Hyleukin-7 (efineptakin alfa) / Genexine, NeoImmuneTech, NovaBridge Biosciences, PT Kalbe Farma - LARVOL DELTA

Dex and IL-7 enhance persistence of CAR T cells to promote long-term remission in mouse models of multiple myeloma (ASH 2025) - "We previously found that dexamethasone (dex)administered ex vivo during manufacturing or in vivo during therapy upregulates IL7R alpha expressionon CAR T cells, can increase persistence and overall efficacy of CAR T cells when combined withexogenous IL-7 and importantly, does not inhibit CAR T cell expansion or activity. Combining CAR T cells with dex and NT-I7 significantly enhanced antitumor efficacy of CAR Tcell therapy for primary and extramedullary, leading to deep remission in both models."

CAR T-Cell Therapy • IO biomarker • Preclinical • Hematological Malignancies • Multiple Myeloma • IL7 • IL7R

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 | Sponsor: Washington University School of Medicine | Trial completion date: Jan 2032 ➔ Apr 2028

Trial completion date • Brain Cancer • Glioma • Oncology • Solid Tumor • IDH1 • MGMT

A Phase 1 study evaluating NT-I7 (efineptakin alfa), a long-acting human IL-7, post-tisagenlecleucel (tisa-cel), post-axicabtagene ciloleucel (axi-cel), or post-lisocabtagene maraleucel (liso-cel) in Relapsed/Refractory large B-cell lymphoma (ASH 2025) - P1 | "NT-I7 at 720 μg/kg was determined to be the RP2D.Correlative data suggest earlier NT-I7 administration post-CART19 infusion may better optimize CART19expansion. Further studies investigating an earlier administration schema are needed."

P1 data • B Cell Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • CD4 • CD8 • IL1B • IL5 • IL6 • IL7

Efineptakin alfa (NT-I7) increases the abundance of stem-like CD8 T cells and induces tertiary lymphoid structures in lung tumors [WITHDRAWN] (ESMO-IO 2025) - No abstract available

Lung Cancer • Oncology • Solid Tumor

NT-I7, a Long-Acting Recombinant IL-7 Molecule, as an Immune Reconstitution Strategy for Lymphopenia in Patients With Progressive Multifocal Leukoencephalopathy (clinicaltrials.gov) - P1 | N=12 | Completed | Sponsor: National Institute of Neurological Disorders and Stroke (NINDS) | Recruiting ➔ Completed | N=18 ➔ 12

Enrollment change • Trial completion • CNS Disorders • Rare Diseases • CD4

NeoImmuneTech announced on the 20th that it received approval from the U.S. Food and Drug Administration (FDA) for a phase 1 clinical trial plan for the combination of Janssen's BCMA CAR-T treatment 'Carvykti (ingredient: Ciltacabtagene autoleucel)' and 'NT-I7 (ingredient: epinephrine-alpha)' for patients with multiple myeloma. [Google translation] (HIT News) - "Through this study, the research team will evaluate the safety and tolerability of NT-I7 after CAR-T treatment in 40 patients with relapsed or refractory multiple myeloma, and will exploratorily confirm efficacy indicators such as complete response (CR)."

IND • New P1 trial • Multiple Myeloma

An "Off-the-Shelf" CD2 Universal CAR-T Therapy Combined with a Long-Acting IL-7 for T-Cell Malignancies (ASH 2023) - "To determine the impact of CD2 antigen loss on CAR-T cell function, CRISPR-mediated CD2 KO was performed in CD19 targeting CAR-T cells (UCART19ΔCD2). We have developed an allogenic "universal" CD2-targeting CAR-T cell UCART2, which is effective against T-ALL and CTCL/T-NHL. We found that CD2 deletion in CAR-T cells resulted in reduced secretion of effector cytokines and reduced anti-tumor activity in vivo, indicating that CD2 is critical for CAR-T function. However, when combined with rhIL-7-hyFc (efineptakin alfa), a long-acting recombinant IL-7, UCART2 induced durable complete responses in both primary and tumor rechallenge experiments in vivo."

Cutaneous T-cell Lymphoma • Graft versus Host Disease • Hematological Malignancies • Immunology • Non-Hodgkin’s Lymphoma • Oncology • T Acute Lymphoblastic Leukemia • CD2 • GZMB • IFNG • IL7

NT-I7, a Long-Acting Interleukin-7 Molecule, Promotes T Cell Reconstitution Following Radiation Injury through Thymic-Dependent and Independent Pathways (ASH 2024) - "The result demonstrated that treatment with NT-I7 also significantly shortened the time required for rejection of the 2nd skin graft compared with the vehicle control group, demonstrating that NT-I7 can also promote functional memory T cell responses in vivo. These results indicate that NT-I7 is a promising therapeutic for significantly accelerating recovery of functional T cells after radiation exposure."

