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    DRUG:

    avipendekin pegol (NKTR-255)

    i
    Other names: NKTR-255, NKTR 255, NKTR255
    Company:
    Nektar Therap
    Drug class:
    IL-15R agonist
    Related drugs:
    29d
    C-TIL051 in Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P1, N=1, Terminated, AbelZeta Inc. | N=20 --> 1 | Trial completion date: Aug 2027 --> Dec 2025 | Recruiting --> Terminated; Sponsor decision
    Enrollment change • Trial completion date • Trial termination
    |
    Keytruda (pembrolizumab) • avipendekin pegol (NKTR-255)
    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
    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)
    9ms
    A Study of the Safety and Efficacy of Various Combinations of Avelumab as Therapy in Locally Advanced or Metastatic Urothelial Carcinoma (JAVELIN Bladder Medley) (clinicaltrials.gov)
    P2, N=256, Active, not recruiting, EMD Serono Research & Development Institute, Inc. | Trial completion date: Jan 2025 --> Jul 2026 | Trial primary completion date: Jan 2025 --> Jun 2025
    Trial completion date • Trial primary completion date
    |
    Bavencio (avelumab) • Trodelvy (sacituzumab govitecan-hziy) • avipendekin pegol (NKTR-255) • dargistotug (M6223)
    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)
    1year
    Combinatorial immunotherapy of anti-MCAM CAR-modified expanded natural killer cells and NKTR-255 against neuroblastoma. (PubMed, Mol Ther Oncol)
    NKTR-255, a polymer-conjugated recombinant human interleukin-15 agonist, significantly stimulated NK cell proliferation and expansion and further enhanced the in vitro cytotoxic activity and in vivo anti-tumor efficacy of anti-MCAM-CAR-NK cells against NB. Our preclinical studies demonstrate that ex vivo expanded and modified anti-MCAM-CAR-NK cells alone and/or in combination with NKTR-255 are promising novel alternative therapeutic approaches to targeting MCAMhigh malignant NB.
    Journal • IO biomarker
    |
    MCAM (Melanoma Cell Adhesion Molecule) • IL15 (Interleukin 15)
    |
    MCAM expression
    |
    avipendekin pegol (NKTR-255)
    over1year
    Circumventing resistance within the Ewing sarcoma microenvironment by combinatorial innate immunotherapy. (PubMed, J Immunother Cancer)
    Our preclinical studies demonstrate that immunotherapy via the innate immune system by combining tumor-targeting CAR-NK cells with an IL-15 agonist and a CD47 blockade is a promising novel therapeutic approach to targeting MCAMhigh malignant metastatic ES.
    Journal • IO biomarker
    |
    IFNG (Interferon, gamma) • MCAM (Melanoma Cell Adhesion Molecule) • IL15 (Interleukin 15)
    |
    MCAM expression
    |
    magrolimab (ONO-7913) • avipendekin pegol (NKTR-255)
    over1year
    A Study of the Safety and Efficacy of Various Combinations of Avelumab as Therapy in Locally Advanced or Metastatic Urothelial Carcinoma (JAVELIN Bladder Medley) (clinicaltrials.gov)
    P2, N=256, Active, not recruiting, EMD Serono Research & Development Institute, Inc. | Recruiting --> Active, not recruiting
    Enrollment closed • Combination therapy • Metastases
    |
    Bavencio (avelumab) • Trodelvy (sacituzumab govitecan-hziy) • avipendekin pegol (NKTR-255) • dargistotug (M6223)