A Randomized, Placebo-Controlled, Double-Blind, Multi-Center Phase 3 Study of Zipalertinib Plus Adjuvant Chemotherapy Versus Placebo Plus Adjuvant Chemotherapy in Stage IB-IIIA NSCLC Patients With Uncommon EGFR Mutations Following Complete Tumor Resection (REZILIENT4)

The purpose of this study is to compare the efficacy of zipalertinib combined standard with adjuvant chemotherapy versus placebo combined standard with adjuvant chemotherapy in participants with early stage (stage IB-IIIA) resected non-small cell lung cancer (NSCLC) harboring uncommon epidermal growth factor receptor mutation (EGFRmt).

开始日期2025-10-01

申办/合作机构

Taiho Oncology, Inc.

CTIS2023-503865-48-00

/ Recruiting临床2期

An Open-Label, Phase 2b, Global Multicenter Cohort Trial to Assess the Safety and Efficacy of Zipalertinib in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer with Exon 20 Insertion and Uncommon/Single or Compound Epidermal Growth Factor Receptor Mutations - TAS6417-201

开始日期2024-02-21

申办/合作机构

Taiho Oncology, Inc.

NCT05967689

/ Recruiting临床2期

An Open-Label, Phase 2b, Global Multicenter Cohort Trial to Assess the Safety and Efficacy of Zipalertinib in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With Exon 20 Insertion and Uncommon/Single or Compound Epidermal Growth Factor Receptor Mutations.

The purpose of this study is to evaluate the safety, efficacy and pharmacokinetics (PK) of zipalertinib in participants with locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) harboring EGFR ex20ins mutations and other mutations.

开始日期2023-07-31

申办/合作机构

Taiho Oncology, Inc.

100 项与 Zipalertinib 相关的临床结果

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100 项与 Zipalertinib 相关的转化医学

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100 项与 Zipalertinib 相关的专利（医药）

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项与 Zipalertinib 相关的文献（医药）

2025-06-01·LUNG CANCER

Novel strategies for rare oncogenic drivers in non-small-cell lung cancer: An update from the 2024 Annual ESMO meeting

Review

作者: van der Wel, J W T ; de Langen, A J

Across the landscape of oncogene-addicted non-small-cell lung cancer (NSCLC), various tyrosine kinase inhibitors (TKIs) have been introduced in the last twenty years. During the 2024 Annual ESMO meeting new therapeutic options were presented for EGFR exon 20 insertion mutation, ALK fusion and ROS1 fusion positive advanced stage NSCLC. For EGFR exon 20 insertion mutation positive NSCLC, results from REZILIENT-1, a single arm phase II study with zipalertinib, were presented, showing an objective response rate (ORR) of 50% in patients that were pretreated with amivantamab, and 25% in patients pretreated with amivantamab and an EGFR exon 20 insertion-directed TKI. The vast majority of these patients also received platinum-doublet chemotherapy. For ALK, results from ALKOVE-1, a single arm phase I/II study with NVL-655, a next generation ALK TKI, were presented. The ORR was 35 % in patients pretreated with ≥ 2 ALK TKIs including lorlatinib and 57 % in patients pretreated with ≥ 1 ALK TKI, excluding lorlatinib. The median number of prior anticancer therapies was 3. Intracranial responses were seen in lorlatinib naïve- and lorlatinib pretreated patients and toxicity was manageable. In addition, results of the first-line randomized phase III INSPIRE study were presented, in which iruplinalkib, an ALK and ROS1 selective TKI, is being evaluated versus crizotinib. Iruplinalkib showed a superior median PFS (36.8 versus 14.55 months for crizotinib), but no difference in 36-month overall survival (OS) rate. Finally, results from ARROS-1, a single arm phase I/II study with zidesamtinib, a ROS1 selective and TRK-sparing TKI, were presented. An ORR of 73% was obtained in patients that were pretreated with crizotinib and an ORR of 38% in patients pretreated with repotrectinib. In this review, we will discuss the relevant study results presented at ESMO 2024 for these three genomic drivers and hypothesize on their respective place in the sequence of treatment options.

2025-02-19·Future Oncology

REZILIENT3: randomized phase III study of first-line zipalertinib plus chemotherapy in patients with EGFR exon 20 insertion-mutated NSCLC

Article

作者: Tan, Daniel SW. ; Heymach, John V. ; Cheng, Ying ; Besse, Benjamin ; Yu, Helena A. ; Wacheck, Volker ; Wei, Li ; Nishio, Makoto

There remains a significant unmet need for effective and tolerable treatments for patients with non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion (ex20ins) mutations in the first-line setting. First and later generation EGFR tyrosine kinase inhibitors (TKIs) have shown efficacy for common EGFR mutations; however, their effectiveness against ex20ins mutations is limited, and platinum-based chemotherapy remains part of the standard of care. Data suggest that combining chemotherapy with EGFR inhibitors offers promise for EGFR ex20ins-mutated NSCLC. REZILIENT3 is an ongoing phase III study evaluating the efficacy and safety of zipalertinib (an orally available, irreversible EGFR-TKI) plus first-line standard-of-care platinum-based chemotherapy with chemotherapy alone in previously untreated patients with nonsquamous NSCLC harboring EGFR ex20ins mutations.Clinical Trial Registration: NCT05973773 (ClinicalTrials.gov).

2024-11-05·PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF THE UNITED STATES OF AMERICA

Biochemical analysis of EGFR exon20 insertion variants insASV and insSVD and their inhibitor sensitivity

Article

作者: Eck, Michael J. ; Beyett, Tyler S. ; Rana, Jaimin K. ; Schaeffner, Ilse K. ; Zhao, Hanchen ; Jiang, Jie ; Santana, Jhasmer ; Jänne, Pasi A.

