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更新于：2026-02-28
Vilastobart
更新于：2026-02-28
概要
基本信息
最高研发阶段临床1/2期 |
首次获批日期- |
最高研发阶段(中国)- |
特殊审评- |
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结构/序列
Sequence Code 523914763H
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Sequence Code 565455358L
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关联
1
项与 Vilastobart 相关的临床试验NCT04896697
A First-in-Human, Multicenter, Phase 1/2, Open-Label Study of Vilastobart (XTX101) Monotherapy and Vilastobart (XTX101) and Atezolizumab Combination Therapy in Patients With Advanced Solid Tumors
This is a first-in-human, Phase 1/2, multicenter, open-label study designed to evaluate the safety and tolerability of vilastobart (XTX101) as monotherapy and vilastobart (XTX101) and atezolizumab combination therapy in patients with advanced solid tumors.
开始日期2021-09-13 |
申办/合作机构 |
100 项与 Vilastobart 相关的临床结果
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100 项与 Vilastobart 相关的转化医学
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100 项与 Vilastobart 相关的专利（医药）
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1
项与 Vilastobart 相关的文献（医药）2023-12-01·Journal for immunotherapy of cancer
XTX101, a tumor-activated, Fc-enhanced anti-CTLA-4 monoclonal antibody, demonstrates tumor-growth inhibition and tumor-selective pharmacodynamics in mouse models of cancer
Article
作者: Liu, Zhen ; Guzman, Wilson ; Park, Miso ; Moore-Lai, Deborah ; Clackson, Tim ; Eskiocak, Ugur ; Flesch, Veronica ; Nicholson, Benjamin ; O’Toole, Caitlin ; Qiu, Huawei ; McLaughlin, Megan ; Johnson, Parker ; Jenkins, Kurt A ; O’Hagan, Ronan C ; Rodeck, Ulrich ; Pederzoli-Ribeil, Magali ; O’Neil, Jennifer ; Williams, John C ; Karow, Margaret
Introduction:
The clinical benefit of the anti-CTLA-4 monoclonal antibody (mAb) ipilimumab has been well established but limited by immune-related adverse events, especially when ipilimumab is used in combination with anti-PD-(L)1 mAb therapy. To overcome these limitations, we have developed XTX101, a tumor-activated, Fc-enhanced anti-CTLA-4 mAb.
Methods:
XTX101 consists of an anti-human CTLA-4 mAb covalently linked to masking peptides that block the complementarity-determining regions, thereby minimizing the mAb binding to CTLA-4. The masking peptides are designed to be released by proteases that are typically dysregulated within the tumor microenvironment (TME), resulting in activation of XTX101 intratumorally. Mutations within the Fc region of XTX101 were included to enhance affinity for FcγRIII, which is expected to enhance potency through antibody-dependent cellular cytotoxicity.
Results:
Biophysical, biochemical, and cell-based assays demonstrate that the function of XTX101 depends on proteolytic activation. In human CTLA-4 transgenic mice, XTX101 monotherapy demonstrated significant tumor growth inhibition (TGI) including complete responses, increased intratumoral CD8+T cells, and regulatory T cell depletion within the TME while maintaining minimal pharmacodynamic effects in the periphery. XTX101 in combination with anti-PD-1 mAb treatment resulted in significant TGI and was well tolerated in mice. XTX101 was activated in primary human tumors across a range of tumor types including melanoma, renal cell carcinoma, colon cancer and lung cancer in an ex vivo assay system.
Conclusions:
These data demonstrate that XTX101 retains the full potency of an Fc-enhanced CTLA-4 antagonist within the TME while minimizing the activity in non-tumor tissue, supporting the further evaluation of XTX101 in clinical studies.
65
项与 Vilastobart 相关的新闻（医药）2026-01-08
Received $35.8 million in gross proceeds from Series B warrant exercises, including full exercise by Coastlands Capital, Frazier Life Sciences and Gilead Sciences, Inc., and extended anticipated cash runway into second quarter of 2027
Achieved development milestone for masked antibody-based program under AbbVie agreement
Nominated development candidate for wholly-owned masked T cell engager program targeting CLDN18.2
Appoints Sara Bonstein as chair of board of directors
WALTHAM, Mass., Jan. 08, 2026 (GLOBE NEWSWIRE) -- Xilio Therapeutics, Inc. (Nasdaq: XLO), a clinical-stage biotechnology company discovering and developing masked immuno-oncology therapies for people living with cancer, today highlighted upcoming milestones and recent corporate updates.
“2025 was marked by robust execution at Xilio as we delivered on key priorities across our deep portfolio of differentiated I-O therapies, demonstrated additional clinical validation of our masking technology and further strengthened our financial position through strategic partnerships and our recent equity financing,” said René Russo, Pharm.D., president and chief executive officer of Xilio. “In the year ahead, we have a strong foundation to advance our potential best-in-class bispecific PD-1/IL-2 and T cell engager programs toward the clinic and maximize the value of our vilastobart and efarindodekin alfa programs through strategic partnerships.”
Xilio also announced the appointment of Sara Bonstein as chair of the board of directors, following the retirement of Paul Clancy. Dr. Russo continued, “Sara has been an invaluable member of our board since 2021 and brings more than two decades of executive leadership in finance, corporate strategy and business operations in the biotechnology industry, as well as extensive experience advancing novel therapies from discovery through commercialization. I look forward to continuing to partner with Sara as we advance our pipeline of masked immuno-oncology therapies through development. On behalf of the entire board, I’d also like to express my gratitude to Paul for his leadership and contributions as chair, which have been instrumental in helping shape Xilio over the past five years.”
Ms. Bonstein added, “During my tenure, Xilio has made significant progress demonstrating validation for its novel masking technology through strategic partnerships with Gilead and AbbVie as well as promising clinical data for its most advanced programs. I am excited to chair the board and look forward to working closely with the management team to advance the company’s deep portfolio of differentiated I-O therapies.”
Corporate Updates
In January 2026, Xilio announced the receipt of $35.8 million in gross proceeds from the exercise of Series B warrants, before deducting underwriting discounts and commissions and any offering expenses, including the full exercise of Series B warrants held by Coastlands Capital, Frazier Life Sciences and Gilead Sciences, Inc. The Series B warrants were issued in connection with a follow-on public offering in June 2025.
