Benzinga | Jun 8, 2021 07:12AM EDT

NeoImmuneTech Announces First Clinical Trial Application Authorization Received in the EU for its Phase 2 Study of NT-I7 and Opdivo

NeoImmuneTech, Inc., a clinical-stage T cell-focused biopharmaceutical company, today 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 (NYSE:BMY) Opdivo(r) (nivolumab), a PD-1 blocking antibody, versus nivolumab monotherapy.

"We are excited to expand our investigation of NT-I7 as a potential therapeutic for cancers and other immune-mediated illnesses into the EU," said NgocDiep Le, M.D., Ph.D., Executive VP and Chief Medical Officer of NeoImmuneTech. "This authorization marks a significant milestone for the development of NT-I7 and provides the opportunity to include additional patients in this study whose treatment outcomes may be improved with the use of NT-I7."

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. More information on this trial can be found at www.clinicaltrials.gov, identifier: NCT04594811

Opdivo(r) is a registered trademark of Bristol Myers Squibb.

About NT-I7

NT-I7 (efineptakin alfa) is the only clinical-stage long-acting human IL-7, and is being developed for oncologic and immunologic indications, in which T cell amplification and enhanced functionality may provide clinical benefit. IL-7 is a fundamental cytokine for na?ve and memory T cell development and for sustaining immune response to chronic antigens (as in cancer) or foreign antigens (as in infectious diseases). In clinical trials to date, NT-I7 has exhibited favorable PK/PD and safety profiles, both as a monotherapy and in combination with other anticancer treatments. NT-I7 is being studied in multiple clinical trials in solid tumors and as a vaccine adjuvant. Studies are being planned for testing in hematologic malignancies, additional solid tumors and other immunology-focused indications.

About NeoImmuneTech

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 complemented by 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.