Drugs / Recombinant human IL-7-hyFc
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT04054752 | May → Nov 2023 | breast carcinoma, colorectal adenocarcinoma, urinary bladder carcinoma | National Cancer Institute (NCI) | Withdrawn | No outcome recorded Stop: Enrollment |
News releases announcing trial results or a regulatory action · 46
| Date | Issuer | Release |
|---|---|---|
| 2026-09-21 | NeoImmuneTech | Results NeoImmuneTech Announces Continued Progress in CD19 CAR-T Combination Trial…Safety Confirmed in First Dose Cohort Following Two Doses of NT-I7 neoimmunetech.com ↗
No dose-limiting toxicities (DLTs) were observed in the DL1 cohort. |
| 2026-05-22 | NeoImmuneTech | Results NeoImmuneTech to Present Collaborative Research with Immunocore at ASCO 2026 neoimmunetech.com ↗
In vitro findings showed that IL7 treatment increased stem-like T cells, reduced immune checkpoint receptor expression, enhanced ImmTAC-mediated IFNγ secretion and tumor cell killing, and reduced T cell exhaustion. |
| 2026-03-18 | NeoImmuneTech | Results NeoImmuneTech Highlights Publication of NT-I7 Study in Genes & Diseases, Demonstrating TLS Formation and Tumor Microenvironment Remodeling neoimmunetech.com ↗
The study demonstrated that NT-I7 induces the formation of tertiary lymphoid structures (TLS)—organized immune cell aggregates within tumors—thereby creating an immune-reactive tumor microenvironment. |
| 2026-02-20 | NeoImmuneTech | Results NeoImmuneTech-Enabled “Expand & Pull” Immunotherapy Strategy for Glioblastoma Published in Nature Communications neoimmunetech.com ↗
As a result, combination therapy significantly improved survival compared with monotherapy in immunotherapy-resistant glioblastoma animal models, with long-term survival observed in a subset of treated animals. |
| 2025-12-17 | NeoImmuneTech | Results NeoImmuneTech Highlights Potential to Overcome CAR-T Limitations at ASH 2025 NT-I7 Combination Enhances Both CAR-T Expansion and Persistence neoimmunetech.com ↗
Early clinical data indicate that NT-I7 may increase CAR-T expansion; the CD19 CAR-T, NT-I7 combination trial was presented in an oral session |
| 2025-11-25 | NeoImmuneTech | Results NeoImmuneTech Confirms NT-I7’s New Mechanism in Tumor Microenvironment Remodeling — Renewed Spotlight on Long-Term Potential in Combination Immunotherapy neoimmunetech.com ↗
According to the study, NT-I7 demonstrated the potential to reprogram the tumor immune microenvironment and induce durable anti-tumor immune responses. |
| 2025-11-20 | NeoImmuneTech | Regulatory NeoImmuneTech Announces FDA IND Clearance for NIT-128, a Combination Trial of NT-I7 with BCMA CAR-T Therapy in Multiple Myeloma neoimmunetech.com ↗
FDA clears IND for investigator-initiated study combining NT-I7 with CARVYKTI® in patients with multiple myeloma |
| 2025-11-06 | NeoImmuneTech | Results NeoImmuneTech announces new insights into IL-7’s anti-tumor mechanism from Cancer-Immunity Cycle Cell Symposia neoimmunetech.com ↗
The findings, which were presented at the prestigious Cancer–Immunity Cycle Cell Symposia, a global life sciences conference hosted by scientific publisher Cell Press, showed that IL-7 (NT-I7) enhances anti-tumor CD8 T cell responses. |
| 2025-11-04 | NeoImmuneTech | Results NeoImmuneTech announces two NT-I7-based combination studies with CAR-T therapy have been accepted for presentation at ASH 2025 neoimmunetech.com ↗
The clinical data demonstrate that NT-I7 may enhance immune cell recovery and prolong anti-tumor activity following CAR-T treatment, addressing current challenges in durability of response. |
