Soquelitinib

Soquelitinib clinical development for atopic dermatitis advancing with Phase 1 cohort 4 positive data and initiation of Phase 2 trial during the quarter New immunologic and biomarker data supporting the potential for drug-free remissions with soquelitinib to be presented at Society for Investigative Dermatology (SID) annual meeting Company hosting investor and analyst meeting to review SID data on May 14, 2026 at 1:30 pm ET (12:30 pm CT) SOUTH SAN FRANCISCO, Calif., May 07, 2026 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, today provided a business update and reported financial results for the first quarter ended March 31, 2026. “We started the year with strong momentum for soquelitinib, our selective ITK inhibitor that we believe is well positioned to improve therapy for a broad range of patients with atopic dermatitis, other immune diseases and cancers,” said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. “The data generated from our clinical and preclinical work support soquelitinib’s potential to provide a new treatment paradigm for these diseases based on a rebalancing of the immune system. We will share additional data supporting this mechanism at the upcoming annual meeting of the Society for Investigative Dermatology, where we are reviewing data from our Phase 1 atopic dermatitis trial in two oral presentations. Looking forward, we are focused on our ongoing and planned soquelitinib clinical trials, including the initiation of new Phase 2 studies in hidradenitis suppurativa and asthma anticipated later this year.” Business Update and Strategy Soquelitinib for Immune Diseases In January 2026, Corvus reported data from cohort 4 of the randomized, blinded, placebo-controlled Phase 1 trial evaluating soquelitinib in patients with moderate-to-severe atopic dermatitis (data as of January 15, 2026). Cohort 4 data demonstrated positive safety and efficacy results, including additional clinical benefit observed following longer 8-week treatment. Final data from the randomized, blinded, placebo-controlled Phase 1 trial evaluating soquelitinib in patients with moderate-to-severe atopic dermatitis will be presented in two oral sessions at the Society for Investigative Dermatology (SID) Annual Meeting, which is taking place May 13-16, 2026 in Chicago. The Company will host an in-person and virtual investor and analyst meeting on May 14, 2026 to review soquelitinib data being presented at SID, including new immunologic and biomarker data that focus on the drug’s mechanism of action and potential for drug-free remissions. Corvus initiated its Phase 2 randomized placebo-controlled atopic dermatitis clinical trial during the first quarter 2026. The trial is anticipated to enroll approximately 200 patients with moderate-to-severe atopic dermatitis that have failed at least one prior topical or systemic therapy. This includes four cohorts of 50 patients each, with soquelitinib doses of 200 mg once per day, 200 mg twice per day and 400 mg once per day, along with a placebo group. The treatment period is 12 weeks with a 90-day follow-up period with no treatment. Angel Pharmaceuticals, Corvus’ partner in China, is enrolling a Phase 1b/2 clinical trial evaluating soquelitinib in patients with moderate-to-severe atopic dermatitis. This is a blinded, placebo-controlled trial that is planned to evaluate a 12-week treatment regimen in 48 patients utilizing soquelitinib doses of 100 mg twice per day, 200 mg once per day, 200 mg twice per day and 400 mg once per day. The patient eligibility and endpoints are similar to those used previously by Corvus. Depending on the results from the Phase 1b portion of the study, an additional 60-90 patients will be enrolled in the Phase 2 portion of the study. The trial is open at several leading dermatology centers in China who have been involved in global registration