Xilio today announced:
The achievement of a development milestone related to the masked antibody-based immunotherapy program under the company’s collaboration, license and option agreement with AbbVie. The nomination of a development candidate for its masked T cell engager program targeting the tumor-associated antigen for CLDN18.2, which has broad potential as a target for gastric, pancreatic, esophageal and lung cancers. The appointment of Sara M. Bonstein as chair of the board of directors of Xilio. Ms. Bonstein has served as a member of Xilio’s board of directors since August 2021 and succeeds Paul Clancy, who retired from the board of directors on January 6, 2026. Ms. Bonstein has more than 10 years of experience as a chief financial officer for public biotechnology companies, and she currently serves as chief financial officer of Insmed, Inc. where she oversees key financial functions including capital raising, investor relations, accounting, treasury, financial planning and analysis and procurement. Earlier in her career, Ms. Bonstein held finance roles of increasing responsibility at Eli Lilly & Company and Johnson & Johnson. Ms. Bonstein holds a B.S. in finance from The College of New Jersey and an M.B.A. from Rider University.
Anticipated Milestones
Xilio’s anticipated upcoming milestones include:
Submit an investigational new drug (IND) application for XTX501 in the middle of 2026 Report initial Phase 1 data for XTX501 in the second half of 2027, subject to clearance of the IND by the U.S. Food and Drug Administration Nominate a development candidate for the STEAP1 program (masked T cell engager with co-stimulation) in the first half of 2026 Advance at least two masked T cell engager programs into IND-enabling studies and submit IND applications for those programs in 2027 Deliver the Phase 1/2 option data package to Gilead for the efarindodekin alfa program in the first half of 2027
Financial Guidance
As of December 31, 2025, Xilio estimates that it had cash and cash equivalents of $137.5 million, including $35.8 million in gross proceeds received in the fourth quarter of 2025 from the exercise of Series B warrants.
Based on its current operating plans, Xilio anticipates that its cash and cash equivalents as of December 31, 2025 will be sufficient to enable it to fund its operating expenses and capital expenditure requirements into the second quarter of 2027.
The cash and cash equivalents information provided above is based on preliminary unaudited information and management estimates for the year ended December 31, 2025, is not a comprehensive statement of the company’s financial results as of and for the fiscal year ended December 31, 2025 and may change. Xilio’s independent registered public accounting firm has not conducted an audit or review of, and does not express an opinion or any other form of assurance with respect to, this preliminary estimate.
About Xilio Therapeutics
Xilio Therapeutics is a clinical-stage biotechnology company discovering and developing masked immuno-oncology (I-O) therapies with the goal of significantly improving outcomes for people living with cancer without the systemic side effects of current I-O treatments. The company is leveraging its proprietary masking technology to advance a pipeline of novel, masked I-O molecules that are designed to optimize the therapeutic index by localizing anti-tumor activity within the tumor microenvironment. Learn more by visiting www.xiliotx.com and follow us on LinkedIn (Xilio Therapeutics, Inc.).
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding plans, expectations, development timelines and anticipated milestones for Xilio’s programs; the timing of data releases or program updates; the potential of Xilio’s programs or platform; the timing and receipt of future contingent payments under Xilio’s collaboration agreements with AbbVie or Gilead; Xilio’s estimated cash and cash equivalents and the sufficiency of, and period in which, Xilio expects to be able to fund its operations and capital expenditure requirements; and Xilio’s strategy, goals and anticipated financial performance, milestones, business plans and focus. The words “aim,” “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “seek,” “target” 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 and are subject to a number of important risks, uncertainties and other factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks related to general market conditions and geopolitical uncertainties; risks and uncertainties related to ongoing and planned research and development activities, including initiating, conducting or completing preclinical studies and clinical trials and the timing and results of such preclinical studies or clinical trials; the delay of any current or planned preclinical studies or clinical trials or the development of Xilio’s current or future product candidates; Xilio’s ability to obtain and maintain sufficient preclinical and clinical supply of current or future product candidates; Xilio’s ability to advance multiple early stage masked T cell engager programs; initial, preliminary, interim or retrospective preclinical or clinical data or results may not be replicated in or predictive of future preclinical or clinical data or results; Xilio’s ability to successfully demonstrate the safety and efficacy of its product candidates and gain approval of its product candidates on a timely basis, if at all; results from preclinical studies or clinical trials for Xilio’s product candidates may not support further development of such product candidates; actions of regulatory agencies may affect the initiation, timing and progress of current or future clinical trials; Xilio’s ability to obtain, maintain and enforce patent and other intellectual property protection for current or future product candidates; Xilio’s need to obtain additional cash resources to advance its pipeline of tumor-activated I-O molecules; the impact of international trade policies on Xilio’s business, including U.S. and China trade policies; and Xilio’s ability to maintain its collaboration or partnership agreements with AbbVie, Gilead and Roche. These and other risks and uncertainties are described in greater detail in the sections entitled “Risk Factor Summary” and “Risk Factors” in Xilio’s filings with the U.S. Securities and Exchange Commission (SEC), including Xilio’s most recent Quarterly Report on Form 10-Q and any other filings that Xilio has made or may make with the SEC in the future. Any forward-looking statements contained in this press release represent Xilio’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Except as required by law, Xilio explicitly disclaims any obligation to update any forward-looking statements.
This press release contains hyperlinks to information that is not deemed to be incorporated by reference in this press release.