Somatic mutations in the epidermal growth factor receptor (EGFR) are a major cause of non–small cell lung cancer. Among these structurally diverse alterations, exon 20 insertions represent a unique subset that rarely respond to EGFR tyrosine kinase inhibitors (TKIs). Therefore, there is a significant need to develop inhibitors that are active against this class of activating mutations. Here, we conducted biochemical analysis of the two most frequent exon 20 insertion variants, V769_D770insASV (insASV) and D770_N771insSVD (insSVD) to better understand their drug sensitivity and resistance. From kinetic studies, we found that EGFR insASV and insSVD are similarly active, but have lower K m, ATP values compared to the L858R variant, which contributes to their lack of sensitivity to 1st-3rd generation EGFR TKIs. Biochemical, structural, and cellular studies of a diverse panel of EGFR inhibitors revealed that the more recently developed compounds BAY-568, TAS6417, and TAK-788 inhibit EGFR insASV and insSVD in a mutant-selective manner, with BAY-568 being the most potent and selective versus wild-type (WT) EGFR. Cocrystal structures with WT EGFR reveal the binding modes of each of these inhibitors and of poziotinib, a potent but not mutantselective inhibitor, and together they define interactions shared by the mutant-selective agents. Collectively, our results show that these exon20 insertion variants are not inherently inhibitor resistant, rather they differ in their drug sensitivity from WT EGFR. However, they are similar to each other, indicating that a single inhibitor should be effective for several of the diverse exon 20 insertion variants.

项与 Zipalertinib 相关的新闻（医药）

2025-08-13

·ioncology

文献速递丨肺癌难治性突变治疗新突破：EGFR 20 外显子插入与 KRAS G12C 突变临床研究解析

点击蓝字关注我们前言靶向治疗因具有高效、低毒的特点，不仅延长了患者的生存时间，同时改善了患者的生存质量，因此，成为携带相应驱动基因突变患者首先考虑的治疗选择。但有两种突变类型——EGFR第20外显子插入突变及KRAS 突变，因蛋白结构的特殊性，导致很长一段时间无相应的靶向治疗药物进入临床。近期，JCO杂志公布了针对EGFR第20外显子插入突变的靶向治疗药物——Zipalertinib和针对KRAS G12C突变的靶向治疗药物Divarasib的早期临床研究数据，有望为这部分患者的靶向治疗带来新的治疗选择。 Zipalertinib治疗EGFR第20外显子插入突变且接受含铂双药化疗±埃万妥治疗后耐药的非小细胞肺癌患者的疗效及安全性研究背景：EGFR第20外显子插入突变是EGFR通路第三常见的突变类型，尽管已经有TKI类药物可以阻断经典突变，但多数药物对于插入突变无效。含铂双药化疗是这部分患者的标准治疗选择，2021年，埃万妥——一款针对EGFR-MET的双特异性抗体，获批单药后线治疗携带EGFR第20外显子插入突变非小细胞肺癌患者适应症；随后，III期PAPILLON研究显示，相较于单纯含铂双药治疗，联合埃万妥单抗一线治疗这部分患者具有更好的疗效并获批适应症。尽管埃万妥治疗这部分患者有效，但伴随明显的毒性，此外患者会出现原发或继发耐药，从而成为具有挑战的问题，需要新的更好的耐受性、口服给药的药物。莫博赛替尼以及帕唑帕尼治疗20外显示插入突变患者展示了轻度的抗肿瘤活性，但莫博赛替尼在确认性临床研究中失败。Zipalertinib是一款不可逆、口服TKI类药物。体外研究发现，该药对20外显子插入突变具有阻断作用。本研究旨在探索该药在EGFR第20外显子插入突变中的疗效及安全性。研究方法：这是一项1/2期、开放标签、多中心临床研究，患者既往接受过含铂双药治疗±埃万妥治疗后出现疾病进展。本次报道了接受Zipalertinib 100mg，口服，每日两次剂量的患者数据，终点为独立评审委员会评估的ORR和DoR，次要研究终点包括研究者评估的ORR、DoR、DCR，PFS、OS、颅内抗肿瘤活性、安全性等。研究结果：最终，共计244例患者纳入本研究，并接受100 mg口服，每日两次的研究药物治疗。数据截止时，62.3%的患者永久性终止药物治疗，既往仅接受过含铂双药治疗和接受过靶向治疗患者分别有143例和101例患者，并分别有33.6%和54.5%的患者在入组时有脑转移，分别有95.1%和98%的患者至少有一个转移病灶既往接受过靶向药物治疗的患者中，埃万妥占比82.8%，莫泊替尼占比39.6%，奥希替尼占比6.9%，既往仅接受过含铂双药治疗的176例患者，ORR为35.2%，DCR为89.2%，临床获益率64.2%，中位DoR为8.8个月；既往接受过针对20外显子插入突变的患者，ORR为40%，DCR为88.8%，临床获益率68%，中位DoR为8.8个月；仅接受过埃万妥治疗的患者，ORR为30%，中位DoR为14.7个月，既往接受过埃万妥和其他靶向药物治疗的患者，ORR为14.3%，中位DoR为4.2个月。全组全因、任何级别不良反应发生率为99.2%，治疗相关不良反应发生率91.4%，3度以上治疗相关不良反应发生率为29.5%。贫血为最常见的治疗相关3度不良反应，发生率为7%，其他的包括肺炎和皮疹，发生率各2.5%，42.2%的患者因不良反应剂量降低，39%的患者治疗中断，8.2%的患者永久性终止治疗。全组的疗效数据研究结论：Zipalertinib在治疗EGFR第20外显子插入突变的非小细胞肺癌患者中，展示了有意义的疗效及可管理的安全性。单剂量Divarasib治疗KRAS G12C突变的非小细胞肺癌患者：一项I期临床研究的长期随访数据研究背景：12~14%的非小细胞肺癌患者携带KRAS G12C突变，尽管索托雷赛和阿达格拉西布已经获批治疗这部分患者且展示了抗肿瘤活性，但仍然有进一步提高疗效及安全性的需求。Divarasib是一款口服、高选择性、下一代KRAS G12C抑制剂，与索托雷赛和阿达格拉西布相比，亲和力提高5~20倍。在一项I期临床研究中，该药400mg，口服，每日一次剂量，ORR为56.4%，中位DoR为11.9个月，中位PFS为13.7个月，本研究报道了该研究的长期随访结果。研究方法：这是一项开放标签、剂量爬坡、队列拓展、多中心、I期临床研究，纳入年龄大于等于18周岁且携带KRAS G12C突变的局部晚期或转移性非小细胞肺癌患者，爬坡剂量为50~400mg，口服，每日一次，直至疾病进展或出现不可耐受毒性反应，主要研究终点为安全性。研究结果：数据分析时，非小细胞肺癌队列纳入65例患者，其中，400 mg、200 mg、100 mg、50 mg，分别入组44例、10例、5例和6例患者，数据分析时，26%的患者仍然在接受研究药物治疗，任何级别治疗相关不良反应发生率为93.8%，3度以上治疗相关不良反应发生率为16.9%，较常见的为腹泻3.1%，谷丙转氨酶升高6.2%，谷草转氨酶升高4.6%，乏力1.5%，恶心1.5%，整体人群的ORR为55.6%，中位DoR为18.0个月，中位PFS为13.8个月。患者的疗效数据研究结论：经过更长时间随访，Divarasib在局部晚期或转移性KRAS G12C突变的NSCLC患者中展示了长久的抗肿瘤活性。研究思考及解读 EGFR 第 20 外显子插入突变与 KRAS 突变是肺癌治疗领域中两类典型的难治性基因突变，长期以来缺乏获批的靶向治疗药物。两项新研究为这类患者带来了潜在治疗新选择，却也各自面临独特挑战。就 Zipalertinib 而言，其确认性临床研究中对照组的选择是关键考量。基于 III 期 PAPILLON 研究数据，当前 EGFR 第 20 外显子插入突变患者的一线中位无进展生存期（PFS）约为 11 个月；后线治疗中，国内已获批的舒沃替尼客观缓解率（ORR）达 60% 左右，中位 PFS 约 10.0 个月。因此，该药在一线及后线注册性临床研究中能否优于现有标准治疗，仍存不确定性。此外，在埃万妥单抗耐药患者中，其尚未展现出显著的耐药克服优势，未来如何实现差异化竞争、精准识别获益人群，仍需深入探索。围绕KRAS G12C突变，目前国内外已经有多款靶向治疗药物获批上市，但整体而言，二线较多西他赛这一当前的标准治疗的提高有限，中位PFS多不足 6 个月。在一线治疗领域，尽管KRAS抑制剂联合化疗、西妥昔单抗、免疫等不同的联合策略在陆续探索中，但联合治疗的共性问题 —— 安全性风险仍难以避但不可避免的面临联合治疗带来的普遍问题——安全性问题。新一代 KRAS G12C 抑制剂 Divarasib 现有数据显示其中位 PFS 达 13.8 个月，疗效前景可观，但其获益仍需前瞻性大样本临床研究进一步验证。参考文献：DOI：10.1200/JCO-25-00040DOI：10.1200/JCO-25-00040 （来源：《肿瘤瞭望》编辑部）声明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

