Soquelitinib is a potential first-in-class ITK inhibitor with broad potential in cancer and immune diseases

Soquelitinib是一种潜在的一流ITK抑制剂，在癌症和免疫疾病中具有广泛的潜力

There are currently no fully approved agents for the treatment of relapsed PTCL and soquelitinib has been granted Orphan Drug Designation and Fast Track Designation by the FDA

目前还没有完全批准用于治疗复发性PTCL的药物，并且soquelitinib已被FDA授予孤儿药指定和快速通道指定

BURLINGAME, Calif., Sept. 10, 2024 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company, today announced that it has initiated a registrational Phase 3 clinical trial of soquelitinib for patients with relapsed/refractory peripheral T-cell lymphoma (PTCL).

加利福尼亚州伯灵格姆，2024年9月10日（环球通讯社）--Corvus Pharmaceuticals，Inc.（纳斯达克：CRVS），一家临床阶段的生物制药公司，今天宣布，它已经启动了索喹替尼治疗复发/难治性外周T细胞淋巴瘤（PTCL）患者的注册3期临床试验。

The clinical trial is a randomized, controlled study that will evaluate the efficacy and safety of soquelitinib compared to standard of care chemotherapy..

该临床试验是一项随机对照研究，将评估索喹替尼与标准化疗相比的疗效和安全性。。

'The initiation of the soquelitinib Phase 3 trial for relapsed PTCL is an important milestone for Corvus and for patients suffering with this disease,' said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. 'Soquelitinib has a unique mechanism of action based on selective ITK inhibition, which we believe has potential for the treatment of T cell lymphomas, as well as for solid tumors and a broad range of immune diseases.”  .

Corvus联合创始人、总裁兼首席执行官理查德·米勒（RichardA.Miller）医学博士说，针对复发性PTCL的索喹替尼3期临床试验的启动，对于Corvus和患有这种疾病的患者来说是一个重要的里程碑Soquelitinib具有基于选择性ITK抑制的独特作用机制，我们认为它具有治疗T细胞淋巴瘤，实体瘤和广泛免疫疾病的潜力。”。

The clinical trial (NCT06561048) is designed to enroll approximately 150 patients with relapsed/refractory PTCL who have failed one to three prior lines of therapy. Patients will be randomized in a 1:1 ratio to receive either 200mg dose of soquelitinib two-times a day or standard of care chemotherapy with either belinostat or pralatrexate.

该临床试验（NCT06561048）旨在招募大约150名复发/难治性PTCL患者，这些患者在之前的一至三个治疗方案中均失败。患者将以1:1的比例随机分组，每天两次接受200mg剂量的索喹替尼，或使用belinostat或pralatrexate进行标准护理化疗。

The primary endpoint of the clinical trial is progression-free survival and secondary endpoints include overall survival, objective response rate, and duration of response. The trial is expected to enroll patients at approximately 40 sites in the United States, Canada, Australia and South Korea..

临床试验的主要终点是无进展生存期，次要终点包括总生存期，客观缓解率和缓解持续时间。该试验预计将在美国、加拿大、澳大利亚和韩国的大约40个地点招募患者。。

'We are excited to participate in this Phase 3 trial evaluating a new therapy for patients with relapsed/refractory PTCL,' said Swaminathan P. Iyer, M.D., principal investigator of the study and Professor in the Department of Lymphoma and Myeloma at The University of Texas MD Anderson Cancer Center.

该研究的首席研究员、德克萨斯大学MD安德森癌症中心淋巴瘤和骨髓瘤系教授Swaminathan P.Iyer医学博士说：“我们很高兴参加这项评估复发/难治性PTCL患者新疗法的3期临床试验。”。

'In earlier stage trials, soquelitinib has been well-tolerated and has demonstrated durable anti-tumor activity in patients with very advanced disease. Soquelitinib’s novel mechanism of action results in enhancement of the host anti-tumor response. In general, chemotherapy drugs have not produced lasting remissions and are sometimes associated with significant toxicity.

“在早期试验中，索喹替尼的耐受性良好，并且在晚期疾病患者中表现出持久的抗肿瘤活性。Soquelitinib的新型作用机制可增强宿主的抗肿瘤反应。一般来说，化疗药物没有产生持久的缓解，有时会产生明显的毒性。

There has been a scarcity of new ideas for the treatment of PTCL and we are eager to see if soquelitinib can offer these patients a more effective and safer treatment.'.

治疗PTCL的新想法很少，我们迫切希望看到索喹替尼能否为这些患者提供更有效和更安全的治疗。”。

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.

关于Corvus PharmaceuticalsCorvus Pharmaceuticals是一家临床阶段的生物制药公司，开创了ITK抑制的发展，作为一种针对多种癌症和免疫疾病的免疫治疗新方法。该公司的主要候选产品是索喹替尼，一种选择性抑制ITK的研究性口服小分子药物。

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

它的其他临床阶段候选者正在开发用于各种癌症适应症。有关更多信息，请访问www.corvuspharma.com。。

About Peripheral T Cell LymphomaPeripheral 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.

关于外周T细胞淋巴瘤外周T细胞淋巴瘤（PTCL）是一组异质性恶性肿瘤，约占西方人群非霍奇金淋巴瘤（NHL）的10%，在亚洲和南美洲的一些地区达到NHL的20%至25%。最常见的亚型是未另外指定的PTCL（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%的患者在头两年内没有反应或复发。复发患者接受各种化疗药物治疗，但总体预后较差，中位无进展生存期为3至4个月，总中位生存期为6至12个月。

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

根据随机试验，复发性PTCL中没有批准的药物。。

PTCL is a disease of mature helper T cells that express ITK, 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的成熟辅助性T细胞疾病，通常包含许多基因突变，并经常与病毒感染有关。最常见的是PTCL的恶性细胞表达Th2表型。

About SoquelitinibSoquelitinib (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.

