ROCKVILLE, Md.–(BUSINESS WIRE)–NeoImmuneTech, Inc. (KOSDAQ: 950220), a clinical-stage T cell-focused biopharmaceutical company, today announced the first patient has been dosed in the Phase 2a portion of a Phase 1b/2a clinical trial evaluating NT-I7 (efineptakin alfa), a novel T cell amplifier, in combination with Merck’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) for the treatment of patients with relapsed/refractory advanced solid tumors.
The Phase 2a portion of this study 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 checkpoint inhibitor (CPI) for triple-negative breast cancer, non-small cell lung cancer, or small cell lung cancer, and CPI-naïve patients with microsatellite stable colorectal cancer or pancreatic cancer.
“We are excited to quickly advance to the Phase 2a portion of this important clinical trial to further evaluate this combination treatment in patients with a variety of advanced solid tumors,” said NgocDiep Le, M.D., Ph.D., Executive VP and Chief Medical Officer of NeoImmuneTech. “We have great confidence in the combination of NT-I7, as a T cell amplifier, with CPI therapies like KEYTRUDA to improve clinical outcomes and become a viable treatment option for many cancer patients, with either CPI-responsive or CPI-resistant tumors.”
The results of this study will be used to guide further clinical development of this combination in select tumor types.
More information on this trial can be found at www.clinicaltrials.gov, identifier: NCT04332653
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 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.