临床结果临床2期申请上市临床3期

2025-08-07

·GlobeNewswire-Health Care

Cullinan Therapeutics Provides Corporate Update and Reports Second Quarter 2025 Financial Results

CLN-978 program now actively enrolling across Phase 1 studies in systemic lupus erythematosus (SLE), rheumatoid arthritis (RA) and Sjögren’s disease BCMA-directed bispecific T cell engager velinotamig in-licensed from Genrix Bio Zipalertinib REZILIENT1 pivotal results shared in oral presentation at ASCO 2025 and in Journal of Clinical Oncology; multiple new data sets across a range of disease settings to be shared at IASLC 2025 WCLC and ESMO Congress 2025 Company appoints Mittie Doyle, M.D., and Andrew Allen, M.D., Ph.D., to its Board of Directors CAMBRIDGE, Mass., Aug. 07, 2025 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM; “Cullinan”), a biopharmaceutical company focused on developing modality-agnostic targeted therapies, today provided an update on recent and anticipated business highlights and announced its financial results for the second quarter ended June 30, 2025. “I am proud of the team’s strong execution throughout the first half of the year as we continue to advance the CLN-978 program across three active studies in SLE, RA, and Sjögren’s disease. With the addition of velinotamig, we further solidified our leadership position in the development of T cell engagers for autoimmune diseases. With these two programs, our portfolio covers the entire breadth of the B cell compartment. Recent data presented at the European Alliance of Associations for Rheumatology (EULAR) meeting reinforced the potential of T cell engagers as disease-modifying therapies across a wide spectrum of autoimmune diseases,” said Nadim Ahmed, Chief Executive Officer of Cullinan Therapeutics. “We also continue making important progress across our oncology portfolio, recently sharing results from the pivotal Phase 2b portion of the REZILIENT1 study of zipalertinib at the 2025 ASCO Annual Meeting, and we look forward to sharing multiple new data sets at upcoming medical conferences. Pending discussions with the U.S. FDA, our partner Taiho plans to submit an NDA in relapsed EGFR ex20ins NSCLC later this year and expects to complete enrollment of the frontline study REZILIENT3 in the first half of 2026. We also plan to share clinical data for CLN-049, our FLT3xCD3 bispecific T cell engager, in patients with relapsed/refractory AML and MDS later this year. With $510.9 million in cash and investments and runway into 2028, we have the resources to generate multiple value-driving catalysts near term and beyond across both our immunology and oncology programs. Lastly, I am pleased to welcome Drs. Mittie Doyle and Andrew Allen to our Board of Directors. They are proven leaders with deep strategic and development expertise in immunology and oncology, respectively, and I believe their contributions will be invaluable as we continue to advance our programs. I would also like to thank Drs. Anne-Marie Martin and David Ryan for their contributions to our progress and success over the last several years.” Portfolio Highlights Immunology CLN-978 (CD19xCD3 bispecific T cell engager): Systemic lupus erythematosus, rheumatoid arthritis, and Sjögren’s disease The global Phase 1 study in patients with moderate to severe SLE is enrolling in the United States, Europe, and Australia, and the Company plans to share initial safety data and B cell depletion data from Part A of the study in Q4 2025.The Phase 1 study in patients with active, difficult-to-treat rheumatoid arthritis is enrolling in Europe. This company-sponsored study is being led by sites at FAU Erlangen-Nuremberg in Germany and Università Cattolica del Sacro Cuore in Italy. The Company plans to share initial data from this study during the first half of 2026.The global Phase 1 study in patients with active, moderate to severe Sjögren’s disease is enrolling in the U.S. and is now also active in Europe following recent regulatory approval. Velinotamig (BCMAxCD3 bispecific T cell engager): Autoimmune diseases In June 2025, the Company entered into an agreement with Genrix Bio for an exclusive global (ex-Greater China) license to velinotamig. Under the agreement, Cullinan paid Genrix Bio an upfront license fee of $20 million. In the future, Genrix Bio will also be eligible to receive up to $292 million in development and regulatory milestones plus up to an additional $400 million in sales-based milestones, as well as tiered royalties on potential ex-Greater China net sales.Genrix Bio plans to initiate a Phase 1 study in patients with autoimmune diseases in China by the end of 2025. Cullinan intends to use the data generated to accelerate global clinical development of the program. Following the completion of the Genrix Bio Phase 1 study, Cullinan will conduct all further development of velinotamig in autoimmune diseases. Oncology Zipalertinib (EGFR ex20ins inhibitor), collaboration with Taiho Oncology: EGFR ex20ins NSCLC In June 2025, results from the pivotal Phase 2b portion of REZILIENT1 in patients with EGFR ex20ins NSCLC who have received prior therapy were shared at the 2025 ASCO Annual Meeting and published simultaneously in the Journal of Clinical Oncology. Cullinan plans to share updated efficacy and safety data in patients previously treated with amivantamab during a mini oral abstract session at the IASLC 2025 WCLC.Pending discussions with the U.S. Food and Drug Administration, Taiho plans to submit an NDA in relapsed EGFR ex20ins NSCLC by the end of 2025. Taiho expects to complete enrollment of the pivotal study REZILIENT3 in 1L EGFR ex20ins NSCLC in the first half of 2026.Taiho plans to share initial data from the REZILIENT2 cohort exploring zipalertinib in patients with uncommon EGFR mutations during a mini oral abstract session at the IASLC 2025 WCLC. Taiho also plans to share initial data from the REZILIENT2 cohort exploring zipalertinib in patients with active brain metastases at the ESMO Congress 2025. CLN-049 (FLT3xCD3 bispecific T cell engager): Acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) Enrollment continues in the Phase 1 study in patients with relapsed/refractory AML or MDS and the company plans to share clinical data from this study in Q4 2025.Enrollment also continues in the Phase 1 study in patients with measurable minimal residual disease in AML. CLN-619 (Anti-MICA/MICB monoclonal antibody): NSCLC and multiple myeloma Enrollment continues in the Phase 1 expansion cohorts in patients with NSCLC and the Phase 1 study in patients with relapsed/refractory multiple myeloma. CLN-617 (IL-2 and IL-12 cytokine fusion protein): Solid tumors Enrollment