Investor Contact Alex Lobo, Precision AQ alex.lobo@precisionaq.com
Media Contact Josie Butler, 1AB josie@1abmedia.com
高管变更引进/卖出免疫疗法财报临床1期
2025-12-21
·研发客
• 天演的安全抗体产品通过“只对肿瘤亮剑，不对患者出手” 突破CTLA-4抗体高剂量伴随严重毒性这一关键瓶颈；
• 在高剂量下，ADG126首次实现了ORR与OS的一致性——短期应答与长期生存齐头并进，这是以往CTLA-4类药物中罕见的特征；
• 从免疫“冻土”破冰：以Treg调控撬动PD-1无效肿瘤，开启广谱双免治疗新路径；
• 在三体抗体平台的技术基础上，今年天演药业已与赛诺菲、Third Arc Bio等MNC及Biotech公司建立起合作伙伴关系。
今年的诺贝尔生理学或医学奖花落调节性T细胞（Treg）在外周免疫耐受方面的研究，为CTLA-4等与Treg密切相关的靶向疗法提供了新的机制解读视角。这也为天演药业近十年来持续推进的肿瘤选择性 CTLA-4 靶向策略，提供了重要的科学依据。
过去十年间，天演药业围绕“如何在激活抗肿瘤免疫的同时尽可能降低自身免疫风险”这一关键挑战，从基础研究出发，逐步将技术理念推进至临床阶段。如今，天演药业的核心产品CTLA-4安全抗体ADG126已获得临床验证：在微卫星稳定型转移性结直肠癌（MSS mCRC）这种对PD-1类疗法没有响应的“冷肿瘤”人群中，相对现有标准疗法，ADG126通过更高暴露和重复给药，实现对肿瘤内Treg的选择性清除，在疗效显著提高的同时仍保持良好的安全性。
而根据早期可替代终点的临床获益，近日ADG126联合KEYTRUDA获得FDA授予的快速通道资格，进一步支持了基于安全抗体（SAFEbody®）技术平台的抗CTLA-4疗法在MSS CRC这一高度未满足人群中的开发潜力。
CTLA-4是最早被验证的免疫检查点之一。从首个CTLA-4抗体伊匹木单抗（ipilimumab）2011年获批上市至今，已有多个基于CTLA-4疗法的长期生存获益而获批上市，PD-1与CTLA-4的双免疫组合一直是重要研究方向之一。然而，CTLA-4抗体的发展始终受限于治疗窗口狭窄——疗效所需的高剂量往往伴随严重毒性，剂量与安全性的矛盾，成为这一靶点难以突破的关键瓶颈。
天演应对这一挑战的核心思路是“肿瘤内激活、外周尽量克制”，或者形象地说是“只对肿瘤亮剑，不对患者出手”（“Attack the tumor — not the patient.”）。其安全抗体产品在高剂量重复给药下在外周组织中保持相对“沉默”，并在肿瘤微环境中实现选择性激活，从而促进CTLA-4介导的肿瘤内Treg清除，并对效应T细胞进行更为温和、可控的免疫启动。目的正是在提升抗肿瘤免疫效应的同时，降低传统免疫疗法中常见的系统性免疫相关不良反应风险。
免疫肿瘤学先驱Axel Hoos博士表示，“天演开发的ADG126仅在进入肿瘤微环境后才与靶点结合，从而在提升疗效的同时显著降低系统性毒性，展现出比伊匹木单抗更强的肿瘤内Treg清除能力，有望打破传统CTLA-4疗法的毒性瓶颈，拓展其临床应用空间。”9月4日，Axel Hoos博士出任天演药业的执行顾问。 “Immuno-Oncology（免疫肿瘤学）”这一术语最早即由他提出，他曾主导了伊匹木单抗的临床开发。
“回望天演十多年的发展，从三体抗体平台的底层创新出发，到率先实现CTLA-4安全抗体在‘冷肿瘤’中精准清除Treg的全球性突破，我们始终坚持走一条艰难而正确的路。” 天演药业创始人罗培志博士说。
天演药业创始人 罗培志博士
“三体抗体平台”是天演自主开发的三个技术平台——NEObody™、SAFEbody®、POWERbody™。今年以来，在三体抗体平台的技术基础上，天演药业已与赛诺菲、Third Arc Bio等MNC及Biotech公司建立起合作伙伴关系，尤其赛诺菲还追加了最高可达2500万美元的战略投资，重点用于推动ADG126针对MSS CRC的Ⅱ期临床试验。
突破CTLA-4的剂量桎梏
正常情况下，Treg是免疫系统的调和者，可防止T细胞误伤自体组织，但在肿瘤环境中会被肿瘤俘获为帮凶，从“和平守护者” 沦为“免疫逃逸帮凶”。尽管 Treg 机制今年终获诺奖认可，但 BMS 与 CytomX 十余年来在 ipilimumab Probody 和 ADCC 增强型屏蔽抗体上的临床探索均告失败，表明在高剂量、连续给药条件下，开发兼具强效活性与良好安全性的抗 CTLA-4 抗体，已被业界普遍视为几乎不可能完成的任务。
罗培志表示，“想要实现持久的肿瘤控制，关键在于选择性清除肿瘤内部CTLA-4高表达的Treg细胞，打掉肿瘤赖以生存的保护伞。”
来源|天演药业
这是因为CTLA-4抗体具有明显的剂量依赖性——剂量越高疗效越强，但毒性也随之增加。纵观CTLA-4靶点的开发历史，堪称一部“剂量与毒性博弈史”。正如罗培志所说，“如何在实现Treg清除的同时，避免系统性毒性，是CTLA-4抗体开发面临的最大挑战” 。
初代CTLA-4抗体伊匹木单抗既往的数据清楚地展示了这一点。如下图所示，在3 mg/kg和10 mg/kg剂量下，初期疗效曲线相近，9个月后10 mg/kg组的总生存期 (OS) 显著优于低剂量组，然而毒性也同步升高。其10 mg/kg剂量组的3级以上不良事件发生率超过30%，治疗相关不良事件引起的停药率高达24%，迫使临床中不得不采用低剂量方案，导致疗效受限。此外，当与PD-1药物联用时，虽显著提升疗效，却也导致毒性急剧升高，严重限制其临床应用。
本图来源于文献：Ascierto PA et al. Ipilimumab 10 mg/kg versus ipilimumab 3 mg/kg in patients with unresectable or metastatic melanoma: a randomised, double‑blind, multicentre, phase 3 trial. Lancet Oncol. 2017 May;18(5):611–622.
