soquelitinib (CPI-818) / Corvus Pharma, Angel Pharma - LARVOL DELTA

Safety and Efficacy of Soquelitinib in Adults With Hidradenitis Suppurativa (clinicaltrials.gov) - P1 | N=25 | Not yet recruiting | Sponsor: Corvus Pharmaceuticals, Inc.

New P1 trial • Dermatology • Hidradenitis Suppurativa • Immunology

Phase 1 Trial with Soquelitinib, a Selective ITK Inhibitor for Treatment of Relapsed/Refractory T Cell Lymphomas. (PubMed, Blood) - P1 | "These studies demonstrate soquelitinib is active in T cell lymphomas with a mechanism related to effects on malignant T cells and/or normal T effector cells. Trial registration: NCT03952078 at www.ClinicalTrials.gov."

IO biomarker • Journal • P1 data • Hematological Malignancies • Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • IL2 • ITK

Corvus Pharmaceuticals Announces Publication in Blood of Final Phase 1 Data from the Soquelitinib Phase 1/1b T Cell Lymphoma Trial (GlobeNewswire) - "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....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 30% of patients progression-free at 18 months, and a median overall survival of 28.1 months with 67% of patients alive at 24 months."

P1 data • Anaplastic Large Cell Lymphoma • Cutaneous T-cell Lymphoma • Natural Killer/T-cell Lymphoma • Peripheral T-cell Lymphoma

Synthesis and characterization of soquelitinib a selective ITK inhibitor that modulates tumor immunity. (PubMed, NPJ Drug Discov) - "Soquelitinib reduced expression of T cell exhaustion markers and was able to restore T effector function to exhausted cells. Pharmacologic selective ITK inhibition may represent a novel approach to cancer immunotherapy."

IO biomarker • Journal • Oncology • CD8 • ITK

Corvus Pharmaceuticals Announces Additional Investment in Angel Pharmaceuticals to Advance the Development of Soquelitinib in China (GlobeNewswire) - "$13.5 million financing, including $5 million from Corvus, supports ongoing generation of soquelitinib clinical data in China for atopic dermatitis and asthma, which are indications also in development by Corvus in the United States....The funding is anticipated to support Angel Pharma’s ongoing Phase 1b/2 trial of soquelitinib for atopic dermatitis and a new Phase 2 trial of soquelitinib for asthma. Angel Pharma anticipates that it will report results from the initial cohort of the Phase 1b portion of the atopic dermatitis trial in late 2026 and will initiate the Phase 2 asthma trial in early 2027."

Financing • New P2 trial • P1 data • Asthma • Atopic Dermatitis

At the 2026 Society for Investigative Dermatology Annual Meeting in Chicago, Illinois, new phase 1 data on soquelitinib for moderate to severe atopic dermatitis (AD) were presented by Albert Chiou... (DermatologyTimes) - "A focused subgroup analysis examined patients treated at the highest tested doses who had documented prior systemic failures. Six patients met this criterion; all had not achieved efficacy with dupilumab, and several had failed additional agents. Four were randomized to active soquelitinib treatment, and 3 of those 4 responded, with 2 showing marked improvement. The 2 patients with documented prior systemic failures randomized to placebo both flared during the trial, defined as requiring rescue medication.While the subgroup is small, the consistency of the directional signal across this population supports continued investigation in later-phase trials....Across all tested cohorts, the adverse event profile for soquelitinib was well balanced relative to placebo."

P1 data • Atopic Dermatitis

Soquelitinib, an ITK inhibitor, Produces Prolonged Drug-Free Remissions in Atopic Dermatitis (SID 2026) - "35% of all patients had received prior systemic AD therapy; efficacy was consistent regardless of prior treatment, including in non-responders to dupilumab or JAK inhibitors. SQL is well tolerated and produces prolonged drug-free remissions following short treatment periods of 4 or 8 weeks. ITK blockade is a novel therapeutic approach for AD and inflammatory diseases that appears to be based on induction of Tregs."

Clinical • Late-breaking abstract • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • FOXP3 • IL2 • ITK

Immunologic and clinical activity of soquelitinib, a selective ITK inhibitor, in atopic dermatitis (SID 2026) - "Combined, these data suggest that selective ITK blockade induces a durable immune reset, characterized by suppression of Th2 responses, expansion of Tregs, and alteration of the SOCS3/JAK1 axis, providing mechanistic support for clinical response. These results indicate that selective ITK blockade is a potential novel approach for AD and other immune diseases."