continues in the Phase 1 study in patients with advanced solid tumors. Corporate Updates Mittie Doyle, M.D., and Andrew Allen, M.D., Ph.D., were appointed to the Board of Directors, effective August 7, 2025. Both board directors bring significant leadership experience, with Dr. Doyle having extensive immunology clinical development expertise, and Dr. Allen with extensive oncology clinical development experience. Anne-Marie Martin, Ph.D., and David Ryan, M.D., will resign from Cullinan’s Board of Directors effective August 7, 2025. Second Quarter 2025 Financial Results Cash Position: Cash, cash equivalents, short- and long-term investments, and interest receivable were $510.9 million as of June 30, 2025. Cullinan continues to expect its cash resources to provide runway into 2028 based on its current operating plan.R&D Expenses: Research and development expenses were $61.0 million for the second quarter of 2025, compared to $36.3 million for the same period in 2024.G&A Expenses: General and administrative expenses were $14.8 million for the second quarter of 2025, compared to $13.8 million for the same period in 2024.Net Loss: Net loss attributable to Cullinan was $70.1 million for the second quarter of 2025, compared to $42.0 million for the same period in 2024. About Cullinan Therapeutics Cullinan Therapeutics, Inc. (Nasdaq: CGEM) is a biopharmaceutical company dedicated to creating new standards of care for patients. Cullinan has strategically built a diversified portfolio of clinical-stage assets that inhibit key drivers of disease or harness the immune system to eliminate diseased cells in both autoimmune diseases and cancer. Cullinan’s portfolio encompasses a wide range of modalities, each with the potential to be best and/or first in class. Anchored in a deep understanding of oncology, immunology, and translational medicine, we create differentiated ideas, identify the most appropriate targets, and select the optimal modality to develop transformative therapeutics across a wide variety of autoimmune and cancer indications. We push conventional boundaries from candidate selection to differentiated therapeutic, applying rigorous go/no go criteria at each stage of development to fast-track only the most promising molecules to the clinic and, ultimately, commercialization. With deep scientific expertise, our teams exercise creativity and urgency to deliver on our promise to bring new therapeutic solutions to patients. Learn more about Cullinan at https://cullinantherapeutics.com/, and follow us on LinkedIn and X. Forward-Looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements regarding the company’s beliefs and expectations regarding: our preclinical and clinical developments plans and timelines for our product candidates, the clinical and therapeutic potential of our product candidates, the strategy of our product candidates, our research and development activities, our plans regarding future data presentations, our cash runway, and other statements that are not historical facts. The words “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “plan,” “potential,” “project,” “pursue,” “will,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs of future events and are subject to known and unknown risks and uncertainties that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These risks include, but are not limited to, the following: uncertainty regarding the timing and results of regulatory submissions; the risk that any INDs, NDAs or other global regulatory submissions we may file with the United States Food and Drug Administration or other global regulatory agencies are not cleared on our expected timelines, or at all; the success of our clinical trials and preclinical studies; the risks related to our ability to protect and maintain our intellectual property position; the risks related to manufacturing, supply, and distribution of our product candidates; the risk that any one or more of our product candidates, including those that are co-developed, will not be successfully developed and commercialized; the risk that the results of preclinical studies or clinical studies will not be predictive of future results in connection with future studies; the effect of changes in global economic conditions, including uncertainties related to international trade policies, tariffs and supply chain dynamics on our business and operations; and the success of any collaboration, partnership, license or similar agreements. These and other important risks and uncertainties discussed in our filings with the Securities and Exchange Commission, including under the caption “Risk Factors” in our most recent Annual Report on Form 10-K and subsequent filings with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change, except to the extent required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Moreover, except as required by law, neither the company nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements included in this press release. Any forward-looking statement included in this press release speaks only as of the date on which it was made. Cullinan Therapeutics, Inc.Selected Condensed Consolidated Balance Sheet Data(unaudited)(in thousands) June 30, 2025 December 31, 2024 Cash, cash equivalents, investments, and interest receivable $510,898 $606,917 Total assets $520,329 $621,824 Total current liabilities $28,058 $30,647 Total liabilities $28,183 $31,496 Total stockholders’ equity $492,146 $590,328 Cullinan Therapeutics, Inc.Consolidated Statements of Operations(unaudited)(in thousands, except per share amounts) Three Months Ended June 30, Six Months Ended June 30, 2025 2024 2025 2024 Operating expenses: Research and development $61,030 $36,259 $102,489 $66,905 General and administrative 14,768 13,768 28,305 26,111 Total operating expenses 75,798 50,027 130,794 93,016 Loss from operations (75,798) (50,027) (130,794) (93,016)Other income (expense): Interest income 5,924 8,071 12,504 13,764 Other income (expense), net (181) (72) (266) (116)Net loss (70,055) (42,028) (118,556) (79,368)Net loss attributable to noncontrolling interests — — — (192)Net loss attributable to Cullinan $(70,055) $(42,028) $(118,556) $(79,176) Basic and diluted net loss per share attributable to Cullinan: Common stock $(1.07) $(0.68) $(1.81) $(1.43)Preferred stock $(10.70) $(6.83) $(18.12) $(14.26)Weighted-average shares used in computing net loss per share attributable to Cullinan: Common stock 59,015 55,052 58,960 49,031 Preferred stock 648 648 648 648 Contacts: InvestorsNick Smith+1 401.241.3516nsmith@cullinantx.com Media  Rose Weldon +1 215.801.7644 rweldon@cullinantx.com

