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    DRUG CLASS:

    IL-2 stimulant

    Related drugs:
    3d
    Efficacy and Safety of Denileukin Diftitox-Cxdl, an Improved Purity Formulation of Denileukin Diftitox, in Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma. (PubMed, J Clin Oncol)
    Efficacy and safety results show that DD-cxdl would potentially fulfill a serious, unmet medical need for patients with R/R CTCL.
    Journal
    |
    IL2 (Interleukin 2)
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    Ontak (denileukin diftitox) • Lymphir (denileukin diftitox-cxdl)
    3d
    A Study of SAR444245 Combined With Cemiplimab for the Treatment of Participants With Various Advanced Skin Cancers (Pegathor Skin 201) (clinicaltrials.gov)
    P1/2, N=46, Terminated, Sanofi | Active, not recruiting --> Terminated; Early discontinuation based on strategic sponsor decision not driven by any safety concerns
    Trial termination • Metastases
    |
    Libtayo (cemiplimab-rwlc) • pegenzileukin (SAR444245)
    4d
    A Phase 1, Open-label, Multicenter, Dose Escalation Study of IBI363 (PD1-IL2m) in Subjects with Advanced Solid Malignancies or Lymphomas (clinicaltrials.gov)
    P1, N=84, Recruiting, Innovent Biologics (Suzhou) Co. Ltd. | Trial completion date: Aug 2024 --> Dec 2026 | Trial primary completion date: Jun 2023 --> Jun 2026
    Trial completion date • Trial primary completion date • Metastases
    6d
    Dose Escalation and Expansion Study of HM16390 in Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=215, Recruiting, Hanmi Pharmaceutical Company Limited | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    HM16390
    6d
    KEYNOTE-D13: A Study of SOT101 in Combination With Pembrolizumab to Evaluate the Efficacy and Safety in Patients With Selected Advanced Solid Tumors (clinicaltrials.gov)
    P2, N=166, Terminated, SOTIO Biotech AG | Active, not recruiting --> Terminated; Due to lack of expected efficacy shown at the time of the interim analysis
    Trial termination • Metastases
    |
    Keytruda (pembrolizumab) • nanrilkefusp alfa (SOT101)
    12d
    Type 2 responses determine skin rash during recombinant interleukin-2 therapy. (PubMed, J Immunotoxicol)
    One of the drugs inducing CADRs is aldesleukin, a recombinant interleukin-2 (recIL-2) originally approved to treat malignant melanoma and metastatic renal cell carcinoma which frequently led to skin rashes when applied in high doses for anti-cancer therapy...Together, this hypothetic irAOP forms a basis to clarify possible cellular and molecular interactions leading to recIL-2-induced skin rash. This might be used to adapt existing or develop new test systems to help predict and prevent cutaneous side effects in future IL-2-based or similar therapies.
    Review • Journal
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    IL2 (Interleukin 2)
    |
    Proleukin (aldesleukin)
    12d
    KEYNOTE-B75: A Study of SAR444245 Combined With Other Anticancer Therapies for the Treatment of Participants With HNSCC (Master Protocol) (Pegathor Head and Neck 204) (clinicaltrials.gov)
    P2, N=59, Terminated, Sanofi | Active, not recruiting --> Terminated; Early discontinuation based on strategic sponsor decision not driven by any safety concerns.
    Trial termination
    |
    Keytruda (pembrolizumab) • Erbitux (cetuximab) • pegenzileukin (SAR444245)
    13d
    Dose Escalation and Expansion Study of HM16390 in Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=215, Not yet recruiting, Hanmi Pharmaceutical Company Limited
    New P1 trial • Metastases
    |
    HM16390
    17d
    A Study of IBI363 in Combination with Bevacizumab in Subjects with Advanced Colorectal Cancer (clinicaltrials.gov)
    P1, N=49, Active, not recruiting, Wuhan Union Hospital, China
    New P1 trial • Combination therapy • Metastases
    |
    Avastin (bevacizumab)
    25d
    Long-term Safety and Efficacy of Efavaleukin Alfa in Participants With Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov)
    P2, N=25, Terminated, Amgen | Active, not recruiting --> Terminated; The parent study 20170104 was terminated due to the study meeting a prespecified futility rule. Consequently, this study was terminated.
