NeoImmuneTech, Inc. presented new data from its phase 2a clinical study NIT-110, at the Society for Immunotherapy of Cancer (SITC) 2022 annual meeting. Results showed the clinical efficacy of NT-I7 (efineptakin alfa) when combined with pembrolizumab in checkpoint-inhibitor-naïve microsatellite stable colorectal cancer (CPI-naïve MSS-CRC) and pancreatic cancer (CPI-naïve PaC). The oral presentation from Dr. A. Naing (University of Texas MD Anderson Cancer Center) has been focused on the follow-up of two cohorts of patients with relapsed/refractory (r/r) gastrointestinal indications: 25 patients with CPI-naïve MSS-CRC and 25 patients with CPI-naïve PaC.

The presentation highlighted results of patients who did not have liver metastasis, which is usually associated with a worse prognosis and is known to be a predictable marker. While historically anti-PD(L) monotherapies have shown no response in these indications, results presented at SITC showed an ORR of 30.8% and a DCR of 69.2% per iRECIST across the groups in patients without liver metastasis (n=13/50). Among the patients without liver metastasis, the probability of survival rate through 60 weeks was 100%, which is significantly higher than in those with liver metastasis.

However, in patients with liver metastasis, the combination of NT-I7 plus pembrolizumab also showed clinical benefit. One patient had a partial response with 46% tumor reduction (per iRECIST) even though the patient had 3 liver lesions at baseline. Immunohistochemistry (IHC) staining confirmed that the combination of NT-I7 plus pembrolizumab boosts CD8+ T cell infiltration in patients regardless of liver metastasis.

Data also suggested that increased CD8+ T cell infiltration correlates with higher OS and favors a tumor microenvironment that contributes to the overall high DCR observed in these hard-to-treat CPI-resistant indications. 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.