临床1期临床2期引进/卖出高管变更财报

2025-08-07

·investors.cullinantherapeutics.com

Cullinan Therapeutics Provides Corporate Update and Reports Second Quarter 2025 Financial Results

CLN-978 program now actively enrolling across Phase 1 studies in systemic lupus erythematosus (SLE), rheumatoid arthritis (RA) and Sjögren’s disease BCMA-directed bispecific T cell engager velinotamig in-licensed from Genrix Bio Zipalertinib REZILIENT1 pivotal results shared in oral presentation at ASCO 2025 and in Journal of Clinical Oncology; multiple new data sets across a range of disease settings to be shared at IASLC 2025 WCLC and ESMO Congress 2025 Company appoints Mittie Doyle, M.D., and Andrew Allen, M.D., Ph.D., to its Board of Directors CAMBRIDGE, Mass., Aug. 07, 2025 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM; “Cullinan”), a biopharmaceutical company focused on developing modality-agnostic targeted therapies, today provided an update on recent and anticipated business highlights and announced its financial results for the second quarter ended June 30, 2025. “I am proud of the team’s strong execution throughout the first half of the year as we continue to advance the CLN-978 program across three active studies in SLE, RA, and Sjögren’s disease. With the addition of velinotamig, we further solidified our leadership position in the development of T cell engagers for autoimmune diseases. With these two programs, our portfolio covers the entire breadth of the B cell compartment. Recent data presented at the European Alliance of Associations for Rheumatology (EULAR) meeting reinforced the potential of T cell engagers as disease-modifying therapies across a wide spectrum of autoimmune diseases,” said Nadim Ahmed, Chief Executive Officer of Cullinan Therapeutics. “We also continue making important progress across our oncology portfolio, recently sharing results from the pivotal Phase 2b portion of the REZILIENT1 study of zipalertinib at the 2025 ASCO Annual Meeting, and we look forward to sharing multiple new data sets at upcoming medical conferences. Pending discussions with the U.S. FDA, our partner Taiho plans to submit an NDA in relapsed EGFR ex20ins NSCLC later this year and expects to complete enrollment of the frontline study REZILIENT3 in the first half of 2026. We also plan to share clinical data for CLN-049, our FLT3xCD3 bispecific T cell engager, in patients with relapsed/refractory AML and MDS later this year. With $510.9 million in cash and investments and runway into 2028, we have the resources to generate multiple value-driving catalysts near term and beyond across both our immunology and oncology programs. Lastly, I am pleased to welcome Drs. Mittie Doyle and Andrew Allen to our Board of Directors. They are proven leaders with deep strategic and development expertise in immunology and oncology, respectively, and I believe their contributions will be invaluable as we continue to advance our programs. I would also like to thank Drs. Anne-Marie Martin and David Ryan for their contributions to our progress and success over the last several years.” Portfolio Highlights Immunology CLN-978 (CD19xCD3 bispecific T cell engager): Systemic lupus erythematosus, rheumatoid arthritis, and Sjögren’s disease The global Phase 1 study in patients with moderate to severe SLE is enrolling in the United States, Europe, and Australia, and the Company plans to share initial safety data and B cell depletion data from Part A of the study in Q4 2025. The Phase 1 study in patients with active, difficult-to-treat rheumatoid arthritis is enrolling in Europe. This company-sponsored study is being led by sites at FAU Erlangen-Nuremberg in Germany and Università Cattolica del Sacro Cuore in Italy. The Company plans to share initial data from this study during the first half of 2026. The global Phase 1 study in patients with active, moderate to severe Sjögren’s disease is enrolling in the U.S. and is now also active in Europe following recent regulatory approval. Velinotamig (BCMAxCD3 bispecific T cell engager): Autoimmune diseases In June 2025, the Company entered into an agreement with Genrix Bio for an exclusive global (ex-Greater China) license to velinotamig. Under the agreement, Cullinan paid Genrix Bio an upfront license fee of $20 million. In the future, Genrix Bio will also be eligible to receive up to $292 million in development and regulatory milestones plus up to an additional $400 million in sales-based milestones, as well as tiered royalties on potential ex-Greater China net sales. Genrix Bio plans to initiate a Phase 1 study in patients with autoimmune diseases in China by the end of 2025. Cullinan intends to use the data generated to accelerate global clinical development of the program. Following the completion of the Genrix Bio Phase 1 study, Cullinan will conduct all further development of velinotamig in autoimmune diseases. The global Phase 1 study in patients with moderate to severe SLE is enrolling in the United States, Europe, and Australia, and the Company plans to share initial safety data and B cell depletion data from Part A of the study in Q4 2025. The Phase 1 study in patients with active, difficult-to-treat rheumatoid arthritis is enrolling in Europe. This company-sponsored study is being led by sites at FAU Erlangen-Nuremberg in Germany and Università Cattolica del Sacro Cuore in Italy. The Company plans to share initial data from this study during the first half of 2026. The global Phase 1 study in patients with active, moderate to severe Sjögren’s disease is enrolling in the U.S. and is now also active in Europe following recent regulatory approval. In June 2025, the Company entered into an agreement with Genrix Bio for an exclusive global (ex-Greater China) license to velinotamig. Under the agreement, Cullinan paid Genrix Bio an upfront license fee of $20 million. In the future, Genrix Bio will also be eligible to receive up to $292 million in development and regulatory milestones plus up to an additional $400 million in sales-based milestones, as well as tiered royalties on potential ex-Greater China net sales. Genrix Bio plans to initiate a Phase 1 study in patients with autoimmune diseases in China by the end of 2025. Cullinan intends to use the data generated to accelerate global clinical development of the program. Following the completion of the Genrix Bio Phase 1 study, Cullinan will conduct all further development of velinotamig in autoimmune diseases. Oncology Zipalertinib (EGFR ex20ins inhibitor), collaboration with Taiho Oncology: EGFR ex20ins NSCLC In June 2025, results from the pivotal Phase 2b portion of REZILIENT1 in patients with EGFR ex20ins NSCLC who have received prior therapy were shared at the 2025 ASCO Annual Meeting and published simultaneously in the Journal of Clinical Oncology. Cullinan plans to share updated efficacy and safety data in patients previously treated with amivantamab during a mini oral abstract session at the IASLC 2025 WCLC. Pending discussions with the U.S. Food and Drug Administration, Taiho plans to submit an NDA in relapsed EGFR ex20ins NSCLC by the end of 2025. Taiho expects to complete enrollment of the pivotal study REZILIENT3 in 1L EGFR ex20ins NSCLC in the first half of 2026. Taiho plans to share initial data from the REZILIENT2 cohort exploring zipalertinib in patients with uncommon EGFR mutations during a mini oral abstract session at the IASLC 2025 WCLC. Taiho also plans to share initial data from the REZILIENT2 cohort exploring zipalertinib in