NeoImmuneTech, Inc., a clinical-stage T cell-focused biopharmaceutical company, today announced the first patient has been dosed in a Phase 2 study of NT-I7 (efineptakin alfa), a novel long-acting human interleukin-7 (IL-7), in combination with Bristol Myers Squibb’s Opdivo® (nivolumab), a PD-1 blocking antibody, versus nivolumab monotherapy. 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 (GEJ), or esophageal adenocarcinoma, and to establish safety and tolerability of the combination in these patients.
“We are thrilled to have dosed the first patient in this trial and to be evaluating a potential new treatment option for these cancers, especially given the current limited treatment options these patients have,” said NgocDiep Le, M.D., Ph.D., Executive VP and Chief Medical Officer of NeoImmuneTech. “NT-I7’s ability to amplify T cells and excellent safety profile in cancer patients makes it an ideal candidate for a combination therapy with checkpoint inhibitors like nivolumab. It is our hope that this study will pave the way for a potential new treatment in a patient population where it is greatly needed.”
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.
More information on this trial can be found at www.clinicaltrials.gov, identifier: NCT04594811
Opdivo® is a registered trademark of Bristol Myers Squibb.
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. (NIT) 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. For more information, please visit www.neoimmunetech.com.