| 2025-10-31 | NeoImmuneTech | Regulatory NeoImmuneTech Announces U.S. FDA IND Submission for Combination Trial of NT-I7 with BCMA CAR-T Therapy Led by Washington University of Medicine in St. Louis— Expanding Its CAR-T Combination Strategy neoimmunetech.com ↗ |
| 2025-08-12 | NeoImmuneTech | Regulatory NeoImmuneTech Announces FDA IND Clearance by Investigator for Repeat-Dosing Trial of NT-I7 post CAR-T Therapy neoimmunetech.com ↗
NeoImmuneTech, Inc. (NIT or “NeoImmuneTech”), a T cell-focused immunotherapy company, today announced that the U.S Food and Drug Administration (FDA) has granted Investigational New Drug (IND) clearance for a follow-up clinical trial evaluating the repeat dosing of its T cell amplifier NT-I7 (efineptakin alfa) in combination with CAR-T therapy. |
| 2025-04-25 | NeoImmuneTech | Results NeoImmuneTech to Present Preclinical Data on NT-I7’ s Immune Recovery and Antitumor Synergy at AACR 2025 neoimmunetech.com ↗
In HNSCC tumor-bearing mouse models, NT-I7 significantly restored the reduced populations of CD4+, CD8+ T cells, and NKT cells, without affecting tumor-infiltrating regulatory T cells (Tregs). |
| 2024-12-07 | NeoImmuneTech | Results New Results Presented at ASH 2024: NeoImmuneTech's NT-I7 Demonstrates Promising T cell Reconstitution Following Radiation Injury neoimmunetech.com ↗
The results showed that NT-I7 induces rapid peripheral and systemic T cell recovery following total body irradiation involving both thymic-dependent and thymic-independent pathways. |
| 2024-06-03 | NeoImmuneTech | Results NeoImmuneTech’s New Data at ASCO 2024 Highlights Enhanced Benefits of Combining NT-I7 with Checkpoint Inhibitors in Immuno-Oncology neoimmunetech.com ↗
Results from study NIT-110 with NT-I7 and CPI combination treatment show median overall survival (mOS) improvements over standard of care treatment in pancreatic cancer and MSS colorectal cancer |
| 2024-04-17 | NeoImmuneTech | Results NeoImmuneTech’s NT-I7 in Combination with Chemotherapy Shows Efficacy in Colorectal Cancer at AACR Meeting neoimmunetech.com ↗ |
| 2024-01-29 | NeoImmuneTech | Regulatory FDA Grants Orphan Drug Designation (ODD) Status to NeoImmuneTech’s NT-I7 for Advanced Pancreatic Cancer Treatment neoimmunetech.com ↗
NeoImmuneTech, Inc. (NIT), a T cell-focused therapeutics company, today announced that the U.S. Food and Drug Administration (FDA) has granted NT-I7 (efineptakin alfa) (rhIL-7-hyFc) Orphan Drug Designation (ODD) for the treatment of pancreatic cancer. |
| 2024-01-28 | NeoImmuneTech | Regulatory Phase II Study Expansion Investigating NeoimmuneTech’s NT-I7 in Head and Neck Cancer neoimmunetech.com ↗
NeoImmuneTech, Inc. (NIT or “NeoImmuneTech”), a clinical-stage T cell-focused biopharmaceutical company, today announced the approval of additional cohorts in the Phase 2 study in head and neck cancer by the Korean Ministry of Food and Drug Safety (MFDS) |
| 2023-11-19 | NeoImmuneTech | Regulatory FDA Grants Orphan Drug Designation to NeoImmuneTech’s NT-I7 for the Treatment of Acute Radiation Syndrome neoimmunetech.com ↗
NeoImmuneTech, Inc. (NIT or “NeoImmuneTech”), a clinical-stage T cell-focused biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for their investigational drug NT-I7 (efineptakin alfa) (rhIL-7-hyFc) for the treatment of Acute Radiation Syndrome (ARS). |
| 2022-11-13 | NeoImmuneTech | Results New evidence of NeoImmuneTech’s NT-I7 clinical efficacy in combination with pembrolizumab in relapsed/refractory (r/r) gastrointestinal tumors neoimmunetech.com ↗
