SOUTH SAN FRANCISCO, Calif. — December 8, 2025 — Leads & Copy — Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS) has presented final data from its Phase 1/1b trial of soquelitinib in patients with T cell lymphoma, showcasing promising results in progression-free and overall survival.
The presentation, which took place at the 67th American Society of Hematology (ASH) Annual Meeting & Exposition in Orlando, FL, highlighted data supporting the development of soquelitinib in oncology and immune and inflammatory diseases, with specific details on its mechanism of action.
According to Ryan Wilcox, M.D., Ph.D., from the University of Michigan Medical School, T-cell lymphomas have dismal outcomes, making the need for effective therapies critical. He stated that the Phase 1 data demonstrated impressive progression-free and overall survival in relapsed/refractory patients treated with soquelitinib, with some patients experiencing complete and durable responses maintained for over two years. Wilcox added that these results provide the foundation for the ongoing registration Phase 3 trial in relapsed/refractory peripheral T cell lymphoma.
The Phase 1/1b trial enrolled 75 patients with various T cell lymphomas, with a median of three prior therapies. Results from the dose escalation portion led to selecting a 200 mg twice-daily dose for the dose expansion portion.
Key data highlights include the following:
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, 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, including:
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%
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.
Richard A. Miller, M.D., president and CEO of Corvus, commented that the data provides foundational information for the future development of soquelitinib and the ITK platform across oncology, immune disease and inflammation. He also noted that the data supports the ongoing registration Phase 3 trial in PTCL and shows immunobiological effects that demonstrate soquelitinib’s mechanism of action of affecting T cell differentiation via ITK inhibition.
Corvus is enrolling patients in a registration Phase 3 clinical trial of soquelitinib in patients with relapsed/refractory PTCL. The primary endpoint of the trial is progression free survival. Interim data from the Phase 3 trial is expected in late 2026, with trial completion anticipated in 2027. The FDA has granted soquelitinib Orphan Drug Designation for the treatment of T cell lymphoma and Fast Track designation for adult patients with relapsed or refractory PTCL after at least 2 lines of systemic therapy.
The ASH oral presentation slides are available on the Publications and Presentations page of the Corvus website.
Corvus Pharmaceuticals is pioneering the development of ITK inhibition as a new approach to immunotherapy for cancer and immune diseases. The Company’s lead product candidate is soquelitinib, now in a registration Phase 3 clinical trial for relapsed/refractory PTCL and in a Phase 1 clinical trial for atopic dermatitis. Its other clinical-stage candidates are being developed for a variety of cancer indications. 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.
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. Studies have demonstrated that ITK controls a switch between the differentiation of Th17 proinflammatory cells and T regulatory suppressor cells.
Peripheral T cell lymphoma is a heterogeneous group of malignancies accounting for about 10% of non-Hodgkin’s lymphomas (NHL) in Western populations and up to 20% to 25% of NHL in some parts of Asia and South America. Patients in relapse are treated with chemotherapy agents but have poor overall outcomes. There are no approved drugs in relapsed/refractory PTCL based on randomized trials.
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.
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
Source: Corvus Pharmaceuticals, Inc.
