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

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

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

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

Inclusion of the ζ-chain drives phosphotyrosine signalling in CD19-CAR T cells. (PubMed, bioRxiv) - "Finally, we find that selective, partial inhibition of Itk using Soquelitinib reduces basal CD69 expression in Jurkat CAR T cells while maintaining their ability to activate in response to antigen. Our data suggest that the ζ-chain determines the pY signalling profile of CD19-CAR Jurkat T cells and that Itk may drive antigen-independent CD19-CAR activation."

Journal • Hematological Malignancies • Lymphoma • Oncology • CD69 • PTPN22

Corvus Pharmaceuticals Announces Partner Angel Pharmaceuticals Received IND Approval for a Phase 1b/2 Clinical Trial of Soquelitinib in China for the Treatment of Atopic Dermatitis (GlobeNewswire) - "Corvus Pharmaceuticals, Inc...today announced that the IND application submitted by its partner in China, Angel Pharmaceuticals Ltd. (Angel Pharma), has been approved by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) to initiate a Phase 1b/2 clinical trial of soquelitinib for the treatment of patients with moderate-to-severe atopic dermatitis in China...The Phase 1b trial will be randomized, double-blinded, placebo-controlled and enroll patients with moderate-to-severe atopic dermatitis....The Phase 2 trial will also be a randomized, double-blinded, placebo-controlled study. It will enroll additional patients and focus on two doses that will be selected based on the safety and efficacy results from the Phase 1b trial."

New P1/2 trial • Atopic Dermatitis

Inhibition of Interleukin-2-Inducible T Cell Kinase with Soquelitinib demonstrates efficacy in preventing lung damage in murine models of systemic sclerosis (EULAR 2025) - " SQL has been evaluated in the bleomycin-induced lung fibrosis mouse model and in the Fra-2 mouse model characterized by interstitial lung disease (ILD) and pulmonary vascular remodeling leading to PH. Our findings suggest that ITK inhibition with SQL, by decreasing Th2 and Th17 activation, provides therapeutic benefits in 2 complementary models of SSc lung damage. Given the importance of T cell activation in the early stages of the disease, there is a strong rationale for the potential benefit of T cell-targeting therapy in SSc. SQL represents a promising new approach for treating lung involvement in SSc, warranting clinical trials."

Preclinical • Cardiovascular • Fibrosis • Immunology • Interstitial Lung Disease • Oncology • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases • Scleroderma • Systemic Sclerosis • CD8 • GATA3 • IL2 • ITK • MMP2

Corvus Pharmaceuticals Presents Soquelitinib Preclinical Data Highlighting Potential of ITK inhibition to Treat Systemic Sclerosis at EULAR 2025 Congress (GlobeNewswire) - "Corvus Pharmaceuticals, Inc...announced preclinical data highlighting the potential of soquelitinib to treat systemic sclerosis will be presented today in a poster session at the European Alliance of Associations for Rheumatology (EULAR) 2025 Congress, which is taking place June 11-14, 2025 in Barcelona."

Preclinical • Systemic Sclerosis

Corvus Pharmaceuticals Announces Full Data from Cohort 3 of Placebo-Controlled Phase 1 Clinical Trial of Soquelitinib for Atopic Dermatitis (GlobeNewswire) - P1 | N=72 | NCT06345404 | Sponsor: Corvus Pharmaceuticals, Inc | "Overall, data from cohorts 1-3 of the trial have demonstrated a favorable safety and efficacy profile, including a statistically significant improvement in Eczema Area and Severity Index (EASI) score for the soquelitinib treated patients compared to placebo at day 28 (p=0.036)...As of May 28, 2025, enrollment in cohorts 1, 2 and 3 has been completed for a total of 48 patients and all patients (36 receiving soquelitinib and 12 placebos) had completed the 28-day treatment course. Patients in cohort 3 had more advanced disease with a higher mean baseline EASI score compared to patients in cohorts 1 and 2. At 28 days, the mean reduction in EASI for cohort 3 (n=12) was 64.8%, compared to 54.6% for cohort 1 and 2 combined (n=24) and 34.4% for placebo (n=12)...As of May 28, 2025, no new safety signals have been observed. Soquelitinib was well tolerated, with no dose limiting toxicities (DLTs)..."

P1 data • Atopic Dermatitis

Safety, Tolerability, and Preliminary Efficacy of Soquelitinib in Participants With Moderate to Severe AD (clinicaltrials.gov) - P1 | N=72 | Recruiting | Sponsor: Corvus Pharmaceuticals, Inc. | Trial completion date: Apr 2025 ➔ Nov 2025 | Trial primary completion date: Apr 2025 ➔ Oct 2025

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

Soquelitinib, a selective ITK inhibitor, demonstrates activity in atopic dermatitis (AD) phase 1 clinical trial by a novel mechanism of action (SID 2025) - "In SQL-treated pts, AEs were limited to 1 Gr 1 nausea and 1 Covid 19; all pts received the full course of treatment. This is the first report of selective ITK inhibition for treatment of AD and indicates that this mechanism has the potential for more durable control of AD with an oral agent due to blockade of multiple Th2/Th17 cytokines, induction of Treg suppression and blockade of ILC2."