patients with active brain metastases at the ESMO Congress 2025. CLN-049 (FLT3xCD3 bispecific T cell engager): Acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) Enrollment continues in the Phase 1 study in patients with relapsed/refractory AML or MDS and the company plans to share clinical data from this study in Q4 2025. Enrollment also continues in the Phase 1 study in patients with measurable minimal residual disease in AML. CLN-619 (Anti-MICA/MICB monoclonal antibody): NSCLC and multiple myeloma Enrollment continues in the Phase 1 expansion cohorts in patients with NSCLC and the Phase 1 study in patients with relapsed/refractory multiple myeloma. CLN-617 (IL-2 and IL-12 cytokine fusion protein): Solid tumors Enrollment continues in the Phase 1 study in patients with advanced solid tumors. In June 2025, results from the pivotal Phase 2b portion of REZILIENT1 in patients with EGFR ex20ins NSCLC who have received prior therapy were shared at the 2025 ASCO Annual Meeting and published simultaneously in the Journal of Clinical Oncology. Cullinan plans to share updated efficacy and safety data in patients previously treated with amivantamab during a mini oral abstract session at the IASLC 2025 WCLC. Pending discussions with the U.S. Food and Drug Administration, Taiho plans to submit an NDA in relapsed EGFR ex20ins NSCLC by the end of 2025. Taiho expects to complete enrollment of the pivotal study REZILIENT3 in 1L EGFR ex20ins NSCLC in the first half of 2026. Taiho plans to share initial data from the REZILIENT2 cohort exploring zipalertinib in patients with uncommon EGFR mutations during a mini oral abstract session at the IASLC 2025 WCLC. Taiho also plans to share initial data from the REZILIENT2 cohort exploring zipalertinib in patients with active brain metastases at the ESMO Congress 2025. Enrollment continues in the Phase 1 study in patients with relapsed/refractory AML or MDS and the company plans to share clinical data from this study in Q4 2025. Enrollment also continues in the Phase 1 study in patients with measurable minimal residual disease in AML. Enrollment continues in the Phase 1 expansion cohorts in patients with NSCLC and the Phase 1 study in patients with relapsed/refractory multiple myeloma. Enrollment continues in the Phase 1 study in patients with advanced solid tumors. Corporate Updates Mittie Doyle, M.D., and Andrew Allen, M.D., Ph.D., were appointed to the Board of Directors, effective August 7, 2025. Both board directors bring significant leadership experience, with Dr. Doyle having extensive immunology clinical development expertise, and Dr. Allen with extensive oncology clinical development experience. Anne-Marie Martin, Ph.D., and David Ryan, M.D., will resign from Cullinan’s Board of Directors effective August 7, 2025. Second Quarter 2025 Financial Results Cash Position: Cash, cash equivalents, short- and long-term investments, and interest receivable were $510.9 million as of June 30, 2025. Cullinan continues to expect its cash resources to provide runway into 2028 based on its current operating plan. R&D Expenses: Research and development expenses were $61.0 million for the second quarter of 2025, compared to $36.3 million for the same period in 2024. G&A Expenses: General and administrative expenses were $14.8 million for the second quarter of 2025, compared to $13.8 million for the same period in 2024. Net Loss: Net loss attributable to Cullinan was $70.1 million for the second quarter of 2025, compared to $42.0 million for the same period in 2024. About Cullinan Therapeutics Cullinan Therapeutics, Inc. (Nasdaq: CGEM) is a biopharmaceutical company dedicated to creating new standards of care for patients. Cullinan has strategically built a diversified portfolio of clinical-stage assets that inhibit key drivers of disease or harness the immune system to eliminate diseased cells in both autoimmune diseases and cancer. Cullinan’s portfolio encompasses a wide range of modalities, each with the potential to be best and/or first in class. Anchored in a deep understanding of oncology, immunology, and translational medicine, we create differentiated ideas, identify the most appropriate targets, and select the optimal modality to develop transformative therapeutics across a wide variety of autoimmune and cancer indications. We push conventional boundaries from candidate selection to differentiated therapeutic, applying rigorous go/no go criteria at each stage of development to fast-track only the most promising molecules to the clinic and, ultimately, commercialization. With deep scientific expertise, our teams exercise creativity and urgency to deliver on our promise to bring new therapeutic solutions to patients. Learn more about Cullinan at https://cullinantherapeutics.com/, and follow us on LinkedIn and X. Forward-Looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements regarding the company’s beliefs and expectations regarding: our preclinical and clinical developments plans and timelines for our product candidates, the clinical and therapeutic potential of our product candidates, the strategy of our product candidates, our research and development activities, our plans regarding future data presentations, our cash runway, and other statements that are not historical facts. The words “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “plan,” “potential,” “project,” “pursue,” “will,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs of future events and are subject to known and unknown risks and uncertainties that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These risks include, but are not limited to, the following: uncertainty regarding the timing and results of regulatory submissions; the risk that any INDs, NDAs or other global regulatory submissions we may file with the United States Food and Drug Administration or other global regulatory agencies are not cleared on our expected timelines, or at all; the success of our clinical trials and preclinical studies; the risks related to our ability to protect and maintain our intellectual property position; the risks related to manufacturing, supply, and distribution of our product candidates; the risk that any one or more of our product candidates, including those that are co-developed, will not be successfully developed and commercialized; the risk that the results of preclinical studies or clinical studies will not be predictive of future results in connection with future studies; the effect of changes in global economic conditions, including uncertainties related to international trade policies, tariffs and supply chain dynamics on our business and operations; and the success of any collaboration, partnership, license or similar agreements. These and other important risks and uncertainties discussed in our filings with the Securities and Exchange Commission, including under the caption “Risk Factors” in our most recent Annual Report on Form 10-K and subsequent filings with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change, except to the extent required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Moreover, except as required by law, neither the company nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements included in this press release. Any forward-looking statement included in this press release speaks only as of the date on which it was made. Contacts: InvestorsNick Smith+1 401.241.3516nsmith@cullinantx.com Media  Rose Weldon +1 215.801.7644 rweldon@cullinantx.com