天演药业在研究中发现，只有当CTLA-4抗体浓度足够高时，才能在肿瘤内部达到所需的活性区域。而传统抗体在组织中的渗透能力本就有限，低剂量时往往无法达到肿瘤深部，从而导致疗效打折。传统CTLA-4抗体之所以不能真正释放全部治疗潜力，正是因为无法平衡这个矛盾。
“基于安全抗体技术，即使将抗体浓度提升至数个数量级，在体外活细胞实验中仍可保持功能沉默；而在体内研究中，安全抗体在高达常规剂量二十倍的条件下依然未被激活，仅在肿瘤微环境中实现特异性激活。这一机制显著拓宽了治疗窗口，构成了我们与传统 CTLA-4 抗体的本质差异。”罗培志表示。
以Xilio Therapeutics的候选产品Vilastobart为例，在其联合PD-L1单抗Tecentriq治疗MSS CRC的Ⅱ期研究中，最高剂量则不到1.5 mg/kg（假设受试者平均体重按照75 kg计算）。（见下图）
来源|Leerink Partners
“天演药业的CTLA-4安全抗体可以做到第一代CTLA-4药物未能实现的0到1的突破，对于第一代已经实现的适应症，天演药业的安全抗体则可以让它们变得更好。”罗培志表示。
他引用了一组具有代表性的数据，对比展示了ADG126在高风险适应症中的临床潜力。目前，已有一款CTLA-4联合疗法刚刚获批用于一线肝癌（1L HCC）治疗。在该方案中，伊匹木单抗使用3 mg/kg剂量时，虽实现了36%的客观缓解率（ORR）和接近两年的中位总生存期（mOS），但在临床干预中即便使用了大量的激素控制，其毒性仍相当显著——3级及以上治疗相关不良事件（TRAEs）发生率超过40%。
“相较之下，ADG126在MSS CRC这个更具挑战性的适应症中，患者在完全没有PD-1基础应答、原始ORR不足5%的背景下，接受20 mg/kg高剂量下的连续治疗，依然实现了近30%的ORR，经过剂量优化之后，可以让疗效与安全性同步得到提升（如20 mg/kg Q6W，≥3级TRAEs发生率低于20%）。”他进一步强调。
“这一效果并非单一机制所致，而是多重设计协同作用的结果：SAFEbody技术（在抗体的Fab端链接掩蔽肽）支持抗体在肿瘤内精准激活；表位增强的ADCC机制有助于促进肿瘤内Treg清除；同时，通过对CTLA-4的‘部分而非完全’阻断，实现更温和的免疫启动与更好的可控性。”罗培志告诉研发客，“上述组合使天演平台在作用机制上与传统CTLA-4抗体形成差异化，也为其在难治性实体瘤领域的进一步拓展打开了空间。”
肝细胞癌（HCC）是Treg高度富集的代表性实体瘤之一，而ADG126单药在临床中已展现出显著的肿瘤内Treg清除能力。“这使我们对与罗氏合作推进的三联（ADG126+ Atezo+Beva）对照标准二联疗法（Atezo+Beva）的试验充满信心——不仅有望在HCC中实现更优的疗效，也可能带来更可控的安全性，为患者提供更理想的治疗选择。”他表示。
在CTLA-4赛道中，除了CTLA-4单抗及其联合疗法外，PD-L1/CTLA-4双抗也是重要的研究方向之一，已有相关产品在临床上实现了一定程度的“减毒增效”。
对此，罗培志则认为，双抗的设计在减少毒性的同时会牺牲一定的疗效。在肿瘤耐受性方面，Treg是主要机制之一，Treg耗竭需要依赖抗体Fc段的功能。然而，目前多数双抗对Fc段采取了“沉默设计”，这样虽降低了系统毒性，却也丧失了ADCC等免疫效应细胞对Treg清除的重要功能。罗培志告诉研发客，“有研究数据显示，通过安全抗体技术设计的ADG126在没有额外Fc工程改造的情况下，其ADCC活性比一线产品还要高出10倍以上。”
啃下“硬骨头”
当多数竞争者聚焦于高PD-L1表达、病毒相关性强、T细胞浸润丰富的“免疫热肿瘤”人群时，天演药业却选择了从PD-L1表达极低同时Treg高表达的MSS CRC作为首发适应症，而且是针对最具挑战性的晚期三线患者群体。
MSS CRC可谓是已知最“冷”的肿瘤之一。约82%的患者PD-L1表达低于1%，肿瘤微环境中调节性T细胞（Treg）占比却高达40%，这意味着这类患者高度耐药，且传统免疫治疗如PD-1单药、PD-1单药联合第一代CTLA-4响应率近于零，而联合化疗或ADC的响应率仅为个位数。
“MSS CRC是PD-1疗法啃不动的‘硬骨头’，但也是通过靶向调控 Treg 以增强 PD-1 治疗应答这一差异化免疫调控机制的试金石。”罗培志表示，“通过CTLA-4清除Treg，上调PD-L1，为联合PD-1疗法创造机会，在这块最顽固的免疫‘冻土’上凿出第一道裂缝。”
在他看来，一旦在这一最具挑战性的、对PD-1疗法完全无效的难治患者群体中验证了疗效与安全性，并确证其瘤内Treg清除机制具有不可替代性——尤其是展现出剂量依赖性的响应特征，后续向免疫治疗更敏感的瘤种拓展将如春水破冰，势不可挡。
在市场潜力方面，罗培志认为将MSS CRC作为首发适应症具备相当的战略价值。以美国市场为例，无肝转移的三线及以上MSS CRC患者人群规模约为1万~1.3万人。在该患者亚组中，公司在研产品ADG126于10 mg/kg剂量下，在已获得的相对成熟数据中显示出较为积极的ORR、缓解持续时间（DoR）、无进展生存期（PFS）及中位总生存期（mOS）信号，并在20 mg/kg 剂量水平下进一步观察到相关疗效指标的改善趋势。随着患者生存获益及生活质量的提升，用药周期有望相应延长。
基于现有治疗方案的定价水平及合理治疗周期假设测算，该细分人群对应的潜在市场规模约处于十亿美元量级，显示出一定的商业发展空间。此外，ADG126双免疗法凭借宽阔的治疗窗，可与现有标准疗法联合使用以覆盖更多的患者（包括肝转移），还将拓展至更早治疗阶段，进一步打开市场空间。根据第三方机构Guggenheim的最新估计，仅美国市场晚线（3L+）转移性结直肠癌（mCRC）患者的整体市场规模可达约40亿美元。
在今年的ASCO上，天演药业更新了其CTLA-4安全抗体ADG126联合Keytruda治疗无肝转移晚期微卫星稳定型结直肠癌（MSS CRC）的Ⅰb/Ⅱ期数据。
在进一步的剂量探索中，ADG126展现出明确的剂量依赖疗效和良好的安全性。在10 mg/kg每3周一次的给药组中，ORR为17%；20 mg/kg 剂量下两个给药方案（20 mg/kg剂量组先行一次20 mg/kg负荷剂量，随后维持剂量10 mg/kg每3周一次或20 mg/kg每6周一次持续给药）均实现了29% ORR。其中，每6周一次给药的方案在维持疗效的同时，显著降低了不良事件的发生频率和严重程度，相较于先给予20 mg/kg负荷剂量、再转为每3周一次10 mg/kg的方案，耐受性更优。
更重要的是，该双免组合的疗效已开始转化为长期生存获益：10 mg/kg组的mOS达到19.4个月，显著优于当前标准治疗的历史数据（在12个月左右）。而20 mg/kg组的mOS尚未达到。
来源|天演药业
值得一提的是，研究中还有一列腹膜转移的患者同样实现了部分缓解（PR）。
来源|天演药业
基于最新的数据，天演药业还将探索ADG126双免与标准疗法联用在MSS CRC肝转移人群的效果，肝转移患者因肝脏免疫耐受微环境而需要借助标准疗法的协同作用增强对免疫治疗的响应。
曾被视为“硬骨头”的难治性肿瘤，在Treg清除型CTLA-4抗体联合PD-1双重作用下，正成为可被精准拿捏的“软柿子”。
“肝转移患者的现有标准疗法毒性较高，如呋喹替尼单药的严重不良反应率达36%~46%，这要求免疫疗法必须具备极高的安全性才能与之联用。我们的临床数据已初步证实，与传统的抗CTLA-4疗法相比，ADG126拥有的治疗窗口可以保障安全性，能够与标准疗法形成良性联用。目前该入组人群已经完成在有效剂量下的早期安全性及疗效评估。”罗培志解释说。
来源|天演药业
与FDA有效沟通剂量探索策略
2025ASCO上，天演药业详细披露了其在剂量探索方面的概念性框架。ADG126采用“高剂量诱导+低剂量维持”的递进式策略——初期以高剂量快速压制肿瘤，待病情稳定后切换至低剂量维持。
“这种策略源于我们对药代动力学（PK）和药效学（PD）的深度理解，” 罗培志解释道，“就像开车时‘先加速再巡航’，我们让药物在不同阶段发挥最佳效能，同时保护疗效窗口与患者耐受性。”
