An Open-Label, Single-Arm, Phase 1/2 Dose-Escalation Trial of Long-Acting Recombinant Human IL-7 (NT-I7, Efineptakin-Alpha) for Idiopathic CD4 Lymphopenia

Background:
Idiopathic CD4 lymphopenia (ICL) is a syndrome characterized by low levels of certain immune cells called CD4 T cells. The low CD4 T cells renders people with ICL prone to many types of severe infections, autoimmune diseases, and cancers. Although these infections and diseases can be treated whenever occur, there is currently no treatment that targeting the underlying deficiency of CD4 T cells can provide a definitive treatment for people with ICL.
Objective:
To test a new drug (NT-17) in people with ICL which can increase the number of CD4 T cells
Eligibility:
People aged 18 to 75 years with ICL who are also enrolled in NIH protocol 09-I-0102.
Design:
Participants will be screened. They will have a physical exam and blood tests. Some participants with high suspicion of central nervous system infection or history of such infections may also undergo a lumbar puncture. A thin needle will be inserted into their lower back to draw out a sample of the fluid around their spinal cord.
Participants will receive 3 doses of NT-17, each about 12 weeks apart. NT-17 is injected into the muscle of the upper arm, thigh, or buttock. They will visit the clinic 5 days before each dose and again 2 and 4 weeks after each dose. Blood will be drawn at all visits.
Participants will undergo leukapheresis 3 times. Blood will be drawn from a needle in one arm. The blood will pass through a machine that separates out the white blood cells. The remaining blood will be given back through a second needle in the other arm.
Some visits will include a rectal swab.
Some participants may have additional tests, including a skin exam, skin biopsies, and medical imaging.
Participants will have 3 follow-up visits every 3 months after they finish treatment.

Start Date04 Nov 2024

Sponsor / Collaborator

National Institute of Allergy & Infectious Diseases

[+1]

NCT04054752 / WithdrawnPhase 1IIT

A Phase 1/1b Study of Enhancement of Immune Reconstitution and Vaccine Responses With Administration of Recombinant Human IL-7-hyFc (NT-I7) in Older Subjects Following Chemotherapy

Background:
People with cancer, and especially older people, have a weakened immune system (the defense system of the body). This is often caused by the treatments for cancer. Older cancer survivors are therefore more prone to getting infections, some of which are preventable through vaccines. But because their immune systems are weakened, their response to vaccines is poor. Researchers want to see if a new drug, NT-I7, can help.
Objective:
To see if NT-I7 can boost the immune system.
Eligibility:
Adults 60 and older who have recently finished chemotherapy for breast, colorectal, or bladder cancer.
Design:
Participants will be screened with a physical exam, medical history, and blood and urine samples. Their heart s electrical activity will be checked. They will have an ultrasound of their spleen. They may give a tissue sample from a previous biopsy.
Participants in phase 1a of the study will get 1 dose of NT-I7. It will be given by injection with a needle into the muscle of the upper arm, thigh, or buttocks.
Participants in phase 1b will get 5 vaccines over a few months. They may get an optional booster and/or 6th vaccine. They will also get NT-I7.
Participants will repeat the screening tests during the study. They may get a peripheral intravenous catheter in a vein in their hand or arm for blood draws.
Participants may have apheresis. For this, blood is taken from an arm vein. The white blood cells are separated from the blood. The rest of the blood, minus the white blood cells, is returned into a vein in the other arm. A catheter may be used.
Participants will have follow-up visits for 1 year.

Start Date30 May 2023

Sponsor / Collaborator

National Cancer Institute

[+1]

NCT05286060 / RecruitingPhase 2IIT

Open-label Phase II Trial for the Combination of GX-188E HPV DNA Vaccine With GX-I7 or Pembrolizumab OR the Triple Combination of GX-188E HPV DNA Vaccine, GX-I7, and Pembrolizumab in Patients With Advanced, Resectable HPV Type 16 or 18 Positive Head and Neck Cancer (Expanded Cohort)

The study is open label, phase II clinical trial for the Combination of GX-188E HPV DNA Vaccine with GX-I7 or Pembrolizumab OR the Triple Combination of GX-188E HPV DNA Vaccine, GX-I7, and Pembrolizumab in Patients With Advanced, Resectable HPV Type 16 or 18 Positive Head and Neck Cancer.

Start Date01 Mar 2022

Sponsor / Collaborator

Yonsei University

[+2]

100 Clinical Results associated with NeoImmuneTech, Inc.

0 Patents (Medical) associated with NeoImmuneTech, Inc.

Literatures (Medical) associated with NeoImmuneTech, Inc.

