On June 3, 2024 NeoImmuneTech, Inc. (NIT), a T cell-focused therapeutics company, reported promising interim results of its major clinical trial NIT-110 of NT-I7 (efineptakin alfa), at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) global meeting held in Chicago, from May 31 to June 4 (Press release, NeoImmuneTech, JUN 3, 2024, View Source [SID1234644047]). The company also presented two additional posters at the conference.

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NIT-110 is a foundational clinical trial for NT-I7 that aims to confirm the safety and efficacy of combining NT-I7 with pembrolizumab (Keytruda) in solid tumors. The data presented at ASCO (Free ASCO Whitepaper) 2024 confirmed that the combination is safe and well-tolerated.

Key findings from NIT-110 include:

Pancreatic cancer – Data showed a median overall survival (mOS) of 11.1 months among the 48 pancreatic cancer patients included in the study. The mOS for pancreatic cancer patients who have received a second-line standard of care treatment is currently known to be 6.1 months[1]. This mOS improvement is particularly noteworthy considering that 93.75% of the patients are receiving the combination treatment as third-line or beyond.
MSS colorectal cancer -The mOS for the 50 microsatellite-stable (MSS) colorectal cancer patients was 13.2 months. The mOS for the current standard of care treatment is 10.8 months[2].
These results underscore the improved efficacy of the NT-I7 and Keytruda combination over existing standard of care treatments.

A separate poster from trial NIT-110 revealed a correlative analysis identifying a potentially predictive biomarker. These biomarkers may help identify patient populations more likely to benefit clinically from the NT-I7 and Keytruda combination. NeoImmuneTech is committed to further biomarker validation to enhance clinical outcomes.

Additionally, a preclinical study presented at ASCO (Free ASCO Whitepaper) 2024 highlighted the combination of NT-I7 with an oncolytic virus (ZIKV) in a glioblastoma animal model. Results demonstrated a significant increase in tumor specific CD8 T cells in the tumor microenvironment, leading to improved survival rates. Furthermore, 80% of cases in the experimental group combining NT-I7 with immune checkpoint inhibitors resulted in complete tumor eradication. NT-I7 continues to show clinical benefits driven by T cell amplification when combined with immune therapies.

NeoImmuneTech’s CEO, Luke Oh, PhD, said: "We are very encouraged by the improved clinical efficacy over standard of care in pancreatic and colorectal cancer, a notoriously difficult to treat cancer. These findings confirm our promising preclinical data and open new pathways to further enhance clinical outcomes. We are actively discussing the next steps with Merck. The results presented at ASCO (Free ASCO Whitepaper) 2024 confirm our strategy to continue to develop NT-I7 in the larger and high-potential immuno-oncology market."

Posters references:

Abstract #

Track

Poster board #

Title

2621 (Link)

Developmental Therapeutics -Immunotherapy

100

A Phase 2a study of NT-I7 (efineptakin alfa), a long-acting IL-7, and pembrolizumab to evaluate efficacy, including overall survival, in hard-to-treat MSS-CRC and PDAC gastrointestinal tumors

2563

(Link)

Developmental Therapeutics -Immunotherapy

42

Investigation of a potential protein biomarker signature that may predict clinical benefit of NT-I7 and pembrolizumab in patients with cold gastrointestinal tumors

2043

(Link)

Central Nervous System Tumors

342

Expand and pull: a new treatment paradigm for glioblastoma using a long-acting recombinant interleukin-7 and oncolytic viral therapy

About Study NIT-110
NIT-110 is an open label Phase 2a clinical trial supported by Merck that aims to confirm the efficacy of combining NT-I7 with Keytruda in two solid tumors. Early results in 2022 had confirmed the efficacy of the combination in pancreatic cancer and MSS colorectal cancer patients, who are known to be unresponsive to immune checkpoint inhibitors alone. Consequently, 24 and 25 additional patients were recruited for each group, respectively, bringing the total to 48 pancreatic cancer patients and 50 MSS colorectal cancer patients currently undergoing clinical trials. Results presented at ASCO (Free ASCO Whitepaper) 2024 provide an updated analysis including the original and expansion cohorts.

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 for 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.