临床1期引进/卖出临床2期财报高管变更

100 项与 Zipalertinib 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
非小细胞肺癌IIIA期	临床3期	-	Taiho Oncology, Inc.	2025-10-01
EGFR 20号外显子插入突变非小细胞肺癌	临床3期	美国	Taiho Oncology, Inc.	2023-06-30
EGFR 20号外显子插入突变非小细胞肺癌	临床3期	日本	Taiho Oncology, Inc.	2023-06-30
EGFR 20号外显子插入突变非小细胞肺癌	临床3期	比利时	Taiho Oncology, Inc.	2023-06-30
EGFR 20号外显子插入突变非小细胞肺癌	临床3期	巴西	Taiho Oncology, Inc.	2023-06-30
EGFR 20号外显子插入突变非小细胞肺癌	临床3期	保加利亚	Taiho Oncology, Inc.	2023-06-30
EGFR 20号外显子插入突变非小细胞肺癌	临床3期	加拿大	Taiho Oncology, Inc.	2023-06-30
EGFR 20号外显子插入突变非小细胞肺癌	临床3期	智利	Taiho Oncology, Inc.	2023-06-30
EGFR 20号外显子插入突变非小细胞肺癌	临床3期	法国	Taiho Oncology, Inc.	2023-06-30
EGFR 20号外显子插入突变非小细胞肺癌	临床3期	德国	Taiho Oncology, Inc.	2023-06-30

