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.
The statements contained herein may contain certain forward-looking statements relating to NeoImmuneTech, Inc. (the “Company”) that are based on its beliefs and expectations about the future. These forward-looking statements are based on a number of assumptions about the future, some of which are beyond the Company’s control and are not a guarantee of future performance or developments. Such forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from those contemplated by the relevant forward-looking statements. The Company does not undertake any obligation to update any forward-looking statements to reflect events that occur or circumstances that arise after the date of these documents. Accordingly, you should not place reliance on any forward-looking information or statements contained herein.
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