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.

开始日期2024-11-06

申办/合作机构

National Institute of Allergy & Infectious Diseases

[+1]

NCT05465954

/ Recruiting临床2期IIT

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.

开始日期2023-01-24

申办/合作机构

Mayo Clinic

[+3]

NCT06344715

/ Recruiting临床1期

A Phase 1, Multi-center, Open-label, Dose-escalating Study to Evaluate the Safety and Tolerability of Triple Combination Regimen of SL-T10, GX-I7 and Pembrolizumab in Patients With Metastatic Castration-resistant Prostate Cancer (mCRPC)

The purpose of this study is to evaluate the efficacy and safety of SL-T10 and GX-I7 or SL-T10, GX-I7 and pembrolizumab in patients with metastatic castration-resistant prostate cancer (mCRPC).

开始日期2022-10-17

申办/合作机构

SL VaxiGen, Inc.

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100 项与依非白介素α 相关的专利（医药）

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项与依非白介素α 相关的文献（医药）

2025-05-01·CTS-Clinical and Translational Science

Dose Optimization of rhIL‐7‐hyFc for Patients With Lymphopenia Using a Neonatal Fc Receptor‐Mediated Recycling‐Based and Target‐Mediated Drug Disposition Pharmacokinetic Model

Article

作者: Yun, Hwi‐yeol ; Jung, Woojin ; Choi, Donghoon ; Chae, Jung‐woo ; Jeon, Hye Seon ; Lee, Soyoung ; Lee, Howard ; Jung, Heeyoon ; Byun, Mi‐Sun ; Kim, Anhye ; Lee, Sang Won

ABSTRACT:

Recombinant human interleukin‐7 hybrid Fc (rhIL‐7‐hyFc) is a homodimer of rhIL‐7 fused to a hyFc. Exogenous IL‐7 promotes T cell proliferation and increases lymphocyte count, making it a potential treatment option for lymphopenia and cancer. To improve therapeutic efficacy, rhIL‐7‐hyFc was developed as a long‐acting IL‐7. This study aimed to create a pharmacokinetic model for rhIL‐7‐hyFc by incorporating neonatal Fc receptor (FcRn)‐mediated recycling and target‐mediated drug disposition (TMDD) of the IL‐7 receptor. Data were collected from a randomized, double‐blind, placebo‐controlled phase 1 trial involving 30 healthy volunteers who received single doses of rhIL‐7‐hyFc. Volunteers received 20 or 60 mg/kg subcutaneously, 60 mg/kg intramuscularly (IM), or a placebo. Clinical data were provided by Genexine Inc. (Seoul, Republic of Korea). A TMDD‐FcRn–mediated recycling pharmacokinetic model was developed using NONMEM 7.5 software, assisted by PsN 5.3.1 software. A quasi‐steady‐state approximation was used to describe drug‐receptor and drug‐FcRn interactions. The model evaluation included goodness of fit, visual predictive checks, and bootstrap analysis. Based on the pharmacokinetic parameters of the final model, a simulation was conducted to select the dosage regimen, ensuring a probability of at least 0.8 for meeting both safety and efficacy criteria. The model successfully described the pharmacokinetic profiles of 24 patients administered rhIL‐7‐hyFc. Based on the simulation results, 670–800 μg/kg every 3 weeks, 1010–1530 μg/kg every 6 weeks, and 1510–2190 μg/kg every 9 weeks IM were proposed. These results may help further understand rhIL‐7‐hyFc characteristics and, moreover, provide guidance for selecting the appropriate dosing regimen in future clinical trials.

2025-03-01·Journal for ImmunoTherapy of Cancer

Correction: rhIL-7-hyFc, a long-acting interleukin-7, improves efficacy of CAR-T cell therapy in solid tumors

Article

2025-02-01·Journal for ImmunoTherapy of Cancer

Phase I study of efineptakin alfa (NT-I7) for the treatment of Kaposi sarcoma

Article

作者: Ekwede, Irene ; Wang, Chia-Ching Jackie ; Menon, Manoj P ; Wright, Anna ; Lurain, Kathryn ; D'Amico, Leonard ; Burnham, Eli ; Ha Lee, Byung ; Ramaswami, Ramya ; Kask, Angela Shaulov ; Cheever, Martin ; Uldrick, Thomas S ; Couey, Paul ; Yarchoan, Robert ; Kwok, Li-Lian ; Fling, Steven P ; Angeldekao, Allysson ; Kaiser, Judith C

