NeoImmuneTech, Inc., a clinical-stage T cell-focused biopharmaceutical company, today announced 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®, a leading checkpoint inhibitor (CPI), for the treatment of patients with relapsed/refractory advanced solid tumors.
“We’re very pleased to further progress this critically important clinical program quickly, despite the challenges due to the COVID-19 pandemic. Dosing the first patient in this study marks a major milestone in the development of NT-I7 for the treatment of patients with advanced solid tumors,” said NgocDiep Le, M.D., Ph.D., Executive VP and Chief Medical Officer of NeoImmuneTech. “We will investigate clinically NT-I7’s potential to augment the already proven anti-tumor activity of pembrolizumab in CPI-responsive tumors. Additionally, we will also explore whether the combination can overcome CPI resistance. We hope that NT-I7 in combination with KEYTRUDA can improve the lives of cancer patients with various solid tumors.”
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.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., USA.
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 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.