Clinical • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • CD4 • IL2 • IL4 • IL5 • ITK • JAK1 • SOCS3

Soquelitinib Phase 2 Atopic Dermatitis Clinical Trial (Business Insider) - "Corvus is currently enrolling patients in the soquelitinib SIERRA1 Phase 2 randomized placebo-controlled clinical trial that is anticipated to enroll approximately 200 patients with moderate-to-severe atopic dermatitis that have failed at least one prior topical or systemic therapy....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."

P2 data • Trial status • Atopic Dermatitis

Clinical Highlights from Soquelitinib Phase 1 Atopic Dermatitis Clinical Trial (Business Insider) - "Key efficacy results from cohorts 3 and 4 (200 mg twice daily) include: Cohort 3: 50% of soquelitinib patients achieved EASI 75, 8% achieved EASI 90 and 25% achieved IGA 0/1; Cohort 4: 75% of soquelitinib patients achieved EASI 75, 25% achieved EASI 90 and 33% achieved IGA 0/1; In both cohorts 3 and 4, disease control continued throughout the post treatment follow up periods (90 and 30 days, respectively)...this compares to published data from approved systemic therapies that show a worsening or rebound of disease usually occurring within four weeks of stopping therapy and in some instances requiring the need for rescue medication."

P1 data • Atopic Dermatitis

Biomarker Highlights and Immunologic Studies from Soquelitinib Phase 1 Atopic Dermatitis Clinical Trial (Business Insider) - "Immunologic and molecular studies on peripheral blood taken from patients in the study were conducted and support soquelitinib’s mechanism of action, including the potential for drug-free remissions: Blocking Th2 and Th17 function and their related downstream cytokines (IL-4, IL-5, IL-13); Increasing persistent Treg cells, both during treatment and in the post-treatment, drug-free period, by regulating the switch to Treg cells from Th17 cells; Inhibiting JAK-STAT signaling, upregulating SOCS3 (suppressor of cytokine signaling 3 protein, a negative regulator of JAK-STAT signaling) and reducing JAK1 and STAT6...The decrease in levels of Th2 cytokines and TARC continue after the treatment is discontinued (drug-free period)."

P1 data • Atopic Dermatitis

Soquelitinib for T Cell Lymphoma (The Manila Times) - "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."

Trial status • Anaplastic Large Cell Lymphoma • Angioimmunoblastic T-cell Lymphoma • Follicular Lymphoma • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma

Business Update and Strategy (The Manila Times) - "Corvus plans to initiate two additional Phase 2 clinical trials evaluating soquelitinib in patients with hidradenitis suppurativa and asthma."

New P2 trial • Asthma • Hidradenitis Suppurativa • Immunology

Business Update and Strategy (The Manila Times) - "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...Angel Pharmaceuticals, Corvus’ partner in China, is enrolling a Phase 1b/2 clinical trial evaluating soquelitinib in patients with moderate-to-severe atopic dermatitis...Results from the initial cohorts are anticipated late this year."

P1 data • Atopic Dermatitis

Corvus Pharmaceuticals to Host Investor and Analyst Meeting on May 14, 2026 to Highlight Soquelitinib Data Being Presented at the Society for Investigative Dermatology (SID) Annual Meeting (GlobeNewswire) - "The meeting will be hosted by Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus, and will feature guest speakers who will discuss the soquelitinib Phase 1 clinical trial data, including new immunologic and biomarker data, that focus on the drug’s mechanism of action and potential for drug-free remissions....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 SID meeting."