trials. The study is conducted in close collaboration with Corvus. Results from the initial cohorts are anticipated late this year. Corvus plans to initiate two additional Phase 2 clinical trials evaluating soquelitinib in patients with hidradenitis suppurativa and asthma. Corvus also continues to advance its next-generation ITK inhibitor preclinical product candidates, which are designed to deliver precise T-cell modulation for specific immunology and oncology indications. Collaboration with National Institute of Allergy and Infectious Diseases (NIAID) The Autoimmune Lymphoproliferative Syndrome (ALPS) Phase 2 clinical trial continues to advance. This trial is being conducted under a clinical research and development agreement with NIAID. The Phase 2 clinical trial ( NCT06730126 ) is anticipated to enroll up to 30 patients aged 16 or older with confirmed ALPS based on genetic testing. Soquelitinib for T Cell Lymphoma Corvus continues to enroll patients in a registrational Phase 3 clinical trial of soquelitinib in patients with relapsed/refractory PTCL at multiple clinical sites. This randomized controlled trial is anticipated to enroll a total of 150 patients with relapsed/refractory PTCL and is evaluating soquelitinib versus physicians’ choice of either belinostat or pralatrexate chemotherapies. The primary endpoint of the trial is progression free survival. There are no FDA fully approved agents for the treatment of relapsed/refractory 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 two lines of systemic therapy. Financial Results As of March 31, 2026, Corvus had cash, cash equivalents and marketable securities of $236.7 million compared to $56.8 million as of December 31, 2025. Cash, cash equivalents and marketable securities as of March 31, 2026 included approximately $189.4 million in net proceeds received in a financing completed on January 23, 2026. Based on its current plans, Corvus expects its cash, cash equivalents and marketable securities to fund operations into the second quarter of 2028. Research and development expenses for the three months ended March 31, 2026 totaled $11.2 million compared to $7.5 million for the same period in 2025. The increase in research and development expenses of $3.7 million was primarily due to higher clinical trial costs associated with the development of soquelitinib as well as an increase in personnel related costs. Net loss for the three months ended March 31, 2026 was $13.7 million compared to net income of $15.2 million for the same period in 2025. Included in net loss for the three months ended March 31, 2026 and net income for the three months ended March 31, 2025 were non-cash losses of $0.6 million and $0.5 million, respectively, from Corvus’ investment in Angel Pharmaceuticals and non-cash income of $25.1 million in the three months ended March 31, 2025 associated with a change in fair value of the Company’s warrant liability. Total stock compensation expense for the three months ended March 31, 2026 was $2.7 million compared to $1.3 million for the same period in 2025. 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 registration Phase 3 clinical trial for relapsed/refractory PTCL and in a Phase 2 clinical trial for the treatment of atopic dermatitis. 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 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. 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. Recent third-party 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. 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 registration 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. 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. About Peripheral T Cell Lymphoma Peripheral T cell lymphoma 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. First line treatment 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 three to four month range and overall median survival of six to 12 months. There are no approved drugs in relapsed/refractory PTCL based on randomized trials. 