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DRUG:

Hyleukin-7 (efineptakin alfa)

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Other names: TJ 107, TJ107, rhIL-7-hyFc, NT-I7, GX-I7, Interleukin-7-hybrid-Fc-recombinant-protein
Company:
Genexine, NeoImmuneTech, NovaBridge Biosciences, PT Kalbe Farma
Drug class:
IL-7 agonist
7d
NT-I7 in Combination With Atezolizumab in Previously Untreated, PD-L1-expressing, Locally Advanced or Metastatic NSCLC (clinicaltrials.gov)
P2, N=33, Terminated, NeoImmuneTech | N=83 --> 33 | Active, not recruiting --> Terminated; sponsor decision (not for safety)
Enrollment change • Trial termination
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PD-L1 (Programmed death ligand 1)
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PD-L1 expression
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PD-L1 IHC 22C3 pharmDx
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Tecentriq (atezolizumab) • Hyleukin-7 (efineptakin alfa)
7d
TRINITY: HPV 16-positive and/or HPV 18-positive Recurrent and/or For Patients With Metastatic Head and Neck Cancer to Evaluate GX-188E DNA Vaccination, GX-I7 and Nivolumab Combination Therapy (clinicaltrials.gov)
P2, N=21, Active, not recruiting, Yonsei University | Recruiting --> Active, not recruiting | Trial completion date: Mar 2026 --> Jan 2027 | Trial primary completion date: Mar 2026 --> Jan 2027
Enrollment closed • Trial completion date • Trial primary completion date
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PD-L1 (Programmed death ligand 1)
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Opdivo (nivolumab) • Papitrol (tirvalimogene teraplasmid) • Hyleukin-7 (efineptakin alfa)
9d
Recombinant Human IL-7 (NT-I7) in Relapsed/Refractory Multiple Myeloma Following BCMA CAR-T Therapy (Cilta-cel) (clinicaltrials.gov)
P1, N=52, Recruiting, Washington University School of Medicine | Not yet recruiting --> Recruiting
Enrollment open
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clonoSEQ®
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Carvykti (ciltacabtagene autoleucel) • Hyleukin-7 (efineptakin alfa)
1m
Long-acting IL-7 restores T-cell reconstitution in a humanized mouse model of lymphopenia. (PubMed, J Allergy Clin Immunol)
A single dose of NT-I7 restored T-cell numbers in a mouse model of ICL and improved lymphocyte counts in a single-patient study.
Preclinical • Journal • IO biomarker
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CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule) • IL7 (Interleukin 7)
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Hyleukin-7 (efineptakin alfa)
2ms
Long-acting IL-7 induces distinct transcriptomic features in peripheral T cells of patients with solid tumors. (PubMed, JCI Insight)
Our results demonstrate that rhIL-7-hyFc induces robust peripheral T-cell expansion and activation in patients with solid tumors, supporting its potential use for lymphopenic patients treated with cancer immunotherapy.
Journal
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MYC (V-myc avian myelocytomatosis viral oncogene homolog) • IL7R (Interleukin 7 Receptor) • PIM1 (Pim-1 Proto-Oncogene) • IL7 (Interleukin 7)
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Hyleukin-7 (efineptakin alfa)
2ms
Enrollment change
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clonoSEQ®
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Carvykti (ciltacabtagene autoleucel) • Hyleukin-7 (efineptakin alfa)
3ms
Expansion and mobilization of virus-specific stem-like CD8 T cells in chronic viral infection after treatment with a long-acting IL-7, NT-I7. (PubMed, Cell Rep)
NT-I7 treatment led to an increase in stem-like CD8 T cells in circulation and peripheral tissues, contrasting with their resident property in lymphoid organs. These findings suggest NT-I7 as a promising strategy to expand and mobilize stem-like CD8 T cells to enhance antiviral and anticancer immunotherapies.
Journal • PD(L)-1 Biomarker • IO biomarker
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CD8 (cluster of differentiation 8) • IL7 (Interleukin 7)
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Hyleukin-7 (efineptakin alfa)
3ms
NT-I7, a long-acting interleukin-7, increases lymphocyte counts and induces CD8+ T cell clonotype expansion in patients with newly diagnosed high-grade gliomas. (PubMed, Clin Cancer Res)
NT-I7 has the potential to maintain and increase lymphocyte counts in HGG patients and warrants further investigation, particularly in combination with immune-based therapies.
Journal
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MGMT (6-O-methylguanine-DNA methyltransferase) • CD8 (cluster of differentiation 8) • CXCL9 (Chemokine (C-X-C motif) ligand 9) • CD4 (CD4 Molecule) • IL7 (Interleukin 7)
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temozolomide • Hyleukin-7 (efineptakin alfa)
3ms
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)
4ms
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)
4ms
Enrollment open
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Yescarta (axicabtagene ciloleucel) • Breyanzi (lisocabtagene maraleucel) • Hyleukin-7 (efineptakin alfa)
4ms
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)