NeoImmuneTech, Inc. (NIT), a leader in T cell-based immunotherapy, has presented promising Phase 1b clinical trial results for their treatment combining CAR-T therapy with
NT-I7 (efineptakin alfa) at the European Society for Medical Oncology (ESMO) conference in Barcelona, Spain. The trial, known as NIT-112, focuses on patients with
Large B-cell Lymphoma (LBCL) and aims to assess the safety, tolerability, and effectiveness of NT-I7 in enhancing CAR-T cell expansion and persistence.
The NIT-112 trial enrolled patients who had received CAR-T therapies, including
Kymriah,
Yescarta, or
Breyanzi, followed by NT-I7 administration 21 days post-CAR-T infusion. Early results demonstrate that NT-I7 can significantly amplify CAR-T cells, enhance their persistence, and increase T cell stemness, which is characterized by a higher frequency of T cells with a stem-cell memory (Tscm) phenotype.
The trial investigated various dose levels of NT-I7, with dose levels 4 and 5, considered mid-range, showing a stable safety profile. Importantly, there were no observed cases of high-risk side effects, such as
Cytokine Release Syndrome (CRS) or Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), which can be severe in CAR-T therapies. The side effects observed were mild and manageable, including injection site erythema and swelling, occurring in 54.5% of patients treated.
Furthermore, NT-I7 administration led to an impressive overall response rate (ORR) of 81.1%, with 7 out of 11 patients achieving a complete response (CR) and 2 achieving a partial response (PR). This is a significant improvement compared to the typical ORR of 52% seen with Kymriah in LBCL patients. These results suggest that NT-I7 can potentially enhance the efficacy of CAR-T therapies while maintaining a strong safety profile.
Dr. Luke Oh, President and CEO of NeoImmuneTech, expressed enthusiasm about the preliminary findings, emphasizing the potential of NT-I7 to amplify CAR-T cells and improve patient outcomes. The company is eager to advance the development of this combination therapy and is actively engaged in discussions with organizations performing preclinical studies involving NT-I7.
NT-I7, also known as efineptakin alfa, is the only long-acting human IL-7 currently in clinical development. It is being explored for its ability to amplify T cells and improve their functionality in various oncologic and immunologic conditions. Given its favorable pharmacokinetics and pharmacodynamics (PK/PD) and safety profiles, NT-I7 is considered an ideal candidate for combination with other immunotherapeutic treatments. Apart from solid tumors, NeoImmuneTech is planning additional studies to test NT-I7 in hematologic malignancies and other immunology-focused indications.
NeoImmuneTech, a clinical-stage biopharmaceutical company, is dedicated to advancing immuno-oncology and enhancing immune responses against infectious diseases. Backed by a robust executive team and led by the scientific founder and inventor of NT-I7, the company is rapidly expanding its operations and partnerships within the industry and academic sectors to explore NT-I7's potential both as a standalone treatment and in combination with other therapies.
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