NeoImmuneTech, Inc. Presents Phase 1 Study Data at Society for Neuro-Oncology Annual Meeting
November 22, 2021 at 07:00 am EST
Share
NeoImmuneTech, Inc. presented data from Phase 1 of an ongoing study at the Society for Neuro-Oncology (SNO) annual meeting. The data show that NT-I7, a novel long-acting human IL-7, was well tolerated following chemoradiation in patients with high-grade gliomas (HGG), supporting continued evaluation in the Phase 2 portion of the study. The data were presented as an oral presentaion, titled ?A phase I/II study evaluating the safety and efficacy of a novel long-acting interleukin-7, NT-I7, for patients with newly diagnosed high-grade gliomas after chemoradiotherapy,? by lead author Jian Li Campian, M.D., Ph.D., of Mayo Clinic. The data show that NT-I7?s maximum tolerated dose in this cohort was 720 ?g/kg. Despite the concomitant administration of chemotherapy (temozolomide, TMZ), the absolute lymphocyte count (ALC) persistently increased 1.3?4.1 fold at week 4 after NT-I7 injection, suggesting that NT-I7 as a single agent could be an effective approach to counteract the treatment-related lymphopenia associated with shorter survival that is commonly observed in HGG patients after chemoradiation. The median progression-free survival for MGMTp unmethylated GBM was 11.6 months, compared to 5.3 months commonly reported in chemoradiation studies. Strikingly, NT-I7 single agent preferentially expanded memory stem T cells (Tscm), a self-renewing T cell subset that has shown better antitumor activity compared with other memory T cell subsets. Thus, although further studies are necessary to determine the clinical benefit, NT-I7 as a single agent added to neoadjuvant chemotherapy has shown encouraging efficacy signals in this aggressive indication. 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.
NeoImmuneTech, Inc. is a clinical-stage T cell-focused biopharmaceutical company. The Company is engaged in the discovery and development of immuno-therapeutics. Its lead asset includes NT-I7 (efineptakin alfa), which is a T Cell Amplifier. NT-I7 is a human IL-7 (Interleukin-7) fusion protein that overcomes the limitations of endogenous IL-7. The IL-7 domain promotes T cell development, which plays a role in the immune response. The N-terminus of the IL-7 domain overcomes its structural instability and enables mass production of NT-I7. NT-I7 is a clinical-stage long-acting human IL-7 and is being developed in oncologic and immunologic indications. It is conducting multiple clinical trials of NT-I7 in multiple indications both as a monotherapy and in combination with other therapeutics, such as checkpoint inhibitors and other. Its products include NIT-106, NIT-109, NIT-110, NIT-119, NIT-120, NIT-104, NIT-107, NIT-112, NIT-105, NIT-108, NIT-113, NIT-114, NIT-115, NIT-116 and NIT-A01.