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

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

Safety, Tolerability, and Preliminary Efficacy of Soquelitinib in Participants With Moderate to Severe AD (clinicaltrials.gov) - P1 | N=72 | Active, not recruiting | Sponsor: Corvus Pharmaceuticals, Inc. | Recruiting ➔ Active, not recruiting | Trial completion date: Nov 2025 ➔ Feb 2026 | Trial primary completion date: Oct 2025 ➔ Feb 2026

Enrollment closed • Trial completion date • Trial primary completion date • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Safety, tolerability, and preliminary efficacy of CPI-818 in the treatment of moderate to severe atopic dermatitis (ChiCTR) - P1/2 | N=123 | Recruiting | Sponsor: Shanghai Skin Disease Hospital; Angel Pharmaceutical | Not yet recruiting ➔ Recruiting

Enrollment open • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Corvus Pharmaceuticals Announces Closing of Upsized Public Offering of Common Stock and Full Exercise of the Underwriters’ Option to Purchase Additional Shares, Generating Gross Proceeds of Approximately $201M (The Manila Times) - "Corvus currently expects to use the net proceeds from this offering for working capital and general corporate purposes, which may include capital expenditures and research and development, including for its Phase 3 T cell lymphoma, and Phase 2 atopic dermatitis, hidradenitis suppurativa and asthma clinical trials, sales and marketing and administrative expenses."

Financing • Asthma • Atopic Dermatitis • Hidradenitis Suppurativa • Immunology • Peripheral T-cell Lymphoma

Corvus Pharmaceuticals said its experimental oral drug soquelitinib produced deeper responses in a Phase I trial of patients with moderate-to-severe atopic dermatitis after a longer duration of treatment, extending signals seen with the oral ITK inhibitor in earlier cohorts. (Firstwordpharma Press Release) - "Among the 12 treated patients with moderate-to-severe atopic dermatitis in Cohort 4 – which extended dosing to 8 weeks compared with the 4-week regimens used in earlier cohorts – 75% achieved EASI-75, 25% reached EASI-90, and 33% achieved an IGA score of 0 or 1. By contrast, the 10 evaluable placebo recipients posted EASI-75 rates of 20%, with no patients reaching EASI-90 or IGA 0/1....With Cohort 4 now complete, Corvus plans to launch a Phase II atopic dermatitis trial in the first quarter of 2026 involving roughly 200 patients who have failed at least one prior topical or systemic therapy. The treatment period is anticipated to be 12 weeks."

New P2 trial • P1 data • Atopic Dermatitis

Corvus Pharmaceuticals…announced that it will host a conference call and webcast on Tuesday, January 20, 2026 at 8:00 am ET (5:00 am PT) to report the results from cohort 4 of the randomized, blinded, placebo-controlled Phase 1 clinical trial evaluating soquelitinib in patients with moderate to severe atopic dermatitis (GlobeNewswire)

P1 data • Atopic Dermatitis

Announce Results from Cohort 4 of Placebo-Controlled Phase 1 Clinical Trial of Soquelitinib for Atopic Dermatitis in January 2026 Following Annual Healthcare Conference (GlobeNewswire)

P1 data • Atopic Dermatitis

Soquelitinib inhibition of IL-2-inducible T cell kinase ameliorates lung damage in murine models of systemic sclerosis. (PubMed, Arthritis Res Ther) - No abstract available

Journal • Preclinical • Immunology • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases • Scleroderma • Systemic Sclerosis • IL2 • ITK

Corvus Pharmaceuticals Presents Final Data from Soquelitinib Phase 1/1b T Cell Lymphoma Trial (Corvus Pharmaceuticals Press Release) - "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...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%....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."

P1 data • Peripheral T-cell Lymphoma

Final results of a phase 1 trial with soquelitinib (SQL), a selective interleukin-2-inducible T cell kinase (ITK) inhibitor for treatment of relapsed/refractory (R/R) T cell lymphomas (TCL) (ASH 2025) - P1, P3 | "Introduction ITK is expressed in T cells and NK cells and is involved in multiple signaling pathways including T cellreceptor (TCR) activation and differentiation of T helper (Th) cells. Thesefindings indicate that the mechanism of action involves the induction of a host anti-tumor immuneresponse that requires a baseline level of immunocompetence. These data suggest that effectivetherapeutic strategies for these lymphomas should extend beyond direct targeting of malignant T cells.SQL is now being evaluated vs standard therapy (belinostat or pralatrexate) in a randomized Phase 3registration trial in PTCL pts with 1-3 prior therapies (NCT06561048)."

