NeoImmuneTech, Inc. (NIT), a clinical-stage T cell-focused biopharmaceutical company, today announced 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) annual meeting, to be held in New Orleans, Louisiana, December10-13, 2022.
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)andthe 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”.
