On November 4, 2022 NeoImmuneTech, Inc. (NIT or "NeoImmuneTech"), a clinical-stage T cell-focused biopharmaceutical company, reported it will present first data from the combination of its main asset, NT-I7 (efineptakin alfa), with the chimeric antigen receptor T-cell (CAR-T) tisagenlecleucel, at the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting, to be held in New Orleans, Louisiana, December 10-13, 2022 (Press release, NeoImmuneTech, NOV 4, 2022, View Source [SID1234623144]).

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The NIT-112 phase 1b study is the first and only clinical trial that aims to evaluate the safety, tolerability, and preliminary anti-tumor activity of a long-acting human IL-7, NT-I7 (efineptakin alfa), after treatment with tisagenlecleucel (Kymriah) in patients with relapsed/refractory large B-cell Lymphoma (r/r LBCL).

Tisagenlecleucel (Kymriah), a CD19-directed chimeric antigen receptor T-cell (CAR-T) therapy, has become standard of care for patients with r/r LBCL. The successful expansion and persistence of CAR-T cells strongly predicts response to this therapy. The scientific hypothesis is that the combination may increase expansion and persistence of CAR-T, increasing tumor response rate and improving clinical outcomes without safety concerns.

As of 30 May, 2022, only the first three dose escalation groups out of seven dose levels (DL1-7: 60, 120, 240, 360, 480, 600, and 720 μg/kg of NT-I7) had completed recruitment. No serious adverse events were observed. All patients experienced treatment-emergent adverse events, most of which were mild. Despite the limited number of patients currently enrolled in the lowest NT-I7 dose levels (DL1-3), and CAR-T levels being near the limit of assay detection, a single dose of NT-I7 at the CAR-T contraction phase (day 21) was able to increase both the absolute lymphocyte count (ALC) and the CAR-T absolute numbers.

Dr Se Hwan Yang, Ph.D., President and Chief Executive Officer of NeoImmuneTech, Inc. said: "The early results of the Phase 1b study NIT-112 are promising and may have strong clinical implications. We feel encouraged to further investigate NT-I7 in combination with tisagenlecleucel as a potential efficacious addition to CAR-T standard of care in relapsed/refractory large B-cell lymphoma".

About NT-I7 (efineptakin alfa) (rhIL-7-hyFc)
NT-I7 (efineptakin alfa) is the only clinical-stage long-acting human IL-7 and is being developed in oncologic and immunologic indications, where T cell amplification and increased functionality may provide clinical benefit. IL-7 is a fundamental cytokine for naïve and memory T cell development and 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 vaccine adjuvant. Studies are being planned for testing in hematologic malignancies, additional solid tumors and other immunology-focused indications.