    Trial termination
    25d
    Autologous CD19 CAR-T Cell Therapy (SYNCAR-001) + Orthogonal IL-2 (STK-009) in Subjects with Severe, Refractory Systemic Lupus Erythematosus (clinicaltrials.gov)
    P1, N=42, Recruiting, Synthekine | Initiation date: Sep 2024 --> Dec 2024
    Trial initiation date • CAR T-Cell Therapy
    |
    STK-009/SYNCAR-001
    27d
    Safety and Efficacy of Efavaleukin Alfa in Participants With Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov)
    P2, N=224, Terminated, Amgen | Active, not recruiting --> Terminated; The study was terminated due to meeting a prespecified futility rule and not related to any safety concerns.
    Trial termination
    1m
    TIL Therapy for Metastatic Renal Cell Carcinoma (clinicaltrials.gov)
    P1, N=5, Completed, Inge Marie Svane | Unknown status --> Completed
    Trial completion • Metastases
    |
    IL2 (Interleukin 2)
    |
    cyclophosphamide • fludarabine IV • Proleukin (aldesleukin)
    1m
    KEYNOTE-E46: Oncolytic Adenovirus TILT-123 With Pembrolizumab as Treatment for Refractory Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P1, N=22, Recruiting, TILT Biotherapeutics Ltd. | Trial completion date: Oct 2025 --> May 2026 | Trial primary completion date: Oct 2024 --> Jan 2026
    Trial completion date • Trial primary completion date • Combination therapy • Oncolytic virus • Checkpoint inhibition
    |
    Keytruda (pembrolizumab) • igrelimogene litadenorepvec (TILT-123)
    1m
    DF-IL2-REP: Ciclosporin Followed by Low-dose IL-2 in Patients with Recently Diagnosed Type 1 Diabetes (clinicaltrials.gov)
    P2, N=24, Recruiting, Assistance Publique - Hôpitaux de Paris | Trial completion date: Jul 2026 --> Apr 2028 | Trial primary completion date: Oct 2024 --> Apr 2026
    Trial completion date • Trial primary completion date
    |
    cyclosporine
    1m
    A Clinical Study of 8MW2311 in Subjects With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1/2, N=216, Suspended, Mabwell (Shanghai) Bioscience Co., Ltd. | Recruiting --> Suspended
    Trial suspension • Metastases
    1m
    Gene and Vaccine Therapy in Treating Patients With Advanced Malignancies (clinicaltrials.gov)
    P2, N=6, Active, not recruiting, Jonsson Comprehensive Cancer Center | Trial completion date: Nov 2025 --> Nov 2026 | Trial primary completion date: Nov 2024 --> Nov 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    CTAG1B (Cancer/testis antigen 1B)
    |
    cyclophosphamide • fludarabine IV • Proleukin (aldesleukin)
    1m
    A First-In Human (FIH) Trial to Find Out if REGN10597 is Safe and How Well it Works for Adult Participants With Advanced Solid Organ Malignancies (clinicaltrials.gov)
    P1/2, N=150, Recruiting, Regeneron Pharmaceuticals | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    1m
    KYANITE-1: A Study Assessing KB707 for the Treatment of Advanced Solid Tumor Malignancies Affecting the Lungs (clinicaltrials.gov)
    P1/2, N=140, Recruiting, Krystal Biotech, Inc. | Phase classification: P1 --> P1/2 | N=80 --> 140
    Phase classification • Enrollment change
    |
    Keytruda (pembrolizumab)
    1m
    OPAL-1: A Study Assessing KB707 for the Treatment of Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1/2, N=140, Recruiting, Krystal Biotech, Inc. | Phase classification: P1 --> P1/2 | N=80 --> 140
    Phase classification • Enrollment change
    |
    Opdualag (nivolumab/relatlimab-rmbw)
    1m
    Single intravenous administration of oncolytic adenovirus TILT-123 results in systemic tumor transduction and immune response in patients with advanced solid tumors. (PubMed, J Exp Clin Cancer Res)
    TILT-123 demonstrated safety and significant intratumoral immunomodulation following a single i.v. administration, warranting further investigation.
