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    DRUG CLASS:

    IL-15R agonist

    Related drugs:
    7d
    A Study of ASKG915 in Patients With Selected Advanced Solid Tumors. (clinicaltrials.gov)
    P1/2, N=594, Recruiting, AskGene Pharma, Inc. | Phase classification: P1 --> P1/2 | N=104 --> 594 | Trial completion date: Dec 2025 --> Jun 2028 | Trial primary completion date: Mar 2024 --> Dec 2026
    Phase classification • Enrollment change • Trial completion date • Trial primary completion date
    |
    Avastin (bevacizumab) • paclitaxel • docetaxel • Fruzaqla (fruquintinib) • ASKG915
    12d
    Phase I/II Clinical Study of SHR-1501 Combined With Adbelizumab in Patients With Malignant Tumors (clinicaltrials.gov)
    P1/2, N=203, Recruiting, Shanghai Hengrui Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    AiRuiLi (adebrelimab) • SHR-1501
    1m
    NKTR-255, a polymer-conjugated IL-15, synergizes with CAR-T cell therapy to activate endogenous anti-tumor immunity and improve tumor control. (PubMed, bioRxiv)
    Consequently, NKTR-255 and CAR-T combination therapy induced complete elimination of ROR1 + tumor and significantly improved survival, with enhanced tumor control dependent on activity of both CAR-Ts and endogenous T cells. Altogether, our data suggest that combining NKTR-255 with CAR-T therapy is a promising strategy to enhance both CAR-T and endogenous anti-tumor immunity to promote coordinated control of aggressive tumors.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    PD-1 (Programmed cell death 1) • ROR1 (Receptor Tyrosine Kinase Like Orphan Receptor 1) • ITGAM (Integrin, alpha M) • IL15 (Interleukin 15)
    |
    avipendekin pegol (NKTR-255)
    1m
    REStoring lymphoCytes Using NKTR-255* After chemoradiothErapy in Solid Tumors (RESCUE) (clinicaltrials.gov)
    P2, N=39, Recruiting, M.D. Anderson Cancer Center | Trial primary completion date: Dec 2025 --> Dec 2027
    Trial primary completion date
    |
    Imfinzi (durvalumab) • avipendekin pegol (NKTR-255)
    4ms
    CXCL10-induced chemotaxis of ex vivo-expanded natural killer cells combined with NKTR-255 enhances anti-tumor efficacy in osteosarcoma. (PubMed, Mol Ther Oncol)
    Single-cell RNA sequencing and mass cytometry revealed upregulated apoptosis and transforming growth factor-β (TGF-β) signaling as the potential mechanisms of response/resistance to NK cell therapy in vivo. Our findings highlight potential application of chemokine-enhanced NK tumor infiltration in combination with an IL-15 agonist as a novel approach to effective treatment of OSA.
    Preclinical • Journal
    |
    CXCL10 (Chemokine (C-X-C motif) ligand 10) • CXCL9 (Chemokine (C-X-C motif) ligand 9) • TGFB1 (Transforming Growth Factor Beta 1) • CXCR3 (C-X-C Motif Chemokine Receptor 3) • IL15 (Interleukin 15)
    |
    avipendekin pegol (NKTR-255)
    5ms
    NCI-2022-02316: NKTR-255 in Combination With CAR-T Cell Therapy for the Treatment of Relapsed or Refractory Large B-cell Lymphoma (clinicaltrials.gov)
    P1, N=28, Active, not recruiting, Fred Hutchinson Cancer Center | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    CD19 (CD19 Molecule)
    |
    cyclophosphamide • Breyanzi (lisocabtagene maraleucel) • fludarabine IV • avipendekin pegol (NKTR-255)
    6ms
    IL-15 Superagonist SHR-1501 Enhances Immune Responses in Lung Cancer by Modulating Tumor Microenvironment. (PubMed, Clin Respir J)
    SHR-1501 demonstrated potent antitumor activity, especially when combined with PD-1 mAb. Its mechanism likely involves promoting CD8+ T cell and NK cell infiltration and enhancing M1 macrophage activity. These findings provide evidence for further clinical trials exploring SHR-1501 in nonsmall cell lung cancer (NSCLC) therapy.