Background:

CD4+T-cell lymphocytopenia and immune dysfunction are factors that drive the onset and persistence of Kaposi sarcoma (KS) in people with (PWH) and without HIV. Standard chemotherapy agents for KS can contribute to increasing CD4+T cell lymphocytopenia. IL-7 is a cytokine that is essential in T-cell development, proliferation and homeostasis. In PWH, IL-7 administration leads to increased numbers of circulating central memory and naïve T-cell phenotypes.

Methods:

In this multicenter phase I study with a 3+3 dose escalation design, participants with KS with or without HIV received up to four intramuscular injections of IL-7 (NT-I7) every 9 weeks. The primary endpoint of the study was to evaluate safety over three escalating dose levels (DL) of NT-I7 (DL1:480 µg/kg, DL2: 960 µg/kg and DL3: 1200 µg/kg) and identify a maximum tolerated dose. Secondary endpoints included evaluation of antitumor activity per the modified AIDS Clinical Trials Group Criteria and assessment of the effect of NT-I7 on the kinetics of CD4+and CD8+T-cells.

Results:

Eight cisgender male participants (five with HIV infection) were enrolled. Six participants were treated at DL1, and two were treated at DL2. The study was closed to accrual after enrolment of the second participant on DL2 due to termination of study funding. Four of the eight participants (three in DL1 and one in DL2) completed all four doses of the NT-I7. With regard to treatment-emergent adverse events (AEs), all participants had <grade 2 AEs, which included injection site reaction and alanine aminotransferase increase. Injection site reaction was a dose-limiting toxicity in one participant at DL1. The overall KS objective response rate to NT-I7 was 42.9% (95% CI 9.9%, 81.6%) and all three responders were PWH. Absolute lymphocyte counts, CD4+and CD8+T-cell counts increased among all participants following administration of NT-I7. Participants who experienced a response had HIV and lower CD4/CD8 ratio at baseline and throughout the study as compared with those who did not have KS response to NT-I7.

Conclusions:

Preliminary data demonstrate safety and activity of IL-7 in patients with KS and activity specifically among individuals HIV-associated KS.

Trial registration number:

NCT04893018.

项与依非白介素α 相关的新闻（医药）

2024-11-28

·PRNewswire

Follicular Lymphoma Clinical Trial Pipeline Appears Robust With 50+ Key Pharma Companies Actively Working in the Therapeutics Segment | DelveInsight

