23 November 2021 - - US-based clinical-stage T cell-focused biopharmaceutical company NeoImmuneTech, Inc. (KOSDAQ: 950220) presented data from Phase 1 of an ongoing study at the Society for Neuro-Oncology annual meeting, the company said.

The data show that NT-I7, a novel long-acting human IL-7, was well tolerated following chemoradiation in patients with high-grade gliomas, 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 µg/kg. Despite the concomitant administration of chemotherapy (temozolomide, TMZ), the absolute lymphocyte count 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.

NT-I7 single agent preferentially expanded memory stem T cells, 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 naïve 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, 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.