- New subset data from 2 cohorts of study NIT-110 confirm anti-tumor activity in heavily pretreated patients for whom checkpoint inhibitors are usually ineffective
NeoImmuneTech, Inc. (NIT or “NeoImmuneTech”), a clinical-stage T cell-focused biopharmaceutical company, presented new subset data from the on‑going clinical study NIT-110 at the European Society of Medical Oncology World Congress on Gastrointestinal Cancer (ESMO GI), Barcelona, Spain, 29 June – 2 July 2022.
In the continuity of the ASCO 2022 congress where preliminary results of NIT-110 were presented, the 2 posters presented at ESMO-GI highlight subset data from the immunologically cold microsatellite stable tumors colorectal cancers (MSS-CRC) cohort, and from the pancreatic ductal adenocarcinoma cancers (PDAC) cohort.
In 27 patients of the MSS-CRC cohort (poster #152), the combination of NT-I7 and pembrolizumab was well-tolerated and achieved an overall response rate (ORR) of 11.1% and a disease control rate (DCR) of 40.7% per iRECIST, with a duration of response (DOR) of 6.7 months.
In 26 patients of the PDAC cohort (poster #139), the combination of NT-I7 and pembrolizumab was also well-tolerated and achieved an ORR of 7.7% and a DCR of 34.6% per iRECIST, with a duration of response (DOR) of 7.2 months. The median progression-free survival (mPFS) tended to be significantly higher in subjects with one or less liver lesions (18 weeks vs 6.0 weeks), with an iDCR of 63.6% vs 13.3%.
In both cohorts, the clinical efficacy of combining NT-I7 with pembrolizumab is encouraging in those immunologically cold indications normally associated with complete lack of efficacy to checkpoint inhibitor (CPI) monotherapy.1, 2 As a reminder, both MSS-CRC and PDAC cohorts have recently been expanded with the planned recruitment of 25 additional patients for each to obtain additional safety and efficacy data.
Dr. Se Hwan Yang, Ph.D., President and Chief Executive Officer of NeoImmuneTech said: “Congress after congress, we continue to gather clinical evidence that combining NT-I7 with a check-point inhibitor like pembrolizumab can lead to enhanced anti-tumor activity in immunologically cold indications such as MSS-CRC and PDAC. We feel encouraged to continue to accelerate the broad development of NT-I7 as a unique T cell amplifier.”
The links to the posters are as follows:
Phase 2a Study of NT-I7, a Long-Acting Interleukin-7, plus Pembrolizumab: Cohort of Subjects with Checkpoint Inhibitor-Naïve Advanced MSS-Colorectal Cancer
Phase 2a Study of NT-I7, a Long-Acting Interleukin-7, plus Pembrolizumab: Cohort of Subjects with Checkpoint Inhibitor-Naïve Advanced Pancreatic Cancer
1 Le, D.T. et al. (2015) N Engl J Med. 372(26):2509-20
2 Miyazawa, M. et al. (2021) J Hepatobiliary Pancreatic Sci. 28(5):419-430
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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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