在年初天演药业与FDA召开的Ⅰ期临床完结会议（EOP1）上，FDA进一步确认了其诱导-维持治疗方案的合理性。FDA同意天演药业在临床中以高于其他抗CTLA-4抗体10~20倍的剂量（即10 mg/kg或20 mg/kg）探索ADG126，且不受ADG126给药周期限制，支持其推进剂量优化的Ⅱ期随机临床试验。此外，FDA还认可天演药业提出的标准治疗（SOC）对照组方案，无需设置ADG126单药组。
从上述研究的数据来看，该方案已经初步显示出积极的趋势。
“20 mg/kg组DoR尚未达到，大多数缓解病例仍在持续治疗中，疗效具有潜在的持久性。10 mg/kg组6.2个月的DoR为后续在PFS和OS上进一步获益打下了良好基础。20 mg/kg组的OS数据虽尚未成熟，从目前趋势看，我们有信心取得比10 mg/kg组更优异的DoR，数据预计在明年初公布。” 罗培志认为，在单臂试验中ORR及DoR数据尤为重要，正是其机制决定了高剂量才是真正发挥疗效的前提。
“CTLA-4抗体通过强力清除肿瘤内Treg，柔性激活免疫反应、诱导免疫记忆。但在低剂量下，Treg清除不足，疗效起效延迟，OS曲线拉开得晚；只有高剂量才能打破这一延迟，带来OS曲线的早期分离。”
更重要的是，在高剂量下，ADG126首次实现了ORR与OS的一致性——短期应答与长期生存齐头并进，这是以往CTLA-4类药物中罕见的特征。
“也因此，OS正在成为FDA愈发重视的评估肿瘤药物临床价值的金标准。”他补充道，“PD-1/VEGF双抗及同类药物在与PD-1药物的比较中，显著的临床OS获益将至关重要。”
平台型公司的寒冬韧性与创新突围
在生物技术行业融资遇冷、资本退潮的周期波动中，天演药业以三体平台作为其技术基础，通过技术升级、AI赋能研发、聚焦核心管线与灵活合作等策略来应对行业周期性挑战，并进行资源配置的优化。
合作伙伴赛诺菲不仅追加了对ADG126项目的战略投资，还发起一项涵盖逾百例晚期实体瘤患者的Ⅰb/Ⅱ期临床研究，用于系统评估ADG126与其内部肿瘤免疫管线药物的联合治疗潜力，推动该产品在多适应症领域的拓展。“值得强调的是，尽管由赛诺菲主导并出资推进上述除与K药联用外的联合用药临床研究，天演仍保有ADG126在全球范围内的全部商业化权益，以确保公司在未来市场拓展、授权合作与价值实现中的灵活性与主导地位。”罗培志表示。
与此同时，随着SAFEbody技术平台下第三个合作抗体项目的同步启动，天演药业与赛诺菲将持续深化合作，共同推动具有差异化安全优势的创新肿瘤免疫疗法进入更广阔的全球临床开发与商业化舞台。此外，天演将陆续公布与多个PD-1双抗的联合临床合作，凸显Treg清除型CTLA-4抗体这一稀缺资产在构建高效安全免疫联合方案中的核心地位。
拓展阅读
十载天演，下一个Genmab？
熬过行业“寒冬”，天演在2025年里进一步验证了其核心技术平台的可拓展性与产业价值。
今年7月，天演药业与美国ConjugateBio公司达成战略合作，根据协议，天演药业将向其提供自主研发抗体，用于其开发ADC双抗。天演药业将获得一笔未披露金额的预付款，并有望获得后续里程碑付款和特许权使用费。同时，天演药业保留该抗体在ADC以外领域的所有权利。
近期，天演药业还与Third Arc Bio达成授权协议，将其安全抗体平台技术用于两款T细胞连接器（TCEs）产品的全球研发、注册及商业化。根据协议条款，天演已获得500万美元的首付款，并有资格在研发推进、监管审批及商业化阶段获得最高达8.4亿美元的里程碑付款，同时还将基于相关产品未来的全球销售额获得特许权使用费。此外，天演保留在大中华区、新加坡及韩国以非独占方式开发和商业化上述候选分子的选择权，在实现全球价值释放的同时，持续保持对亚洲核心市场的战略灵活性。
在罗培志看来，该项合作是对天演安全抗体平台的重要外部验证，“是一次由全球肿瘤药物研发领域公认的权威专家主导、对天演安全抗体多抗平台在实体瘤领域系统性价值的高质量背书”。
Third Arc Bio由Peter Lebowitz 博士创立并领导。Lebowitz 博士曾任强生公司全球肿瘤研发负责人，在其职业生涯中主导并深度参与推动 13 款肿瘤创新药物成功上市，并构建和管理过具有重要行业影响力的全球肿瘤研发管线；其过往还包括参与推动 Pharmacyclics、Legend Biotech 等具有标志性的行业项目与国际合作，在全球肿瘤药物研发与市场化方面具备公认的专业判断力与战略前瞻性。Tec-Dara 联合方案在三期临床中的积极结果，验证了其在 TCE 领域的前瞻性布局与显著的先发优势。
罗培志告诉研发客，AI技术的深度融入是天演药业平台进化的 “加速器”，作为最早将AI应用到抗体设计工程及定量生物学中的生物药企，天演药业将AI从早期的靶点表位识别延伸至PK/PD剂量优化、临床设计及数据实时追踪及分析的全流程优化。
过去几年，天演药业增加了动态精准抗体库的多样性，实现了安全抗体及多抗平台的分子设计及临床落地，并针对特定靶点进行了特异性优化，改进了抗体尤其是多抗免疫细胞连接器的设计与筛选流程。
“特别是安全抗体在肿瘤组织内的特异性激活机制，这些优化使得我们的技术平台能在复杂生物学背景下针对更多靶点及新治疗范式产出优异结果，为后续管线开发奠定坚实的基础。”罗培志说，“三体平台还为合作伙伴提供真正具备差异化优势的解决方案，提升竞争力，而这恰是当前大型药企面临专利到期悬崖、FDA强调OS在临床试验中的必要性，加速引进外部创新背景下最看重的核心价值。”
他本人更期待，随着诺贝尔奖对 Treg 机制的权威认可，天演的“安全抗体”策略有望加速推动免疫治疗从“毒性妥协”向“精准调控”的范式跃迁——通过选择性清除肿瘤微环境中的 Treg，不仅可能在 PD-1 无效的“冷肿瘤”中实现突破，更有望重塑以安全性为基石的新一代免疫治疗标准。当科学突破与临床需求同频共振，那些曾被视为“几乎不可能实现”的目标，终将成为改变行业的里程碑。
编辑 | 姚嘉
yao.jia@PharmaDJ.com
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免疫疗法快速通道
2025-11-13
Reported late-breaking Phase 2 data at SITC for vilastobart demonstrating a 40% ORR in heavily pretreated patients with MSS mCRC without liver metastases and high plasma tumor mutational burden
Presented Phase 1 data at SITC for efarindodekin alfa showing promising monotherapy anti-tumor activity and generally well-tolerated safety profile in patients with advanced solid tumors
Announced new preclinical data at SITC for masked T cell engager programs supporting best-in-class potential and showing efficient masking, potent anti-tumor activity and broad therapeutic index
Anticipate cash runway into the first quarter of 2027
WALTHAM, Mass., Nov. 13, 2025 (GLOBE NEWSWIRE) -- Xilio Therapeutics, Inc. (Nasdaq: XLO), a clinical-stage biotechnology company discovering and developing tumor-activated immuno-oncology therapies for people living with cancer, today announced pipeline progress and business updates and reported financial results for the third quarter ended September 30, 2025.
