Last update 01 Jul 2024

Efineptakin alfa (Genexine)

Last update 01 Jul 2024

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Fusion protein

Synonyms

Efineptakin alfa, Efineptakin alfa (USAN), Efineptakin alfa NT-I7

+ [21]

Target

IL-7Rα

Mechanism

IL-7Rα agonists(Interleukin-7 receptor subunit alpha agonists)

Therapeutic Areas

NeoplasmsInfectious DiseasesNervous System Diseases+ [10]

Active Indication

Glioblastoma, IDH-WildtypeGliosarcomaHigh Grade Astrocytic Tumor+ [21]

Inactive Indication

Adenocarcinoma of large intestineAdvanced Gastroesophageal Junction AdenocarcinomaBladder Cancer+ [11]

Originator Organization

Genexine, Inc.

Active Organization

NeoImmuneTech, Inc.Merck Sharp & Dohme LLC

I-MAB Biopharma Co., Ltd.

+ [4]

Inactive Organization

Washington University School of Medicine

Seoul National University Hospital

Drug Highest PhasePhase 2

First Approval Date-

RegulationOrphan Drug (US), Orphan Drug (EU)

Gene Sequence

Sequence Code 12978924

Source: *****

Clinical Trials associated with Efineptakin alfa (Genexine)

NCT05600920 / Not yet recruitingPhase 1/2IIT

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 Date27 Jun 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]

NCT05465954 / RecruitingPhase 2

Efficacy and Safety Study of Neoadjuvant Efineptakin Alfa (NT-I7) and Pembrolizumab in Recurrent Glioblastoma

This phase II trial tests the safety and side effects of efineptakin alfa and pembrolizumab in treating patients with glioblastoma that has come back (recurrent). Efineptakin alfa is an immunotherapy drug that works by helping the immune system fight tumor cells. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving efineptakin alfa and pembrolizumab may kill more tumor cells in patients with recurrent glioblastoma.

Start Date20 Jan 2023

Sponsor / Collaborator

Mayo Clinic

[+2]

100 Clinical Results associated with Efineptakin alfa (Genexine)

100 Translational Medicine associated with Efineptakin alfa (Genexine)

100 Patents (Medical) associated with Efineptakin alfa (Genexine)

Literatures (Medical) associated with Efineptakin alfa (Genexine)

01 Jan 2024·Cell reports. Medicine

Fc-fused IL-7 provides broad antiviral effects against respiratory virus infections through IL-17A-producing pulmonary innate-like T cells

Article

Author: Kim, Jong Kyoung ; Chang, Jun ; Choi, Donghoon ; Lee, Seung-Woo ; Choi, Yoon Ha ; Baek, Seungtae ; Kong, Hyun-Jung ; You, Gihoon ; Kim, Young-Min ; Kwon, Dong-Il ; Oh, Youngsik ; Min, Jeongyong ; Lee, Kun-Joo ; Song, Manki ; Jeong, Yujin L ; Choi, Youngwon ; Jeong, Chaerim ; Choi, Jung-Ah ; Kang, Yeon-Woo ; Im, Sun-Kyoung ; Lee, Changhyung ; Park, Subin

Repeated pandemics caused by the influenza virus and severe acute respiratory syndrome coronavirus (SARS-CoV) have resulted in serious problems in global public health, emphasizing the need for broad-spectrum antiviral therapeutics against respiratory virus infections. Here, we show the protective effects of long-acting recombinant human interleukin-7 fused with hybrid Fc (rhIL-7-hyFc) against major respiratory viruses, including influenza virus, SARS-CoV-2, and respiratory syncytial virus. Administration of rhIL-7-hyFc in a therapeutic or prophylactic regimen induces substantial antiviral effects. During an influenza A virus (IAV) infection, rhIL-7-hyFc treatment increases pulmonary T cells composed of blood-derived interferon γ (IFNγ)+ conventional T cells and locally expanded IL-17A+ innate-like T cells. Single-cell RNA transcriptomics reveals that rhIL-7-hyFc upregulates antiviral genes in pulmonary T cells and induces clonal expansion of type 17 innate-like T cells. rhIL-7-hyFc-mediated disease prevention is dependent on IL-17A in both IAV- and SARS-CoV-2-infected mice. Collectively, we suggest that rhIL-7-hyFc can be used as a broadly active therapeutic for future respiratory virus pandemic.

