Soquelitinib

Clinical trial designed to demonstrate proof-of-concept for soquelitinib in the treatment of hidradenitis suppurativa and evaluate its effects on Th17 biology SOUTH SAN FRANCISCO, Calif., Sept. 30, 2026 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company, today announced that enrollment has begun in its Phase 1b clinical trial of soquelitinib for the treatment of patients with hidradenitis suppurativa. “The initiation of our Phase 1b hidradenitis suppurativa trial provides an important opportunity to expand the potential of soquelitinib to a wider range of diseases,” said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. “In addition to evaluating safety and efficacy, the trial is designed to evaluate soquelitinib’s ability to modulate Th17-driven disease, complementing the results we have already seen in Th2-driven diseases such as atopic dermatitis. Hidradenitis suppurativa is primarily driven by Th17 cells, which we have shown to be reduced in patients with atopic dermatitis treated with soquelitinib. We look forward to exploring the potential of selective ITK inhibition with soquelitinib to provide an oral and potentially more effective treatment option for hidradenitis suppurativa with a novel mechanism of action.” The Phase 1b clinical trial is designed to enroll up to 25 patients 18 years and older with moderate to severe hidradenitis suppurativa. All patients will receive a soquelitinib dose of 200 mg twice per day for 12 weeks, followed by a 90-day follow-up period with no treatment. The primary endpoint of the trial is safety and tolerability. The key efficacy endpoint is the proportion of patients achieving Hidradenitis Suppurativa Clinical Response (HiSCR) 50/75 at week 12, and the trial will also evaluate skin and blood biomarkers. This is the fourth indication under clinical development for soquelitinib, which is also in a registrational Phase 3 trial for relapsed/refractory peripheral T cell lymphoma (PTCL), a Phase 2 trial (SIERRA1) for moderate to severe atopic dermatitis (AD), and a Phase 2 trial for autoimmune lymphoproliferative syndrome (ALPS). Corvus also plans to initiate a Phase 2 clinical trial of soquelitinib in patients with asthma later this year. About Corvus Pharmaceuticals 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 immune diseases and cancer. The Company’s lead product candidate is soquelitinib, an investigational, oral, small molecule drug that selectively inhibits ITK. Soquelitinib is being evaluated in a registrational Phase 3 clinical trial for relapsed/refractory PTCL, a Phase 2 clinical trial for the treatment of atopic dermatitis, and a Phase 1b clinical trial for hidradenitis suppurativa. Its other clinical-stage candidates are being developed for a variety of cancer indications. For more information, visit or follow the Company on LinkedIn . About Hidradenitis Suppurativa 1 Hidradenitis suppurativa (HS) is a chronic inflammatory skin condition characterized by painful lesions such as deep-seated nodules, abscesses, skin tunnels, and fibrotic scars. The condition’s impact extends beyond physical discomfort, with associated pain, drainage, malodor, and scarring often leading to profound negative psychosocial implications for affected individuals. Treatments include topical therapies, oral therapies, systemic injectable biologic therapies, and direct interventions. HS is associated with elevated levels of Th17 cells compared to regulatory T cells (Tregs), leading to high levels of IL-17 and other cytokines that cause inflammation. About 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. 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. 