Hematological Disorders • Infectious Disease • CD24 • CD8 • GZMB • IFNG • IL7 • TNFA

NeoImmuneTech announced phase 1 findings for its long-acting human IL-7 formulation NT-I7 (efineptakin alfa) in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL). (Korea Biomedical Review) - "In this study involving 17 participants, NT-I7 was administered safely, with all drug-related adverse events occurring at Grade 1 or 2 levels. Per-protocol efficacy analysis showed an objective response rate (ORR) of 87.5 percent and a complete remission (CR) rate of 75 percent."

P1 data • Diffuse Large B Cell Lymphoma

Relapsed/Refractory Large B-cell Lymphoma With NT-I7 Post-CD19 CAR T-cell Therapy (clinicaltrials.gov) - P1 | N=17 | Completed | Sponsor: NeoImmuneTech | Recruiting ➔ Completed | N=57 ➔ 17 | Trial completion date: Feb 2026 ➔ Mar 2025

Enrollment change • Trial completion • Trial completion date • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • High-grade B-cell lymphoma • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Primary Mediastinal Large B-Cell Lymphoma

NT-I7, a novel long-acting interleukin-7, promotes anti-PD-1 efficacy in an autologous humanized melanoma model. (PubMed, Sci Rep) - "We discovered a synergistic effect between NT-I7 and anti-PD-1 (Pembrolizumab) that notably augments immunotherapeutic efficacy through the expansion of TCM cells and sustained cytotoxicity. In sum, our humanized model reveals that NT-I7 holds great promise as a next-generation therapy to enhance clinical responses and patient care."

Journal • Melanoma • Oncology • Solid Tumor • IL7

Population Pharmacokinetic and Pharmacodynamic Modeling Analysis of rhIL-7-hyFc, a Hybrid Fc-Fused Long-Acting Interleukin-7, to Support Optimal Dosing Regimens in Patients with Solid Cancer. (PubMed, Drug Des Devel Ther) - P1b | "A dose range of 0.6-1.2 mg/kg administered at intervals of 6 to 12 weeks was suggested as feasible for the RP2D in further clinical trials. A population PK-PD modeling and simulation results demonstrated a strong exposure-response relationship for ALC across dosing intervals, underscoring the mechanism-based therapeutic potential of rhIL-7-hyFc in cancer immunotherapy."

Journal • PK/PD data • Oncology • Solid Tumor • IL7

Long-Acting Recombinant IL-7 (rhIL-7-hyFc) Enhances the Primary and Memory Neoantigen-Specific Immune Response to Breast Cancer Personalized Cancer Vaccines. (PubMed, Cancers (Basel)) - " We found that the combination of rhIL-7-hyFc and DNA PCV treatment prolonged neoantigen-specific CD8+ T cell responses, improved functional memory as measured based on in vivo cytotoxicity, and increased the number of neoantigen-specific tumor-infiltrating lymphocytes (TILs), resulting in improved prophylactic tumor protection and durable memory responses. Our findings support the potential of rhIL-7-hyFc to enhance the efficacy of PCVs and suggest clinical utility for adjuvant rhIL-7-hyFc in cancer immunotherapy."

Journal • Breast Cancer • Oncology • Solid Tumor • IL7

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 | Sponsor: Washington University School of Medicine

New P1 trial • Hematological Malignancies • Multiple Myeloma • Oncology

Efineptakin alfa (NT-I7) improves overall survival and induces tertiary lymphoid structures in murine lung tumors. (PubMed, bioRxiv) - "This study demonstrates the ability of efineptakin alfa (NT-I7) to potentially augment the clinical efficacy of cancer immunotherapy by inducing tertiary lymphoid structures in the tumor microenvironment."

IO biomarker • Journal • Preclinical • Lung Cancer • Oncology • Solid Tumor • CD8 • IL7 • PD-L1

Gosha-Jinki-Gan Reduces Inflammation in Chronic Ischemic Stroke Mouse Models by Suppressing the Infiltration of Macrophages. (PubMed, Biomolecules) - "On the other hand, the administration of TJ107 was proven to reduce the infarct area, with decreased GFAP expression, suppressed macrophage infiltration in the brain, and reduced TNF-α, IL-1β, and IL-17 production compared with the MCAO mice. This study first demonstrated Gosha-jinki-gan's therapeutic effects on the chronic ischemic stroke."

