Data shows positive one-year safety and efficacy data from three patients enrolled in ongoing Phase 2 clinical trial being led by researchers at the National Institute of Allergy and Infectious Diseases (NIAID)
Safety profile consistent with results from soquelitinib T cell lymphoma and atopic dermatitis clinical trials
SOUTH SAN FRANCISCO, Calif., Nov. 04, 2026 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, today announced that initial data from a Phase 2 clinical trial of soquelitinib for the treatment of patients with autoimmune lymphoproliferative syndrome (ALPS), a rare genetic disease, will be presented in a poster session at the 68th American Society of Hematology (ASH) Annual Meeting & Exposition, which is taking place December 12-15, 2026 in New Orleans, LA.
The Phase 2 ALPS trial was initiated by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and led by V. Koneti Rao, MD, FRCPA, Senior Research Physician, Primary Immune Deficiency Clinic (ALPS Clinic) at NIH Clinical Center. There currently is no cure or approved treatment for ALPS and the disorder is managed by a variety of empirical methods aimed at addressing pathological changes caused by the disease, such low blood-cell counts (cytopenias), excessive lymphocyte production (lymphoproliferation), enlarged spleen or lymph nodes, and lymphoma. Treatments may include corticosteroids such as prednisone and other immunosuppressive medications to modulate the immune system, or cancer therapies to address lymphoma.
As of August 3, 2026, three ALPS patients were enrolled in the Phase 2 trial and completed one year of treatment with a 200 mg twice per day dose of soquelitinib. The treatment was well tolerated, with no grade 3 or 4 adverse events and no interruptions in therapy. All three patients were able to discontinue background medications including steroids and reported improvement in ALPS related systemic symptoms. Corvus believes the data supports continued enrollment in the trial and based on the results to-date, we plan to explore longer treatment durations and enroll younger pediatric patients.
Details regarding the poster presentation are as follows:
Session Name: 203. Lymphocytes and Acquired or Congenital Immunodeficiency Disorders: Poster III
Session Date: December 14, 2026
Session & Presentation Time: 6:00 - 8:00 PM
Publication Number: 4743
Title: Clinical assessment of soquelitinib, an interleukin-2-inducible T cell kinase (ITK) inhibitor, for treatment of autoimmune lymphoproliferative syndrome (ALPS)-FAS
The abstract accepted for presentation can be viewed online at the ASH abstracts site here, and will appear in the November supplemental issue of Blood.
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 peripheral T cell lymphoma (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 www.corvuspharma.com 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. 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.
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.
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; the potential use of soquelitinib to improve therapy for a broad range of patients with atopic dermatitis, immune and allergic diseases and cancers; and 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. 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 September 30, 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; and regulatory developments in the United States and foreign countries. 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 third quarter ended September 30, 2026 are not necessarily indicative of its operating results for any future periods.
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
