶向CDH6（钙粘蛋白-6或K-钙粘蛋白）的新型ADC，独特的结合表位对肿瘤抗原的亲和力高于同类候选药物。其中，CDH6在多种癌症中高度表达，而在正常成人组织中表达量有限，使其成为ADC药物的理想靶点。此外，SIM0505采用了先声再明专有的TOPO异构酶1抑制剂（TOPOi）有效载荷，在具有强抗肿瘤活性的同时，具有较高的系统清除率，从而扩大治疗窗口。临床前研究表明，该药物在多种实体瘤模型中均表现出强抑瘤效果，并且在毒理学模型中具有良好的安全性。SIM0505目前正在中国进行I期临床试验。NextCure计划于2025年第三季度在美国启动临床试验。此次合作还包括授权NextCure使用先声再明ADC技术平台专有的连接子和TOPOi有效载荷，用于NextCure一款临床前阶段新型靶点ADC的开发。先声再明将拥有这款新型靶点ADC在大中华区的权利。NextCure是美国一家临床阶段的生物制药公司，聚焦肿瘤IO疗法。目前市值约1400万美元，财务数据显示，近年来，NextCure持续亏损，且现金储备有限。2024年11月，NextCure宣布了一项重大的战略转型，决定降低其临床阶段免疫肿瘤资产NC410（一种LAIR-2融合蛋白）的优先级，转而“全力以赴”投入ADC领域。这一转型表明NextCure急需在ADC领域取得突破，以提升自身竞争力和市场价值。引进SIM0505对NextCure而言是一场豪赌。它为NextCure带来了一款具有‘同类最佳’潜力的资产，以及一个即将到来的临床催化剂。而预计将于2026年上半年公布的初步临床数据，将成为决定此次合作价值乃至NextCure公司未来的关键转折点。02强手如林：CDH6靶向疗法的竞争格局针对CDH6靶点的药物开发正日趋白热化，尤其是在ADC领域，多家公司都在力争证明其候选药物拥有更优的疗效和安全性。除了ADC，其他新兴技术如T细胞衔接器和CAR-T疗法也开始布局此靶点，展现出了巨大的治疗潜力。ADC是当前CDH6靶点竞争最激烈的赛道。各家公司通过优化有效载荷、连接子和抗体技术，力求在疗效和安全性之间找到平衡点，并实现突破。以下是主要临床阶段CDH6 ADC的对比：第一三共/默沙东的DS-6000无疑是该领域的领导者，已进入关键的Ⅲ期临床试验，并以46%的ORR设定了极高的疗效标杆。然而，其致命弱点在于安全性，特别是导致患者死亡的间质性肺病（ILD）风险，这为后来者创造了巨大的机会窗口。SIM0505和CUSP06等挑战者均旨在利用DS-6000的安全性弱点。SIM0505宣称，其有效载荷具备‘较高系统清除率’的特性，从而扩大治疗窗口。CUSP06则已在临床中初步证明了其“可控的安全性”和36%的ORR，显示出强大的潜力。CDH6靶向药的竞争核心很可能取决于最佳的综合治疗指数，而非单纯追求最高的疗效。德琪医药正在开发的ATG-106是一款CDH6/CD3 TCE，拟用于卵巢癌和肾癌。Phrontline Biopharma正在开发的TJ102是一款同时靶向CDH6和FRα的双特异性、双有效载荷ADC，来增强肿瘤特异性并可能克服耐药性。随着全球肿瘤发病率的逐年上升，以及对肿瘤治疗的重视程度不断提高，患者对精准且有效的治疗药物的需求正日益增长。据相关统计，卵巢癌的发病率在2017年到2021年的全球年复合增长率达到了2.5%，且预测该病2025年全球发病人数将达到35万人，在2030年全球发病人数预计将达到37万人。CDH6靶向药在卵巢癌等肿瘤治疗领域的应用前景广阔，有望分享这一市场的增长红利。艾伯维以101亿美元收购ImmunoGen，以获得其靶向FRα ADC药物Elahere，用于卵巢癌的治疗，为该领域成功药物的潜在估值提供了一个强有力的参照。总体而言，NextCure通过与先声再明的合作，获得了具有潜力的CDH6 ADC药物SIM0505，并借助先声再明的技术平台加速自身在ADC领域的研发进程。这一合作将为NextCure提供重要的产品和技术支持，有望改善其在ADC领域的竞争地位。但SIM0505的最终成功将由临床数据决定，SIM0505如果能在提供与DS-6000相当疗效的同时，展现出明显改善的安全性，那么它就有望成为一个极具价值的商业资产。但NextCure能否成功抓住这一机会，还需在研发、商业化等方面不断努力，以应对激烈的市场竞争和技术挑战。往期推荐1医健企业前沿动态2医健行业BD/出海/投融资洞察___*声明：本文仅为作者观点，不构成任何投资建议，且非治疗方案推荐素材来源公司官媒/网络新闻关于贝壳社贝壳社是国内领先的医健创新创业服务平台，构建了"产业空间+创业教育+投资孵化+资本运作"四位一体服务体系，为医健领域创业企业提供全周期赋能。通过深度挖掘高成长项目、精准匹配产业资源及全球化生态网络，覆盖企业从孵化培育到加速发展的全链路，重点提供包括空间落地、创业培训、资本运作及跨境资源链接服务。贝壳社以加速科学技术成果转化与产业升级为目标，致力于成为医健领域的孵化器、加速器、连接器。

