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

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

Selective interleukin-2 inducible T cell kinase (ITK) inhibitor for the treatment of allergic diseases: Preliminary results from a Phase 1 trial in atopic dermatitis induction reduction in disease severity and Th2, Th17 cytokines (AAD 2025) - "Soquelitinib (SQL) is an oral, specific ITK inhibitor that spares RLK (resting lymphocyte kinase), resulting in blockade of the production of Th2 and Th17 cytokines...No significant adverse events have been noted. This ongoing trial demonstrates that a specific inhibitor of ITK may be effective for the treatment of AD and potentially other inflammatory diseases that are mediated by Th2, Th17 or ILC2 cells."

P1 data • Allergy • Asthma • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • Psoriasis • Respiratory Diseases • Scleroderma • Systemic Sclerosis • IL13 • IL17A • IL2 • IL33 • IL4 • IL5 • ITK

Corvus Pharmaceuticals Announces Data from Cohort 2 of Placebo-Controlled Phase 1 Clinical Trial of Soquelitinib for Atopic Dermatitis (GlobeNewswire) - P1 | N=64 | NCT06345404 | Sponsor: Corvus Pharmaceuticals, Inc. | "The Company is reporting results from 16 patients in Cohort 1...and 10 patients in Cohort 2...for which 28 days of treatment have been completed. For those 19 patients in the soquelitinib group, 26% achieved IGA 0 or 1 and 37% achieved EASI 75; and of the seven in the placebo group, none achieved IGA 0 or 1 or EASI 75 (see Figure 1 below). IGA 0 or 1 and EASI 75 have been determined by the U.S. Food and Drug Administration (FDA) to be clinically meaningful and approvable endpoints and have been the endpoints used in clinical trials for other FDA approved treatments for atopic dermatitis. No significant safety issues were observed and no clinically significant laboratory abnormalities were seen...Cohort 2 of the trial is fully enrolled (N=16) and the Company plans to report full results from all four study cohorts in the second quarter 2025."

P1 data • Atopic Dermatitis

Corvus Pharmaceuticals Announces Interim Data from Placebo-Controlled Phase 1 Clinical Trial of Soquelitinib for Atopic Dermatitis (Businesswire) - P1 | N=64 | NCT06345404 | Sponsor: Corvus Pharmaceuticals, Inc. | "Cohort 1 Efficacy Data: EASI scores at 28-day and 58-day follow-up demonstrate a favorable effect of soquelitinib treatment compared to placebo. The soquelitinib mean EASI score reduction was 55.9% at 28 days (n=12) compared to mean EASI reduction of 27.0% in placebo. At day 58, continued improvement in the soquelitinib group was seen with mean EASI reduction of 69.1% (n=10) compared to mean EASI reduction of 19.1% for the placebo group....Cohort 2 Initial Efficacy and Safety Data: As of December 16, the Company has enrolled 12 patients in Cohort 2 of the trial (soquelitinib 200 mg oral once per day). As of December 7, Day 28 follow up data is available for three patients with efficacy results consistent with that seen in Cohort 1. No clinically significant laboratory abnormalities or treatment related adverse events have been reported in any of the patients enrolled in Cohort 2."

P1 data • Atopic Dermatitis

Corvus Pharmaceuticals to Announce Interim Data from Placebo-Controlled Phase 1 Clinical Trial of Soquelitinib for Atopic Dermatitis on December 18, 2024 (GlobeNewswire) - "Corvus Pharmaceuticals...will announce interim data from the randomized, double-blind, placebo-controlled Phase 1 clinical trial evaluating soquelitinib in patients with moderate to severe atopic dermatitis tomorrow, December 18, 2024. The data will be provided in a press release and presented during a conference call and webcast."

P1 data • Atopic Dermatitis

Study of the ITK Inhibitor Soquelitinib to Reduce Lymphoproliferation and Improve Cytopenias in Autoimmune Lymphoproliferative Syndrome (ALPS)-FAS Patients (clinicaltrials.gov) - P2 | N=14 | Recruiting | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

New P2 trial • Hematological Disorders • Immunology

Corvus Pharmaceuticals Announces Publication of Biochemistry and Preclinical Data Demonstrating Potential of ITK Inhibition with Soquelitinib as a Novel Approach to Modulate Tumor Immunity (GlobeNewswire) - "The data was published in npj Drug Discovery (part of the Nature portfolio of journals), an open access, international, peer-reviewed journal dedicated to publishing the highest quality research relevant to all aspects of drug design and discovery....The data also shows that soquelitinib increases effector function of cytotoxic CD8 positive T cells and leads to an increase in memory T cells with enhanced effector function....The Company plans to initiate a Phase 1 clinical trial of soquelitinib in patients with solid tumors."

New P1 trial • Preclinical • Solid Tumor

Inhibition of Interleukin-2-Inducible T Cell Kinase with Soquelitinib Demonstrates Efficacy in Preventing Lung Damage in Murine Models of Systemic Sclerosis (ACR Convergence 2024) - "Given the immune pathogenesis of SSc with predominant Th2 and Th17 polarization, we aimed at investigating the efficacy of SQL in two mouse models of lung fibrosis, and related pulmonary hypertension (PH), mimicking lung involvement in SSc. 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 Announces New Preclinical Data Highlighting Potential of Soquelitinib to Treat Systemic Sclerosis (GlobeNewswire) - "The researchers utilized a Fra-2 transgenic mouse model that encompasses many of the features of systemic sclerosis in humans...These mice also exhibit an accumulation of Th2 helper T cells...The Fra-2 transgenenic mice were treated with oral soquelitinib for seven weeks, compared to control (untreated) Fra-2 transgenic mice. Compared to the control, the mice treated with soquelitinib showed: Significant reduction in lung infiltration and fibrosis, assessed by histology; Significant improvement in clinical score, which measures disease severity; Reduced vascular smooth muscle hypertrophy, assessed by histology; Reduced right ventricular systolic blood pressure, consistent with improvement in pulmonary hypertension....The data will be presented in a poster session on Sunday, November 17 at ACR Convergence 2024, the annual meeting of the American College of Rheumatology, taking place November 14-19, 2024 in Washington, D.C."

Preclinical • Immunology • Systemic Sclerosis

Corvus Pharmaceuticals Provides Business Update and Reports Third Quarter 2024 Financial Results (GlobeNewswire) - "Soquelitinib for Immune Diseases: Corvus continues to enroll patients at multiple clinical sites in its randomized, placebo-controlled Phase 1 clinical trial of soquelitinib in patients with moderate to severe atopic dermatitis. The trial is planned to enroll 64 patients that have failed at least one prior therapy across four different 28-day dosing regimens of soquelitinib compared to a placebo group....Enrollment in the first cohort (100 mg, twice per day) has been completed and the data review committee has met and found no safety signals. The second cohort (200 mg, once-daily) is now enrolling patients. Corvus plans to announce interim data from the Phase 1 clinical trial in December 2024."

P1 data • Trial status • Atopic Dermatitis