“As we advance our robust pipeline of innovative masked immunotherapies, we continue to provide additional validation of our proprietary masking technology and ability to deliver differentiated molecules across a wide range of targets and design formats,” said René Russo, Pharm.D., president and chief executive officer of Xilio. “At SITC, we presented compelling data across our clinical and preclinical programs, including data supporting the best-in-class potential of our masked T cell engager programs to meaningfully widen the therapeutic window relative to non-masked T cell engagers as well as our unique ability to incorporate co-stimulation to substantially improve the durability of T cell response.”
Dr. Russo added, “For our clinical-stage programs, we continue to be encouraged by the promising data for both vilastobart and efarindodekin alfa, which have each shown differentiated clinical efficacy and safety for patients with high unmet need. In particular, new data for vilastobart leveraging plasma TMB as a predictive biomarker showed a 40% response rate in patients with MSS mCRC without liver metastases, supporting the significant opportunity for vilastobart as a combination therapy. As we look ahead to 2026, we are focused on execution across our clinical programs, while rapidly advancing XTX501, our bispecific PD-1/IL-2, toward a planned IND submission in mid 2026 and our masked T cell engager programs into IND-enabling studies.”
Pipeline and Business Updates
Vilastobart: tumor-activated, Fc-enhanced anti-CTLA-4
Vilastobart is currently being evaluated in combination with atezolizumab (Tecentriq®) in Phase 1C combination dose escalation in patients with advanced solid tumors and in a Phase 2 clinical trial in patients with microsatellite stable (MSS) metastatic colorectal cancer (mCRC).
In November 2025, Xilio announced new late-breaking data from its ongoing Phase 2 clinical trial at the Society for Immunotherapy of Cancer (SITC) 40th Annual Meeting. These data demonstrated a 40% objective response rate (ORR) in heavily pre-treated, plasma tumor mutational burden (TMB) high patients (≥10 mutations/Mb) with MSS mCRC without liver metastases and showed a statistically significant correlation (p=0.05) between plasma TMB status and response. Approximately 55% of patients with MSS mCRC are estimated to have high plasma TMB, representing a meaningful patient population with high unmet need. For more information, read the press release here, and watch a replay of the webcast with leading colorectal cancer experts here. In November 2025, Xilio announced additional new Phase 2 data presented at SITC, which demonstrated the potential for circulating tumor DNA (ctDNA) as an early predictive biomarker for response to treatment with vilastobart in combination with atezolizumab in patients with MSS mCRC. For more information, read the press release here. Based on the promising clinical activity and safety profile demonstrated by vilastobart as a combination therapy, including in patients who had high plasma TMB, Xilio is actively seeking a partner to develop vilastobart in combination with PD-(L)1 or PD1-VEGF in MSS CRC and other tumor types.
Efarindodekin Alfa: tumor-activated IL-12
Xilio is evaluating efarindodekin alfa as a monotherapy in an ongoing Phase 1/2 clinical trial in patients with advanced solid tumors.
In November 2025, Xilio presented Phase 1 monotherapy dose escalation data for efarindodekin alfa at SITC demonstrating promising monotherapy anti-tumor activity in patients with advanced solid tumors as well as a generally well-tolerated safety profile at doses over 100-fold greater than the maximum tolerated dose of recombinant human IL-12. For more information, read the press release here. In September 2025, Xilio announced the selection of an initial recommended phase 2 dose (RP2D) and schedule for efarindodekin alfa and initiated patient dosing in the Phase 2 portion of the clinical trial. In connection with the initiation of Phase 2, Xilio achieved a development milestone of $17.5 million under its license agreement with Gilead Sciences, Inc. (Gilead). For more information, read the press release here. Xilio has completed enrollment in the Phase 1A monotherapy dose escalation and Phase 1B monotherapy dose expansion portions of the ongoing Phase 1/2 clinical trial, and evaluation of those patients is ongoing.
XTX501: bispecific PD-1 / masked IL-2
XTX501 is a novel, bispecific PD-1 / masked IL-2 designed to selectively stimulate PD-1 positive, antigen-experienced T cells and enhance their function. XTX501 incorporates masking designed to overcome IL-2 receptor-mediated clearance and peripheral activity. In preclinical studies, XTX501 demonstrated robust monotherapy activity (including in settings insensitive to PD-1) and tumor-selective pharmacodynamics consistent with its intended mechanism of action.
XTX501 is currently advancing through investigational new drug (IND)-enabling studies, and Xilio plans to submit an IND application for XTX501 in the middle of 2026.
Masked T Cell Engager Programs
Xilio is leveraging its proprietary, clinically validated tumor-activation platform to advance multiple preclinical programs for masked T cell engagers, including wholly owned programs targeting tumor-associated antigens for PSMA (prostate cancer), CLDN18.2 (gastric, pancreatic, esophageal and lung cancers) and STEAP1 (prostate, colorectal and lung cancers), as well as an additional program in collaboration with AbbVie Group Holdings Limited (AbbVie).
