25 June 2020 - - The first patient has been dosed at The University of Texas MD Anderson Cancer Center in the Phase 1b/2a clinical trial of NT-I7 (efineptakin alfa) in combination with Keytruda, US-based Merck's (NYSE: MRK) checkpoint inhibitor, for the treatment of patients with relapsed/refractory advanced solid tumors, US-based clinical-stage T cell-focused biopharmaceutical company NeoImmuneTech, Inc said.

The goal of the Phase 1b portion of the study, which will enroll up to 18 patients, is to establish a recommended dosing regimen.

The Phase 2a portion will enroll up to 150 patients and will explore the preliminary anti-tumor activity of the combination therapy both in patients who have been treated with a CPI and patients who are CPI-naïve.

The results of this study will be used to guide further clinical development of this combination in select 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).

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.