On November 22, 2021 NeoImmuneTech, Inc. (KOSDAQ: 950220), a clinical-stage T cell-focused biopharmaceutical company, reported that data from Phase 1 of an ongoing study at the Society for Neuro-Oncology (SNO) annual meeting (Press release, NeoImmuneTech, NOV 22, 2021, View Source [SID1234595922]). 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.
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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 (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.
"We are pleased to report encouraging data on NT-I7 following chemotherapy in high-grade gliomas, which are aggressive and can have a severe impact on patients," said Se Hwan Yang, Ph.D., President and Chief Executive Officer of NeoImmuneTech. "NT-I7’s demonstrated ability to increase ALC and its high tolerability in this patient population supports continued investigation to further assess its potential to improve outcomes for patients living with this devastating disease."
About NT-I7
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.