Advances in immunotherapy have ushered in a new era of treatment for follicular lymphoma (FL), particularly for patients who have experienced relapse after conventional chemotherapy regimens. This paradigm shift is characterized by the emergence of innovative therapies like CAR T-cell therapy and bispecific antibodies, which have demonstrated remarkable efficacy in targeting and eradicating lymphoma cells. CAR T-cell therapy represents a groundbreaking approach where a patient's own T-cells are genetically engineered to recognize and attack cancer cells. This personalized treatment has shown significant promise, especially for individuals who have undergone extensive previous therapies. One notable example is Axicabtagene ciloleucel (Yescarta), a CAR T-cell therapy approved for use in patients with relapsed or refractory follicular lymphoma. Clinical trials have highlighted its ability to induce durable remissions, with some patients experiencing long-term remission even after multiple prior therapies. LAS VEGAS, Nov. 28, 2024 /PRNewswire/ -- DelveInsight's ' Follicular Lymphoma Pipeline Insight 2024 ' report provides comprehensive global coverage of pipeline follicular lymphoma therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the follicular lymphoma pipeline domain. Key Takeaways from the Follicular Lymphoma Pipeline Report DelveInsight's follicular lymphoma pipeline report depicts a robust space with 50+ active players working to develop 55+ pipeline therapies for follicular lymphoma treatment. Key follicular lymphoma companies such as Chia Tai Tianqing Pharmaceutical Group, Incyte Corporation, Mabworks, Johnson & Johnson Innovative Medicine, Nektar Therapeutics, Xynomic Pharmaceuticals, Merck Sharp & Dohme, Jiangsu HengRui Medicine Co., Ltd., ADC Therapeutics, Bristol-Myers Squibb, Swedish Orphan Biovitrum, Zhejiang DTRM Biopharma, Immpact Bio, Galapagos, Immunitas Therapeutics, Enterome, CRISPR Therapeutics, CHO Pharma, Shanghai Blueray Biopharma, BeiGene, AstraZeneca, AVM Biotechnology, Mustang Bio, Merck, Pell Bio-Med Technology, Schrodinger Inc., Sana Biotechnology, Poseida Therapeutics, OncoNano Medicine, Inc., Nurix Therapeutics, Inc., NovalGen, Pfizer, Xencor, Wellington Zhaotai Therapies, MEI Pharma, Sutro Biopharma, Synthekine, Verismo Therapeutics, Vincerx Pharma, Novartis, Century Therapeutics, Newave Pharmaceuticals, Bio-Path Holdings, Affimed GmbH, Iksuda Therapeutics, Allogene Therapeutics, Adicet Bio, Carna Biosciences, Inc., BeiGene, Boryung Pharmaceutical, Accutar Biotechnology, Atara Biotherapeutics, AbbVie, InnoCare Pharma, NeoImmuneTech, and others are evaluating new follicular lymphoma drugs to improve the treatment landscape. Promising follicular lymphoma pipeline therapies such as Parsaclisib, TQ-B3525, Tafasitamab, MIL62, Ibrutinib, AZD0486, NKTR-255, Abexinostat, Acalabrutinib, Zilovertamab vedotin, SHR2554, Nivolumab, Loncastuximab tesirine, Golcadomide, Emapalumab, DTRM-555, Capivasertib, IMPT 314, GLPG5101, IMT-009, EO2463, CTX112, CHO-H01, BR1733, BGB-16673, BGB-10188, AZD5492, AVM0703, MB106, MK-1026, PL001, SGR-1505, SC291, SC262, P-CD19CD20-ALLO1, ONM 501, NX-5948, NX 2127, NVG-111, Mevrometostat, Plamotamab, WZTL-002, Voruciclib, STRO001, SYNCAR-001 + STK-009, SynKIR-310, VIP-152, VAY736, CNTY-101, LP-168, BP1002, IOA-244, IKS 03, ALLO-501, ADI-001, AS-1763, BGB-21447, BR101801, AC676, ATA3219, ABBV-319, ABBV-101, ICP-B02, ICP-B05, C-CAR039, Efineptakin Alfa, and others are under different phases of follicular lymphoma clinical trials. In August 2024, the company expects to file a supplemental Biologics License Application for tafasitamab for the treatment of patients with FL who have failed at least one prior systemic anti-CD20 immunotherapy or chemo-immunotherapy by the end of 2024 based on the positive Phase III results. In June 2024, a consortium of Eugene Private Equity and Korea Development Bank Private Equity announced that they would acquire 80% of South Korean vaccine maker Boryung Biopharma Co. for 320 billion won (USD 231 million). In February 2024, Incyte announced that it had entered into an asset purchase agreement with MorphoSys AG, which gives Incyte exclusive global rights for tafasitamab. Incyte will now recognize revenue and cost for all US commercialization and clinical development and MorphoSys will no longer be eligible to receive future milestone, profit split and royalty payments. In September 2023, OncoNano Medicine, Inc. announced a clinical trial supply agreement with Regeneron for the use of Libtayo (cemiplimab), a PD-1 