Interleukin-7(Cytheris SA)

Results from study NIT-110 with NT-I7 and CPI combination treatment show median overall survival (mOS) improvements over standard of care treatment in pancreatic cancer and MSS colorectal cancer Correlative analysis identified potentially predictive protein biomarkers associated with patients experiencing the most clinical benefits from combination treatment of NT-I7 and CPI Combination of NT-I7 and oncolytic virus demonstrates clear survival improvement in preclinical glioblastoma results ROCKVILLE, Md., June 3, 2024 /PRNewswire/ -- NeoImmuneTech, Inc. (NIT), a T cell-focused therapeutics company, today announced promising interim results of its major clinical trial NIT-110 of NT-I7 (efineptakin alfa), at the 2024 American Society of Clinical Oncology (ASCO) global meeting held in Chicago, from May 31 to June 4. The company also presented two additional posters at the conference. NIT-110 is a foundational clinical trial for NT-I7 that aims to confirm the safety and efficacy of combining NT-I7 with pembrolizumab (Keytruda®) in solid tumors. The data presented at ASCO 2024 confirmed that the combination is safe and well-tolerated. Key findings from NIT-110 include: Pancreatic cancer - Data showed a median overall survival (mOS) of 11.1 months among the 48 pancreatic cancer patients included in the study. The mOS for pancreatic cancer patients who have received a second-line standard of care treatment is currently known to be 6.1 months[1]. This mOS improvement is particularly noteworthy considering that 93.75% of the patients are receiving the combination treatment as third-line or beyond. MSS colorectal cancer -The mOS for the 50 microsatellite-stable (MSS) colorectal cancer patients was 13.2 months. The mOS for the current standard of care treatment is 10.8 months[2]. These results underscore the improved efficacy of the NT-I7 and Keytruda combination over existing standard of care treatments. A separate poster from trial NIT-110 revealed a correlative analysis identifying a potentially predictive biomarker. These biomarkers may help identify patient populations more likely to benefit clinically from the NT-I7 and Keytruda combination. NeoImmuneTech is committed to further biomarker validation to enhance clinical outcomes. Additionally, a preclinical study presented at ASCO 2024 highlighted the combination of NT-I7 with an oncolytic virus (ZIKV) in a glioblastoma animal model. Results demonstrated a significant increase in tumor specific CD8 T cells in the tumor microenvironment, leading to improved survival rates. Furthermore, 80% of cases in the experimental group combining NT-I7 with immune checkpoint inhibitors resulted in complete tumor eradication. NT-I7 continues to show clinical benefits driven by T cell amplification when combined with immune therapies. NeoImmuneTech's CEO, Luke Oh, PhD, said: "We are very encouraged by the improved clinical efficacy over standard of care in pancreatic and colorectal cancer, a notoriously difficult to treat cancer. These findings confirm our promising preclinical data and open new pathways to further enhance clinical outcomes. We are actively discussing the next steps with Merck. The results presented at ASCO 2024 confirm our strategy to continue to develop NT-I7 in the larger and high-potential immuno-oncology market." Posters references: About Study NIT-110 NIT-110 is an open label Phase 2a clinical trial supported by Merck that aims to confirm the efficacy of combining NT-I7 with Keytruda in two solid tumors. Early results in 2022 had confirmed the efficacy of the combination in pancreatic cancer and MSS colorectal cancer patients, who are known to be unresponsive to immune checkpoint inhibitors alone. Consequently, 24 and 25 additional patients were recruited for each group, respectively, bringing the total to 48 pancreatic cancer patients and 50 MSS colorectal cancer patients currently undergoing clinical trials. Results presented at ASCO 2024 provide an updated analysis including the original and expansion cohorts. 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 . 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] Wang-Gillam et al. Lancet. 2016. doi:10.1016/S0140-6736(15)00986-1 [2] Prager et al. N Engl J Med. 2023. doi:10.1056/NEJMoa221496 SOURCE The NeoImmuneTech, Inc

NT-I7 maintains cancer-specific T-cell amplifying efficacy when combined with standard of care colorectal cancer therapy FOLFOX® Study indicates interest for potential combination therapy with chemotherapeutic agents. ROCKVILLE, Md., April 9, 2024 /PRNewswire/ -- NeoImmuneTech, Inc. (NIT), a global leader in T-cell-based immunotherapy, today presented a poster on a pre-clinical study that opens a new field of potential applications for NT-I7 (efineptakin alfa). The poster was presented at the 2024 American Association for Cancer Research (AACR) Annual Meeting (April 5-10, 2024, San Diego, CA). The study explored the efficacy of NT-I7 (efineptakin alfa) in combination with FOLFOX® (a combination of 5-fluorouracil, leucovorin, and oxaliplatin), a first-line standard of care (SoC) for colorectal cancer, in an animal model of colorectal cancer (MC38, C57BL/6 mice). The study's findings suggest a significant improvement in treatment outcomes when NT-I7 is used alongside FOLFOX®, demonstrating a 69% reduction in tumor size compared to the administration of FOLFOX® alone. While the overall Absolute Lymphocyte Count (ALC) in the blood was reduced by FOLFOX® treatment, the number of anti-cancer specific T cells in the tumor was significantly increased in the combination group compared to FOLFOX® alone. Dr. Luke Oh, President and CEO of NeoImmuneTech said: "We are very excited by results that shows NT-I7 might be effective in combination with cytotoxic chemotherapeutic agents. As chemotherapeutic agents are still the standard of care for most early-stage cancer indications, combining NT-I7 with various chemotherapeutic agents might bring new hope to patients in situations where immuno-oncology is not used." About Colorectal Cancer Colorectal cancer is the third most commonly diagnosed cancer and the second most common cause of cancer-related death worldwide. It often begins with growths on the inner lining of the colon or rectum called polyps, which can change into cancer over time. Colorectal cancer affects more than 150,000 people in the US and 1.8 million people worldwide each year. Despite progress in treatment in the last decade, the 5-year survival rate is still only 63% overall and a meager 13% for patients with metastatic disease. 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. NIT is led by a strong executive team and talented members with rich industry experience. NIT is expanding rapidly in its 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 . 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. SOURCE The NeoImmuneTech, Inc