Results showed the clinical efficacy of NT-I7 (efineptakin alfa) when combined with pembrolizumab in checkpoint-inhibitor-naïve microsatellite stable colorectal cancer (CPI-naïve MSS-CRC) and pancreatic cancer (CPI-naïve PaC). |
| 2022-11-03 | NeoImmuneTech | Results NeoImmuneTech to Present First Data on NT-I7 (efineptakin alfa) in Combination with CAR-T tisagenlecleucel, at 2022 ASH Annual Meeting neoimmunetech.com ↗
Early preliminary results show NT-I7 treatment led to a sustained increase in absolute lymphocyte counts (ALC) and increased CAR-T cell absolute numbers in the peripheral blood |
| 2022-09-12 | NeoImmuneTech | Results NeoImmuneTech’s NT-I7 Creates a More Immunogenic Tumor Microenvironment when Associated with Pembrolizumab neoimmunetech.com ↗
New data presented in a poster at ESMO Congress 2022 suggest that the combination of NT-I7 and pembrolizumab induces infiltration of CD8 T cells into the tumor microenvironment in more than 80% of analyzed samples. |
| 2022-07-12 | NeoImmuneTech | Regulatory FDA Grants Orphan Drug Designation (ODD) Status to NeoImmuneTech’s NT-I7 for the treatment of Glioblastoma Multiforme neoimmunetech.com ↗
NeoImmuneTech, Inc. (NIT), a T cell-focused therapeutics company, today announced that the U.S. Food and Drug Administration (FDA) has granted NT-I7 (efineptakin alfa) (rhIL-7-hyFc) Orphan Drug Designation for the treatment of Glioblastoma Multiforme. |
| 2022-07-03 | NeoImmuneTech | Results Interest of Combining NeoImmuneTech’s Lead Asset NT-I7 (efineptakin alfa) with Pembrolizumab keeps Growing neoimmunetech.com ↗
In both cohorts, the clinical efficacy of combining NT-I7 with pembrolizumab is encouraging in those immunologically cold indications normally associated with complete lack of efficacy to checkpoint inhibitor (CPI) monotherapy. |
| 2022-06-15 | NeoImmuneTech | Results A Study in Nature Communications Reports that NeoImmuneTech's NT-I7 Enhances CAR-T Cell Expansion, Persistence and Anti-tumor Activity neoimmunetech.com ↗
NT-I7 enhanced the efficacy of CAR-T therapy against acute myeloid leukemia and B cell lymphoma, significantly prolonging survival in murine models. |
| 2022-06-06 | NeoImmuneTech | Results NeoImmuneTech’s Lead Asset NT-I7 (efineptakin alfa) Shows Preliminary Anticancer Activity in Combination with Check-Point Inhibitors neoimmunetech.com ↗
In the phase 2a study NIT-110, NT-I7 combined with pembrolizumab showed preliminary anticancer activity and a manageable toxicity profile in heavily pretreated patients with immunologically cold microsatellite stable tumors (MSS), colorectal cancers (CRC), and pancreatic ductal adenocarcinoma cancers (PDAC) not previously treated with CPIs, as well as in CPI-treated patients with triple negative breast cancers (TNBC), non-small cell lung cancers (NSCLC), and small-cell lung cancers (SCLC). |
| 2022-05-18 | NeoImmuneTech | Results NeoImmuneTech to Present at Immuno-Oncology Summit Europe 2022 neoimmunetech.com ↗
NT-I7, a long-acting IL-7, has shown promising early anti-tumor activity in MMS CRC or PaC when used in combination with pembrolizumab, |
| 2022-04-13 | NeoImmuneTech | Results NeoImmuneTech Demonstrates NT-I7’s Broad Combination Potential with Immune Checkpoint Inhibitors and Immunocytokine at AACR 2022 neoimmunetech.com ↗
Additionally, data from the second pre-clinical study showed that NT-I7 in combination with anti-TIGIT or anti-VEGF, enhanced the anti-tumor responses and this effect was further increased when NT-I7 was combined with anti-TIGIT and anti-PD-1 in triple combination. |
