- Adequate cell expansion and persistence remains a key
challenge that limits the efficacy of chimeric antigen
receptor T (CAR-T) cell therapies
- New clinical results presented at ESMO 2024 show NT-I7
treatment following CAR-T cell administration is safe and well
tolerated and improves clinical outcomes through
successful expansion of CAR-T cells
ROCKVILLE, Md. ,
Sept. 9,
2024 /PRNewswire/ -- NeoImmuneTech, Inc. (NIT or
"NeoImmuneTech"), a global leader in T cell-based immunotherapy,
will present interim results of the Phase 1b clinical trial (NIT-112) combining a CAR-T
therapy with NT-I7 (efineptakin alfa) during the 'Mini oral
session 1: Haematological malignancies' at the European Society for
Medical Oncology (ESMO) in Barcelona,
Spain, from September 13 to
17. These initial results present a promising approach to
enhancing the potential of CAR-T therapies while maintaining a
stable safety profile.
The NIT-112 clinical trial involves patients with Large B-cell
Lymphoma (LBCL) who received CAR-T therapies such as Kymriah,
Yescarta, or Breyanzi, followed by NT-I7 administration 21 days
after CAR-T infusion. The trial aims to evaluate safety,
tolerability, the recommended Phase 2 dose (RP2D), and the
potential for NT-I7 to enhance CAR-T expansion, persistence and
stemness.
Interim results show that at dose levels 4 and 5, which are
considered mid-level doses (360, 480 µg/kg), NT-I7 demonstrated a
stable safety profile. No cases of Cytokine Release Syndrome
(CRS) or Immune Effector Cell-Associated Neurotoxicity Syndrome
(ICANS), which are known as high-risk side effects of CAR-T
therapies, were observed subsequent to NT-I7 administration. Only
mild, manageable side effects (Grade 1-2), such as injection site
erythema and swelling were observed in 6 out of 11 patients
(54.5%). Overall, a strong safety profile was observed.
NT-I7 administration resulted in significant amplification of
CAR-T cells, prolonged persistence and an increase in T cell
stemness, characterized by a higher frequency of T cells with a
stem-cell memory (Tscm) phenotype (CD45RA+CCR7+CD95+). The
overall response rate (ORR) from the interim results was 81.1% (9
out of 11 patients), with 7 achieving a complete response (CR) and
2 achieving a partial response (PR). Kymriah is known to have an
ORR of 52% in LBCL patients.
Dr Luke Oh, President and Chief
Executive Officer of NeoImmuneTech, Inc., said: "We are thrilled by
the preliminary results of study NIT-112 showing NT-I7's ability to
amplify CAR-T cells. This successful amplification of CAR-T cells
is expected to translate into improved patient outcomes. NIT plans
to actively pursue technology transfer related to the combination
of NT-I7 with CAR-T therapies and we look forward to accelerating
our discussions with the organizations already conducting
preclinical studies combining NT-I7 with our own CAR-T
technologies."
Title: Phase 1b study
of NT-I7 (efineptakin alfa), a long-acting IL-7, post-CD19-directed
CAR T cell therapy in diffuse large B-cell lymphoma (DLBCL)
Presentation Number: 806MO
Speakers: Armin Ghobadi
(St. Louis, United States of America)
Lecture Time: 15:05 – 15:10 (Fri, 2024. 09. 13)
Session Name: Mini oral session 1: Hematological
malignancies (ID 31)
Room: Toledo Auditorium – Hall 3
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 companydedicated 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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"Company") that are based on its beliefs and expectations about the
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events that occur or circumstances that arise after the date of
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based on various factors.
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SOURCE The NeoImmuneTech, Inc