Soquelitinib

Trial is evaluating ciforadenant as a potential first line therapy for metastatic renal cell cancer (RCC) in combination with ipilimumab (anti-CTLA-4) and nivolumab (anti-PD-1) Interim data shows triplet therapy with ciforadenant, ipilimumab and nivolumab is feasible and well tolerated; longer follow-up with patients still on therapy needed to determine potential benefit of blocking adenosine signaling SOUTH SAN FRANCISCO, Calif.,, Oct. 17, 2025 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, today announced that interim data from the Phase 1b/2 clinical trial of ciforadenant for patients with metastatic renal cell cancer (RCC) will be presented today in an oral presentation at the European Society for Medical Oncology (ESMO) Congress 2025, which is taking place October 17-21, 2025 in Berlin, Germany. The data will be presented by Katy Beckermann, M.D., Ph.D., Director of Genitourinary Cancer Research at Tennessee Oncology and member of the Kidney Cancer Research Consortium (KCRC), the group that is conducting the trial in collaboration with Corvus. “We are encouraged by these results exploring ciforadenant in combination with ipilimumab and nivolumab as a potential front-line treatment for renal cell carcinoma,” said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. “Despite enrolling patients with more unfavorable disease compared to historical trials, the triplet combination demonstrated activity that compares favorably to historical results with the doublet alone. These data support our view that blocking adenosine signaling with ciforadenant may provide meaningful benefit for RCC patients. We appreciate the partnership with the Kidney Cancer Research Consortium and we look forward to continuing to follow the 19 patients who remain on therapy to better understand the potential of this approach.” The open-label Phase 1b/2 clinical trial is evaluating ciforadenant, the Company’s adenosine A2a receptor inhibitor, as a potential first line therapy for metastatic RCC in combination with ipilimumab (anti-CTLA-4) and nivolumab (anti-PD-1). The trial enrolled 50 patients (8 in Phase 1b portion, 42 in Phase 2 portion) with newly diagnosed or recurrent stage IV clear cell RCC that had not received any prior systemic therapy. Patients received ciforadenant 100 mg oral, twice-daily in combination with ipilimumab (anti-CTLA-4) 1mg/kg given once every three weeks for twelve weeks (4 doses) and nivolumab (anti-PD-1) 3mg/kg given once every three weeks. The primary endpoint for the Phase 1b portion is safety, tolerability and anti-tumor response. The primary endpoint for the Phase 2 portion is the percent of patients that achieve a deep response, defined as complete response or depth of partial response of >50% tumor volume reduction. Historical data from the Kidney Cancer Research Consortium has shown that deep responses correlate with prolonged progression free survival and that they occur in approximately 32% of patients receiving ipilimumab and nivolumab. Secondary endpoints for the Phase 2 portion include objective response rate (ORR), progression-free survival (PFS) and treatment-related adverse events. The interim data being presented at ESMO demonstrates that triplet therapy with ciforadenant, ipilimumab and nivolumab