Clinical • IO biomarker • P1 data • Cutaneous T-cell Lymphoma • Dermatology • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Peripheral T-cell Lymphoma • Pruritus • CD4 • CD8 • GATA3 • HAVCR2 • IFNG • IL2 • ITK • LAG3 • TNFA

The Company anticipates reporting interim data from the Phase 3 trial in late 2026 and completing the trial in 2027. (Corvus Pharmaceuticals Press Release) - "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."

P3 data • Trial completion date • Peripheral T-cell Lymphoma

Dynamic Single-Cell Profiling Reveals Novel Immune Regulatory Mechanism of ITK Inhibitor Soquelitinib in Refractory T Cell Lymphoma (ASH 2023) - P1 | "Conclusions Our findings reveal a novel immune regulatory mechanism by which the ITK inhibitor soquelitinib induced normal CD4+ Th1 cells and CD8+ TEMRA cells and reduced CD4+ Treg cells in the tumor microenvironment in responding patients. These findings demonstrate the potential of soquelitinib as a novel immunotherapy for the treatment of T-cell lymphomas and solid tumors."

IO biomarker • B Cell Lymphoma • Breast Cancer • Colon Cancer • Colorectal Cancer • Gastrointestinal Cancer • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor • T Cell Non-Hodgkin Lymphoma • CD4 • CD8 • CTLA4 • GZMA • GZMB • GZMH • GZMK • HAVCR2 • IFNG • IL2 • ITK • LAG3 • NKG7 • PD-1 • PRF1 • STAT5 • TBX21 • TNFA

Soquelitinib for T Cell Lymphoma (GlobeNewswire) - "Corvus continues to enroll patients in a registrational Phase 3 clinical trial of soquelitinib in patients with relapsed/refractory PTCL at multiple clinical sites....The final data from the Company’s Phase 1/1b clinical trial evaluating soquelitinib in patients with T cell lymphoma will be reported in an oral presentation at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition in December 2025."

Trial status • Peripheral T-cell Lymphoma

Corvus Pharmaceuticals Provides Business Update… (GlobeNewswire) - "Completed enrollment in soquelitinib atopic dermatitis Phase 1 trial extension cohort 4 (200 mg BID dose with 8-week treatment period) with data announcement anticipated in January; Soquelitinib atopic dermatitis phase 2 trial on track to initiate in early Q1 2026."

Enrollment closed • New P2 trial • P1 data • Atopic Dermatitis

Safety, tolerability, and preliminary efficacy of CPI-818 in the treatment of moderate to severe atopic dermatitis (ChiCTR) - P1/2 | N=123 | Not yet recruiting | Sponsor: Shanghai Skin Disease Hospital; Angel Pharmaceutical

New P1/2 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Corvus Pharmaceuticals to Present Final Data from Soquelitinib Phase 1/1b T Cell Lymphoma Trial at the 67th American Society of Hematology Annual Meeting & Exposition (GlobeNewswire)

P1 data • T Cell Non-Hodgkin Lymphoma

Phosphoproteomic analysis of successive Jurkat CD19-CAR generations reveals TCRζ-driven signalling. (PubMed, Cell Signal) - "Finally, we found that selective, partial inhibition of Itk using Soquelitinib reduced basal CD69 expression in CAR-Jurkat cells while maintaining their ability to activate in response to antigen. These data suggest that TCRζ determines the pY signalling profile and that Itk drives basal activation of CD19-CAR Jurkats, which may impact evaluation of new CAR designs in CAR-Jurkat screens."

IO biomarker • Journal • Hematological Malignancies • Lymphoma • Oncology • CD47 • CD69 • PTPN22

Corvus Pharmaceuticals Provides Business Update and Reports Second Quarter 2025 Financial Results (GlobeNewswire) - "'We are excited by the data reported from our Phase 1 trial of soquelitinib for atopic dermatitis and are advancing its development for this indication on multiple fronts.'....'This includes patient enrollment in the extension cohort 4 of the Phase 1 trial, which is exploring an 8-week treatment period and is on track to report data in the fourth quarter 2025, along with near-final plans for a Phase 2 trial that we expect to initiate before year-end.'"

New P2 trial • P1 data • Trial status • Atopic Dermatitis