Xilio’s masked T cell engager programs include bispecific molecules designed using its advanced tumor-activated cell engager (ATACR) format, which consists of a T cell engager with a masked CD3 targeting domain, and tri-specific molecules designed using its selective effector-enhanced cell engager (SEECR) format. The SEECR format builds upon the ATACR format by adding co-stimulatory signaling designed to further enhance potency and durability of T cell activation.
In November 2025, Xilio presented new preclinical data at SITC highlighting the potential for the company’s masking technology to significantly expand the therapeutic window for T cell engagers and overcome the challenges associated with current, systemically active non-masked T cell engagers. Xilio’s masked T cell engager molecules demonstrated potent anti-tumor activity with evidence of reduced systemic toxicity in murine models, supporting its broad applicability and potential best-in-class profile across a diverse range of targets, and the incorporation of co-stimulatory signaling in Xilio’s proprietary SEECR format enhanced durability of anti-tumor activity compared with T cell engager molecules that lacked co-stimulation. For more information, read the press release here. In the third quarter of 2025, Xilio nominated a development candidate for its PSMA program (ATACR format). Xilio anticipates nominating development candidates for its CLDN18.2 program (ATACR format) in the fourth quarter of 2025 and for its STEAP1 program (SEECR format) in the first half of 2026. Xilio anticipates advancing at least two of these programs into IND-enabling studies and submitting IND applications for those programs in 2027.
Third Quarter 2025 Financial Results
Cash Position: Cash and cash equivalents were $103.8 million as of September 30, 2025, compared to $55.3 million as of December 31, 2024. The increase was primarily driven by $52.0 million in total upfront payments under the collaboration, license and option agreement and stock purchase agreement entered into in February 2025 with AbbVie and $47.0 million in net proceeds received from Xilio’s June 2025 follow-on public offering, partially offset by cash used for operating activities.In the fourth quarter of 2025, Xilio received the $17.5 million development milestone payment under its license agreement with Gilead.
Collaboration and License Revenue: Collaboration and license revenue was $19.1 million for the quarter ended September 30, 2025, compared to $2.3 million for the quarter ended September 30, 2024. Collaboration and license revenue for the quarter ended September 30, 2025 consisted of revenue recognized in connection with Xilio’s collaborations with AbbVie and Gilead, and collaboration and license revenue for the quarter ended September 30, 2024 consisted of revenue recognized in connection with Xilio’s collaboration with Gilead. Research & Development (R&D) Expenses: R&D expenses were $14.3 million for the quarter ended September 30, 2025, compared to $10.8 million for the quarter ended September 30, 2024. The increase was primarily driven by increased clinical development activities related to efarindodekin alfa, manufacturing activities related to IND-enabling studies and preclinical development activities for XTX501, increased costs related to early-stage programs and indirect research and development and increased personnel-related costs. General & Administrative (G&A) Expenses: G&A expenses were $6.7 million for the quarter ended September 30, 2025, compared to $6.3 million for the quarter ended September 30, 2024. The increase was primarily driven by an increase in professional and consulting fees, including legal fees and other professional costs, which were partially offset by a decrease in costs related to directors’ and officers’ liability insurance. Net Loss: Net loss was $16.3 million for the quarter ended September 30, 2025, compared to $14.0 million for the quarter ended September 30, 2024.
Financial Guidance
Based on its current operating plans, Xilio anticipates that its cash and cash equivalents as of September 30, 2025, together with the $17.5 million development milestone received under its license agreement with Gilead, will be sufficient to enable it to fund its operating expenses and capital expenditure requirements into the first quarter of 2027.
About Vilastobart
Vilastobart is an investigational tumor-activated, Fc-enhanced, high affinity binding anti-CTLA-4 monoclonal antibody designed to block CTLA-4 and deplete regulatory T cells when activated in the tumor microenvironment (TME). In 2023, Xilio entered into a co-funded clinical trial collaboration with Roche to evaluate vilastobart in combination with atezolizumab (Tecentriq®) in a multi-center, open-label Phase 1/2 clinical trial. Xilio is currently evaluating the safety of the combination in Phase 1C dose escalation in patients with advanced solid tumors and the efficacy and safety of the combination in Phase 2 in patients with microsatellite stable (MSS) metastatic colorectal cancer (mCRC) with and without liver metastases. Please refer to NCT04896697 on www.clinicaltrials.gov for additional details.
About Efarindodekin Alfa
Efarindodekin alfa (XTX301) is an investigational tumor-activated IL-12 designed to potently stimulate anti-tumor immunity and reprogram the tumor microenvironment (TME) of poorly immunogenic “cold” tumors towards an inflamed or “hot” state. Xilio is currently evaluating the safety and tolerability of efarindodekin alfa as a monotherapy in patients with advanced solid tumors in the Phase 1 portion of a first-in-human, multi-center, open-label Phase 1/2 clinical trial and the safety and efficacy of efarindodekin alfa as a monotherapy in the Phase 2 portion in patients with advanced solid tumors. The Phase 2 portion of the trial is anticipated to enroll approximately 40 patients in specific tumor types at multiple sites in the United States. Please refer to NCT05684965 on www.clinicaltrials.gov for additional details.
In March 2024, Xilio entered into an exclusive global license agreement with Gilead to develop and commercialize efarindodekin alfa and specified other molecules directed to IL-12.Xilio is responsible for conducting clinical development for efarindodekin alfa through the initial Phase 2 portion of the ongoing Phase 1/2 clinical trial. Following the delivery by Xilio of a specified clinical data package for efarindodekin alfa related to the Phase 1/2 clinical trial, Gilead can elect to transition responsibilities for the development and commercialization of efarindodekin alfa to Gilead, subject to the terms of the license agreement and payment by Gilead of a $75.0 million transition fee. If Gilead exercises its option for efarindodekin alfa, Xilio will be eligible to receive up to $500.0 million in specified development, regulatory and sales-based milestones and will be eligible to receive tiered royalties ranging from high single digits to mid-teens on annual global net product sales.
About Xilio Therapeutics
Xilio Therapeutics is a clinical-stage biotechnology company discovering and developing tumor-activated, or masked, immuno-oncology (I-O) therapies with the goal of significantly improving outcomes for people living with cancer without the systemic side effects of current I-O treatments. The company is leveraging its proprietary platform to advance a pipeline of novel, tumor-activated I-O molecules that are designed to optimize the therapeutic index by localizing anti-tumor activity within the tumor microenvironment. Learn more by visiting www.xiliotx.com and follow us on LinkedIn (Xilio Therapeutics, Inc.).
