NeoImmuneTech, Inc. Announces First Clinical Trial Application Authorization Received in the EU for its Phase 2 Study of NT-I7 (efineptakin alfa) and Opdivo®
June 08, 2021 at 04:30 pm IST
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NeoImmuneTech, Inc. announced the first Clinical Trial Application (CTA) authorization in the European Union (EU). This authorization comes from Italy’s Agenzia Italiana Del Farmaco (AIFA) for the company’s ongoing Phase 2 study of NT-I7 (efineptakin alfa), a novel long-acting human interleukin-7 (IL-7), in combination with Bristol-Myers Squibb Company’s Opdivo® (nivolumab), a PD-1 blocking antibody, versus nivolumab monotherapy. This ongoing Phase 2, randomized, proof-of-principle 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 or gastro-esophageal junction (GEJ) cancer, or esophageal adenocarcinoma, and to assess safety and tolerability of the combination in these patients. AIFA’s CTA authorization is for the phase 2 part of the study, upon successful completion of the dose escalation phase. The results of this study will be used to further clinical development of this combination in selected clinical settings and tumor types.
NeoImmuneTech, Inc. is a clinical-stage T cell-focused biopharmaceutical company. The Company is engaged in the discovery and development of immuno-therapeutics. Its lead asset includes NT-I7 (efineptakin alfa), which is a T Cell Amplifier. NT-I7 is a human IL-7 (Interleukin-7) fusion protein that overcomes the limitations of endogenous IL-7. The IL-7 domain promotes T cell development, which plays a role in the immune response. The N-terminus of the IL-7 domain overcomes its structural instability and enables mass production of NT-I7. NT-I7 is a clinical-stage long-acting human IL-7 and is being developed in oncologic and immunologic indications. It is conducting multiple clinical trials of NT-I7 in multiple indications both as a monotherapy and in combination with other therapeutics, such as checkpoint inhibitors and other. Its products include NIT-106, NIT-109, NIT-110, NIT-119, NIT-120, NIT-104, NIT-107, NIT-112, NIT-105, NIT-108, NIT-113, NIT-114, NIT-115, NIT-116 and NIT-A01.
NeoImmuneTech, Inc. Announces First Clinical Trial Application Authorization Received in the EU for its Phase 2 Study of NT-I7 (efineptakin alfa) and Opdivo®