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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


NCT04036682 (REZILIENT1, Pubmed \| J Clin Oncol)	临床1/2期	EGFR阳性非小细胞肺癌 EGFR exon 20 insertion	244	Zipalertinib 100 mg twice daily	網簾積蓋齋窪築遞觸繭(鹹網醖糧構鹽膚夢積衊) = 餘餘憲簾淵襯觸遞窪範鬱構鏇廠積鏇蓋窪選齋 (簾製簾網餘淵窪艱鹽衊, 28.2 ~ 42.8) 更多	积极	2025-06-01
NCT04036682 (REZILIENT1, Pubmed \| J Clin Oncol)	临床1/2期	EGFR阳性非小细胞肺癌 EGFR exon 20 insertion	244	Platinum-based chemotherapy without ex20ins-targeted therapy	網簾積蓋齋窪築遞觸繭(鹹網醖糧構鹽膚夢積衊) = 築膚窪淵襯糧憲憲繭鹹鬱構鏇廠積鏇蓋窪選齋 (簾製簾網餘淵窪艱鹽衊 ) 更多	积极	2025-06-01
NCT04036682 (REZILIENT1, ASCO2025) 人工标引	临床2期	EGFR 20号外显子插入突变非小细胞肺癌 EGFR Exon 20 Insertion	176	Zipalertinib 100mgZipalertinib 100mg+platinum-based chemotherapy	築廠範夢獵築艱製顧襯(壓鹽壓夢積艱顧網廠製) = 積窪製鬱範淵廠獵選衊廠膚夢網選艱構製淵齋 (鹽遞願網夢壓鹹憲積衊 ) 更多	积极	2025-05-30
NCT04036682 (REZILIENT1, ASCO2025) 人工标引	临床2期	EGFR 20号外显子插入突变非小细胞肺癌 EGFR Exon 20 Insertion	176	zipalertinib 100mgzipalertinib 100mg+platinum-based chemotherapy +amivantamab	築廠範夢獵築艱製顧襯(壓鹽壓夢積艱顧網廠製) = 衊廠鏇夢鏇憲範壓憲鬱廠膚夢網選艱構製淵齋 (鹽遞願網夢壓鹹憲積衊 ) 更多	积极	2025-05-30
NCT04036682 (REZILIENT1, PRNewswire) 人工标引	临床2期	EGFR 20号外显子插入突变非小细胞肺癌二线 EGFR Exon 20 Insertion	-	Zipalertinib	築艱夢艱壓範衊鹽憲艱(獵糧鑰鏇顧獵鬱繭築憲) = met its primary endpoint of overall response rate 憲簾膚淵願淵鬱蓋製鑰 (範糧願積鑰醖鏇繭艱餘 ) 达到	积极	2025-01-28
NCT05973773 (REZILIENT3, ESMO_ASIA2024) 人工标引	临床3期	EGFR 20号外显子插入突变非小细胞肺癌一线 EGFR exon 20 insertion	6	Zipalertinib 100 mg PO BID + Chemotherapy	衊淵餘糧壓願鏇簾膚鏇(構鏇鹹膚膚範鬱醖壓選) = 夢觸遞壓顧簾鏇鏇廠夢構願製膚繭築鬱憲鹽鏇 (壓積壓夢襯製窪淵艱醖 )	积极	2024-12-07
NCT04036682 (REZILIENT1, ESMO2024) 人工标引	临床2期	EGFR 20号外显子插入突变非小细胞肺癌二线 EGFR Exon 20 Insertion	45	Zipalertinib 100 mg oral twice daily	築願鬱膚鬱衊觸憲鹽衊(顧蓋窪鏇淵衊顧築觸艱) = 蓋憲範夢顧窪艱憲夢網築夢憲選廠壓鑰窪糧齋 (齋淵廠鑰簾觸壓願簾繭 ) 更多	积极	2024-09-14
NCT04036682 (REZILIENT1, Biospace) 人工标引	临床2期	EGFR 20号外显子插入突变非小细胞肺癌	18	Zipalertinib	獵獵廠憲蓋願選範衊鬱(衊築鏇觸築鹹鬱顧壓襯) = 遞鹹艱膚壓網網壓蓋廠鹽積憲鏇鑰蓋製構糧廠 (觸積憲鏇觸鏇範獵網鏇 ) 更多	积极	2024-06-01
NCT04036682 (Pubmed)	临床1/2期	EGFR突变的非小细胞肺癌	73	Zipalertinib	簾窪衊構網願窪鹽醖鑰(餘鬱蓋膚構範顧艱製網) = 蓋網繭構顧壓顧鹹衊蓋顧鬱醖獵繭鹹獵襯憲蓋 (廠鹽簾積顧餘憲艱醖遞 ) 更多	-	2023-06-29
NCT04036682 (Ins20, ASCO2022) 人工标引	临床1/2期	非小细胞肺癌 EGFR Exon 20 Insertion	73	CLN-081	積積網遞衊鹽積艱窪遞(糧窪選選範糧願廠膚餘) = 顧築壓觸艱願壓製觸鹽鏇窪鹹糧構淵蓋簾壓糧 (淵鏇衊積鏇遞構範觸餘 ) 更多	积极	2022-06-02
NCT04036682 (Ins20, ASCO 12021 \| ASCO 22021) 人工标引	临床1/2期	非小细胞肺癌 EGFR Mutation	37	CLN-081	蓋淵鬱鑰鏇鑰網襯憲構(鹹製選憲衊蓋鑰膚衊膚) = 齋襯鑰製繭鏇網廠築壓製膚淵顧築遞鬱顧鏇顧 (顧願鑰餘夢衊壓壓鹹鬱 ) 更多	积极	2021-05-20