Corvus Pharmaceuticals宣布了 Soquelitinib在 T细胞淋巴瘤患者中的 1/1b期临床试验的更多数据展示-动脉网

Corvus Pharmaceuticals Announces Presentation of Additional Data from the Phase 1/1b Clinical Trial of Soquelitinib for Patients with T Cell Lymphoma

Corvus Pharma 等信源发布 2025-03-20 08:00

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可切换为仅中文

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Data to be presented in oral session and poster at the 16th Annual T-Cell Lymphoma Forum

将在第16届年度T细胞淋巴瘤论坛的口头会议和海报中展示的数据

SOUTH SAN FRANCISCO, Calif.

加利福尼亚州南旧金山

，

March 20, 2025

2025年3月20日

(GLOBE NEWSWIRE) --

（环球新闻网）--

Corvus Pharmaceuticals

Corvus制药公司

, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company, today announced that additional data from the Company’s Phase 1/1b clinical trial of soquelitinib for the treatment of patients with T cell lymphoma (TCL) is being presented at the 16

公司（纳斯达克股票代码：CRVS）是一家临床阶段的生物制药公司，今天宣布其针对治疗T细胞淋巴瘤（TCL）患者的Soquelitinib的1/1b期临床试验的更多数据正在第16届会议上展示。

泰国语

Annual

年度的

T-Cell Lymphoma Forum

T细胞淋巴瘤论坛

taking place

发生

March 20-22, 2025

2025年3月20日至22日

在里面

San Diego, CA.

加利福尼亚州圣迭戈。

“The data from the Phase 1/1b clinical trial of soquelitinib in patients with T cell lymphoma continues to demonstrate strong indications of anti-tumor activity in a significant number of patients,” said

“索喹替尼在T细胞淋巴瘤患者中的1/1b期临床试验数据继续显示，在相当数量的患者中具有强烈的抗肿瘤活性迹象，”表示

Richard A. Miller

理查德·A·米勒

, M.D., co-founder, president and chief executive officer of Corvus. “We are encouraged by the high complete response, prolonged median progression free survival and high rate of 18-month progression free survival, which all appear superior to standard of care agents such as belinostat and pralatrexate. In addition, analysis of patient blood samples at baseline and on treatment show that soquelitinib reduces T cell exhaustion, which may allow for improved T cell function and anti-tumor immunity. Supported by this data, our registrational Phase 3 trial of soquelitinib is enrolling patients with relapsed peripheral T cell lymphoma at multiple sites in the .

医学博士，Corvus公司联合创始人、总裁兼首席执行官表示：“我们对高完全缓解率、延长的中位无进展生存期和高比率的18个月无进展生存期感到鼓舞，这些数据似乎都优于标准治疗药物如贝利司他和普拉曲沙。此外，对患者基线和治疗期间血液样本的分析表明，soquelitinib减少了T细胞耗竭，这可能会改善T细胞功能和抗肿瘤免疫力。基于这些数据支持，我们的注册性III期soquelitinib试验正在多个地点招募复发性外周T细胞淋巴瘤患者。”

U.S.

美国

，

Canada

加拿大

and

和

Australia

澳大利亚

, along with our Phase 1 trial in atopic dermatitis that is anticipated to deliver data in the second quarter 2025.”

“, 以及我们预计在 2025 年第二季度提供数据的特应性皮炎 1 期试验。”

The soquelitinib data from the Phase 1/1b clinical trial of soquelitinib for TCL will be presented by John Reneau, MD, PhD, Assistant Professor in the

索喹替尼用于TCL的1/1b期临床试验数据将由约翰·勒内奥博士，医学博士，助理教授展示，

College of Medicine

医学院

and The Ohio State University Comprehensive Cancer Center. Dr. Reneau is a hematologist who specializes in treating patients with lymphoma and an investigator in the trial. The details of Dr. Reneau’s presentations are as follows:

俄亥俄州立大学综合癌症中心。雷内奥博士是一位专门治疗淋巴瘤患者的血液科医生，并且是这项试验的研究者。雷内奥博士的演讲详情如下：

Oral Presentation

口头报告

Title: Selective ITK Inhibition for Treatment of PTCL

标题：选择性ITK抑制剂用于PTCL的治疗

Time: 4:50 –

时间：4:50 –

5:10 pm PT

下午5点10分（太平洋时间）

在

March 20, 2025

2025年3月20日

Poster Presentation

海报展示

Abstract Title: Soquelitinib, a Selective ITK Inhibitor for Treatment of T Cell Lymphomas: Results of Ph1 trial Reveal Novel Mechanisms of Action

摘要标题：Soquelitinib，一种用于治疗T细胞淋巴瘤的选择性ITK抑制剂：Ph1期试验结果显示新的作用机制

Soquelitinib Phase 1/1b Overview and Key Data

Soquelitinib 1/1b期概述与关键数据

A total of 25 patients were enrolled in the Phase 1/1b trial at the optimum 200 mg two-times a day dose and would have met the eligibility criteria for the ongoing registrational Phase 3 clinical trial based on ≥1 and ≤3 prior therapies, including 23 evaluable patients. For the 23 evaluable patients:.