关于soquelitinib soquelitinib（以前称为CPI-818）是一种口服给药的研究性小分子药物，旨在选择性抑制ITK（白细胞介素-2诱导型T细胞激酶），ITK是一种主要在T细胞中表达的酶，在T细胞和自然杀伤（NK）细胞免疫功能中起作用。

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 has initiated a registrational Phase 3 clinical trial (NCT06561048) of soquelitinib in patients with relapsed PTCL.

根据难治性T细胞淋巴瘤患者1/1b期临床试验的中期结果，该试验证明了非常晚期，难治性，难治性T细胞恶性肿瘤的肿瘤反应，该公司启动了索喹替尼治疗复发性PTCL患者的注册3期临床试验（NCT06561048）。

Soquelitinib is also now being investigated in a randomized placebo controlled phase 1 clinical trial in patients with atopic dermatitis. The immunologic effects of soquelitinib lead to what is known as Th1 skewing and inhibition of Th2 and Th17 cells. Research on soquelitinib’s mechanism of action suggests that it has the potential to control differentiation of normal T helper cells and enhance immune responses to tumors by augmenting the generation of cytotoxic killer T cells and the production of cytokines that inhibit cancer cell survival.

Soquelitinib目前也正在一项针对特应性皮炎患者的随机安慰剂对照1期临床试验中进行研究。索喹替尼的免疫作用导致所谓的Th1偏斜和Th2和Th17细胞的抑制。对索喹替尼作用机制的研究表明，它有可能通过增加细胞毒性杀伤性T细胞的产生和抑制癌细胞存活的细胞因子的产生来控制正常T辅助细胞的分化并增强对肿瘤的免疫应答。

Soquelitinib has also been shown to prevent T cell exhaustion, a major limitation of current immunotherapy and CAR-T therapies. 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也被证明可以预防T细胞衰竭，这是目前免疫疗法和CAR-T疗法的主要局限性。已显示索喹替尼影响T细胞分化并诱导Th1辅助细胞的产生，同时阻断Th2和Th17细胞的发育及其分泌的细胞因子的产生。

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.

Th1 T细胞是对肿瘤，病毒感染和其他传染病免疫所必需的。Th2和Th17辅助性T细胞参与许多自身免疫和过敏性疾病的发病机制。该公司认为特定分子靶标的抑制作用。

Forward-Looking StatementsThis press release contains forward-looking statements, including statements related to the potential safety and efficacy of the Company’s product candidates including soquelitinib; the potential use of soquelitinib to treat PTCL, solid tumors and a broad range of autoimmune diseases; the Company’s ability and its partners’ ability, as well as the timing thereof, to develop and advance product candidates into and successfully complete preclinical studies and clinical trials, including the Company’s Phase 3 clinical trial for PTCL with soquelitinib; and the design of clinical trials, including the target or expected number of patients to be enrolled, expected number of sites and certain other product development milestones, including in regards to the Phase 3 clinical trial for PTCL with soquelitinib.

前瞻性声明本新闻稿包含前瞻性声明，包括与公司候选产品（包括索喹替尼）的潜在安全性和有效性有关的声明；索喹替尼治疗PTCL，实体瘤和广泛的自身免疫性疾病的潜在用途；公司及其合作伙伴开发和推进候选产品进入并成功完成临床前研究和临床试验的能力及其时间安排，包括公司使用索喹替尼进行PTCL的3期临床试验；以及临床试验的设计，包括登记患者的目标或预期数量，预期的站点数量和某些其他产品开发里程碑，包括关于使用索喹替尼的PTCL的3期临床试验。

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.

除本新闻稿中包含的历史事实声明外，所有声明均为前瞻性声明。这些陈述通常包括“相信”，“期望”，“预期”，“打算”，“计划”，“估计”，“寻求”，“将”，“可能”或类似的表达。前瞻性陈述受到许多风险和不确定性的影响，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 June 30, 2024, filed with the Securities and Exchange Commission on August 6, 2024, as well as other documents that may be filed by the Company from time to time with the Securities and Exchange Commission.

由于多种因素，公司的实际业绩可能与前瞻性声明中所述或暗示的业绩存在重大差异，包括但不限于公司于2024年8月6日向证券交易委员会提交的截至2024年6月30日三个月的10-Q表季度报告中详列的风险，以及公司可能不时向证券交易委员会提交的其他文件。

In particular, the following factors, among others, cou.

特别是，除其他因素外，还有以下因素。

INVESTOR CONTACT:Leiv LeaChief Financial OfficerCorvus Pharmaceuticals, Inc.+1-650-900-4522llea@corvuspharma.com

投资者联系人：Leiv LeaChief Financial OfficerCorvus Pharmaceuticals，Inc+1-650-900-4522llea@corvuspharma.com

MEDIA CONTACT:Sheryl SeapyReal Chemistry+1-949-903-4750sseapy@realchemistry.com

媒体联系人：Sheryl SeapyReal Chemistry+1-949-903-4750sseapy@realchemistry.com

Source: Corvus Pharmaceuticals, Inc.

资料来源：Corvus Pharmaceuticals，Inc。