Interleukin-7(Cytheris SA)

This regulatory milestone marks an acceleration of the process around NT-I7's potential first indication, after other recent positive news. NeoImmuneTech's NT-I7 has shown potential in nonclinical studies to address the immunosuppressive effects of ARS. ROCKVILLE, Md. , June 4, 2024 /PRNewswire/ -- NeoImmuneTech, Inc. (NIT or "NeoImmuneTech"), a clinical-stage T cell-focused biopharmaceutical company, today announced that the European Medicines Agency (EMA) has granted Orphan Drug Designation (ODD) to NT-I7 (efineptakin alfa) for the treatment of Acute Radiation Syndrome (ARS). This regulatory milestone follows the ODD granted to NT-I7 by the FDA in the US for the same indication in November 2023. It is the second ODD received by NT-I7 from the EMA, following the one granted in Idiopathic CD4+ Lymphocytopenia (ICL) in May 2017. ARS is a critical condition resulting from a high dose of radiation exposure, causing severe, sometimes fatal damage to the bone marrow and the immune system. Currently, there are no treatments available that effectively promote T cell recovery after such exposure. NT-I7, a novel long-acting human interleukin-7 (IL-7), has shown promise to accelerate T cell reconstitution and enhance the immune response, offering a potential solution for this medical unmet need. Clinical studies have shown that NT-I7 significantly boosts T cell counts, while maintaining a high level of safety and tolerability. NeoImmuneTech is actively developing NT-I7 in ARS through partnerships with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) and Duke University. Recently, Duke University secured a $6 million grant from NIAID for NT-I7 development in ARS. Luke Oh, Ph.D., President and Chief Executive Officer of NeoImmuneTech, said: "We are thrilled to see the deep interest of the scientific and regulatory community around the potential use of NT-I7 as a medical countermeasure in ARS. The EMA Orphan Drug Designation marks a new milestone for us, following our recent pre-IND discussions we had with the FDA to accelerate our development program. It is an important acknowledgment of the potential that NT-I7 holds in providing a beacon of hope for the treatment of ARS." ODD is a status assigned to a medicine intended for use against a rare disease or condition. The designation provides incentives to advance the development of treatments for rare diseases, including reduced fees for multiple steps in the development process, such as protocol assistance, marketing authorization applications, and inspections before authorization. About Acute Radiation Syndrome (ARS) Acute Radiation Syndrome (ARS) is an acute illness caused by irradiation of the entire body by a high dose of penetrating radiation in a very short period of time (typically a matter of minutes or less). Examples of people who suffered from ARS are individuals exposed during the Hiroshima and Nagasaki atomic bombings, and the firefighters that responded after the Chernobyl Nuclear Power Plant incident in 1986.[1] 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] SOURCE The NeoImmuneTech, Inc

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