01 Dec 2023·Leukemia

An “off-the-shelf” CD2 universal CAR-T therapy for T-cell malignancies

Article

Author: Cooper, Matthew L ; O' Neal, Julie ; Staser, Karl W ; Carter, Alun J ; DiPersio, John F ; Ritchey, Julie K ; Turk, Rolf ; Rettig, Garrett ; Devenport, Jessica M ; Lee, Byung Ha ; Rettig, Michael P ; Xiang, Jingyu ; Gao, Feng ; Kim, Miriam Y

Abstract:

T-cell malignancies are associated with frequent relapse and high morbidity, which is partly due to the lack of effective or targeted treatment options. To broaden the use of CAR-T cells in pan T-cell malignancies, we developed an allogeneic “universal” CD2-targeting CAR-T cell (UCART2), in which the CD2 antigen is deleted to prevent fratricide, and the T-cell receptor is removed to prevent GvHD. UCART2 demonstrated efficacy against T-ALL and CTCL and prolonged the survival of tumor-engrafted NSG mice in vivo. To evaluate the impact of CD2 on CAR-T function, we generated CD19 CAR-T cells (UCART19) with or without CD2 deletion, single-cell secretome analysis revealed that CD2 deletion in UCART19 reduced frequencies of the effector cytokines (Granzyme-B and IFN-γ). We also observed that UCART19ΔCD2 had reduced anti-tumor efficacy compared to UCART19 in a CD19+NALM6 xenograft model. Of note is that the reduced efficacy resulting from CD2 deletion was reversed when combined with rhIL-7-hyFc, a long-acting recombinant human interleukin-7. Treatment with rhIL-7-hyFc prolonged UCART2 persistence and increased survival in both the tumor re-challenge model and primary patient T-ALL model in vivo. Together, these data suggest that allogeneic fratricide-resistant UCART2, in combination with rhIL-7-hyFc, could be a suitable approach for treating T-cell malignancies.

24 Oct 2023·Blood advances

Anti-myeloma efficacy of CAR-iNKT is enhanced with a long-acting IL-7, rhIL-7-hyFc.

Article

Author: Ritchey, Julie K ; Street, Emily ; Rettig, Mike P ; Haas, Gabriel J ; Amayta, Parmeshwar N ; Carter, Alun ; Cooper, Matthew L ; Zhou, Alice ; DiPersio, John F ; Fehniger, Todd A ; Choi, Donghoon ; Berrien-Elliott, Melissa ; Gladney, Susan ; González, L Sofía ; Lee, Byung Ha ; O'Neal, Julie ; Niswonger, Jessica ; Gao, Feng

Multiple myeloma (MM), a malignancy of mature plasma cells, remains incurable. B-cell maturation antigen (BCMA) is the lead protein target for chimeric antigen receptor (CAR) therapy because of its high expression in most MM, with limited expression in other cell types, resulting in favorable on-target, off tumor toxicity. The response rate to autologous BCMA CAR-T therapy is high; however, it is not curative and is associated with risks of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome. Outcomes in patients treated with BCMA CAR-T cells (CAR-Ts) may improve with allogeneic CAR T-cell therapy, which offer higher cell fitness and reduced time to treatment. However, to prevent the risk of graft-versus-host disease (GVHD), allogenic BCMA CAR-Ts require genetic deletion of the T-cell receptor (TCR), which has potential for unexpected functional or phenotype changes. Invariant natural killer T cells (iNKTs) have an invariant TCR that does not cause GVHD and, as a result, can be used in an allogeneic setting without the need for TCR gene editing. We demonstrate significant anti-myeloma activity of BCMA CAR-iNKTs in a xenograft mouse model of myeloma. We found that a long-acting interleukin-7 (IL-7), rhIL-7-hyFc, significantly prolonged survival and reduced tumor burden in BCMA CAR-iNKT-treated mice in both primary and re-challenge settings. Furthermore, in CRS in vitro assays, CAR-iNKTs induced less IL-6 than CAR-Ts, suggesting a reduced likelihood of CAR-iNKT therapy to induce CRS in patients. These data suggest that BCMA CAR-iNKTs are potentially a safer, effective alternative to BCMA CAR-Ts and that BCMA CAR-iNKT efficacy is further potentiated with rhIL-7-hyFc.

News (Medical) associated with Efineptakin alfa (Genexine)

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

09 Apr 2024

·www.prnewswire.com

NeoImmuneTech's NT-I7 in Combination with Chemotherapy Shows Efficacy in Colorectal Cancer at AACR Meeting

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

ImmunotherapyAACRClinical StudyClinical Result

100 Deals associated with Efineptakin alfa (Genexine)

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KEGG	Wiki	ATC	Drug Bank
D11957	-	-	DB16395

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Glioblastoma, IDH-Wildtype	Phase 2	US	Merck Sharp & Dohme LLC	20 Jan 2023
Gliosarcoma	Phase 2	US	Merck Sharp & Dohme LLC	20 Jan 2023
High Grade Astrocytic Tumor	Phase 2	US	Merck Sharp & Dohme LLC	20 Jan 2023
Skin Neoplasms	Phase 2	-	NeoImmuneTech, Inc.	27 Apr 2022
Recurrent Glioblastoma	Phase 2	KR	Genexine, Inc.	26 Jan 2022
Solid tumor	Phase 2	CN	I-Mab Biopharma US Ltd.	22 Dec 2021
Squamous Cell Carcinoma of Head and Neck	Phase 2	CN	-	22 Dec 2021
Non-Small Cell Lung Cancer	Phase 2	US	NeoImmuneTech, Inc.	03 Nov 2021
Glioblastoma	Phase 2	CN	I-MAB Biopharma Co., Ltd.	31 Dec 2020
Glioblastoma	Phase 2	CN	I-Mab Biopharma Hong Kong Ltd.	31 Dec 2020