| 2022-01-23 | NeoImmuneTech | Results Preclinical Data on NT-I7 Published in Clinical Cancer Research neoimmunetech.com ↗
These data show that NT-I7, in combination with radiation therapy, significantly prolonged survival in two glioma models dependent on the NT-I7-driven increase of CD8 T cells. |
| 2021-11-21 | NeoImmuneTech | Results NeoImmuneTech Presents Phase 1 Study Data at Society for Neuro-Oncology Annual Meeting neoimmunetech.com ↗
The data show that NT-I7, a novel long-acting human IL-7, was well tolerated following chemoradiation in patients with high-grade gliomas (HGG), supporting continued evaluation in the Phase 2 portion of the study. |
| 2021-11-15 | NeoImmuneTech | Results NeoImmuneTech Presents Data in Three Posters at Society for Immunotherapy of Cancer Annual Meeting neoimmunetech.com ↗
The interim analysis of the phase 2 met the primary endpoint of overall response rate (ORR) in these cohorts. |
| 2021-07-25 | NeoImmuneTech | Regulatory NeoImmuneTech Receives U.S. FDA IND Clearance for Phase 1 Study of NT-I7 (efineptakin alfa) for the Treatment of Kaposi Sarcoma in Patients With or Without HIV Infection neoimmunetech.com ↗ |
| 2021-06-07 | NeoImmuneTech | Regulatory NeoImmuneTech Announces First Clinical Trial Application Authorization Received in the EU for its Phase 2 Study of NT-I7 (efineptakin alfa) and Opdivo® (nivolumab) neoimmunetech.com ↗ |
| 2021-06-07 | NeoImmuneTech | Results NeoImmuneTech Trial Data Presented at American Society of Clinical Oncology Annual Meeting neoimmunetech.com ↗
Encouraging efficacy signals were also noted with this therapeutic regimen, including significant increase in T cell counts in both the tumor microenvironment and peripheral blood, indicating strong pharmacodynamic effects. |
| 2021-02-22 | NeoImmuneTech | Regulatory NeoImmuneTech Receives U.S. FDA IND Clearance for Pilot Study of NT-I7 (efineptakin alfa) in Progressive Multifocal Leukoencephalopathy neoimmunetech.com ↗ |
| 2020-11-15 | NeoImmuneTech | Regulatory NeoImmuneTech Receives U.S. FDA IND Clearance for Phase 2 Study of NT-I7 (efineptakin alfa) in combination with PD-L1 checkpoint inhibitor in First-line Non-small Cell Lung Cancer neoimmunetech.com ↗
This IND clearance allows NeoImmuneTech (NIT) to initiate a multicenter Phase 2 study evaluating the anti-tumor efficacy and safety of NT-I7 in combination with atezolizumab as a first-line (1L) treatment for NSCLC. |
| 2020-07-26 | NeoImmuneTech | Regulatory NeoImmuneTech Announces Receipt of IND Clearance to Conduct Window-of-Opportunity Trial of NT-I7 (efineptakin alfa) in Patients with Locally Recurrent Squamous Cell Carcinoma of Head and Neck neoimmunetech.com ↗
today announced receipt of IND clearance from the US Federal Drug Administration (FDA) |
| 2020-07-19 | NeoImmuneTech | Regulatory NeoImmuneTech Receives U.S. FDA Clearance of IND Application for Phase 2 Study of NT-I7 (efineptakin alfa) and Opdivo® (nivolumab) neoimmunetech.com ↗
NeoImmuneTech, Inc. , a clinical-stage T cell-focused biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for the combination of NeoImmuneTech’s NT-I7 (efineptakin alfa), a novel long-acting human interleukin-7 (IL-7), and Bristol Myers Squibb’s Opdivo® (nivolumab), a PD-1 blocking antibody, for the treatment of patients with advanced or metastatic gastric, gastro-esophageal junction (GEJ), or esophageal adenocarcinoma (EAC). |
| 2020-07-14 | NeoImmuneTech | Regulatory NeoImmuneTech Announces Clearance for Investigational New Drug Application of NT-I7 (efineptakin alfa) in Adults with Mild COVID-19 neoimmunetech.com ↗ |