    Journal • Oncolytic virus • IO biomarker • Metastases
    |
    TNFA (Tumor Necrosis Factor-Alpha) • IL2 (Interleukin 2)
    |
    igrelimogene litadenorepvec (TILT-123)
    2ms
    Bempegaldesleukin plus nivolumab in first-line advanced/metastatic urothelial carcinoma: Results from a phase II single-arm study (PIVOT-10). (PubMed, Urol Oncol)
    BEMPEG plus NIVO did not meet the efficacy threshold for ORR in patients with previously untreated locally advanced or metastatic urothelial carcinoma and low PD-L1 expression.
    P2 data • Journal • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    PD-L1 (Programmed death ligand 1) • IL2 (Interleukin 2)
    |
    PD-L1 expression • PD-L1 underexpression • PD-L1-L
    |
    Opdivo (nivolumab) • bempegaldesleukin (NKTR-214)
    2ms
    Adoptive Cell Therapy Across Cancer Diagnoses (clinicaltrials.gov)
    P1/2, N=25, Completed, Inge Marie Svane | Unknown status --> Completed
    Trial completion
    |
    IL2 (Interleukin 2)
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • cyclophosphamide • fludarabine IV • Proleukin (aldesleukin)
    2ms
    KEYNOTE-B71: A Study of SAR444245 Combined With Other Anticancer Therapies for the Treatment of Participants With Lung Cancer or Mesothelioma (Pegathor Lung 202) (clinicaltrials.gov)
    P2, N=106, Terminated, Sanofi | Active, not recruiting --> Terminated; Early discontinuation based on strategic sponsor decision not driven by any safety concerns.
    Trial termination
    |
    PD-L1 expression
    |
    Keytruda (pembrolizumab) • pegenzileukin (SAR444245)
    2ms
    MK-6194 Site of Injection Study in Healthy Adult Participants (MK-6194-013) (clinicaltrials.gov)
    P1, N=16, Completed, Merck Sharp & Dohme LLC
    New P1 trial
    2ms
    Phase 1b Study of the Immunocytokine Simlukafusp alfa (FAP-IL2v), in Combination with Cetuximab in Patients with Head and Neck Squamous Cell Carcinoma. (PubMed, Clin Cancer Res)
    The safety profile of FAP-IL2v in combination with cetuximab was acceptable and pharmacodynamic markers support the proposed mode-of-action of this combination, but the overall low antitumor activity does not warrant further clinical exploration in HNSCC. [Part C of Study BP29842 (NCT02627274).].
    P1 data • Journal • Combination therapy
    |
    CD8 (cluster of differentiation 8) • IL2RA (Interleukin 2 receptor, alpha) • ISG20 (Interferon Stimulated Exonuclease Gene 20)
    |
    Erbitux (cetuximab) • simlukafusp alfa (RG7461)
    2ms
    Genetically Modified T-Cells Followed by Aldesleukin in Treating Patients with Stage III-IV Melanoma (clinicaltrials.gov)
    P1, N=34, Active, not recruiting, M.D. Anderson Cancer Center | N=15 --> 34 | Trial completion date: Jun 2025 --> Oct 2027 | Trial primary completion date: Jun 2024 --> Oct 2027
    Enrollment change • Trial completion date • Trial primary completion date • Metastases
    |
    NGFR (Nerve Growth Factor Receptor) • TGFA (Transforming Growth Factor Alpha)
    |
    cyclophosphamide • fludarabine IV • Proleukin (aldesleukin)
    2ms
    Theratri: A Study to Evaluate the Safety and Preliminary Signs of Efficacy of [177Lu]Lu-OncoFAP-23 Alone or in Combination with L19-IL2 As a Treatment of Metastatic FAP-positive Solid Tumors (clinicaltrials.gov)
    P1, N=56, Not yet recruiting, Philogen S.p.A.