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04332653 (ASCO2024)	Phase 2	Gastrointestinal Neoplasms TPEX \| TSCM	53	NT-I7 1200 µg/kg	jctwougier(bqegiqrwzm) = tugbygbsvu gqjvtikxpp (nixyfrmvzq )	Positive	24 May 2024
				Pembrolizumab 200 mg	jctwougier(bqegiqrwzm) = tzrhbwonzw gqjvtikxpp (nixyfrmvzq )
NCT04332653 (Phase 2a study of NT-I7, ASCO2024)	Phase 2	Gastrointestinal Neoplasms	98	NT-I7 1200 µg/kg	mijtjhhowm(udhevcgruy) = loyehvxilf rxdhfsyrnz (cqwxyuhyil ) View more	Positive	24 May 2024
				Pembrolizumab 200 mg	mijtjhhowm(udhevcgruy) = awutwnommz rxdhfsyrnz (cqwxyuhyil ) View more
NCT05286060 (GENUINE, ASCO2023) Manual	Phase 2	Human Papillomavirus-Related Squamous Cell Carcinoma of Head and Neck Neoadjuvant HPV-16 Positive \| HPV-18 Positive	11	GX-I7+GX-188E+pembrolizumab	xuermtyssz(aiyqeclkey) = bokgylxpdr hdixkoqpax (tlqzgpdtzm ) View more	Positive	26 May 2023
ASH2022 Manual	Phase 1	Diffuse large B-cell lymphoma recurrent	7	Tisagenlecleucel+Efineptakin Alfa	vvhbrcvsou(jadpzhibxu) = xkksfcqngc nlzwypqiqo (dlddeaecka ) View more	Positive	15 Nov 2022
NCT03687957 (SITC2022) Manual	Phase 1/2	High grade glioma	19	NT-I7	qnheptzqcm(qdnsckjkue) = NT-I7 was well-tolerated with grade 1/2 injection site reactions (42%) the most common treatment-related adverse event (TRAE). wjngjkjdlc (geepwglkio ) View more	Positive	01 Nov 2022
				NT-I7 (harder-to-treat unmethylated GBM patients)
NCT04332653 (P-48, ESMO_GI2022)	Phase 2	Pancreatic Cancer	32	NT-I7	lndynvqsng(xffxiszidh) = NT-I7 treatment-related adverse events (trAEs) occurred in 23 (71.9%) subjects, 18 (56.2%) G1-2, 3 (9.4%) G3; 2 (6.3%) G4; no G5 trAEs were reported rvruelekji (dqyszbozzh )	-	02 Jul 2022
NCT04332653 (P-54, ESMO_GI2022)	Phase 2	Microsatellite Stable Colorectal Carcinoma	28	NT-I7 + Pembrolizumab	iadhtegpyi(pgxdhtzbfn) = Treatment-related adverse events (trAEs) occurred in 27 (96.4%) subjects, 12 (42.8%) G1-2 events and 14 (50%) G3 events; 1 (3.6%) G4 and no G5 trAEs were reported. No subjects discontinued from the study due to trAE ooconkjgbb (pmdqqgytln ) View more	-	02 Jul 2022
				Pembrolizumab
NCT04332653 (KEYNOTE A60, ASCO2022) Manual	Phase 2	HR-positive/HER2-low Solid Tumors	92	pembrolizumab+NT-I7 (PDAC)	bkujofrfza(rljvlyfnlx) = mmbijafhag wqlnwyazit (yslhcxeotp ) View more	Positive	02 Jun 2022
				pembrolizumab+NT-I7 (MSS-CRC)	bkujofrfza(rljvlyfnlx) = wscnfbrkbh wqlnwyazit (yslhcxeotp ) View more
NCT03752723 (KEYNOTE-899, ASCO2022) Manual	Phase 1/2	Triple Negative Breast Cancer	84	GX-I7+pembrolizumab (phase 1b)	tpkmsodhsn(fctqbkslqk) = GX-I7 1,200 µg/kg Q9W dsekvfupci (odracggrot ) View more	Positive	02 Jun 2022
				GX-I7+pembrolizumab (phase 2)
NCT03901573 (ASCO2022)	Phase 1/2	Skin Neoplasms	16	NT-I7	cmbobhibqv(nexyinirin) = nruvoroowo idrseejmig (saxhddkcrt )	-	02 Jun 2022

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