ROCKVILLE, Md. – NeoImmuneTech, Inc., a clinical-stage T cell-focused biopharmaceutical company, today announced that the first patient has been dosed in the Phase 2 portion of a study evaluating NT-I7 (efineptakin alfa), a novel long-acting human IL-7, in patients with newly diagnosed, non-severe lymphopenic high grade glioma (HGG), following standard radiation therapy and temozolomide. The investigator-initiated trial is being conducted by neuro-oncologist Jian Li Campian, M.D., Ph.D., of Washington University School of Medicine in St. Louis.
The primary endpoint of the Phase 2 part of this study is to measure the effect of NT-I7 on absolute lymphocyte count (ALC) compared to placebo control.
“Standard radiation and chemotherapy can reduce the number and function of immune cells in HGG patients, so it is essential to investigate therapeutic options that can support the rejuvenation of T cells and combat lymphopenia in these patients,” said Dr. Campian, an Associate Professor of Medicine at Washington University. “Evidence suggests that NT-I7 can increase lymphocyte count and may stimulate the immune response, and we’ll be evaluating its potential for improving treatment outcomes for patients with HGG.”
“Current conventional therapy for HGG is insufficient, with only 25% of patients surviving more than 1 year, and new treatment options are in dire need,” added NgocDiep Le, M.D., Ph.D., Executive Vice President and Chief Medical Officer of NeoImmuneTech. “We are excited to see the potential utility of our unique T cell amplifier, NT-I7, in a larger patient group and look forward to evaluating its potential to enhance the standard of care and improve patient outcomes.”
About High Grade Gliomas
High grade gliomas (HGGs) indicate collectively the presence of grade 3 or 4 malignant tumors, which tend to grow rapidly and spread faster than tumors of a lower grade, in brain tissue. Standard therapy for HGGs such as glioblastoma includes both surgery and chemotherapy. The average survival rate is about 12 months, relatively shorter than other solid tumors. When glioblastoma patients are treated with standard radiation and chemotherapy, approximately 40% experience a severe reduction in their immune cells, especially T cells. Recent data suggest that the inferior survival rate in patients with glioblastoma is associated with very low T cell counts.
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 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 a 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.