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    DRUG CLASS:

    IL-7 agonist

    Related drugs:
    4d
    Recombinant Human IL-7 (NT-I7) in Relapsed/Refractory Multiple Myeloma Following BCMA CAR-T Therapy (Cilta-cel) (clinicaltrials.gov)
    P1, N=40, Not yet recruiting, Washington University School of Medicine | Trial completion date: Jul 2028 --> Nov 2028 | Initiation date: Jan 2026 --> May 2026 | Trial primary completion date: Oct 2027 --> Feb 2028
    Trial completion date • Trial initiation date • Trial primary completion date
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    clonoSEQ
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    Carvykti (ciltacabtagene autoleucel) • Hyleukin-7 (efineptakin alfa)
    13d
    Recombinant Glycosylated Human Interleukin-7 (CYT107) for the Treatment of Kaposi Sarcoma in Participants With HIV and Immune Non-Response (REGIMENKS HIV) (clinicaltrials.gov)
    P2, N=55, Recruiting, National Cancer Institute (NCI) | Not yet recruiting --> Recruiting
    Enrollment open
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    CD4 (CD4 Molecule)
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    CYT107
    1m
    Long-acting interleukin-7 improves the efficacy of oncolytic viral therapy in glioblastoma. (PubMed, Nat Commun)
    To overcome these challenges, here we develop a treatment strategy we term "expand and pull," which uses systemic administration of rhIL-7-hyFc, a long-acting recombinant human interleukin-7, to increase peripheral T cell abundance ("expand"), followed by intratumoral oncolytic virus treatment to recruit these cells to the tumor microenvironment ("pull")...We observe similar survival efficacy in experiments using a safer, genetically modified Δ10 3'-UTR ZIKV, as well as the clinically tested oncolytic adenovirus, Delta24-RGD. Collectively, our findings demonstrate that augmentation of both the systemic and local immune responses improves the utility of GBM-targeted immunotherapies.
    Journal • IO biomarker
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    IL7 (Interleukin 7)
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    Hyleukin-7 (efineptakin alfa)
    1m
    NT-I7 (Efineptakin Alfa), a Long-acting Human IL-7, Post-Axicabtagene Ciloleucel or Post-Lisocabtagene Maraleucel in Subjects With Relapsed/Refractory Large B-cell Lymphoma (clinicaltrials.gov)
    P1, N=24, Recruiting, Washington University School of Medicine | Not yet recruiting --> Recruiting
    Enrollment open
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    Yescarta (axicabtagene ciloleucel) • Breyanzi (lisocabtagene maraleucel) • Hyleukin-7 (efineptakin alfa)
    1m
    Phase 1 open-label study of ASP9801, an oncolytic virus, in patients with advanced or metastatic solid tumors. (PubMed, J Immunother Cancer)
    Treatment with ASP9801 alone or plus pembrolizumab was generally well tolerated; however, the study was stopped due to lack of efficacy during dose expansion.
    P1 data • Journal
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    IL7 (Interleukin 7)
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    Keytruda (pembrolizumab)
    1m
    GENUINE: Trial of the Combination of GX-188E Vaccination, GX-I7 and Pembrolizumab in Patients With Advanced, Resectable HPV Type 16 and/or 18 Positive Head and Neck Cancer (clinicaltrials.gov)
    P2, N=56, Active, not recruiting, Yonsei University | Recruiting --> Active, not recruiting | Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Aug 2025 --> Oct 2026
    Enrollment closed • Trial completion date • Trial primary completion date
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    PD-L1 (Programmed death ligand 1)
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    Keytruda (pembrolizumab) • Papitrol (tirvalimogene teraplasmid) • Hyleukin-7 (efineptakin alfa)
    2ms
    IL7-TBRII, a Dual Cytokine Modulator Targeting IL-7 and TGF-β Pathways, Inhibits Tumor Progression and Metastasis. (PubMed, Immune Netw)
    As TGF-β impairs CD8+ T cell function and antagonizes IL-7 signaling, we developed a bifunctional fusion protein, recombinant human IL-7 (rhIL-7)-hyFc-sTBRII (IL7-TBRII), by fusing a TGF-β trap (Fc-TBRII) to rhIL-7-hyFc (IL7-Fc)...Furthermore, IL7-TBRII reduced metastasis in the 4T1 breast cancer model by reshaping the immune cell composition, and demonstrated synergistic efficacy when combined with radiotherapy or anti-CTLA-4 therapy in the EMT6 breast tumor model. These findings suggest that dual modulation of the IL-7 and TGF-β pathways by IL7-TBRII effectively reprograms the immune microenvironment in both primary and metastatic tumors, particularly by promoting CD8+ T cell activation and infiltration, thus offering a promising strategy to improve clinical responses to immunotherapy.
    Journal
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    CD8 (cluster of differentiation 8) • TGFBR2 (Transforming Growth Factor Beta Receptor 2) • TGFB1 (Transforming Growth Factor Beta 1) • IL7 (Interleukin 7)
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    Hyleukin-7 (efineptakin alfa)
    3ms
    Recombinant Glycosylated Human Interleukin-7 (CYT107) for the Treatment of Kaposi Sarcoma in Participants With HIV and Immune Non-Response (REGIMENKS HIV) (clinicaltrials.gov)
    P2, N=55, Not yet recruiting, National Cancer Institute (NCI)
    New P2 trial
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    CYT107
    3ms
    GEN001-201: GEN-001 in Combination With Avelumab for Patients With PD-L1 Positive Gastric Cancer (clinicaltrials.gov)
    P2, N=42, Completed, Genome & Company | Active, not recruiting --> Completed
    Trial completion
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    PD-L1 (Programmed death ligand 1)
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    PD-L1 expression
    |
    Bavencio (avelumab) • GEN-001
    3ms
    KEYNOTE-D86: GEN-001 Plus Pembrolizumab for Patients With Advanced Refractory Biliary Tract Cancer (clinicaltrials.gov)
    P2, N=10, Terminated, Genome & Company | Recruiting --> Terminated | N=148 --> 10; Sponsor decision
    Enrollment change • Trial termination
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    Keytruda (pembrolizumab) • GEN-001
    4ms
    NT-I7 (Efineptakin Alfa), a Long-acting Human IL-7, Post-Yescarta® (Axicabtagene Ciloleucel) or Post-Breyanzi® (Lisocabtagene Maraleucel) in Subjects With Relapsed/Refractory Large B-cell Lymphoma (clinicaltrials.gov)
    P1, N=24, Not yet recruiting, Washington University School of Medicine | Trial completion date: Apr 2028 --> Aug 2028 | Initiation date: Oct 2025 --> Feb 2026 | Trial primary completion date: Jul 2027 --> Nov 2027
    Trial completion date • Trial initiation date • Trial primary completion date
    |
    Yescarta (axicabtagene ciloleucel) • Breyanzi (lisocabtagene maraleucel) • Hyleukin-7 (efineptakin alfa)
    4ms
    rhIL-7-hyFc on Increasing Lymphocyte Counts in Patients With Newly Diagnosed Non-severe Lymphopenic Gliomas Following Radiation and Temozolomide (clinicaltrials.gov)
    P1/2, N=42, Active, not recruiting, Washington University School of Medicine | Trial completion date: Jan 2032 --> Apr 2028
    Trial completion date
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • MGMT (6-O-methylguanine-DNA methyltransferase)
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    IDH wild-type • IDH1 R132
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    temozolomide • Hyleukin-7 (efineptakin alfa)