Clinical • P1 data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Infectious Disease • Novel Coronavirus Disease • FOXP3 • IL2 • IL4 • IL5 • ITK • TSLP

Corvus Pharmaceuticals Provides Business Update and Reports First Quarter 2025 Financial Results (Corvus Pharmaceuticals Press Release) - P1 | N=74 | NCT06345404 | Sponsor: Corvus Pharmaceuticals, Inc. | "Overall, all three cohorts showed significant responses in the soquelitinib treatment groups compared to placebo for clinically significant endpoints of EASI (Eczema Area and Severity Index) 75 and IGA (Investigator Global Assessment) 0 or 1. Soquelitinib was well tolerated, with no dose limiting toxicities (DLTs) and no clinically significant laboratory abnormalities observed in any of the cohorts. Corvus amended the clinical trial protocol to replace cohort 4 (400 mg once per day) with 24 patients randomized 1:1 between active and placebo. Treatment for this group will be extended to 8 weeks with additional 30 day follow-up with no treatment. The dose level for this group is planned to be the same as cohort 3 – 200 mg orally twice per day."

Clinical protocol • P1 data • Atopic Dermatitis

Corvus Pharmaceuticals to Present New Interim Data from Placebo-Controlled Phase 1 Clinical Trial of Soquelitinib for Atopic Dermatitis on May 8, 2025 (GlobeNewswire) - "Corvus Pharmaceuticals...announced that new interim data from the randomized, double-blind, placebo-controlled Phase 1 clinical trial evaluating soquelitinib in patients with moderate to severe atopic dermatitis will be presented in an oral session and poster at the Society for Investigative Dermatology 2025 Annual Meeting....Data from Cohorts 1-3 of trial to be presented in an oral session and poster at the Society for Investigative Dermatology (SID) 2025 Annual 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: Sep 2027 ➔ Jul 2028 | Trial primary completion date: Feb 2026 ➔ Nov 2026

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

Corvus Pharmaceuticals Provides Business Update and Reports Fourth Quarter and Full Year 2024 Financial Results (GlobeNewswire) - "Our clinical strategy is to demonstrate the value of soquelitinib’s novel mechanism of action in both cancers and immune diseases, across multiple disease indications. This includes our planned solid tumor clinical trial, which we now anticipate initiating in the third quarter 2025."

New trial • Solid Tumor

Corvus Pharmaceuticals Provides Business Update and Reports Fourth Quarter and Full Year 2024 Financial Results (GlobeNewswire) - "Soquelitinib (Corvus’ selective ITK inhibitor): Corvus is nearing completion of patient enrollment in the third cohort (200 mg orally twice per day) of the trial and plans to announce additional results from the study including data from Cohorts 1, 2 and 3 in May 2025....The atopic dermatitis Phase 1 clinical trial is enrolling patients with moderate to severe atopic dermatitis that previously failed at least one prior topical or systemic therapy. Enrollment in the first two cohorts is complete, and the third cohort is near completion of enrollment."

Enrollment status • P1 data • Atopic Dermatitis

Corvus Pharmaceuticals Announces Presentation of Additional Data from the Phase 1/1b Clinical Trial of Soquelitinib for Patients with T Cell Lymphoma (GlobeNewswire) - P1/1b | N=151 | NCT03952078 | Sponsor: Corvus Pharmaceuticals, Inc. | "Data to be presented in oral session and poster at the 16th Annual T-Cell Lymphoma Forum....For the 23 evaluable patients: Objective responses (complete response, CR, plus partial response, PR) were seen in nine patients (39%), including six CRs (26%) and three PRs. The median duration of response (DOR) for the nine patients with objective response by Lugano criteria was 17.2 months. Three patients continue on therapy at 25+ months, 18+ months and 14+ months. Kaplan Meier estimated median progression free survival (PFS) was 6.2 months. At 18-month follow-up, the PFS rate was 30%, which compares favorably to 18-month PFS of <20% with belinostat or pralatrexate. Soquelitinib was well-tolerated, with no new safety signals, drug interruptions or dose reductions."

P1 data • T Cell Non-Hodgkin Lymphoma

Corvus Pharmaceuticals Announces Initiation of Phase 2 Clinical Trial of Soquelitinib for Patients with Autoimmune Lymphoproliferative Syndrome (ALPS) (GlobeNewswire) - "Corvus Pharmaceuticals, Inc...today announced that the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), has initiated a Phase 2 clinical trial of soquelitinib for the treatment of patients with autoimmune lymphoproliferative syndrome (ALPS), a rare genetic disease....The Phase 2 clinical trial...is designed to enroll up to 30 patients aged 16 or older with confirmed ALPS-FAS based on genetic testing."

Trial status • Genetic Disorders • Immunology

Corvus also plans to initiate a Phase 1 clinical trial (GlobeNewswire) - "Corvus also plans to initiate a Phase 1 clinical trial of soquelitinib in patients with solid tumors in the second quarter 2025."

New P1 trial • Solid Tumor