NeoImmuneTech's Lead Asset NT-I7 (efineptakin alfa) Shows Preliminary Anticancer Activity in Combination with Check-Point Inhibitors

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Jun 06, 2022, 07:00 ET

- NT-I7 plus pembrolizumab showed anti-tumor activity in heavily pretreated patients for whom checkpoint inhibitors are usually ineffective

- NT-I7 and atezolizumab showed preliminary favorable safety and anticancer activity in relapsed/refractory high-risk skin cancer patients

ROCKVILLE, Md., June 6, 2022 /PRNewswire/ -- NeoImmuneTech, Inc. (NIT or "NeoImmuneTech"), a clinical-stage T cell-focused biopharmaceutical company, presented new data from two on-going clinical studies at the American Society of Clinical Oncology (ASCO) 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 (CPI) 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 (MSS), colorectal cancers (CRC), and pancreatic ductal adenocarcinoma cancers (PDAC) not previously treated with CPIs, as well as in CPI-treated patients with triple negative breast cancers (TNBC), non-small cell lung cancers (NSCLC), 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 (per iRECIST). 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 (RP2D) 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.

Dr. Se Hwan Yang, Ph.D., President and Chief Executive Officer of NeoImmuneTech said: "We are pleased to gather additional evidence of the efficacy and safety of NT-I7 in combination with check-point inhibitors. Encouraging preliminary results from study NIT-110 led us to expand patient recruitment in the MSS-CRC and PDAC cohorts in order to enhance statistical significance. While study NIT-110 is still on-going, we look forward to more mature data by Q4 2022 that could confirm the benefit of combining our T cell amplifier NT-I7 with a checkpoint inhibitor (CPI) in patients with immune-cold microsatellite stable colorectal cancer or pancreatic cancer and in those who progressed on previous CPI treatment."

As part of the ASCO 2022 poster program, a Trial-in-Progress poster was also presented on the design of Phase 1b study NIT-112, indicating progress of NT-I7 plus CAR-T development.

The links to the posters are as follows:

Primary Author	Poster Title	Poster link
Naing, A	Efficacy and Safety of NT-I7, Long-Acting Interleukin-7, plus Pembrolizumab in patients with advanced solid tumors: results from the Phase 2a study	Poster #170
Gastman, B	A phase 1b/2a study of safety and efficacy of NT-I7 in combination with anti-PD-L1 (atezolizumab) in patients with anti-PD-1/PD-L1 naïve or relapsed/refractory (R/R) high-risk skin cancers: The phase 1b report.	Poster #154
Ghobadi, A	Trial in Progress: A phase 1b study evaluating the safety, tolerability and preliminary anti-tumor activity of NT-I7 (efineptakin alfa), a long-acting human IL-7, post- tisagenlecleucel in subjects with relapsed/refractory large B-cell lymphoma	Poster #239b

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.

About NeoImmuneTech, Inc.

NeoImmuneTech, Inc. (NIT) is a clinical-stage T cell-focused biopharmaceutical company, dedicated 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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SOURCE The NeoImmuneTech, Inc