共有25名患者以最佳的每日两次200毫克剂量参加了1/1b期试验，并且根据≥1和≤3既往治疗（包括23名可评估患者）符合正在进行的注册性3期临床试验的资格标准。对于这23名可评估患者：

Objective responses (complete response, CR, plus partial response, PR) were seen in nine patients (39%), including six CRs (26%) and three PRs.

客观反应（完全缓解CR加上部分缓解PR）出现在九名患者（39%）中，其中包括六名CR（26%）和三名PR。

The median duration of response (DOR) for the nine patients with objective response by Lugano criteria was 17.2 months.

根据Lugano标准，九名患者客观缓解的中位持续时间（DOR）为17.2个月。

Three patients continue on therapy at 25+ months, 18+ months and 14+ months.

三名患者分别在25个月以上、18个月以上和14个月以上继续接受治疗。

Kaplan Meier estimated median progression free survival (PFS) was 6.2 months.

Kaplan Meier 估计的中位无进展生存期 (PFS) 为 6.2 个月。

At 18-month follow-up, the PFS rate was 30%, which compares favorably to 18-month PFS of <20% with belinostat or pralatrexate.

在18个月的随访中，PFS率为30%，相比之下，贝利司他或普拉曲沙的18个月PFS率不到20%。

Peripheral blood samples were collected from patients both prior to the initiation of soquelitinib therapy and during the course of treatment. These samples were analyzed for markers of T cell exhaustion in normal T cells. The results indicated that the majority of patients exhibited a reduction in T cell exhaustion markers on both CD4+ and CD8+ cells after 21 days of treatment.

在患者开始索奎替尼治疗前和治疗过程中均采集了外周血样本。这些样本被用于分析正常T细胞中T细胞耗竭的标志物。结果显示，大多数患者在治疗21天后，CD4+和CD8+细胞上的T细胞耗竭标志物均有所减少。

T cell exhaustion is a state in which T cells exhibit diminished functionality due to prolonged exposure to antigens..

T细胞耗竭是一种由于长时间暴露于抗原而导致T细胞功能减弱的状态。

Soquelitinib was well-tolerated, with no new safety signals, drug interruptions or dose reductions.

Soquelitinib耐受性良好，未出现新的安全性信号、药物中断或剂量减少。

Based on the results from the Phase 1/1b trial, Corvus is enrolling patients in a registrational Phase 3 clinical trial of soquelitinib in patients with relapsed Peripheral T cell lymphoma (PTCL) at multiple sites. This randomized controlled trial is anticipated to enroll a total of 150 patients with relapsed PTCL and is evaluating soquelitinib versus physicians’ choice of either belinostat or pralatrexate.

基于1/1b期试验的结果，Corvus正在多个地点进行一项针对复发性外周T细胞淋巴瘤（PTCL）患者的soquelitinib的注册性3期临床试验。这项随机对照试验预计总共招募150名复发性PTCL患者，并评估soquelitinib与医生选择的贝利司他或普拉曲沙的效果。

The primary endpoint of the trial is PFS. There are no FDA fully approved agents for the treatment of relapsed PTCL and the FDA has granted soquelitinib Orphan Drug Designation for the treatment of T cell lymphoma and Fast Track designation for treatment of adult patients with relapsed or refractory PTCL after at least 2 lines of systemic therapy..

试验的主要终点是无进展生存期（PFS）。目前尚无FDA完全批准的用于治疗复发性PTCL的药物，而FDA已授予soquelitinib治疗T细胞淋巴瘤的孤儿药资格，并授予其在至少两线系统治疗后用于治疗成人复发或难治性PTCL的快速通道资格。

About Peripheral T Cell Lymphoma

关于外周T细胞淋巴瘤

Peripheral T cell lymphoma (PTCL) is a heterogeneous group of malignancies accounting for about 10% of non-Hodgkin’s lymphomas (NHL) in western populations, reaching 20% to 25% of NHL in some parts of Asia and South America. The most common subtypes are PTCL-not otherwise specified (PTCL-NOS) and T follicular helper cell lymphoma.

