- Overall Response Rate (ORR) of 30.8% and Disease Control Rate (DCR) of 69.2% in patients with checkpoint-inhibitor-naïve microsatellite stable colorectal cancer and pancreatic cancer in the absence of liver metastasis
NeoImmuneTech, Inc. (NIT or “NeoImmuneTech”), a clinical-stage T cell-focused biopharmaceutical company, today 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)1 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.
Dr. Se Hwan Yang, Ph.D., President and Chief Executive Officer of NeoImmuneTech said: “The results presented today at SITC are very encouraging for patients with relapsed/refractory gastrointestinal indications, whose tumors have not metastasized in liver, where treatment options are very limited. The combination of NT-I7 plus pembrolizumab drives CD8 T-cell infiltration, favoring a tumor microenvironment that contributes to the overall clinical efficacy observed in the study. This is associated with longer overall survival”.
NIT oral presentation at the 2022 SITC Annual Meeting:
CD8 T-cell infiltration in immune-excluded liver metastasis in MSS-Colorectal and Pancreatic cancer in patients treated with NT-I7 and pembrolizumab
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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 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.
The statements contained herein may contain certain forward-looking statements relating to NeoImmuneTech, Inc. (the “Company”) that are based on its beliefs and expectations about the future. These forward-looking statements are based on a number of assumptions about the future, some of which are beyond the Company’s control and are not a guarantee of future performance or developments. Such forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from those contemplated by the relevant forward-looking statements. The Company does not undertake any obligation to update any forward-looking statements to reflect events that occur or circumstances that arise after the date of these documents. Accordingly, you should not place reliance on any forward-looking information or statements contained herein.
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