inhibitor, in the combination stage of the first human trial of ONM-501, a dual-activating STING (STimulator of INterferon Genes) agonist and lead therapeutic development candidate. The ONM-501 first-in-human trial is a multicenter Phase Ia/b dose escalation and dose expansion study of intratumoral ONM-501 as monotherapy and in combination with Libtayo in patients with advanced solid tumors and lymphomas. OncoNano is the sponsor of the clinical trial, and Regeneron will supply cemiplimab. In May 2023, Janssen Pharmaceutical Companies of Johnson & Johnson announced that it had entered into a worldwide collaboration and license agreement with Cellular Biomedicine Group Inc. (CBMG) to develop, manufacture, and commercialize next-generation chimeric antigen receptor (CAR) T-cell therapies for the treatment of B-cell malignancies. Under the terms of the agreement, CBMG will grant Janssen a worldwide license to develop and commercialize the CAR-T assets, except in Greater China. Janssen and CBMG will negotiate an option for Janssen to commercialize the products in the Chinese territory. Janssen will make an upfront payment of USD 245 million that will be accounted for in the second quarter as a research and development expense. Additional future payments will be based upon achieving certain development, regulatory, and sales milestones, as well as tiered royalty payments on worldwide net trade sales, excluding Greater China. Request a sample and discover the recent advances in follicular lymphoma treatment drugs @ Follicular Lymphoma Pipeline Report The follicular lymphoma pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage follicular lymphoma drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the follicular lymphoma clinical trial landscape. Follicular Lymphoma Overview Follicular lymphoma is a common type of non-Hodgkin lymphoma (NHL) that originates from B-cells, a kind of white blood cell responsible for producing antibodies. This cancer is characterized by the growth of abnormal lymphoid follicles, which can disrupt normal lymphatic function. While the exact causes of follicular lymphoma are not fully understood, certain factors may increase the risk, including age (most commonly affecting adults over 60), a family history of lymphoma, and potential environmental factors such as exposure to pesticides or chemicals. Symptoms of follicular lymphoma can vary widely but may include painless swelling of lymph nodes in the neck, armpit, or groin, unexplained weight loss, night sweats, fatigue, and fever. Some patients may remain asymptomatic for extended periods, as this type of lymphoma can progress slowly. Diagnosis typically involves a combination of physical examinations, blood tests, imaging studies (like CT scans), and a biopsy of affected lymph nodes. The biopsy helps determine the subtype and stage of the lymphoma, which is crucial for planning treatment. Treatment for follicular lymphoma depends on the stage of the disease and the patient's overall health. Options may include watchful waiting for asymptomatic cases, chemotherapy, immunotherapy (such as monoclonal antibodies), and targeted therapies. In some cases, stem cell transplants may be considered for patients with more aggressive forms or those who do not respond to initial treatments. Given the indolent nature of follicular lymphoma, ongoing management, and regular monitoring are vital for achieving the best possible outcomes. Find out more about follicular lymphoma treatment drugs @ Drugs for Follicular Lymphoma Treatment A snapshot of the Follicular Lymphoma Pipeline Drugs mentioned in the report: Learn more about the emerging follicular lymphoma pipeline therapies @ Follicular Lymphoma Clinical Trials Follicular Lymphoma Therapeutics Assessment The follicular lymphoma pipeline report proffers an integral view of the follicular lymphoma emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Follicular Lymphoma Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Intra-articular, Intraocular, Intrathecal, Intravenous, Oral, Parenteral, Subcutaneous, Topical, Transdermal Therapeutics Assessment By Molecule Type: Oligonucleotide, Peptide, Small molecule Therapeutics Assessment By Mechanism of Action: Phosphatidylinositol 3 kinase delta inhibitors, Phosphatidylinositol 3 kinase gamma inhibitors, Emt protein-tyrosine kinase inhibitors, Interleukin 15 receptor agonists, Histone deacetylase inhibitors, Rad51 recombinase inhibitors, Agammaglobulinaemia tyrosine kinase inhibitors, Apoptosis stimulants, Cell cycle inhibitors, Tubulin