Corvus Pharmaceuticals Announces Publication in Blood of Final Phase 1 Data from the Soquelitinib Phase 1/1b T Cell Lymphoma Trial
Rhea-AI Summary
Corvus Pharmaceuticals (Nasdaq: CRVS) reported peer‑reviewed final data in Blood from its Phase 1/1b trial of soquelitinib in T cell lymphoma, supporting its development in oncology and immune/inflammatory diseases, according to Corvus.
The study enrolled 75 heavily pre‑treated patients across multiple T cell lymphoma subtypes. Doses up to 600 mg twice daily were well tolerated with no dose‑limiting toxicities, significant adverse events, myelosuppression or immunosuppression. A 200 mg twice‑daily dose was chosen for expansion based on complete ITK target occupancy.
In the 200 mg cohort (N=36), patients with one to three prior therapies (N=24) achieved 9 objective responses (six complete, three partial), median progression‑free survival of 6.2 months, 30% progression‑free at 18 months, and median overall survival of 28.1 months with 67% alive at 24 months. Corvus highlighted a mechanism involving selective ITK inhibition, Th1 skewing and both tumor‑intrinsic and microenvironment effects.
Corvus is enrolling a registration Phase 3 trial in relapsed/refractory PTCL (150 patients) comparing soquelitinib to physician’s choice of belinostat or pralatrexate, with progression‑free survival as the primary endpoint. Soquelitinib has FDA Orphan Drug and Fast Track designations for T cell lymphoma and relapsed/refractory PTCL, respectively.
Positive
- Durable efficacy signals in 24-patient subgroup: 9/24 objective responses, including 6 complete responses, with median overall survival of 28.1 months and 67% alive at 24 months.
- Safety profile across doses up to 600 mg twice-daily showed no dose-limiting toxicities, significant adverse events, myelosuppression or immunosuppression.
- Mechanism of action supported by in vitro and in vivo data demonstrating selective ITK inhibition, Th1 skewing and changes in tumor microenvironment.
- Registration Phase 3 trial underway in relapsed/refractory PTCL, randomized against physician’s choice of belinostat or pralatrexate, targeting 150 patients.
- Regulatory support with FDA Orphan Drug Designation for T cell lymphoma and Fast Track designation for adult relapsed/refractory PTCL after at least two prior systemic therapies.
Negative
- Efficacy outcomes such as 9 objective responses and 28.1-month median overall survival are based on a 24-patient subset with one to three prior therapies.
- Development risk remains as the pivotal registration Phase 3 trial in relapsed/refractory PTCL is ongoing and results have not yet been reported.
Key Figures
Previous Clinical trial Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| May 14 | Phase 1 dermatitis data | Positive | -13.8% | Positive atopic dermatitis efficacy and safety data presented at SID |
| Jan 20 | Phase 1 cohort results | Positive | +166.0% | Cohort results showed efficacy, biomarker changes, and statistically significant separation |
| Dec 08 | Phase 1/1b lymphoma data | Positive | -2.8% | Lymphoma data showed responses, survival outcomes, and tolerability |
| Oct 17 | Phase 1b/2 renal data | Positive | -8.0% | Interim renal cancer data reported response and progression-free survival outcomes |
| Jun 11 | Preclinical ITK data | Positive | +5.9% | Preclinical findings highlighted potential systemic sclerosis applications |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Comparable clinical-trial news produced mixed reactions, with three divergences and two alignments.
Key Terms
itk inhibition medical
tumor microenvironment medical
progression-free survival medical
orphan drug designation regulatory
fast track designation regulatory
AI-generated analysis. How Rhea-AI works. Not financial advice.
Data supports ongoing registration Phase 3 trial in r/r PTCL, Phase 2 trial in atopic dermatitis and planned trials for hidradenitis suppurativa and asthma
Data in T cell lymphoma demonstrated anti-tumor activity based on tumor intrinsic and tumor extrinsic effects on microenvironment
Highlights ITK inhibition novel mechanism of action, aligned with recently presented immunologic and biomarker data from the soquelitinib Phase 1 atopic dermatitis trial
SOUTH SAN FRANCISCO, Calif., Aug. 27, 2026 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, today announced the publication of peer-reviewed final data from its Phase 1/1b trial of soquelitinib in patients with T cell lymphoma. The publication in Blood, the journal of the American Society of Hematology, provides the medical and scientific community with clinical and immunologic data supporting the development of soquelitinib in oncology and immune and inflammatory diseases.
“The publication of these data in Blood brings our soquelitinib findings to a wide audience of clinicians and researchers,” said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. “In patients with advanced, aggressive and difficult-to-treat T cell lymphomas, soquelitinib demonstrated durable responses, including complete responses, maintained for more than two years in some patients and a median overall survival exceeding two years. This compares favorably to currently available therapies, providing the rationale for our ongoing registration Phase 3 trial in relapsed/refractory PTCL. The peer-reviewed data also detail soquelitinib’s mechanism of action, with selective ITK inhibition driving Th1 skewing and blocking of Th2 and Th17 differentiation. We believe these data support soquelitinib’s broad potential across immune and inflammatory diseases, reinforcing our development strategy including our ongoing SIERRA1 Phase 2 trial in atopic dermatitis and planned trials in hidradenitis suppurativa and asthma.”
The Phase 1/1b trial enrolled 75 heavily pre-treated 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 three (range 1-18), with only
Soquelitinib was well tolerated across all dose cohorts up to 600 mg twice-daily, with no dose-limiting toxicities or significant adverse events and, notably, no myelosuppression or immunosuppression. In the 200 mg twice-daily cohort (N=36), there were objective and durable tumor responses, including six complete responses. Within this group, patients with one to three prior therapies were determined to be most likely to respond to therapy (N=24) and achieved the following results: objective responses in 9 of 24 patients (six complete and three partial), a median progression-free survival of 6.2 months with
The publication also characterizes soquelitinib’s mechanism of action. In vitro studies showed that appropriate doses resulted in Th1 skewing by blocking Th2 differentiation, and biomarker analyses of patient blood and tumor samples also demonstrated this effect in vivo, with increased Th1 cells and reduced serum IL-5. In six patients with paired tumor biopsies analyzed by RNA sequencing, treatment increased intratumoral Th1 cells by day 8, which Corvus believes reflects the direct linkage between the drug’s clinical activity and its underlying immunobiology. These findings are consistent with an anti-tumor mechanism of action involving both direct effects on the tumor (tumor intrinsic) as well as a tumor extrinsic effect on the tumor microenvironment leading to an enhanced host immune response against the tumor.
The publication is available online at the Blood website and on the Publications and Presentations page of the Corvus website. It will also be published in an upcoming print edition of the journal.
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.
About Blood
Blood is the flagship journal of the American Society of Hematology, providing an international forum for the publication of original articles describing basic laboratory, translational, and clinical investigations in hematology.
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 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 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 is enrolling 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
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
Forward-Looking Statements
This press release contains forward-looking statements, including statements related to Phase 1 data from the soquelitinib Phase 1/1b T cell lymphoma trial as support for ongoing and planned trials; 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, 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, 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 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: no head-to-head clinical trials have been conducted comparing soquelitinib to available therapies for patients with T cell lymphoma; 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:
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
jstern@realchemistry.com