    New P1 trial • Combination therapy • Metastases
    |
    darleukin (L19IL2)
    2ms
    Phase 2 study of the antitumour activity and safety of simlukafusp alfa (FAP-IL2v) combined with atezolizumab in patients with recurrent and/or metastatic cervical squamous cell carcinoma. (PubMed, EBioMedicine)
    FAP-IL2v plus atezolizumab is clinically active and has manageable safety in patients with recurrent and/or metastatic cervical SCC.
    Clinical • P2 data • Preclinical • Retrospective data • Review • Journal • Metastases
    |
    PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8)
    |
    PD-L1 expression • PD-L1 negative
    |
    Tecentriq (atezolizumab) • simlukafusp alfa (RG7461)
    3ms
    Intraperitoneal immunotherapy with denileukin diftitox (ONTAK) in recurrent refractory ovarian cancer. (PubMed, Gynecol Oncol)
    Denileukin diftitox (ONTAK) can be safely administered intraperitoneally to recurrent refractory ovarian cancer patients. Regulatory T cells were reduced in ascites and peripheral blood, but there were no significant changes in cytokine levels.
    Journal
    |
    CXCL8 (Chemokine (C-X-C motif) ligand 8) • IL2RA (Interleukin 2 receptor, alpha) • TGFB1 (Transforming Growth Factor Beta 1)
    |
    Ontak (denileukin diftitox)
    3ms
    STIL101 for Injection for the Treatment of Locally Advanced, Metastatic or Unresectable Pancreatic Cancer, Colorectal Cancer, Renal Cell Cancer, Cervical Cancer and Melanoma (clinicaltrials.gov)
    P1, N=12, Not yet recruiting, City of Hope Medical Center
    New P1 trial
    |
    cyclophosphamide • fludarabine IV • Proleukin (aldesleukin)
    3ms
    KEYNOTE-B78: A Study of SAR444245 Combined With Other Anticancer Therapies for the Treatment of Participants With Gastrointestinal Cancer (Master Protocol) (Pegathor Gastrointestinal 203) (clinicaltrials.gov)
    P2, N=138, Terminated, Sanofi | Active, not recruiting --> Terminated; Early discontinuation based on strategic sponsor decision not driven by any safety concerns.
    Trial termination
    |
    PD-L1 (Programmed death ligand 1) • MSI (Microsatellite instability)
    |
    Keytruda (pembrolizumab) • Erbitux (cetuximab) • pegenzileukin (SAR444245)
    3ms
    Safety and Efficacy of Efavaleukin Alfa in Participants With Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov)
    P2, N=224, Active, not recruiting, Amgen | Recruiting --> Active, not recruiting | Trial completion date: Dec 2025 --> Oct 2024 | Trial primary completion date: Feb 2025 --> Oct 2024
    Enrollment closed • Trial completion date • Trial primary completion date
    3ms
    Efficacy of PD-1 Inhibitor Combination Therapy in Non-small Cell Lung Cancer Patients Who Have Not Achieved Major Pathologic Response After Neoadjuvant Immunotherapy: a Multicenter, Phase II Clinical Trial (clinicaltrials.gov)
    P2, N=296, Not yet recruiting, Shanghai Pulmonary Hospital, Shanghai, China
    New P2 trial
    |
    Tyvyt (sintilimab)
    3ms
    Long-term Safety and Efficacy of Efavaleukin Alfa in Participants With Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov)
    P2, N=25, Active, not recruiting, Amgen | Recruiting --> Active, not recruiting | N=92 --> 25 | Trial completion date: Jan 2028 --> Oct 2024 | Trial primary completion date: Jan 2028 --> Oct 2024
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date
    3ms
    A precision engineered interleukin-2 (IL-2) for bolstering CD8+ T- and NK-cell activity without eosinophilia and vascular leak syndrome in non-human primates. (PubMed, Cancer Res Commun)
    We have created a precisely pegylated IL-2 [SAR-444245 (SAR'245) or pegenzileukin, previously THOR- 707] designed for proliferation of target CD8+ T and NK cells for anti-cancer activity, with minimal expansion of anti-target regulatory CD4+ T cells (Tregs) that counter their action, or eosinophils that trigger vascular leak syndrome (VLS)...Ex vivo, SAR'245 enhanced T-cell receptor responses alone and in combination with PD-1 inhibitors without inducing cytokines associated with cytokine release syndrome or VLS. Results support the clinical development of SAR'245 as a drug candidate for the treatment of solid tumors, alone or in combination with PD-1 inhibitory agents.