P1 data • Atopic Dermatitis

Soquelitinib vs Standard of Care in Participants With Relapsed/Refractory Peripheral T-cell Lymphoma Not Otherwise Specified, Follicular Helper T-cell Lymphomas, or Systemic Anaplastic Large-cell Lymphoma (clinicaltrials.gov) - P3 | N=150 | Recruiting | Sponsor: Corvus Pharmaceuticals, Inc. | Trial completion date: Jul 2028 ➔ Dec 2028 | Trial primary completion date: Nov 2026 ➔ Nov 2027

Trial completion date • Trial primary completion date • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • Systemic Anaplastic Large Cell Lymphoma • T Cell Non-Hodgkin Lymphoma

Phosphotyrosine proteomics reveals novel Zap70 and Itk pathway targets downstream of TCR and CAR in Jurkat T cells. (PubMed, Sci Rep) - "Here, using three T cell activation methods (soluble antibodies, APC-pMHC/TCR, and CD19-CAR/Raji), we evaluated the effects of two novel inhibitors, RDN2150 (RDN, Zap70) and Soquelitinib (Soq, Itk), on T cell activation...Finally, we identified new, noncanonical pY sites responsive to RDN and Soq, providing new insights into the pathways regulated by Zap70 and Itk. Together, our work provides a basis for further study on RDN and Soq, as well as a molecular roadmap for the effects of these inhibitors."

Journal • IL2 • ITK • ZAP70

Study of the ITK Inhibitor Soquelitinib to Reduce Lymphoproliferation and Improve Cytopenias in Autoimmune Lymphoproliferative Syndrome (ALPS)-FAS Patients (clinicaltrials.gov) - P2 | N=15 | Recruiting | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Trial primary completion date: Mar 2026 ➔ Dec 2026

Trial primary completion date • Hematological Disorders • Immunology

Soquelitinib (Corvus’ selective ITK inhibitor) for Immune Diseases (GlobeNewswire) - "Corvus initiated its Phase 2 randomized placebo-controlled atopic dermatitis clinical trial during Q1 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....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....Results from the initial cohorts are anticipated late this year."

P1 data • Trial status • Atopic Dermatitis

Safety, Tolerability, and Preliminary Efficacy of Soquelitinib in Participants With Moderate to Severe AD (clinicaltrials.gov) - P1 | N=82 | Completed | Sponsor: Corvus Pharmaceuticals, Inc. | Active, not recruiting ➔ Completed

Trial completion • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

ITK-targeted immune remodeling enhanced the efficacy of anti-CD19 CAR-T cell therapy. (PubMed, Cell Death Discov) - "Importantly, the modulation of transcription factors like TOX and TCF1 suggested a delay in T cell exhaustion and maintenance of effector functions. These findings provide a compelling rationale for the integration of clinical stage ITK inhibitor soquelitinib with CAR-T therapy, highlighting its potential to improve treatment outcomes in hematological malignancies and solid tumors."

IO biomarker • Journal • B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor • T Cell Non-Hodgkin Lymphoma • CD8 • GZMB • HAVCR2 • IFNG • LAG3 • TNFA

SIERRA1: Study to Evaluate Soquelitinib in Participants With Moderate to Severe AD (clinicaltrials.gov) - P2 | N=200 | Recruiting | Sponsor: Corvus Pharmaceuticals, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

SIERRA1: Study to Evaluate Soquelitinib in Participants With Moderate to Severe AD (clinicaltrials.gov) - P2 | N=200 | Not yet recruiting | Sponsor: Corvus Pharmaceuticals, Inc.

New P2 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Corvus Pharmaceuticals Highlights Soquelitinib Pipeline... (MarketBeat) - "He noted that soquelitinib is in a phase III registrational trial for peripheral T-cell lymphoma (PTCL), with an interim analysis expected by year-end 2026."

P3 data • Peripheral T-cell Lymphoma

Next steps: phase II AD trial and upcoming milestones (MarketBeat) - "Arcara said Corvus plans to begin a phase II AD trial 'very shortly,' describing an international study planned to enroll 200 moderate-to-severe patients randomized into four cohorts: 200 mg once daily, 200 mg twice daily, 400 mg once daily, and placebo (50 patients per arm). Treatment duration is planned for 12 weeks followed by an off-treatment follow-up period, with the primary endpoint being mean reduction in EASI at 12 weeks. He said the study is expected to open in Q1 2026....In addition to the AD trial, Arcara cited 2026 milestones including the start of proof-of-concept studies in asthma and HS, presentations of biomarker data at upcoming AAD and SID meetings..."

Clinical data • New P2 trial • Asthma • Atopic Dermatitis • Hidradenitis Suppurativa • Immunology