NeoImmuneTech, Inc. presented new data from two on-going clinical studies at the American Society of Clinical Oncology Annual Meeting, 3-7 June 2022. The data, presented in poster discussion and poster display sessions, combine its lead asset NT-I7 (efineptakin alfa), a long-acting human IL-7, with check-point inhibitors pembrolizumab and atezolizumab, and showed that anti-cancer and safety results associated with NT-I7 were consistent with previously communicated results. In the phase 2a study NIT-11o, NT-I7 combined with pembrolizumab showed preliminary anticancer activity and a manageable toxicity profile in heavily pretreated patients with immunologically cold microsatellite stable tumors, colorectal cancers (CRC), and pancreatic ductal adenocarcinoma cancers not previously treated with CPIs, as well as in CPI-treated patients with triple negative breast cancers, non-small cell lung cancers, and small-cell lung cancers (SCLC).

CPIs are usually ineffective in patients with immunologically cold tumors, such as MSS-CRC or PDAC, and in patients progressing despite prior PD-1/PD-L1 inhibition. ORR for the MSS-CRC cohort was 11.1% with 40.7% DCR; and the PDAC cohort had an ORR of 7.7% with 34.6% DCR. Two patients out of 26 in the PDAC cohort showed significant target lesion reduction (- 100% and -72% respectively).

In all cohorts, including CPI-treated and CPI-naïve subjects, NT-I7 plus pembrolizumab led to an increase in change of mean absolute lymphocyte count from baseline. In the phase 1b/2a study NIT-106, the combination of NT-I7 with atezolizumab showed favorable safety and anticancer activity in CPI-relapsed/refractory high-risk skin cancer patients. The recommended phase 2 dose was determined so that phase 2a dose expansion is now enrolling.

The combination increased by 30-fold the stem-cell memory T cells (Tscm), which may be associated to better anti-tumor activity. 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.