NEW YORK – NeoImmuneTech on Monday announced that the US Food and Drug Administration had accepted an investigational new drug application for the company's lead drug candidate, NT-I7, in combination with the CD19 CAR T-cell therapy tisagenlecleucel (Novartis' Kymriah) for patients with relapsed or refractory large B cell lymphoma.
Rockville, Maryland-based NeoImmuneTech will accordingly begin evaluating the safety, tolerability, and preliminary anti-tumor activity of the combination in a multicenter Phase I clinical trial.
NT-17 is a long-acting human interleukin-7 called efineptakin alfa. The agent, designed to promote T cell development for sustained immune response, is also being evaluated as a monotherapy and in combination with immune checkpoint inhibitors for multiple solid tumors and as a vaccine adjuvant. The company also plans to evaluate NT-17 for additional solid tumor types as well as hematologic malignancies and immunology-focused indications, including in a clinical trial for COVID-19, in which NT-17 will be assessed for its ability to increase lymphocyte counts and enhance immune clearance of SARS-CoV-2.
Within the large B cell lymphoma trial, patients will be treated with NT-17 following the standard-of-care tisagenlecleucel CAR T-cell therapy. In preclinical studies in animal models, adding NT-I7 to CAR T cells increased CAR T cell proliferation, persistence, and target-specific tumor killing, ultimately prolonging survival.
"This latest IND clearance marks another achievement for our robust clinical development program of NT-I7, which has multiple ongoing trials in both cancer and infectious diseases," NgocDiep Le, NeoImmuneTech's executive vice president and chief medical officer said in a statement. "As CAR T cell expansion is a strong predictor of response to CAR T-cell therapy, we believe that treatment with NT-I7 following Kymriah could potentially enhance the response rate and duration of response to Kymriah, and ultimately improve the clinical outcome for patients with relapsed or refractory large B cell lymphoma."