    Journal
    |
    CD4 (CD4 Molecule) • IL2 (Interleukin 2)
    |
    pegenzileukin (SAR444245)
    3ms
    A Clinical Study of MK-6194 for the Treatment of Vitiligo (MK-6194-007) (clinicaltrials.gov)
    P2, N=165, Active, not recruiting, Merck Sharp & Dohme LLC | Recruiting --> Active, not recruiting
    Enrollment closed
    3ms
    A534260: IT-hu14.18-IL2 With Radiation, Nivolumab and Ipilimumab for Melanoma (clinicaltrials.gov)
    P1/2, N=61, Suspended, University of Wisconsin, Madison | Trial completion date: Aug 2025 --> Aug 2026 | Trial primary completion date: Aug 2024 --> Aug 2025
    Trial completion date • Trial primary completion date • IO biomarker • Metastases
    |
    IL2 (Interleukin 2)
    |
    PD-L1 expression
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • lorukafusp alfa (APN301)
    3ms
    KEYNOTE-C39: A Study of SAR444245 With or Without Other Anticancer Therapies for the Treatment of Adults and Adolescents With Relapsed or Refractory B Cell Lymphoma (Master Protocol) [Pegathor Lymphoma 205] (clinicaltrials.gov)
    P2, N=14, Terminated, Sanofi | Trial completion date: Jan 2025 --> Sep 2024 | Active, not recruiting --> Terminated; Early discontinuation based on strategic sponsor decision not driven by any safety concerns.
    Trial completion date • Trial termination
    |
    Keytruda (pembrolizumab) • pegenzileukin (SAR444245)
    3ms
    Autologous CD19 CAR-T Cell Therapy (SYNCAR-001) + Orthogonal IL-2 (STK-009) in Subjects With Severe, Refractory Systemic Lupus Erythematosus (clinicaltrials.gov)
    P1, N=42, Recruiting, Synthekine | Not yet recruiting --> Recruiting
    Enrollment open • CAR T-Cell Therapy
    |
    STK-009/SYNCAR-001
    3ms
    HAMMER: A Study Evaluating Safety and Therapeutic Activity of THOR-707 in Adult Subjects With Advanced or Metastatic Solid Tumors (THOR-707-101) (clinicaltrials.gov)
    P1/2, N=250, Active, not recruiting, Synthorx, Inc, a Sanofi company | Recruiting --> Active, not recruiting
    Enrollment closed • Combination therapy • Metastases
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation
    |
    Keytruda (pembrolizumab) • Erbitux (cetuximab) • pegenzileukin (SAR444245)
    3ms
    AURELIO-03: Study of Nanrilkefusp Alfa Alone and With Pembrolizumab in Adult Patients With Advanced/Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=200, Active, not recruiting, SOTIO Biotech AG | Trial primary completion date: Aug 2024 --> Dec 2024
    Trial primary completion date • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab) • nanrilkefusp alfa (SOT101)