is feasible and well tolerated. Key highlights from the presentation (data as of May 2025) include: Patients in the trial had a median age of 61.5 years (53-70 years range) and had unfavorable disease characteristics, with only 54% having a prior nephrectomy (~75-85% is typical for studies involving similar patients). Nephrectomy is associated with improved outcomes in advanced RCC and is often not performed in patients with poor prognosis. In addition, 82% of patients in the trial had a poor or intermediate prognosis by International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) criteria.The treatment was well-tolerated, in-line with the safety profile of combination treatment with ipilimumab and nivolumab.The deep response rate was 34%, demonstrating an improvement compared to historical data for the combination of ipilimumab and nivolumab alone, though not statistically significant at this point in time. 19 patients with stable or responding disease remain on therapy with the potential to achieve deep responses.The ORR by was 46%, including two complete responses and 21 partial responses. The median PFS is 11.04 months. Dr. Beckermann commented, “Early results from this trial are encouraging, demonstrating consistent efficacy and favorable safety in a challenging RCC population, and we look forward to data from the 19 patients still on treatment.” About Corvus PharmaceuticalsCorvus Pharmaceuticals is a clinical-stage biopharmaceutical company pioneering the development of ITK inhibition as a new approach to immunotherapy for a broad range of cancer and immune diseases. The Company’s lead product candidate is soquelitinib, an investigational, oral, small molecule drug that selectively inhibits ITK. Its other clinical-stage candidates are being developed for a variety of cancer indications. For more information, visit www.corvuspharma.com or follow the Company on LinkedIn. About CiforadenantCiforadenant (CPI-444) is an investigational small molecule, oral, checkpoint inhibitor designed to disable a tumor’s ability to subvert attack by the immune system by blocking the binding of adenosine to immune cells present in the tumor microenvironment. Adenosine, a metabolite of ATP (adenosine tri-phosphate), is produced within the tumor microenvironment where it may bind to the adenosine A2a receptor present on immune cells and block their activity. Ciforadenant has been shown to block the immunosuppressive effects of myeloid cells present in tumors and preclinical studies published in 2018 demonstrated synergy with combinations of anti PD1 and anti-CTLA4 antibodies. Forward-Looking StatementsThis press release contains forward-looking statements, including statements related to the potential safety and efficacy of the Company’s product candidates; the interim results from the Phase 1b/2 clinical trial in patients with metastatic RCC, including feasibility, tolerability and potential to achieve deep responses; ongoing conduct of the trial; and potential benefits for RCC patients; . All statements other than statements of historical fact contained in this press release are forward-looking statements. These statements often include words such as “believe,” “expect,” “anticipate,” “intend,” “plan,” “estimate,” “seek,” “will,” “may” or similar