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. The Company believes the inhibition of specific molecular targets in T cells may be of therapeutic benefit for patients with autoimmune and allergic diseases and in cancers, including solid tumors. Based on results from a Phase 1/1b clinical trial in patients with refractory T cell lymphomas (published in Blood), which demonstrated tumor responses in very advanced, refractory, difficult to treat T cell malignancies, the Company is enrolling a registrational Phase 3 clinical trial (NCT06561048) of soquelitinib in patients with relapsed/refractory PTCL. Soquelitinib is also now being investigated in a randomized placebo-controlled Phase 2 clinical trial in patients with atopic dermatitis and a Phase 1b clinical trial in patients with hidradenitis suppurativa. A publication describing the chemistry, enzymology, and biology of soquelitinib appeared in npj Drug Discovery in December 2024 and is available online at the Nature website and on the Publications and Presentations page of the Corvus website. Forward-Looking Statements This press release contains forward-looking statements, including statements related to the potential safety, tolerability, clinical benefit, and efficacy of the Company’s product candidates, including soquelitinib; the potential use of soquelitinib to improve therapy for a broad range of patients with T cell lymphoma, atopic dermatitis, hidradenitis suppurativa, other immune diseases, and cancers; and clinical strategy and the design of clinical trials, including the timeline for initiation, target or expected number of patients to be enrolled, dose levels, and other product development milestones. 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 quarter ended June 30, 2026, filed with the Securities and Exchange Commission on August 6, 2026, 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; 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: Zack Kubow Vice President, Investor Relations and Corporate Communications Corvus Pharmaceuticals, Inc. investors@corvuspharma.com MEDIA CONTACT: Julia Stern Real Chemistry media@corvuspharma.com _________________________ 1

2026年5月14日，美国Corvus Pharmaceuticals公布了口服ITK抑制剂soquelitinib（研发代号CPI-818）用于中重度特应性皮炎的I期最终数据。 在Cohort 4中，200mg每日两次治疗56天后，用药组12人中有9人的EASI评分较基线降低至少75%（即EASI 75达标）。安慰剂组入组12人，其中2人缺席第56天访视，按10名可评估患者计算，EASI 75达标率为20%（2/10）。整个I期试验共入组72人。 这个药跟大家熟悉的度普利尤单抗（dupilumab，商品名达必妥/Dupixent）不一样：达必妥是打针的生物制剂，soquelitinib是口服小分子。它在中国的开发权益归和剂药业（Angel Pharmaceuticals）所有。 Soquelitinib I期Cohort 4第56天数据对比（来源：Corvus SID 2026公布）这个药跟达必妥、JAK抑制剂有什么不一样 目前中重度特应性皮炎的靶向系统治疗主要包括两类。 一类是生物制剂，代表是度普利尤单抗（dupilumab，达必妥/Dupixent），阻断IL-4和IL-13通路。2025年全球净销售额约178亿美元。成人通常每两周皮下注射一次。在成人单药研究SOLO 1和SOLO 2中，第16周EASI 75达标率分别为51%和44%，安慰剂组为15%和12%。 另一类是口服JAK抑制剂，比如乌帕替尼（upadacitinib，瑞福/RINVOQ）。口服方便，但FDA给了黑框警告，提示严重感染、恶性肿瘤、血栓和心血管事件风险。 soquelitinib走的是另一条路：口服、高度选择性ITK抑制剂。ITK是T细胞内的一个信号激酶，在Th2和Th17这两条导致过敏炎症的通路上游起作用。抑制ITK可以减少IL-4、IL-5、IL-13等炎症因子的分泌，同时让调节性T细胞增多。 皮肤瘙痒场景示意（视觉中国） 目前中重度特应性皮炎主流生物制剂达必妥（度普利尤单抗）药盒（赛诺菲中国官方产品图）I期数据到底怎么样 Corvus公布的是随机、双盲、安慰剂对照的I期试验。这里要说清楚样本量： Cohort 3：200mg每日两次，治疗28天。用药组12人，EASI 75达标率50%，EASI 90达标率8%，IGA 0/1（皮肤干净或几乎干净）25%。 Cohort 4：200mg每日两次，治疗56天。用药组12人，第56天EASI 75达标率75%（9/12），EASI 90达标率25%，IGA 0/1达标率33%。安慰剂组10人，EASI 75达标率20%（2/10）。 有几个细节： **关于"停药不反弹"**：Cohort 3治疗28天后停药随访90天，Cohort 4治疗56天后停药随访30天。在这两个随访期内，研究者没有观察到明显的疾病反弹。但这只是短随访期内的观察，不能等同于长期停药不复发。 **关于既往治疗失败的患者**：Cohort 4中有一个亚组是之前接受过系统治疗的患者（包括生物制剂和JAK抑制剂等，不限于某一种）。该亚组用药组5人中有3人达到EASI 75（60%），安慰剂组7人中0人达标。用药组仅5人，不能直接解读为"达必妥耐药患者60%有效"。 **关于安全性**：在这个小样本、短疗程的I期中，没有报告严重或重度不良事件，也没有观察到具有临床意义的实验室指标异常。但这不代表未来大规模、长周期使用没有风险。 生物制药实验室（Visit NH）谁在做这个药 原研是美国Corvus Pharmaceuticals（纳斯达克：CRVS），2020年10月5日Corvus宣布与和剂药业开展战略合作，和剂获得soquelitinib在大中华区的开发和商业化权益。按剔除员工持股计划预留股权的口径，Corvus持有和剂约48.6%的股份（截至2026年6月30日）。 和剂药业2026年6月9日宣布完成近1亿元人民币融资，主要用于推进soquelitinib在中国的临床。 目前临床进展分两条线： • 美国Corvus正在推进复发/难治外周T细胞淋巴瘤（PTCL）的全球III期注册临床（NCT06561048），预计2027年初开展中期无效性分析。 • 中国和剂药业2026年1月29日宣布中国1b/2期试验已全面启动，目前正在入组。 皮肤科门诊（视觉中国）离上市还有多远 特应性皮炎这条线，美国正在做II期SIERRA1，约200例患者，12周治疗。中国这边1b/2期刚在入组。按这个节奏，国内什么时候能获批还不确定，取决于后续试验数据和监管审评进度。 中国特应性皮炎患者超过6500万，其中近28%为中重度（和剂药业2026年1月公告口径）。达必妥进医保后降价了，但打针这件事本身让不少人犹豫。JAK抑制剂有效但黑框警告摆在那里。如果soquelitinib后续II期数据能重复I期的信号，它可能成为一个口服的、不需要注射的新选择。但现在说这些还太早，12个人的数据说明不了太多问题。 ---数据来源 1. Corvus Pharmaceuticals官方新闻稿：Soquelitinib Phase 1 Atopic Dermatitis Data at SID，2026年5月14日 2. Corvus Pharmaceuticals 2026年Q2财报及10-Q，2026年8月6日 3. 和剂药业：完成近1亿元融资推进soquelitinib中国临床，2026年6月9日 4. 和剂药业：中国特应性皮炎1b/2期临床试验启动，2026年1月29日 5. 再生元2025年全年财报（达必妥销售额），2026年1月30日 6. 达必妥官方临床数据页面（SOLO 1/2 EASI结果） 本文仅作医药资讯整理，不构成诊疗或用药建议。特应性皮炎治疗方案请在皮肤科医生指导下进行，具体以国家药监局批准信息及药品说明书为准。