inhibitors, Tubulin polymerisation inhibitors, Enhancer of zeste homolog 2 protein inhibitors, Antibody-dependent cell cytotoxicity, Programmed cell death 1 receptor antagonists, T lymphocyte stimulants, Alkylating agents, DNA cross-linking agents Key Follicular Lymphoma Companies: Chia Tai Tianqing Pharmaceutical Group, Incyte Corporation, Mabworks, Johnson & Johnson Innovative Medicine, Nektar Therapeutics, Xynomic Pharmaceuticals, Merck Sharp & Dohme, Jiangsu HengRui Medicine Co., Ltd., ADC Therapeutics, Bristol-Myers Squibb, Swedish Orphan Biovitrum, Zhejiang DTRM Biopharma, Immpact Bio, Galapagos, Immunitas Therapeutics, Enterome, CRISPR Therapeutics, CHO Pharma, Shanghai Blueray Biopharma, BeiGene, AstraZeneca, AVM Biotechnology, Mustang Bio, Merck, Pell Bio-Med Technology, Schrodinger Inc., Sana Biotechnology, Poseida Therapeutics, OncoNano Medicine, Inc., Nurix Therapeutics, Inc., NovalGen, Pfizer, Xencor, Wellington Zhaotai Therapies, MEI Pharma, Sutro Biopharma, Synthekine, Verismo Therapeutics, Vincerx Pharma, Novartis, Century Therapeutics, Newave Pharmaceuticals, Bio-Path Holdings, Affimed GmbH, Iksuda Therapeutics, Allogene Therapeutics, Adicet Bio, Carna Biosciences, Inc., BeiGene, Boryung Pharmaceutical, Accutar Biotechnology, Atara Biotherapeutics, AbbVie, InnoCare Pharma, NeoImmuneTech, and others. Key Follicular Lymphoma Pipeline Therapies: Parsaclisib, TQ-B3525, Tafasitamab, MIL62, Ibrutinib, AZD0486, NKTR-255, Abexinostat, Acalabrutinib, Zilovertamab vedotin, SHR2554, Nivolumab, Loncastuximab tesirine, Golcadomide, Emapalumab, DTRM-555, Capivasertib, IMPT 314, GLPG5101, IMT-009, EO2463, CTX112, CHO-H01, BR1733, BGB-16673, BGB-10188, AZD5492, AVM0703, MB106, MK-1026, PL001, SGR-1505, SC291, SC262, P-CD19CD20-ALLO1, ONM 501, NX-5948, NX 2127, NVG-111, Mevrometostat, Plamotamab, WZTL-002, Voruciclib, STRO001, SYNCAR-001 + STK-009, SynKIR-310, VIP-152, VAY736, CNTY-101, LP-168, BP1002, IOA-244, IKS 03, ALLO-501, ADI-001, AS-1763, BGB-21447, BR101801, AC676, ATA3219, ABBV-319, ABBV-101, ICP-B02, ICP-B05, C-CAR039, Efineptakin Alfa, and others. Dive deep into rich insights for new drugs for follicular lymphoma treatment, visit @ Follicular Lymphoma Drugs Table of Contents For further information on the follicular lymphoma pipeline therapeutics, reach out @ Follicular Lymphoma Treatment Drugs Related Reports Follicular Lymphoma Market Follicular Lymphoma Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key follicular lymphoma companies including Epizyme, Eisai, Bayer Healthcare Pharmaceuticals, Verastem Oncology, Gilead Sciences, TG Therapeutics, Bristol-Myers-Squibb, Roche, Incyte Corporation, Bristol Myers Squibb, ADC Therapeutics, MorphoSys, Nordic Nanovector, AbbVie, Regeneron Pharmaceuticals, Janssen Research & Development, Novartis, MEI Pharma, and BeiGene, among others. Non-Hodgkin Lymphoma Market Non-Hodgkin Lymphoma Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key Non-Hodgkin lymphoma companies, including Roche, Pfizer, Amgen, Novartis, Teva Pharmaceuticals, Genentech, ACD Therapeutics, among others. Non-Hodgkin Lymphoma Pipeline Non-Hodgkin Lymphoma Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key Non-Hodgkin lymphoma companies, including Novartis, AstraZeneca, Genentech, BioInvent, Genmab, SystImmune, Nordic Nanovector, Pacylex Pharmaceuticals, Artiva Biotherapeutics, Inc., Chipscreen Biosciences, Ltd., Timmune Biotech Inc., Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Gilead Sciences, Acerta Pharma BV, Adagene Inc, Conjupro Biotherapeutics, Inc., Rhizen Pharmaceuticals, Juventas Cell Therapy Ltd., Incyte Corporation, HUYA Bioscience International, SecuraBio, Genor Biopharma Co., Ltd., Kyowa Kirin Co., Ltd., Antengene Therapeutics Limited, Regeneron Pharmaceuticals, Jiangsu HengRui Medicine Co., Ltd., Xynomic Pharmaceuticals, Inc., BioTheryX, Inc., UWELL Biopharma, Kronos Bio, Bio-Thera Solutions, Spectrum Pharmaceuticals, Inc., Aptose Biosciences Inc., Miltenyi Biomedicine GmbH, Precision BioSciences, Inc., Teneobio, Inc., TCR2 Therapeutics, IGM Biosciences, Inc, among others. Diffuse Large B-cell Lymphoma Market Diffuse Large B-cell Lymphoma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key DLBCL companies, including AbbVie, Genmab, Merck, Roche, Xencor, Janssen, Denovo Biopharma, Calithera Biosciences IMV, Biogen, Autolus Therapeutics, Allogene Therapeutics, Novartis, Miltenyi Biomedicine, Regeneron Pharmaceuticals, Debiopharm, Seagen, Takeda, AstraZeneca, Gilead Sciences, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