expressions. Forward-looking statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances that are beyond the Company’s control. The Company’s actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including but not limited to, risks detailed in the Company’s Quarterly Report on Form 10-Q for the second quarter ended June 30, 2025, filed with the Securities and Exchange Commission on August 7, 2025, as well as other documents that may be filed by the Company from time to time with the Securities and Exchange Commission. In particular, the following factors, among others, could cause results to differ materially from those expressed or implied by such forward-looking statements: the Company’s ability to demonstrate sufficient evidence of efficacy and safety in its clinical trials of its product candidates; the accuracy of the Company’s estimates relating to its ability to initiate and/or complete preclinical studies and clinical trials and release data from such studies and clinical trials; the results of preclinical studies and interim data from clinical trials not being predictive of future results; the Company’s ability to enroll sufficient numbers of patients in its clinical trials; the unpredictability of the regulatory process; regulatory developments in the United States and foreign countries; the costs of clinical trials may exceed expectations; the Company’s ability to accurately estimate the cash on hand providing funding into the fourth quarter of 2026 and the Company’s ability to raise additional capital. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee that the events and circumstances reflected in the forward-looking statements will be achieved or occur, and the timing of events and circumstances and actual results could differ materially from those projected in the forward-looking statements. Accordingly, you should not place undue reliance on these forward-looking statements. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise. INVESTOR CONTACT:Leiv LeaChief Financial OfficerCorvus Pharmaceuticals, Inc.+1-650-900-4522llea@corvuspharma.com MEDIA CONTACT:Sheryl SeapyReal Chemistry+1-949-903-4750sseapy@realchemistry.com

编者按：淋巴瘤作为最常见的血液肿瘤，近年来在病理机制研究和创新疗法开发上进展显著。全球已有数十款创新药物获批，使其成为控制率和治愈率最高的恶性肿瘤之一。然而，该领域仍存在诸多挑战。科学界正积极研发更多治疗手段，旨在提升患者生存期与生活质量，向“治愈”目标不断迈进。目前，尚有数百款在研新药处于临床阶段，持续拓展淋巴瘤治疗的潜力。作为全球医药及生命科学行业值得信赖的合作伙伴和重要贡献者，药明康德在25年发展历程中，很荣幸见证了包括淋巴瘤在内的各类癌症创新疗法从实验室到临床应用的突破历程，更通过提供一体化、端到端的新药研发和生产服务，助力全球合作伙伴加速多款淋巴瘤创新疗法的研发进程，造福病患。 淋巴瘤是一类起源于淋巴系统的恶性肿瘤，主要分为霍奇金淋巴瘤（HL，约占10%）和非霍奇金淋巴瘤（NHL，约占90%）两大类，其中B细胞淋巴瘤又占NHL的85%以上。 当前，淋巴瘤已成为控制率、治愈率最高的恶性肿瘤之一。临床研究数据显示，在多种治疗方案的加持下，当前霍奇金淋巴瘤的治愈率（治愈通常指肿瘤消失且长期不复发）已经能达到75%~80%，早期患者甚至可达90%以上。针对最常见的B细胞淋巴瘤，标准一线治疗方案带来的临床治愈率也可达到70%以上。 与此同时，科学界仍在探索更多的治疗手段，旨在进一步提升淋巴瘤患者的生存期和生活质量，向“治愈癌症”的终极目标迈进。数据显示，当下还有数百款在研新药处于临床研究阶段，以探索治疗各类淋巴瘤的潜力。它们不仅涵盖CD38、CD22、CD47、ROR1、ITK等新靶点，还涵盖了丰富的分子类型，包括小分子抑制剂、靶向蛋白降解剂、抗体、双靶点CAR-T、核酸、多肽等。 2025年以来，淋巴瘤新药研发领域也取得多项新进展，涉及小分子靶向药、蛋白降解疗法、抗体、ADC等等，不断涌现的新治疗方案正在为患者带来新的希望。 图片来源：123RF 小分子靶向疗法持续突破，新靶点崭露头角 BTK抑制剂的问世是淋巴瘤治疗领域的里程碑，显著改变了该疾病的治疗格局。全球已有多个BTK抑制剂获批，治疗多种类型的淋巴瘤。在该领域，2025年也迎来新进展，多款新药持续拓展新适应症： 阿斯利康（AstraZeneca）于5月宣布其BTK抑制剂Calquence（阿可替尼，acalabrutinib）联合苯达莫司汀和利妥昔单抗的方案，已在欧盟获批用于不适合自体造血干细胞移植的初治套细胞淋巴瘤（MCL）成人患者。该组合疗法用于该适应症也于今年1月获美国FDA批准，成为首个获批用于MCL一线治疗的BTK抑制剂。 