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. About Atopic Dermatitis Atopic dermatitis, also called eczema, is a chronic disease that can cause inflammation, redness, scaly patches, blisters and irritation of the skin. It affects up to 20% of children and up to 10% of adults, and treatments include topical therapies, oral therapies and systemic injectable biologic therapies. It is frequently associated with other allergic disorders such as food allergies and asthma. Atopic dermatitis, like asthma and allergy, involves the participation of Th2 lymphocytes which secrete cytokines that result in inflammation. Soquelitinib has been shown in preclinical studies to inhibit cytokine production from Th2 lymphocytes. About Autoimmune Lymphoproliferative Syndrome (ALPS) ALPS is a rare genetic disease affecting children that manifests with lymphadenopathy, splenomegaly, cytopenias (low blood counts), proteinuria and autoimmunity. The disease is caused by a mutation in the Fas gene, which provides instructions for making a signaling protein involved in the induction of apoptosis. The mutation results in immune dysregulation due to abnormally high levels of “double negative” T cells (CD4 and CD8 double negative), which infiltrate the blood, spleen and lymphoid tissues. Fas signaling is regulated by ITK and T cell receptor signaling and patients with ALPS have an imbalance in this regulation resulting in a failure of T cells to undergo apoptosis and an accumulation of abnormal T cells. About Angel Pharmaceuticals Angel Pharmaceuticals is a privately held biopharmaceutical company developing a pipeline of precisely targeted investigational medicines for cancer, autoimmune, infectious and other serious diseases in China. Angel Pharmaceuticals was launched through a collaboration with Corvus and investments from investors in China. Angel Pharmaceuticals licensed the rights to develop and commercialize Corvus’ three clinical-stage candidates – soquelitinib, ciforadenant and mupadolimab – in greater China and obtained global rights to Corvus’ BTK inhibitor preclinical programs. Under the collaboration, Corvus currently has a 49.7% equity stake in Angel Pharmaceuticals excluding 7% of Angel’s equity reserved for issuance under the Angel employee stock ownership plan, and Corvus has designated three individuals on Angel’s five-person Board of Directors. For more information, visit . Forward-Looking Statements This press release contains forward-looking statements, including statements related to the potential safety and efficacy of the Company’s product candidates; the potential use of soquelitinib to improve therapy for a broad range of patients with atopic dermatitis, other immune diseases and cancers; clinical strategy and the design of clinical trials, including the Company’s collaborations and the timeline for initiation, target or expected number of patients to be enrolled, dose levels, number of sites and other product development milestones; and the amount of cash to fund operations into the second quarter of 2028. 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 March 31, 2026, filed with the Securities and Exchange Commission on or about the date hereof, 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 second quarter of 2028 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. The Company’s results for the first quarter ended March 31, 2026 are not necessarily indicative of its operating results for any future periods. CORVUS PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except share and per share data) Three Months Ended March 31, 2026 2025 (unaudited) Operating expenses: Research and development $ 11,175 $ 7,453 General and administrative 