New evidence of NeoImmuneTech's NT-I7 clinical efficacy in combination with pembrolizumab in relapsed/refractory (r/r) gastrointestinal tumors

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

ROCKVILLE, Md., Nov. 11, 2022 /PRNewswire/ -- 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[1]^,[2], 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:

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.

Forward-looking Statements
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.

Some of the data contained in these documents were obtained from various external sources, and the Company has not independently verified such data. Accordingly, the Company makes no representations as to the accuracy or completeness of the data, and such data involves risks and uncertainties and is subject to change based on various factors.

[1] KEYNOTE-016. Le DT et al., PD-1 Blockade in Tumors with Mismatch-Repair Deficiency (2015) N Engl J Med

[2] O'Reilly et al., Durvalamab with or without Tremelimumab for patients with metastatic pancreatic ductal adenocarcinoma (2019) JAMA Oncol

SOURCE The NeoImmuneTech, Inc

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