Patients in 200 mg BID cohort had median progression free survival of 6.2 months and median overall survival of 28.1 months, comparing favorably to results with other therapies
Data supports ongoing registration Phase 3 trial in r/r PTCL, Phase 1 trial in atopic dermatitis and potential expansion into other immune and inflammatory diseases
Highlights ITK inhibition novel mechanism of action affecting T cell receptor signaling and T cell differentiation
Presented in an oral session at the 67th American Society of Hematology Annual Meeting & Exposition
SOUTH SAN FRANCISCO, Calif., Dec. 08, 2025 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company, announced the presentation of final data from its Phase 1/1b trial of soquelitinib in patients with T cell lymphoma today in an oral session at the 67th American Society of Hematology (ASH) Annual Meeting & Exposition, which is taking place December 6-9, 2025 in Orlando, FL. The presentation highlights preclinical and clinical data supporting the development of soquelitinib in oncology and immune and inflammatory diseases, including data detailing its mechanism of action.
“The T-cell lymphomas are devastating diseases, associated with dismal outcomes, and are thus an area of high unmet need,” said Ryan Wilcox, M.D., Ph.D., Associate Professor of Internal Medicine, University of Michigan Medical School. “In the relapsed/refractory setting, complete and durable responses are rarely achieved with currently available agents. The Phase 1 data demonstrate impressive progression free and overall survival in relapsed/refractory patients treated with soquelitinib. Several patients experienced complete and durable responses, some of which were maintained on therapy more than two years. For most relapsed/refractory PTCL patients, an overall survival less than 6 months is anticipated. In the phase 1 study, median progression free survival was 6.2 months and median overall survival exceeded 2 years. These results provide the foundation for the ongoing registration Phase 3 trial in relapsed/refractory peripheral T cell lymphoma.”
The trial enrolled 75 patients (27 in dose escalation portion and 48 in dose expansion portion) with various T cell lymphomas, including peripheral T cell lymphoma (PTCL), T follicular helper cell lymphoma (TFHC), natural killer cell T cell lymphoma (NKTCL), cutaneous T cell lymphoma (CTCL), anaplastic large cell lymphoma (ALCL) and adult T cell lymphoma/leukemia (ATLL). The median number of prior therapies was 3 (range 1-18), with only 31% achieving an objective response to their most recent prior therapy. In the dose escalation portion, patients received a twice-daily dose of soquelitinib of 100 mg, 200 mg, 400 mg or 600 mg, and the 200 mg twice-daily dose was selected for the dose expansion portion based on biomarker studies indicating that doses of 200mg or higher achieved complete occupancy of the ITK target with the drug.
Key highlights from the data supporting the ongoing registration Phase 3 trial in relapsed/refractory PTCL include:
- No dose limiting toxicities or significant adverse events were observed in any patients in all dose cohorts up to 600 mg twice-daily, including no myelosuppression or immunosuppression
- Objective and durable tumor responses were seen in the 200 mg twice-daily cohort (N=36) with 6 patients experiencing complete responses
- In the 200 mg twice-daily cohort, it was determined that patients with between ≥1 and ≤3 prior therapies and an adequate peripheral blood lymphocyte count (N=24) were most likely to be responders to therapy. In this patient population:
- Objective responses were seen in 9 of 24 patients including 6 complete responses and 3 partial responses
- Median progression free survival (PFS) was 6.2 months, including an 18-month PFS of 30%
- Median overall survival (OS) was 28.1 months, including a 24-month OS of 67%
Key highlights from the data supporting soquelitinib’s mechanism of action (Th1 skewing and blocking Th2 and Th17 differentiation) and use in immune and inflammatory diseases include:
- In vitro studies demonstrated that at appropriate doses, soquelitinib produces Th1 skewing, which is an immunologic property resulting from the blockade of Th2 differentiation and a shift to Th1
- Biomarker studies evaluating blood samples and tumor biopsies showed an increase in Th1 in blood and tumor samples and a reduction in serum IL-5, consistent with inhibiting Th2 and Th17 cells
- For 6 patients, paired tumor biopsies were compared at baseline and day 8 and showed an increase in intratumor Th1 cells with treatment analyzed using RNA sequencing
“The data presented at ASH provides foundational information for the future development of soquelitinib and our ITK platform across oncology, immune disease and inflammation,” said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. “In oncology, the data show that soquelitinib could be a new treatment option for T cell lymphomas, including in patients with advanced, aggressive disease. The data not only support our ongoing registration Phase 3 trial in PTCL, but also show immunobiological effects that demonstrate soquelitinib’s mechanism of action of affecting T cell differentiation via ITK inhibition. The mechanism operates upstream in T cell signaling pathways, which may indicate that resistance pathways are unlikely to evolve.”
Dr. Miller added, “Outside of oncology, we are focused on the development of soquelitinib in atopic dermatitis and evaluating its potential in a broad range of immune and inflammatory diseases. We plan to present additional data from extension cohort 4 of our Phase 1 atopic dermatitis trial in January and initiate a Phase 2 trial in this indication in early Q1 2026.”
Corvus is currently enrolling patients in a registration 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. 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 2 lines of systemic therapy. The Company anticipates reporting interim data from the Phase 3 trial in late 2026 and completing the trial in 2027.
The ASH oral presentation slides are available on the Publications and Presentations page of the Corvus website.
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 cancer and immune diseases. The Company’s lead product candidate is soquelitinib, an investigational, oral, small molecule drug that selectively inhibits ITK. Soquelitinib is now in a registration Phase 3 clinical trial for relapsed/refractory PTCL and in a Phase 1 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 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. 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 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 1 clinical trial in patients with atopic dermatitis. A recent 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 in the T cell receptor signaling pathway. These mutations can result in tonic signaling and play a role in lymphomagenesis. ITK plays a crucial role in T cell receptor signaling, and treatment with an ITK inhibitor can block the signaling pathway. 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.
Forward-Looking Statements
This press release contains forward-looking statements, including statements related to data supporting the Company’s ongoing clinical trial, development of soquelitinib in oncology and immune and inflammatory diseases, soquelitinib’s mechanism of action and soquelitinib as a new treatment option for T cell lymphomas, including in patients with advanced, aggressive disease; the potential safety and efficacy of the Company’s product candidates; clinical strategy and the design of clinical trials, including 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 availability and timing of clinical and preclinical data announcements and clinical readouts, including data from extension cohort 4 of the Phase 1 clinical trial for atopic dermatitis with soquelitinib. 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 third quarter ended September 30, 2025, filed with the Securities and Exchange Commission on November 4, 2025, 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 fourth quarter of 2026 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:
Leiv Lea
Chief Financial Officer
Corvus Pharmaceuticals, Inc.
+1-650-900-4522
llea@corvuspharma.com
MEDIA CONTACT:
Sheryl Seapy
Real Chemistry
+1-949-903-4750
sseapy@realchemistry.com