3,702 2,469 Total operating expenses 14,877 9,922 Loss from operations (14,877 ) (9,922 ) Interest income and other expense, net 1,784 525 Change in fair value of warrant liability - 25,129 Income (loss) before equity method investment (13,093 ) 15,732 Loss from equity method investment (599 ) (539 ) Net (loss) income $ (13,692 ) $ 15,193 Net (loss) income per share, basic $ (0.15 ) $ 0.21 Net loss per share, diluted $ (0.15 ) $ (0.13 ) Shares used to compute net (loss) income per share, basic 89,996,728 72,126,496 Shares used to compute net loss per share, diluted 89,996,728 75,152,514 CORVUS PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands) March 31, December 31, 2026 2025 (unaudited) Assets Cash, cash equivalents and marketable securities $ 236,714 $ 56,750 Operating lease right-of-use asset 751 839 Other assets 5,234 2,539 Investment in Angel Pharmaceuticals 10,496 10,991 Total assets $ 253,195 $ 71,119 Liabilities and stockholders' equity Accounts payable and accrued liabilities and other liabilities $ 11,682 $ 8,977 Operating lease liability 834 937 Stockholders' equity 240,679 61,205 Total liabilities and stockholders' equity $ 253,195 $ 71,119 INVESTOR CONTACT: Leiv Lea Chief Financial Officer Corvus Pharmaceuticals, Inc. +1-650-900-4522 llea@corvuspharma.com MEDIA CONTACT: Julia Stern Real Chemistry +1-949-903-4750 sseapy@realchemistry.com

导 语 2017年，度普利尤单抗（达必妥）获批，标志着AD进入靶向治疗时代。截至2026年，全球已有7款靶向药物获批用于中重度AD，另有10余款进入III期临床。这些药物聚焦“屏障-免疫”双螺旋机制，针对不同靶点解决未被满足的临床需求。 一、五大研发赛道：解决核心痛点 1. 赛道一：IL-4Rα 、IL-13——标杆与挑战者 l 度普利尤单抗：阻断IL-4Rα，单药EASI 75达44-52%，联用TCS提升至69%，适应症覆盖6月龄以上AD及哮喘、慢性鼻窦炎等2型炎症疾病。弱点：35-40%患者应答不足，结膜炎发生率10-15%，每2周注射依从性差。 l 来瑞组单抗（Lebrikizumab）：仅阻断IL-13，结膜炎发生率降至5-8%，适用于度普利尤单抗不耐受、头颈部皮损患，EASI 75为52.1%，每4周注射一次，提升依从性。 l IBI3002 项目（信达）：IL-4Rα和TSLP的双特异性抗体，目前正在开展Ⅱ期临床，招募18-65岁中重度特应性皮炎患者。 相关文章： 1.达必妥打了几针还没反应，要不要停药？说明书里这样定标准 2.EADV 大会认证！来瑞组单抗成多线治疗失败新选择，中重度 AD 真实世界数据 3.过万补贴，IL-4Rα和TSLP双靶点特应性皮炎新药IBI3002 II 期招募【杭州/沈阳/北京/广州】 2. 赛道二：JAK抑制剂——疗效强但枷锁重 l 乌帕替尼（Upadacitinib）30mg：EASI 75达73-80%，EASI 90约60%。口服、起效快、疗效高，但是有黑框警告，FDA因托法替尼类风湿关节炎研究数据，对所有JAK抑制剂加上严重心血管事件、血栓、感染等风险警告，限制阿布昔替尼、乌帕替尼这类高选择性JAK1抑制剂仅用于二线治疗。 相关文章： 1.乌帕替尼吃多了会有抗体没效果吗？6年安全性数据打破皮炎耐药误区 2.AD 头颈皮损反复？阿布昔替尼 12 周 68% 改善率，长期吃影响免疫吗？ 3. 赛道三：IL-31RA、IL-25——瘙痒治疗 l 奈莫利珠单抗（Nemolizumab）：靶向IL-31（直接瘙痒介质），用药第1周瘙痒显著缓解，第2天或现改善信号。EASI 75为42-44%，但皮损清除能力有限，定位为瘙痒主导型AD或难治性瘙痒的附加治疗。 l SM17 项目：靶向白细胞介素-25（IL-25）受体，1b期研究高剂量组数据显示：91.7%的患者瘙痒程度获得缓解（瘙痒数字评分量表NRS改善≥4分）；75%的患者皮损面积与严重度改善≥75%（EASI 75）；41.7%的患者达到皮损近乎完全清除（研究者整体评估IGA 0/1）。研究提示该药物具备缓解瘙痒与修复皮肤屏障的潜力。目前正在开展Ⅱ期临床。 相关文章： 1.200周研究：中重度AD患者长期用奈莫利珠单抗会出现什么副作用？ 2.91.7%特应性皮炎患者瘙痒缓解！IL-25 新靶点药 SM17 全国招募中 4. 赛道四：OX40/OX40L——从终身用药到停药不复发 l Rocatinlimab（抗OX40）：Ⅱb期研究显示，停药20周后73-96%患者维持EASI 75应答，Ⅲ期研究（2025年）验证长效缓解。 l Amlitelimab（抗OX40L）：每12周给药一次，EASI 75应答率超50%，赛诺菲布局其作为度普利尤单抗迭代产品。 l IBI356项目（抗OX40L）：IBI356是第一个在国内得到临床试验许可的OX40L单抗，主要用于治疗特应性皮炎。目前正在开展Ⅱ期临床，招募18周岁以上中重度特应性皮炎患者。 相关文章： 1.打一针管12周的AD新药：Amlitelimab（OX40L）计划申报上市，安全耐药性如何？ 2.有望一年四针的OX40L单抗，赛诺菲新药Amlitelimab三期开启全国临床招募 5. 赛道五：新一代口服靶点（STAT6、ITK）——2027关键数据 l STAT6降解剂：直接降解STAT6蛋白，绕开JAK抑制风险。Kymera的KT-621：1b期研究显示，28天口服后皮肤组织STAT6降解率达94%，EASI平均改善63%，瘙痒NRS下降40%，无严重不良事件。 l ITK抑制剂：精准调控Th2/Th17通路。Corvus的Soquelitinib（高选ITK，无JAK活性）2期临床启动，若EASI 75≥50%，或成最安全口服药，数据2027年公布。 二、2027年：AD治疗格局分水岭 关键节点：KT-621的IIb期、Soquelitinib的II期数据将决定“无黑框口服治疗”能否落地。若STAT6降解剂16周EASI 75达55-65%且安全性无风险，AD治疗或从终身注射转向口服精准根治。 现状提醒：AD临床试验安慰剂效应高达21%，早期数据需谨慎解读，2027年前不宜过度乐观。 三、未来趋势：个体化治疗 五条赛道对应五大临床需求，未来AD治疗将走向个体化分层，2027-2028年将是格局分水岭。 你对AD新药最期待哪一点？欢迎留言讨论！ 文中提到的多种药物或同靶点新药：乌帕替尼同靶点，达必妥头对头，赛诺菲信达OX40L 单抗，IL-4Rα和TSLP双靶点等正在招募AD患者参与临床试验。 如果您符合条件（中重度AD），可报名参与，提前接触前沿治疗！（三甲医院专家随访，补贴可观，用药体检不收费） 更多新药 咨询报名 特皮病友群  用药反馈 参考文献 1.Kymera Therapeutics. (2025). BroADen Study Results. 2.Corvus Pharmaceuticals. (2026). Soquelitinib Phase 2 Clinical Trial Protocol. 3.FDA. (2021). JAK Inhibitor Safety Update. 本文仅做参考，不提供任何诊疗意见，不构成对任何药物的推广或宣传，如有任何问题，请前往医院向专业医师咨询。部分材料和图片源于网络，侵删 点赞是一种动力 分享是一种美德