| 2020-06-14 | NeoImmuneTech | Regulatory NeoImmuneTech Receives FDA Orphan Drug Designation for NT-I7 (efineptakin alfa) for the Treatment of Progressive Multifocal Leukoencephalopathy neoimmunetech.com ↗
NeoImmuneTech, Inc. , a clinical-stage T cell-focused biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to NeoImmuneTech’s NT-I7 (efineptakin alfa), the only clinical-stage long-acting human IL-7, for the treatment of Progressive Multifocal Leukoencephalopathy (PML). |
| 2020-01-27 | NeoImmuneTech | Regulatory NeoImmuneTech Received U.S. FDA Clearance of IND Application for Phase 1b/2a Study of Hyleukin-7™ (NT-I7) and KEYTRUDA® (Pembrolizumab) in Relapsed/Refractory Advanced Solid Tumors neoimmunetech.com ↗
This IND clearance allows NeoImmuneTech to initiate a Phase 1b/2a basket study evaluating this combination in patients with both checkpoint inhibitor (CPI)-treated and CPI-naïve R/R advanced solid tumors. |
| 2019-05-23 | NeoImmuneTech | Regulatory NeoImmuneTech Announces that the FDA has Allowed the Center for Cancer Research, National Cancer Institute to Proceed with an Investigational New Drug Application to Initiate a Clinical Trial for Hyleukin-7™ with Vaccines in Elderly Cancer Survivors neoimmunetech.com ↗ |
| 2019-04-15 | NeoImmuneTech | Regulatory FDA Grants Orphan Drug Designation Status to NeoImmuneTech’s Hyleukin-7 for Idiopathic CD4+ Lymphocytopenia Treatment neoimmunetech.com ↗
April 16, 2019 — ROCKVILLE, Md.– (BUSINESS WIRE)–NeoImmuneTech, Inc. (NIT), a T cell-focused therapeutics company, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Hyleukin-7 TM , a T cell amplifier, in development for the treatment of Idiopathic CD4+ Lymphocytopenia (ICL). |
| 2019-04-02 | NeoImmuneTech | Results NeoImmuneTech, Genexine, SNUH and POSTECH researchers Announce Presentations at the American Association for Cancer Research (AACR) Annual Meeting 2019 neoimmunetech.com ↗
Hyleukin-7 administration was well-tolerated, exhibited dose-dependent increases in T cells, and significantly increased killer and memory T cells, which are crucial for effective anti-tumor response. |
| 2019-01-15 | NeoImmuneTech | Regulatory NeoImmuneTech Receives Authorization to Proceed from the FDA for IND Application to Evaluate Hyleukin-7 TM in Combination with a PD-L1 Inhibitor in Advanced High-Risk Skin Cancers neoimmunetech.com ↗ |
| 2018-12-02 | NeoImmuneTech | Results NeoImmuneTech Presents Hyleukin-7 TM and Universal CAR-T Combination Therapy Preclinical Data at ASH Annual Meeting neoimmunetech.com ↗
Hyleukin-7 TM was shown to dramatically enhance UCART proliferation, persistence and tumor killing in vivo, resulting in enhanced survival in both models. |
| 2018-10-28 | NeoImmuneTech | Regulatory NeoImmuneTech Announces Initiation of Clinical Trial for Hyleukin-7 TM Treatment in Combination with Standard Therapy for Newly Diagnosed Brain Cancer Patients neoimmunetech.com ↗
today announced the U.S. Food and Drug Administration (FDA) approved its Investigational New Drug (IND) application for a clinical trial for the treatment of newly diagnosed high grade glioma (HGG) patients with a combination of HYLEUKIN-7® and standard therapy. |
All press releases naming this drug 72 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Recombinant human IL-7-hyFc | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04054752 ↗ |
| Known as | NT-I7 | “Recombinant human IL-7-hyFc (NT-I7)” NCT04054752 ↗ |
| Modality | Protein / enzyme biologic | “a long acting IL-7 cytokine” NCT04054752 ↗ |
| Route | Intramuscular | “a single dose of NT-I7 will be delivered intramuscularly.” NCT04054752 ↗ |