抗体药物偶联物引进/卖出细胞疗法临床1期免疫疗法

100 项与 NC-410 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
转移性胰腺癌	临床2期	美国	NextCure, Inc.	2025-09-04
子宫内膜癌	临床2期	美国	NextCure, Inc.	2022-10-06
食管癌	临床2期	美国	NextCure, Inc.	2022-10-06
肺癌	临床2期	美国	NextCure, Inc.	2022-10-06
宫颈癌	临床2期	美国	NextCure, Inc.	2022-10-06
晚期恶性实体瘤	临床2期	美国	NextCure, Inc.	2020-06-10
结直肠癌	临床2期	美国	NextCure, Inc.	2020-06-10
卵巢癌	临床2期	美国	NextCure, Inc.	2020-06-10
胃癌	临床2期	美国	NextCure, Inc.	2020-06-10

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临床结果

适应症

分期

评价

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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


NCT05572684 (632, SITC2024)	临床1期	结直肠癌 CD8+ \| CD45RO \| fibronectin ... 更多	70	NC410 + Pembrolizumab	構顧憲壓廠艱獵壓膚願(齋鹹鑰築廠糧壓獵繭淵) = 夢淵鹽遞艱製鏇積鹽艱淵簾蓋顧廠簾齋壓製鏇 (窪襯鹽廠願鹹蓋壓夢鑰 ) 更多	积极	2024-11-05
NCT05572684 (ESMO2024) 人工标引	临床1期	微卫星稳定型结直肠癌 MSI-Low \| Microsatellite Stable (MSS)	70	NC410 + Pembrolizumab	鏇衊廠壓願繭構簾鹹鬱(窪廠壓顧網蓋糧網蓋築) = 艱廠構淵襯襯鬱憲繭願顧夢膚窪簾選鬱衊鹹獵 (觸範夢糧遞築鬱觸淵廠 ) 更多	积极	2024-09-16
				NC410 + Pembrolizumab (without liver metastases)	餘蓋願製膚鹽鹹鏇窪範(廠遞簾廠網獵製積蓋遞) = 蓋齋膚襯繭遞鹹鹹齋齋蓋糧醖衊鬱顧鹹齋憲範 (鹽築襯憲憲範積糧鹹膚 ) 更多
NCT05572684 (ESMO2024) 人工标引	临床1期	卵巢癌 MSS/MSI-L	18	NC410 + Pembrolizumab	衊膚獵膚顧艱製獵醖齋(鏇繭艱顧襯糧製觸築觸) = 鬱糧鹹顧積蓋醖鏇觸糧夢襯構願齋憲範醖襯選 (鬱選膚衊壓鹹觸糧範構 ) 更多	积极	2024-09-14
NCT04408599 (CTgov)	临床1/2期	卵巢癌 \| 晚期恶性实体瘤 \| 结直肠癌 ... 更多	46	NC410 (NC410 3mg)	窪廠鏇觸構膚艱製憲憲 = 鬱製衊選鑰淵艱鹹齋糧鬱顧鹽鏇夢積壓觸窪選 (網夢願窪餘獵鑰窪膚繭, 選積淵壓顧鑰獵網範餘 ~ 艱觸鏇衊簾製襯網醖衊) 更多	-	2024-07-25
				NC410 (NC410 6mg)	窪廠鏇觸構膚艱製憲憲 = 選蓋獵餘壓齋觸積壓廠鬱顧鹽鏇夢積壓觸窪選 (網夢願窪餘獵鑰窪膚繭, 願淵獵蓋憲鑰窪壓觸鬱 ~ 鹽衊齋鑰餘糧願製窪範) 更多
NEWS 人工标引	临床1期	微卫星稳定型结直肠癌 \| 卵巢癌 \| 结直肠癌 MSI-Low \| Microsatellite Stable (MSS)	-	NC410+pembrolizumab (结直肠)	憲鑰糧窪壓獵廠鑰膚構(構繭淵鬱願簾鏇鹹淵網) = 襯衊獵醖廠鹹鑰範淵廠衊願鹹襯範積選蓋遞鏇 (壓鏇鑰簾艱醖膚窪遞餘 ) 更多	积极	2024-06-03
				NC410+pembrolizumab (卵巢癌)	憲鑰糧窪壓獵廠鑰膚構(構繭淵鬱願簾鏇鹹淵網) = 願鑰製衊簾鹹膚簾鏇選衊願鹹襯範積選蓋遞鏇 (壓鏇鑰簾艱醖膚窪遞餘 )
NCT05572684 (ASCO2024) 人工标引	临床1/2期	错配修复缺陷或微卫星高度不稳定性结直肠癌 \| 卵巢癌 \| 结直肠癌 Microsatellite Stable (MSS) \| MSI-Low	65	NC410pembrolizumab	築獵顧衊淵廠膚製齋願(鹽網製獵壓遞窪蓋夢遞) = 餘鬱壓構鬱鏇醖醖鹽餘糧顧鹽糧選齋蓋獵壓網 (選壓鑰衊壓齋餘顧簾積 ) 更多	积极	2024-05-24
				NC410 + pembrolizumab (MSS/MSI-L CRC)	鑰襯淵鹹鹽遞顧醖齋鑰(鑰遞鹹製獵鬱鬱顧範餘) = 襯構艱觸鑰夢窪顧製壓齋構蓋獵壓鏇觸膚鏇鏇 (廠網遞窪簾襯積繭廠鏇 ) 更多