- Early preliminary results show NT-I7 treatment led to a sustained increase in absolute lymphocyte counts (ALC) and increased CAR-T cell absolute numbers in the peripheral blood
NeoImmuneTech, Inc. (NIT or “NeoImmuneTech”), 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, December 10-13, 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) 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”.
|Primary Author||Abstract Title||Presentation Details|
|Ghobadi, A||A Phase 1b Dose Expansion Study Evaluating Safety, Preliminary Anti-Tumor Activity, and Accelerated T Cell Reconstitution with NT-I7 (Efineptakin Alfa), a Long-Acting Human IL-7, Administered Following tisagenlecleucel in Subjects with Relapsed/Refractory Large B-Cell Lymphoma||
- Abstract #4655
- Session: 704. Cellular Immunotherapies: Early Phase and Investigational Therapies: Poster III
- Date: Monday, December 12, 2022
- Time: 6:00 PM - 8:00 PM
- Location: Ernest N. Morial Convention Center, Hall D
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.
About NeoImmuneTech, Inc.
NeoImmuneTech, Inc. (NIT) 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 has a strong executive team with rich industry experience. 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. For more information, please visit www.neoimmunetech.com.
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