礼来公司（Eli Lilly and Company）非共价选择性BTK抑制剂Jaypirca（匹妥布替尼，pirtobrutinib）也迎新进展：7月，该产品在针对慢性淋巴细胞白血病或小淋巴细胞淋巴瘤（CLL/SLL）患者的BRUIN CLL-314临床3期试验中取得积极顶线结果；9月，该产品在治疗初治CLL/SLL患者的BRUIN CLL-313临床3期试验中取得积极顶线结果。基于两项研究的结果，礼来计划于今年内启动全球范围的监管申报，拓展该药物治疗群体。 除了BTK抑制剂，还有多项创新靶点小分子药物于今年陆续披露早期临床数据，尤其是针对复发/难治性淋巴瘤治疗： 7月，Lantern Pharma公布其在研药物LP-284的1期试验结果：一例多次治疗失败的弥漫性大B细胞淋巴瘤患者，经LP-284治疗两个周期后达到完全代谢缓解。LP-284是一种新一代酰基富烯类化合物，通过合成致死机制靶向DNA损伤修复缺陷的癌细胞。 Schrödinger于6月报告其口服MALT1抑制剂SGR-1505的1期试验积极结果。该药靶向NF-κB信号通路关键节点MALT1，旨在阻断癌细胞存活与增殖。在45例可评估疗效的复发/难治性B细胞恶性肿瘤患者中，总缓解率（ORR）为22%，并在多种亚型中观察到缓解，包括部分经BTK或BCL-2抑制剂治疗失败的患者。 再如，Corvus Pharmaceuticals于3月公布了ITK抑制剂soquelitinib治疗T细胞淋巴瘤的1/1b期试验数据。在23例可评估患者中，9例（39%）达客观缓解，包括6例完全缓解和3例部分缓解。Soquelitinib可抑制T细胞和NK细胞中的ITK激酶，从而调控免疫及炎症反应。 缓解率达94%！蛋白降解疗法多项早期临床数据公布 在小分子新药研发领域，蛋白降解疗法近年来“异军突起”，持续展现临床治疗潜力。针对淋巴瘤治疗，当下也有数十款蛋白降解疗法进入临床研究阶段，靶点涵盖了BTK、BCL2L1、BRD4、BCL6等等。2025年以来，该领域多款新药公布最新的临床进展： 6月，Nurix Therapeutics公布了其具有穿越血脑屏障能力的口服小分子BTK蛋白降解剂bexobrutideg的1a/1b期临床试验新数据：在47例可评估的复发/难治性CLL患者中，客观缓解率（ORR）达80.9%；在19例可评估华氏巨球蛋白血症患者中，ORR为84.2%。 同期，百时美施贵宝在欧洲血液学协会（EHA）年会上展示了其蛋白降解剂研发进展。其中，分子胶药物golcadomide联合利妥昔单抗治疗复发/难治性滤泡性淋巴瘤疗效显著，ORR达94%，CR率为63%。此外，口服BCL6降解剂BMS-986458在非霍奇金淋巴瘤中的初步结果也获公布：该研究纳入31例重度经治患者，在外周血和肿瘤组织中均观察到BCL6快速持久降解。在21例可评估疗效患者中，ORR为81%，CR率为23.8%。 100%疾病控制率！新型抗体治疗特殊淋巴瘤试验结果亮眼 淋巴瘤抗体药物领域，今年同样取得多项新进展，多款已上市产品相继拓展新适应症或提交相关申请： 今年8月，Genmab与艾伯维共同宣布，美国FDA已受理CD3/CD20双抗Epkinly（艾可瑞妥单抗，epcoritamab）联合R2方案用于至少接受过一种系统治疗的复发/难治性滤泡性淋巴瘤（R/R FL）患者的补充生物制品许可申请（sBLA），并授予优先审评资格。该申请基于首次中期分析数据，显示联合疗法总缓解率达95.7%，无进展生存期亦显著改善。若获批，该方案有望成为首个用于R/R FL二线治疗的双特异性抗体组合疗法。 罗氏（Roche）于今年6月公布了3期SUNMO研究结果，其CD20/CD3靶向双特异性抗体Lunsumio（莫妥珠单抗，mosunetuzumab）联合ADC药物Polivy（维泊妥珠单抗，polatuzumab vedotin）在无法接受干细胞移植的R/R大B细胞淋巴瘤患者中，相较于R-GemOx方案，无进展生存期与客观缓解率均获显著改善。罗氏计划向全球监管机构提交该数据。 此外，罗氏另一款CD3/CD20双特异性抗体Columvi（格菲妥单抗，glofitamab）于今年4月获欧盟委员会批准，联合化疗用于不适合自体干细胞移植的R/R弥漫性大B细胞淋巴瘤成人患者。 同样在6月，Incyte宣布其CD19靶向单抗Monjuvi（坦昔妥单抗，tafasitamab）获美国FDA批准，联合利妥昔单抗与来那度胺用于R/R滤泡性淋巴瘤成人患者。 辉瑞（Pfizer）公司旗下Seagen开发的CD30靶向ADC药物Adcetris（维布妥昔单抗，brentuximab vedotin）则于今年2月获FDA批准，联合来那度胺与利妥昔单抗，用于经两线及以上治疗且不适合干细胞移植或CAR-T治疗的R/R大B细胞淋巴瘤成人患者。 此外，还有多款在研抗体及ADC新药公布新的临床进展： 5月，默沙东（MSD）公布其在研靶向ROR1的ADC药物zilovertamab vedotin联合R-GemOx治疗复发/难治性弥漫大B细胞淋巴瘤的2/3期研究结果。在1.75 mg/kg剂量组中，客观缓解率为56.3%。 4月，ALX Oncology公布其下一代CD47阻断疗法evorpacept联合R²方案治疗复发/难治性B细胞非霍奇金淋巴瘤的1/2期研究数据：联合组（n=20）两年无进展生存率为69%，两年OS率为84%；完全缓解（CR）率为80%，最佳总缓解率为90%。在18例惰性NHL患者中，CR率达83%（这也意味着80%的患者癌细胞“完全消失”），显著高于历史对照（R²方案为34%）。Evorpacept采用经工程改造的Fc结构域，旨在降低CD47靶向相关毒副作用。 还有在研新药针对特殊类型淋巴瘤取得亮眼数据： 比如，6月，BioInvent International公布其抗TNFR2抗体BI-1808单药治疗皮肤T细胞淋巴瘤（CTCL）的2a期研究数据：在9例可评估CTCL患者中，疾病控制率达100%，其中1例完全缓解、3例部分缓解、5例疾病稳定。 再如，Innate Pharma今年2月宣布其KIR3DL2靶向抗体lacutamab获FDA突破性疗法认定，用于经至少两种系统治疗后的复发/难治性Sézary综合征成人患者。该病为CTCL常见亚型，高达90%的Sézary综合征患者表达KIR3DL2。 今年以来，还有其他多款创新药在淋巴瘤治疗领域取得新进展，此处不再一一列举，很高兴看到该领域丰富的创新疗法涌现，为患者带来新的希望。 一体化平台赋能淋巴瘤新药开发 作为全球医药创新的赋能者，药明康德很高兴能助力合作伙伴，加速多款治疗血液肿瘤的创新疗法问世，造福病患。长期以来，药明康德都在支持全球合作伙伴从药物研究（R）、开发（D）到商业化生产（M）各个阶段的需求，通过独特的一体化、端到端CRDMO模式，助力更多药物加速从实验室来到患者身边。过去25年间，全球监管机构批准了几十款淋巴瘤创新疗法，其中不少新药还获批多个淋巴瘤适应症。作为创新的赋能者，药明康德很高兴能为其中多款疗法提供赋能，助力合作伙伴的这些创新疗法来到全球患者身边。 在抗击淋巴瘤的征程中，每一项重大突破的背后，都凝聚着科学家挑战成规的远见与勇气，也离不开从学术界到产业界在转化医学中的紧密协作。期待更多的突破性进展出现，药明康德也期待与业界同仁继续同行，助力让更多创新疗法来到患者身边。 参考资料： [1] Eyre TA et al.(2025)ESMO Guidelines Committee. Lymphomas: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. doi: 10.1016/j.annonc.2025.07.014.  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「医药观澜」微信公众号回复“转载”，获取转载须知。