01 Aug 2024·Molecular Therapy

Targeting ROS-sensing Nrf2 potentiates anti-tumor immunity of intratumoral CD8+ T and CAR-T cells

Article

Author: Shim, Ju A. ; Lee, So Min ; Jeong, Juhee ; Kim, Chan Hyuk ; Lee, Byung Ha ; Im, Sun-Kyoung ; Jeong, Jin Woo ; Kim, Yun Hak ; Kim, Chi Dae ; Kim, Hyori ; Kim, Segi ; Choi, Donghoon ; Shim, Ju A ; Jo, Yuna ; Hong, Changwan

Cytotoxic T lymphocytes (CTLs) play a crucial role in cancer rejection. However, CTLs encounter dysfunction and exhaustion in the immunosuppressive tumor microenvironment (TME). Although the reactive oxygen species (ROS)-rich TME attenuates CTL function, the underlying molecular mechanism remains poorly understood. The nuclear factor erythroid 2-related 2 (Nrf2) is the ROS-responsible factor implicated in increasing susceptibility to cancer progression. Therefore, we examined how Nrf2 is involved in anti-tumor responses of CD8⁺ T and chimeric antigen receptor (CAR) T cells in the ROS-rich TME. Here, we demonstrated that tumor growth in Nrf2^-/- mice was significantly controlled and was reversed by T cell depletion and further confirmed that Nrf2 deficiency in T cells promotes anti-tumor responses using an adoptive transfer model of antigen-specific CD8⁺ T cells. Nrf2-deficient CTLs are resistant to ROS, and their effector functions are sustained in the TME. Furthermore, Nrf2 knockdown in human CAR-T cells enhanced the survival and function of intratumoral CAR-T cells in a solid tumor xenograft model and effectively controlled tumor growth. ROS-sensing Nrf2 inhibits the anti-tumor T cell responses, indicating that Nrf2 may be a potential target for T cell immunotherapy strategies against solid tumors.

01 Jun 2024·Journal of Clinical Oncology

Expand and pull: A new treatment paradigm for glioblastoma using a long-acting recombinant interleukin-7 and oncolytic viral therapy.

Author: Kesarwani, Ashwani ; Lee, Byung Ha ; Diamond, Michael ; Ferrando-Martinez, Sara ; Chheda, Milan G ; Wolfarth, Alexandra ; Li, Yuping Derek ; Hu, Tong ; Costa, Amanda

2043 Background: Patients with glioblastoma (GBM) face three major challenges. First, the tumor itself as well as chemoradiation treatment result in lymphopenia, which is associated with shorter survival. Second, the tumor microenvironment (TME) has a paucity of T cells and consequently, immunotherapies have failed in multiple phase 3 clinical trials for GBM. Third, a treatment resistant population of cancer stem cells (CSCs) contribute to inevitable tumor recurrence. In preclinical models, we have shown that a long-acting IL-7, NT-I7, significantly increases peripheral CD8 T cells and separately, oncolytic Zika virus (ZIKV) directly targets CSC and induces an anti-tumor CD8 T cell response. The aim of this study was to determine whether we can leverage the NT-I7 driven T cell expansion peripherally and combine it with ZIKV therapy to pull immune cells into the TME to successfully treat a highly immunosuppressive mouse model of GBM. Methods: SB28 syngeneic tumor cells were intracranially implanted in C57BL/6J mice. Mice were treated with NT-I7 subcutaneously on days 7 and 10 post tumor implantation, followed by intratumoral ZIKV on day 14. Mice were monitored for survival and bled weekly to assess the systemic T-cell response to NT-I7. Immunoprofiling of brain, draining lymph node, and peripheral blood via flow cytometry was done on days 17 and 21. Results: NT-I7 significantly expanded peripheral T cells compared to control (5,623 cells/µL vs 136 cells/µL, p<0.05). Cytotoxic CD8 T cells were particularly increased (4,776 cells/µL vs 47 cells/µL, p<0.05), with the expansion peak at day 7 after the first dose of NT-I7 and persisting for 21 days. When ZIKV was administered at the peak of the NT-I7-driven CD8 T cell expansion, the combination resulted in significant improvement in survival compared to NT-I7 or ZIKV monotherapy (median 47 days vs 35 days and 33 days, respectively, p<0.05). Combined NT-I7 and ZIKV treatment significantly increased TME CD8 T cell infiltration (369,814 cells/g vs 23,947 cells/g and 63,961 cells/g, respectively) as well as increased expression of interferon-γ, TNF-α, perforin, and granzyme B (p<0.05). Long-term survivors were protected against tumor rechallenge, suggesting that this treatment strategy confers immune memory against tumor antigens. The addition of immune checkpoint blockade with anti-PD1 antibody resulted in nearly 80% complete tumor clearance. Conclusions: Timing the oncolytic ZIKV injection with the NT-I7-induced peak expansion of peripheral CD8 T cells greatly increased tumor infiltration of cytotoxic T cells and improved survival in the immunotherapy resistant SB28 glioma model. This work suggests a new “expand and pull” approach for the treatment of highly immunosuppressive tumors such as GBM: priming the systemic immune system with NT-I7, followed by an oncolytic stimulus to draw them into the TME to engage and clear tumor cells.