    Journal
    |
    KRAS (KRAS proto-oncogene GTPase) • CD8 (cluster of differentiation 8)
    |
    KRAS G12D • KRAS G12
    |
    SHR-1501
    6ms
    NKTR-255 Enhances Complete Response Following CD19 CAR-T in Patients with Relapsed/Refractory Large B-cell Lymphoma. (PubMed, Blood Adv)
    In this phase 2, randomized, double-blind, placebo-controlled, multicenter study of NKTR-255 versus placebo following CD19 CAR T-cell therapy, eligible patients with R/R LBCL were treated with one of two FDA-approved CAR T-cell products, axicabtagene ciloleucel (axi-cel) or lisocabtagene maraleucel (liso-cel). NKTR-255 was well-tolerated, safe, and augmented CR6 for LBCL patients. Based on the findings, additional confirmatory studies with NKTR-255 as adjuvant treatment to CAR T-cell, including other cellular therapies, are warranted (ClinicalTrials.gov number NCT05664217).
    Clinical • Journal
    |
    CD19 (CD19 Molecule) • CD8 (cluster of differentiation 8)
    |
    Yescarta (axicabtagene ciloleucel) • Breyanzi (lisocabtagene maraleucel) • avipendekin pegol (NKTR-255)
    7ms
    Phase I/II Clinical Study of SHR-1501 Combined With Adbelizumab in Patients With Malignant Tumors (clinicaltrials.gov)
    P1/2, N=203, Not yet recruiting, Shanghai Hengrui Pharmaceutical Co., Ltd.
    New P1/2 trial
    |
    AiRuiLi (adebrelimab) • SHR-1501
    10ms
    A phase 1, first-in-human, dose-escalation, expansion trial of cytokine encoding synthetic mRNA-mixture alone or with cemiplimab in advanced solid tumors. (PubMed, Clin Cancer Res)
    Intratumoral administration of SAR441000 in combination with cemiplimab, was generally well tolerated with anti-tumor activity in loco-regional disease setting. Anecdotal evidence of pharmacodynamic immune-modulatory effect and distant non-injected lesion anti-tumor response was observed, without significant effect in patients with advanced solid tumors previously treated with anti-PD1 therapies.
    P1 data • Journal
    |
    IFNG (Interferon, gamma) • IFNA1 (Interferon Alpha 1) • IL15 (Interleukin 15)
    |
    Libtayo (cemiplimab-rwlc) • SAR441000
    12ms
    NKTR-255 vs Placebo Following CD19-directed CAR-T Therapy in Patients With Relapsed/Refractory Large B-cell Lymphoma (clinicaltrials.gov)
    P2/3, N=15, Terminated, Nektar Therapeutics | N=400 --> 15 | Trial completion date: Jan 2029 --> Aug 2024 | Recruiting --> Terminated | Trial primary completion date: Jan 2027 --> May 2024; Sponsor decided to end the study
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date
    |
    CD19 (CD19 Molecule)
    |
    avipendekin pegol (NKTR-255)
    1year
    NCI-2022-02316: NKTR-255 in Combination With CAR-T Cell Therapy for the Treatment of Relapsed or Refractory Large B-cell Lymphoma (clinicaltrials.gov)
    P1, N=24, Recruiting, Fred Hutchinson Cancer Center | Trial completion date: Dec 2025 --> Jun 2026 | Trial primary completion date: Dec 2024 --> Jun 2025
    Trial completion date • Trial primary completion date
    |
    CD19 (CD19 Molecule)
    |
    cyclophosphamide • Breyanzi (lisocabtagene maraleucel) • fludarabine IV • avipendekin pegol (NKTR-255)