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding plans, expectations, development timelines and anticipated milestones for Xilio’s programs; the timing of data releases or program updates; the potential of Xilio’s programs or platform; the ultimate safety and efficacy of Xilio’s current or future products as a monotherapy or combination therapy in any indication; the potential for plasma-based TMB as a predictive biomarker for response in patients with MSS mCRC; the receipt of future contingent payments under Xilio’s collaboration agreements with AbbVie or Gilead; the ability to partner the vilastobart program; the sufficiency of, and the period in which Xilio expects to have, cash to fund its operations, capital expenditure requirements, and development plans and milestones; and Xilio’s strategy, goals and anticipated financial performance, milestones, business plans and focus. The words “aim,” “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “seek,” “target” 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 and are subject to a number of important risks, uncertainties and other factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks related to general market conditions and geopolitical uncertainties; risks and uncertainties related to ongoing and planned research and development activities, including initiating, conducting or completing preclinical studies and clinical trials and the timing and results of such preclinical studies or clinical trials; the delay of any current or planned preclinical studies or clinical trials or the development of Xilio’s current or future product candidates; Xilio’s ability to obtain and maintain sufficient preclinical and clinical supply of current or future product candidates; Xilio’s ability to advance multiple early stage masked T cell engager programs; initial, preliminary, interim or retrospective preclinical or clinical data or results may not be replicated in or predictive of future preclinical or clinical data or results; Xilio’s ability to successfully demonstrate the safety and efficacy of its product candidates and gain approval of its product candidates on a timely basis, if at all; results from preclinical studies or clinical trials for Xilio’s product candidates may not support further development of such product candidates; actions of regulatory agencies may affect the initiation, timing and progress of current or future clinical trials; Xilio’s ability to obtain, maintain and enforce patent and other intellectual property protection for current or future product candidates; Xilio’s need to obtain additional cash resources to advance its pipeline of tumor-activated I-O molecules; the impact of international trade policies on Xilio’s business, including U.S. and China trade policies; and Xilio’s ability to maintain its collaboration or partnership agreements with AbbVie, Gilead and Roche. These and other risks and uncertainties are described in greater detail in the sections entitled “Risk Factor Summary” and “Risk Factors” in Xilio’s filings with the U.S. Securities and Exchange Commission (“SEC”), including Xilio’s most recent Quarterly Report on Form 10-Q and any other filings that Xilio has made or may make with the SEC in the future. Any forward-looking statements contained in this press release represent Xilio’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Except as required by law, Xilio explicitly disclaims any obligation to update any forward-looking statements.
This press release contains hyperlinks to information that is not deemed to be incorporated by reference in this press release.
Tecentriq® is a registered trademark of Genentech USA, Inc., a member of the Roche Group.
Investor Contact Alex Lobo, Precision AQalex.lobo@precisionaq.com
Media Contact Josie Butler, 1ABjosie@1abmedia.com
(1) Operating expenses include the following amounts of non-cash stock-based compensation expense:
(2) Weighted average common shares outstanding, basic and diluted, includes prefunded warrants to purchase common stock issued in connection with (i) the company’s private placements with certain existing investors and Gilead in 2024 and (ii) the company’s June 2025 follow-on public offering, as the prefunded warrants are exercisable at any time for nominal cash consideration.
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 晚期恶性实体瘤 | 临床2期 | 美国 | 2021-09-13 | |
| 实体瘤 | 临床2期 | 美国 | 2021-09-13 | |
| 实体瘤 | 临床2期 | 美国 | 2021-09-13 |
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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 |
|---|
临床2期 | 转移性微卫星稳定结直肠癌 microsatellite stable (MSS) | 44 | 膚衊廠淵築範憲膚艱糧(鑰範構鏇簾廠觸選觸製) = 膚鹹構艱窪鹹糧醖膚膚 鹹淵選遞鏇選觸醖壓艱 (願衊壓願製構窪顧齋構 ) 更多 | 积极 | 2025-11-05 | ||
临床1/2期 | 40 | (Advanced Solid Tumors + Phase 1A/B) | 獵壓憲夢鏇糧製窪齋製(願遞壓鹽選顧繭觸壓艱) = In Phase 1A/B, no endocrine irAEs and limited skin irAEs. At the RP2D, colitis of any grade was reported in 3 patients (14%): 2 patients with Grade 3 (10%) and no Grade 4 or 5. No Grade 4 or 5 TRAEs were reported with vilastobart at the monotherapy RP2D. In Phase 1C, across all vilastobart dose levels (75-150 mg), minimal irAEs observed, colitis of any grade was experienced in 5% of patients (1 patient with Grade 3). No Grade 4 or 5 TRAEs at any dose level. 衊艱鬱範齋壓夢觸鏇願 (憲鬱淵遞獵鑰壓顧獵觸 ) 更多 | 积极 | 2025-01-25 | ||
(Advanced Solid Tumors + Phase 1C) | |||||||
临床1期 | 15 | (Part 1C) | 艱齋鬱鹽襯夢窪淵憲襯(蓋觸簾顧餘遞選夢艱餘) = infusion reactions (n=4), fatigue and diarrhea (n=2 each), and no G4 or G5 TRAEs were reported. 觸夢顧廠繭壓衊鏇願餘 (齋選廠鹽壓蓋糧齋顧顧 ) 更多 | 积极 | 2024-11-05 | ||
临床1期 | 18 | XTX101 150mg | 鑰顧鑰觸壓鬱蓋鬱獵鬱(夢顧廠構齋鹹願鹽繭遞) = 醖壓選鹹襯蓋網網網積 淵鏇齋窪遞夢廠膚鏇廠 (鹽壓範積鑰觸網衊艱醖 ) 更多 | 积极 | 2023-12-07 | ||
临床1/2期 | 22 | 構蓋遞醖選遞鹽淵鏇簾(繭壓製艱鏇鬱餘選壓夢) = 1 dose limiting toxicity (DLT) of colitis among 8 patients treated at 60 mg Q3W, while 2 DLTs of colitis were reported among 6 pts at 180 mg Q3W. 鹹鬱鏇製築鑰構積夢壓 (艱糧積顧獵鏇餘鹽艱窪 ) 更多 | 积极 | 2023-05-26 | |||
临床1/2期 | 12 | 壓築鑰製積製艱淵願觸(壓構製積膚網蓋築艱築) = A maximum tolerated dose (MTD) has not yet been determined, and enrollment in the dose-escalation cohort is ongoing. 膚顧鏇醖淵鑰製遞壓鑰 (廠構齋顧簾築選繭構憲 ) 更多 | 积极 | 2022-08-09 |
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