01 Jun 2024·Journal of Clinical Oncology

A phase 2a study of NT-I7 (efineptakin alfa), a long-acting IL-7, and pembrolizumab to evaluate efficacy, including overall survival, in hard-to-treat gastrointestinal tumors.

Author: Ferrando-Martinez, Sara ; Kim, Richard D. ; Mamdani, Hirva ; Barve, Minal A. ; Chaney, Marya F. ; Murphy, Julie A. ; Naing, Aung ; Johnson, Melissa Lynne ; Yang, Se Hwan ; Trogun, Lauren ; Lee, Byung Ha

2621 Background: Microsatellite-stable colorectal (MSS-CRC) and pancreatic cancer (PDAC) are immunologically cold tumors with null response to checkpoint inhibitors (CPI). NT-I7, a long-acting IL-7, in combination with pembrolizumab (pembro) has shown to significantly increase intratumoral T cell infiltration and elicit some tumor control in these hard-to-treat gastrointestinal indications. The original MSS-CRC and PDAC cohorts, enrolling 25 patients (pts) each, were expanded to 50 pts per indication. Here, we provide an updated analysis including the original and expansion cohorts. Methods: Open-label Phase 2a study in subjects with relapsed/refractory CPI-naïve MSS-CRC and PDAC; NT-I7 1200 µg/kg IM every 6 weeks (Q6W), pembro 200 mg IV Q3W. Antitumor activity assessed by RECIST v1.1/iRECIST. Results: As of 02OCT2023, 98 subjects were efficacy-evaluable (50 MSS-CRC, 48 PDAC); median age 61.0 years, all with baseline ECOG status 0-1. 95.9% (94/98) received study treatment ≥3rd line, with a median follow -up of 6.1 months. Safety profile for NT-I7 was similar to previous reports. In MSS-CRC pts, 1 pt and 3 pts achieved confirmed partial responses per RECIST and iRECIST, respectively; median duration of response (DOR/iDOR) was 13.1/13.0 months (mo) and 2 responders were alive with no progression at data cutoff. Disease control rate (DCR/iDCR) was 36.0% (18/50) / 38.0% (19/50), with a duration of response and stable disease (DORSD/iDORSD) of 3.2/14.5mo. Interestingly, iDCR was 71.4% (5/7) in MSS-CRC pts with primary tumor in the rectum, versus 30.8% (12/39) in pts with primary tumor in the colon. With 11 pts on follow up, progression free survival (PFS/iPFS) was 1.5/3.8 mo. Among PDAC pts, 2 and 3 pts achieved confirmed PR and iPR, with DOR/iDOR of NE/9.7 mo; 1 responder was alive with no progression at data cutoff. DCR/iDCR was 25.0% (12/48) / 27.1% (13/48), and DORSD/iDORSD was 2.9/9.8mo. With 11 pts on follow up, PFS/iPFS was 1.4/2.1 mo. Clinical benefit in MSS-CRC and PDAC was most evident by a notable median overall survival (mOS); 13.2 mo in MSS-CRC [95% CI 8.9 – 18.6 mo] and 11.1 mo in PDAC [95% CI 4.1 – 13.3 mo], compared to historical mOS for standard of care, 10.8 mo (MSS-CRC) and 6.1 mo (PDAC). Conclusions: NT-I7 and pembro treatment was associated with longer mOS relative to historical studies. Identification of predictive biomarkers that may define pts with higher likelihood of clinical benefit would be a promising step to maximizing potential of the NT-I7 + pembro treatment combination for pts with these indications. Research in this area is ongoing. Clinical trial information: NCT04332653 .

News (Medical) associated with NeoImmuneTech, Inc.