免疫疗法引进/卖出临床3期疫苗细胞疗法

2024-09-09

·PRNewswire

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

免疫疗法临床结果临床1期细胞疗法

2024-06-04

·PRNewswire

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

免疫疗法放射疗法孤儿药临床研究

100 项与依非白介素α 相关的药物交易

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KEGG	Wiki	ATC	Drug Bank
D11957	-	-	DB16395

研发状态

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适应症	最高研发状态	国家/地区	公司	日期
特发性CD4阳性T淋巴细胞减少症	临床2期	美国	NeoImmuneTech, Inc.	2024-11-06
胶质母细胞瘤，IDH野生型	临床2期	美国	NeoImmuneTech, Inc.	2023-01-24
胶质母细胞瘤，IDH野生型	临床2期	美国	Merck Sharp & Dohme LLC	2023-01-24
神经胶质肉瘤	临床2期	美国	NeoImmuneTech, Inc.	2023-01-24
神经胶质肉瘤	临床2期	美国	Merck Sharp & Dohme LLC	2023-01-24
高级别星形细胞瘤	临床2期	美国	NeoImmuneTech, Inc.	2023-01-24
高级别星形细胞瘤	临床2期	美国	Merck Sharp & Dohme LLC	2023-01-24
皮肤肿瘤	临床2期	-	NeoImmuneTech, Inc.	2022-04-27
复发性胶质母细胞瘤	临床2期	美国	Genexine, Inc.	2022-01-26
实体瘤	临床2期	中国	天境生物科技（上海）有限公司	2021-12-22

