The purpose of this study is to evaluate preliminary anti-tumor activity of NT-I7 and nivolumab, compared with nivolumab alone, in patients with previously treated advanced or metastatic gastric, gastro-esophageal junction, or esophageal adenocarcinoma, and to establish safety and tolerability of the combination in these patients.
The results of this Phase 2, randomized, proof-of-principle study will be used to further clinical development of this combination in selected clinical settings and tumor types.
NT-I7 (efineptakin alfa) is the only clinical-stage long-acting human IL-7, and is being developed in oncologic and immunologic indications, where T cell amplification and increased functionality may provide clinical benefit.
IL-7 is a fundamental cytokine for naïve and memory T cell development and for sustaining immune response to chronic antigens (as in cancer) or foreign antigens (as in infectious diseases). NT-I7 exhibits favorable PK/PD and safety profiles, making it an ideal combination partner.
NT-I7 is being studied in multiple clinical trials in solid tumors and as vaccine adjuvant. Studies are being planned for testing in hematologic malignancies, additional solid tumors and other immunology-focused indications.
NeoImmuneTech, Inc. is a clinical-stage T cell-focused biopharmaceutical company, dedicated to expanding the horizon of immuno-oncology and enhancing immunity to infectious diseases.
NIT is led by the scientific founder and inventor of NT-I7 (efineptakin alfa) and a strong executive team with rich industry experience at companies such as Novartis, BMS, GSK, Pfizer, Amgen, Eli Lilly, MedImmune/AstraZeneca and PwC.
NIT is expanding rapidly in personnel and operations, as well as partnering with industry and academic leaders to investigate NT-I7 as monotherapy and in combination with various immunotherapeutics.
Roivant to announce Q3 2026 financial results
Blacksmith Medicines granted European patent for LpxC-targeting antibacterial compounds
PharmaJet® and EVA Pharma Partner to Scale Needle-free Polio Immunisation Across Egypt
4basebio synthetic DNA used in Phase I/II mRNA therapy trial
Arcturus reports interim Phase 2 data for ARCT-032 in cystic fibrosis
Cumberland Pharmaceuticals adds FDA-approved oral capsule for H. pylori to commercial portfolio
Merck KGaA to acquire JSR Life Sciences chromatography business to expand Protein A capabilities
60 Degrees reports first patient has tested negative for babesiosis in tafenoquine study
INOVIO announces inducement grant to new employee
Hologic receives FDA clearance and CE mark for new gastrointestinal bacterial assays