09 Sep 2024

·www.prnewswire.com

NeoImmuneTech Presents Promising Interim Results of CAR-T Combination with its NT-I7 Asset at ESMO 2024

Adequate cell expansion and persistence remains a key challenge that limits the efficacy of chimeric antigen receptor T (CAR-T) cell therapies New clinical results presented at ESMO 2024 show NT-I7 treatment following CAR-T cell administration is safe and well tolerated and improv es clinical outcomes through successful expansion of CAR-T cells ROCKVILLE, Md. , Sept. 9, 2024 /PRNewswire/ -- NeoImmuneTech, Inc. (NIT or "NeoImmuneTech"), a global leader in T cell-based immunotherapy, will present interim results of the Phase 1b clinical trial (NIT-112) combining a CAR-T therapy with NT-I7 (efineptakin alfa) during the 'Mini oral session 1: Haematological malignancies' at the European Society for Medical Oncology (ESMO) in Barcelona, Spain, from September 13 to 17. These initial results present a promising approach to enhancing the potential of CAR-T therapies while maintaining a stable safety profile. The NIT-112 clinical trial involves patients with Large B-cell Lymphoma (LBCL) who received CAR-T therapies such as Kymriah, Yescarta, or Breyanzi, followed by NT-I7 administration 21 days after CAR-T infusion. The trial aims to evaluate safety, tolerability, the recommended Phase 2 dose (RP2D), and the potential for NT-I7 to enhance CAR-T expansion, persistence and stemness. Interim results show that at dose levels 4 and 5, which are considered mid-level doses (360, 480 µg/kg), NT-I7 demonstrated a stable safety profile. No cases of Cytokine Release Syndrome (CRS) or Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), which are known as high-risk side effects of CAR-T therapies, were observed subsequent to NT-I7 administration. Only mild, manageable side effects (Grade 1-2), such as injection site erythema and swelling were observed in 6 out of 11 patients (54.5%). Overall, a strong safety profile was observed. NT-I7 administration resulted in significant amplification of CAR-T cells, prolonged persistence and an increase in T cell stemness, characterized by a higher frequency of T cells with a stem-cell memory (Tscm) phenotype (CD45RA+CCR7+CD95+). The overall response rate (ORR) from the interim results was 81.1% (9 out of 11 patients), with 7 achieving a complete response (CR) and 2 achieving a partial response (PR). Kymriah is known to have an ORR of 52% in LBCL patients. Dr Luke Oh, President and Chief Executive Officer of NeoImmuneTech, Inc., said: "We are thrilled by the preliminary results of study NIT-112 showing NT-I7's ability to amplify CAR-T cells. This successful amplification of CAR-T cells is expected to translate into improved patient outcomes. NIT plans to actively pursue technology transfer related to the combination of NT-I7 with CAR-T therapies and we look forward to accelerating our discussions with the organizations already conducting preclinical studies combining NT-I7 with our own CAR-T technologies." Title: Phase 1b study of NT-I7 (efineptakin alfa), a long-acting IL-7, post-CD19-directed CAR T cell therapy in diffuse large B-cell lymphoma (DLBCL) Presentation Number: 806MO Speakers: Armin Ghobadi (St. Louis, United States of America) Lecture Time: 15:05 – 15:10 (Fri, 2024. 09. 13) Session Name: Mini oral session 1: Hematological malignancies (ID 31) Room: Toledo Auditorium – Hall 3 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 companydedicated 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. SOURCE The NeoImmuneTech, Inc

ImmunotherapyClinical ResultPhase 1Cell Therapy

04 Jun 2024

·www.prnewswire.com

EMA Grants Orphan Drug Designation to NeoImmuneTech's NT-I7 for the Treatment of Acute Radiation Syndrome

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

ImmunotherapyRadiation TherapyOrphan DrugClinical Study

03 Jun 2024

·www.prnewswire.com

NeoImmuneTech's New Data at ASCO 2024 Highlights Enhanced Benefits of Combining NT-I7 with Checkpoint Inhibitors (CPI) in Immuno-Oncology

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

Clinical ResultImmunotherapyASCOPhase 2

100 Deals associated with NeoImmuneTech, Inc.

100 Translational Medicine associated with NeoImmuneTech, Inc.

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Drug(Targets)	Indications	Global Highest Phase

Efineptakin alfa (Genexine) ( IL-7Rα )	Squamous Cell Carcinoma of Head and Neck More	Phase 2
Atezolizumab ( PDL1 )	Non-Small Cell Lung Cancer More	Phase 2
Tirvalimogene Teraplasmid	Squamous Cell Carcinoma of Head and Neck More	Phase 2
PB-101(Panolos Bioscience) ( PIGF x VEGF-A x VEGF-B )	Neoplasms More	Preclinical
NT-3020 ( CD3 x TAA )	Solid tumor More	Discontinued

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