外周T细胞淋巴瘤（PTCL）是一组异质性恶性肿瘤，约占西方人群中非霍奇金淋巴瘤（NHL）的10%，在亚洲和南美洲部分地区可占NHL的20%至25%。最常见的亚型是PTCL-未另作说明（PTCL-NOS）和T滤泡辅助细胞淋巴瘤。

Initial therapy for these diseases is typically combination chemotherapy; however, approximately 75% of patients either do not respond or relapse within the first two years. Patients in relapse are treated with various chemotherapy agents but have poor overall outcomes with median progression-free survival in the 3 to 4 month range and overall median survival of 6 to 12 months.

这些疾病的初始治疗通常是联合化疗；然而，大约75%的患者要么无反应，要么在头两年内复发。复发患者会接受各种化疗药物的治疗，但总体预后较差，中位无进展生存期为3至4个月，总体中位生存期为6至12个月。

There are no approved drugs in relapsed PTCL based on randomized trials..

基于随机试验，复发性PTCL尚无获批药物。

PTCL is a disease of mature helper T cells that express ITK (interleukin-2-inducible T cell kinase), often containing numerous genetic mutations and frequently associated with viral infection. Most often the malignant cells of PTCL express a Th2 phenotype.

PTCL是一种表达ITK（白细胞介素2诱导的T细胞激酶）的成熟辅助T细胞疾病，常包含许多基因突变，并且常与病毒感染相关。PTCL的恶性细胞大多数表现为Th2表型。

About Soquelitinib

关于Soquelitinib

Soquelitinib (formerly CPI-818) is an investigational small molecule drug given orally designed to selectively inhibit ITK (interleukin-2-inducible T cell kinase), an enzyme that is expressed predominantly in T cells and plays a role in T cell and natural killer (NK) cell immune function. Soquelitinib has been shown to affect T cell differentiation and induce the generation of Th1 helper cells while blocking the development of both Th2 and Th17 cells and production of their secreted cytokines.

Soquelitinib（以前称为CPI-818）是一种研究性小分子口服药物，旨在选择性抑制ITK（白细胞介素-2诱导的T细胞激酶），这种酶主要在T细胞中表达，并在T细胞和自然杀伤（NK）细胞的免疫功能中起作用。Soquelitinib已被证明能够影响T细胞分化，诱导Th1辅助细胞的生成，同时阻断Th2和Th17细胞的发育及其分泌细胞因子的产生。

Th1 T cells are required for immunity to tumors, viral infections and other infectious diseases. Th2 and Th17 helper T cells are involved in the pathogenesis of many autoimmune and allergic diseases. The Company believes the inhibition of specific molecular targets in T cells may be of therapeutic benefit for patients with cancers, including solid tumors, and in patients with autoimmune and allergic diseases.

Th1型T细胞对于肿瘤、病毒感染和其他传染病的免疫至关重要。Th2和Th17辅助T细胞则参与多种自身免疫和过敏性疾病的发病机制。公司认为，抑制T细胞中的特定分子靶点可能对癌症（包括实体瘤）患者以及自身免疫和过敏性疾病患者具有治疗益处。

Recent studies have demonstrated that ITK controls a switch between the differentiation of Th17 proinflammatory cells and T regulatory suppressor cells. Inhibition of ITK leads to a shift toward T regulatory cell differentiation which has the potential to suppress autoimmune and inflammatory reactions.

最近的研究表明，ITK 控制着 Th17 促炎细胞和 T 调节抑制细胞之间分化的转换。抑制 ITK 会导致向 T 调节细胞分化转变，这有潜力抑制自身免疫和炎症反应。

Based on interim results from a Phase 1/1b clinical trial in patients with refractory T cell lymphomas, which demonstrated tumor responses in very advanced, refractory, difficult to treat T cell malignancies, the Company is conducting a registrational Phase 3 clinical trial (.

基于一项针对难治性T细胞淋巴瘤患者的1/1b期临床试验的中期结果，该结果展示了在病情非常晚期、难治性、难以治疗的T细胞恶性肿瘤中的肿瘤反应，公司正在进行一项注册性的3期临床试验。

NCT06561048

) of soquelitinib in patients with relapsed PTCL. Soquelitinib is also being investigated in a randomized placebo-controlled Phase 1 clinical trial in patients with atopic dermatitis and a Phase 2 clinical trial in patients with autoimmune lymphoproliferative syndrome (ALPS), a rare genetic disease.