Journal • Preclinical • Cardiovascular • CNS Disorders • Inflammation • Ischemic stroke • Vascular Neurology • FAP • GFAP • IL17A • IL1B • IL23A • TLR2 • TLR4 • TNFA

KEYNOTE A60: NT-I7 (Efineptakin Alfa) in Combination With Pembrolizumab in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=215 | Completed | Sponsor: NeoImmuneTech | Active, not recruiting ➔ Completed

Trial completion • Breast Cancer • Colorectal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Small Cell Lung Cancer • Solid Tumor • Triple Negative Breast Cancer • ALK • BRAF • ROS1

Phase I study of NT-I7, a long-acting interleukin-7, in severe treatment-related lymphopenia following standard radiation and temozolomide for high-grade glioma. (PubMed, Neurooncol Adv) - "Eligible HGG patients had CD4 counts <300 cells/mm3 after 5 weeks of standard chemoradiation and were receiving either ≤0.75 or ≥4 mg/day of dexamethasone. Correlative immune profiling revealed increased Ki67 expression in CD4 (P < .005) and CD8 (P < .05) after one week, along with the expansion of CD4 and CD8 T-cell subsets and CD56 + natural killer cells. NT-I7 is well tolerated and effectively increases lymphocyte and CD4 counts in severe TRL patients, regardless of glucocorticoid use, suggesting its potential to mitigate TRL and improve outcomes in HGG."

Journal • P1 data • Brain Cancer • Glioma • High Grade Glioma • Human Immunodeficiency Virus • Infectious Disease • Oncology • Solid Tumor • CD4 • CD8 • IL7 • NCAM1

NeoImmuneTech, CAR-T Combination NT-I7 Repeat Administration Follow-up Clinical Trial US FDA IND Application [Google translation] (BioTimes) - "NeoImmuneTech, a global company specializing in T cell-based immunotherapy, announced on the 14th that it has submitted an investigational new drug (IND) plan for a follow-up clinical trial on the combination of NT-I7 (efineptakin alfa), a T cell booster, and CAR-T treatment to the U.S. Food and Drug Administration (FDA)....This trial, planned at the request of Dr. DiPersio, will evaluate a two-dose strategy of NT-I7 administered on days 10 and 31 after CAR-T therapy in patients with large B-cell lymphoma (LBCL) receiving Yescarta or Breyanzi. Designed as a phase 1b study to determine the additional safety associated with changing the timing and frequency of dosing, the trial plans to administer NT-I7 600 μg/kg and 720 μg/kg to up to six patients each (n=3+3)."

IND • Large B Cell Lymphoma

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 | Sponsor: Washington University School of Medicine

New P1 trial • B Cell Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

rhIL-7-hyFc on Increasing Lymphocyte Counts in Patients With Newly Diagnosed Non-severe Lymphopenic Gliomas Following Radiation and Temzolomide (clinicaltrials.gov) - P1/2 | N=42 | Active, not recruiting | Sponsor: Washington University School of Medicine | Trial primary completion date: May 2025 ➔ Sep 2025

Trial primary completion date • Brain Cancer • Glioma • Oncology • Solid Tumor • IDH1 • MGMT

NT-I7, a Long-Acting Recombinant IL-7 Molecule, as an Immune Reconstitution Strategy for Lymphopenia in Patients With Progressive Multifocal Leukoencephalopathy (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: National Institute of Neurological Disorders and Stroke (NINDS) | N=12 ➔ 18

Enrollment change • CNS Disorders • Rare Diseases • CD4

GX-I7, a long-acting IL-7, safely and effectively increased peripheral CD8+/CD4+ T cells and TILs in patients with locally advanced or metastatic solid tumours. (PubMed, Br J Cancer) - P1b | "Findings suggest GX-I7 is a safe T cell-amplifying agent with peripheral immune activation. Ongoing studies are exploring its ability to enhance immune responses in peripheral immune cells and tumour cells when combined with other anti-cancer agents."

Journal • Oncology • Solid Tumor • CD4 • CD8 • IL7

Dose Optimization of rhIL-7-hyFc for Patients With Lymphopenia Using a Neonatal Fc Receptor-Mediated Recycling-Based and Target-Mediated Drug Disposition Pharmacokinetic Model. (PubMed, Clin Transl Sci) - "Based on the simulation results, 670-800 μg/kg every 3 weeks, 1010-1530 μg/kg every 6 weeks, and 1510-2190 μg/kg every 9 weeks IM were proposed. These results may help further understand rhIL-7-hyFc characteristics and, moreover, provide guidance for selecting the appropriate dosing regimen in future clinical trials."

Clinical • Journal • PK/PD data • Oncology

NeoImmuneTech's high-dose CAR-T combo for lymphoma hits 100% ORR (Korea Biomedical Review) - P1 | N=57 | NCT05075603 | Sponsor: NeoImmuneTech | "Headquartered in Maryland, the U.S., with a Korean subsidiary in Bundang, the biotech on Monday released topline results from NIT-112, a U.S. trial evaluating NT-I7 (efineptakin alfa) in 17 patients with relapsed or refractory large B-cell lymphoma....Regulatory documents released the same day showed that among the seven dose levels tested, the clearest signal came in the 480 to 720 μg/kg group. All eight patients in that cohort achieved a 100 percent overall response rate (ORR), including six complete responses (CR) and two partial responses. Six had complete responses and two had partial responses, including one patient who later converted to a CR. By the six-month mark, seven of the eight remained in response."

P1 data • Diffuse Large B Cell Lymphoma