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


CTIM-24 (SNO2024)	临床2期	高级别胶质瘤 IDH-wildtype glioblastoma \| MGMT methylation status	22	rhIL-7-hyFc (720mcg/kg)	窪鑰窪觸獵襯構鏇醖夢(糧製範廠淵願製築鹹築) = 築鹹獵夢艱繭積襯窪簾廠艱選衊鑰積鑰積淵膚 (壓鹹膚齋簾糧窪範網鑰 ) 更多	积极	2024-11-11
				Placebo	窪鑰窪觸獵襯構鏇醖夢(糧製範廠淵願製築鹹築) = 鑰艱餘積鏇遞簾蓋窪簾廠艱選衊鑰積鑰積淵膚 (壓鹹膚齋簾糧窪範網鑰 ) 更多
NCT05075603 (ESMO2024) 人工标引	临床1期	弥漫性大B细胞淋巴瘤	11	NT-I7 (efineptakin alfa)	簾遞鬱夢積夢夢廠繭窪(簾鬱築憲憲艱鏇齋獵窪) = most commonly injection site erythema and injection site swelling (2 subjects each, 18.2%) 衊廠構範顧獵齋憲衊鏇 (繭窪襯淵憲淵選鏇淵壓 )	积极	2024-09-13
NCT04893018 (Phase I study of efineptakin alfa (NT-I7), CTgov)	临床1期	艾滋病相关性卡波西肉瘤	8	NT-I7 (Efineptakin Alfa) (NT-I7 (Efineptakin Alfa) Dose Level 1)	範遞積壓鏇鹽蓋鹹選鏇 = 選壓醖襯製壓糧蓋範積夢醖獵醖選膚醖築衊衊 (願鏇繭顧鹽憲憲夢鹹窪, 繭壓鑰繭簾選襯遞糧顧 ~ 廠淵願顧夢壓衊顧鏇網) 更多	-	2024-06-27
				NT-I7 (Efineptakin Alfa) (NT-I7 (Efineptakin Alfa) Dose Level 2)	範遞積壓鏇鹽蓋鹹選鏇 = 範鹽範網膚齋廠繭遞鏇夢醖獵醖選膚醖築衊衊 (願鏇繭顧鹽憲憲夢鹹窪, 憲鬱積積鹹衊窪蓋鹽廠 ~ 壓鏇壓廠顧壓糧願顧網) 更多
NCT04332653 (ASCO2024) 人工标引	临床2期	微卫星稳定型结直肠癌 \| 胰腺癌	98	NT-I7opembrolizumabg	齋遞獵衊構鬱願淵選淵(蓋憲齋夢壓憲憲壓鑰鏇) = 窪願構製製鹽築糧窪範網蓋艱網壓鬱壓製蓋遞 (願憲淵衊鹽膚襯膚衊鬱 ) 更多	积极	2024-05-24
				NT-I7 pembrolizumab	齋遞獵衊構鬱願淵選淵(蓋憲齋夢壓憲憲壓鑰鏇) = 衊鹹齋遞鏇遞糧衊獵憲網蓋艱網壓鬱壓製蓋遞 (願憲淵衊鹽膚襯膚衊鬱 ) 更多
NCT04332653 (ASCO2024) 人工标引	临床2期	微卫星稳定型结直肠癌 \| 胰腺癌一线 Microsatellite Stable (MSS)	53	NT-I7 1200 µg/kgPembrolizumab	築繭鹽艱憲築醖構遞憲(鑰顧齋築蓋網顧網壓壓) = 艱蓋遞壓鏇淵窪簾衊簾繭網齋醖繭廠糧夢願鹽 (構積鹽鹹鏇獵壓網鑰夢 )	积极	2024-05-24
				NT-I7olizumab 200 mgPembrolizumab	-
NCT05286060 (GENUINE, ASCO 12023 \| ASCO 22023) 人工标引	临床2期	人乳头瘤病毒相关的头颈部鳞状细胞癌新辅助 HPV-16 Positive \| HPV-18 Positive	11	GX-I7+GX-188E+pembrolizumab	獵膚觸糧網範構鏇憲遞(艱選築積襯構鏇餘獵獵) = 鹽艱簾膚遞壓觸夢壓積築繭齋鏇糧範構鹹夢簾 (襯遞範築鬱艱簾蓋範鹹 ) 更多	积极	2023-05-26
ASH 12022 \| ASH 22022 人工标引	临床1期	复发性弥漫性大B细胞淋巴瘤	7	Tisagenlecleucel+Efineptakin Alfa	衊獵餘製鏇糧醖鏇醖糧(製膚夢鑰憲遞網獵願憲) = 構憲選鑰構襯簾鹽願鑰範蓋遞網顧淵範願築構 (醖觸廠糧糧壓鬱觸顧選 ) 更多	积极	2022-11-15
NCT04332653 (657, SITC2022)	临床2期	结直肠癌 \| 胰腺癌 TMB \| CD8+TCF1+ lymphocytes	53	NT-I7	艱簾鹹蓋膚憲築糧製鏇(鏇憲選獵製鑰觸願簾艱) = 鹹簾淵製範鬱願餘網蓋餘鏇糧遞鹹鏇醖糧構鬱 (獵廠憲廠構鹹衊選繭鏇 ) 更多	积极	2022-11-07
				Pembrolizumab	艱簾鹹蓋膚憲築糧製鏇(鏇憲選獵製鑰觸願簾艱) = 夢網鏇顧積繭積醖醖築餘鏇糧遞鹹鏇醖糧構鬱 (獵廠憲廠構鹹衊選繭鏇 )
NCT03687957 (SITC 12022 \| SITC 22022) 人工标引	临床1/2期	高级别胶质瘤	19	NT-I7	願壓構壓齋艱遞構繭鏇(糧繭簾窪壓繭簾蓋遞獵) = NT-I7 was well-tolerated with grade 1/2 injection site reactions (42%) the most common treatment-related adverse event (TRAE). 網構艱廠觸淵艱選築顧 (繭醖廠廠繭範顧願淵積 ) 更多	积极	2022-11-01
				NT-I7 (harder-to-treat unmethylated GBM patients)
NCT04332653 (P-48, ESMO_GI2022)	临床2期	胰腺癌	32	NT-I7	夢願艱壓網餘齋鏇遞鏇(襯網鑰網鑰願蓋觸夢選) = 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 淵壓鏇淵醖鏇網鏇膚蓋 (鹽憲壓鹽願衊願鬱獵鹹 )	-	2022-07-02