）在复发性PTCL患者中研究索喹替尼。索喹替尼还正在一项随机、安慰剂对照的1期临床试验中进行研究，用于治疗特应性皮炎患者，并在一项2期临床试验中用于治疗自身免疫性淋巴增生综合征（ALPS）患者，这是一种罕见的遗传病。

A recent publication describing the chemistry, enzymology and biology of soquelitinib appeared in NPJ Drug Discovery in .

最近一篇描述索喹替尼的化学、酶学和生物学的论文发表在《NPJ药物发现》上。

December 2024

2024年12月

and is available online at the

并且可以在线获取 tại

Nature

自然

website and on the

网站以及

Publications and Presentations

出版物与演讲

page of the Corvus website.

Corvus网站的页面。

About Corvus Pharmaceuticals

关于Corvus制药公司

Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company pioneering the development of ITK inhibition as a new approach to immunotherapy for a broad range of cancers and immune diseases. The Company’s lead product candidate is soquelitinib, an investigational, oral, small molecule drug that selectively inhibits ITK.

Corvus Pharmaceuticals是一家临床阶段的生物制药公司，率先开发ITK抑制作为一种针对多种癌症和免疫疾病的新免疫疗法。该公司的主要候选产品是soquelitinib，一种研究性、口服、小分子药物，可选择性抑制ITK。

Its other clinical-stage candidates are being developed for a variety of cancer indications. For more information, visit .

其其他临床阶段的候选药物正在被开发用于各种癌症适应症。欲了解更多信息，请访问。

www.corvuspharma.com

。

Forward-Looking Statements

前瞻性声明

This press release contains forward-looking statements related to the potential of the Company’s product candidates including soquelitinib. This includes the outlook for the registrational Phase 3 trial of soquelitinib; the potential use of soquelitinib to treat autoimmune lymphoproliferative syndrome and other immune diseases; the Company’s conduct of, enrollment in and timing of clinical trials and results; and the potential of ITK inhibition as a new approach to immunotherapy.

本新闻稿包含与公司产品候选物（包括soquelitinib）潜力相关的前瞻性声明。其中包括soquelitinib注册性III期试验的展望；soquelitinib用于治疗自身免疫性淋巴组织增生综合征及其他免疫疾病的潜在用途；公司开展的临床试验、入组情况、时间安排及结果；以及ITK抑制作为免疫治疗新方法的潜力。

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.

本新闻稿中包含的所有非历史事实的声明均为前瞻性声明。这些声明通常包括诸如“相信”、“预期”、“预见”、“打算”、“计划”、“估计”、“寻求”、“将”、“可能”或类似表达。前瞻性声明受多种风险和不确定性影响，其中许多涉及公司无法控制的因素或情况。

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 three months ended .

由于多种因素，包括但不限于公司截至三个月末的10-Q季度报告中详述的风险，公司的实际结果可能与前瞻性陈述中所述或暗示的结果存在重大差异。

September 30, 2024

2024年9月30日

, filed with the

，提交给

Securities and Exchange Commission

证券交易委员会

在

November 12, 2024

2024年11月12日

, as well as other documents that may be filed by the Company from time to time with the

以及公司不时向其提交的其他文件

Securities and Exchange Commission

证券交易委员会

. 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 number of patients in its clinical trials; the unpredictability of the regulatory process; regulatory developments in .

特别是，以下因素等可能导致实际结果与这些前瞻性陈述中明示或暗示的结果存在重大差异：公司在其产品候选者的临床试验中证明有效性和安全性的充分证据的能力；公司对其启动和/或完成临床前研究和临床试验并从这些研究和试验中发布数据的能力的估计的准确性；临床前研究结果和临床试验的中期数据不能预测未来结果；公司在其临床试验中招募足够数量患者的能力；监管过程的不可预测性；监管的发展。

the United States

美国

and foreign countries; the costs of clinical trials may exceed expectations; 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.

和外国；临床试验的成本可能超出预期；以及公司筹集额外资本的能力。尽管公司认为前瞻性陈述中反映的预期是合理的，但不能保证前瞻性陈述中反映的事件和情况将会实现或发生，事件和情况的时间以及实际结果可能与前瞻性陈述中的预测有重大差异。

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..

因此，你不应过分依赖这些前瞻性陈述。所有这些陈述仅截至作出之日有效，公司不承担公开更新或修改任何前瞻性陈述的义务，无论是否由于新信息、未来事件或其他原因。

INVESTOR CONTACT:

投资者联系方式：

Leiv Lea

莱夫·莱亚

Chief Financial Officer

首席财务官

Corvus Pharmaceuticals, Inc.

Corvus制药公司

+1-650-900-4522

llea@corvuspharma.com

MEDIA CONTACT: