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Last update 10 May 2025
Sitocabnagene loxiveluecel
Last update 10 May 2025
Overview
Basic Info
Drug Type CAR-NK |
Synonyms Anti-CD19 CAR NK-cell therapy, SFG.iC9.2A.CAR.CD19-28-3zeta.2A.IL15, Sitocabnagene Loxiveleucel + [2] |
Target |
Action modulators |
Mechanism CD19 modulators(B-lymphocyte antigen CD19 modulators) |
Therapeutic Areas |
Active Indication- |
Inactive Indication |
Originator Organization |
Active Organization- |
Inactive Organization |
License Organization |
Drug Highest PhaseDiscontinuedPhase 2 |
First Approval Date- |
Regulation- |
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Structure/Sequence
Sequence Code 1201809980
Source: *****
Related
2
Clinical Trials associated with Sitocabnagene loxiveluecelNCT06377228
A Phase 1b, Open-Label, Multicenter Study to Evaluate the Safety and Efficacy of TAK-007, an Allogeneic Anti-CD19 Chimeric Antigen Receptor Natural Killer Cell (CD19 CAR-NK) Therapy, in Adult Subjects With Refractory Lupus Nephritis or Refractory Systemic Sclerosis
The main aim of the trial is to learn how well adults with refractory lupus nephritis (LN) or refractory systemic sclerosis (SSc) tolerate TAK-007 and to check for side effects (adverse events).
Other aims are to learn how effective treatment with TAK-007 is in adults with refractory LN or refractory SSc, what effects TAK-007 has on the human body, and whether participants will produce antibodies against TAK-007.
Other aims are to learn how effective treatment with TAK-007 is in adults with refractory LN or refractory SSc, what effects TAK-007 has on the human body, and whether participants will produce antibodies against TAK-007.
Start Date13 Jun 2025 |
Sponsor / Collaborator |
NCT05020015
A Phase 2, Open-label, Multicenter Study of the Safety and Efficacy of TAK-007 in Adult Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma
This study has 2 parts.
The main aim of Part 1 is to check for side effects from TAK-007 in adults with relapsed or refractory (r/r) B-cell Non-Hodgkin Lymphoma (NHL),
The main aim of Part 2 is to learn whether lymphoma disease responds to treatment with TAK-007 in adults with r/r B-cell NHL or iNHL.
Participants will receive 3 days of chemotherapy to reduce a type of white blood cells called lymphocytes, in the blood. This is called lymphodepleting chemotherapy (LDC) or lymphodepletion. After LDC, patients will receive a single injection of TAK-007 or three weekly injections of TAK-007 (multi-dose injection). After this, participants will regularly visit the clinic for check-ups.
The main aim of Part 1 is to check for side effects from TAK-007 in adults with relapsed or refractory (r/r) B-cell Non-Hodgkin Lymphoma (NHL),
The main aim of Part 2 is to learn whether lymphoma disease responds to treatment with TAK-007 in adults with r/r B-cell NHL or iNHL.
Participants will receive 3 days of chemotherapy to reduce a type of white blood cells called lymphocytes, in the blood. This is called lymphodepleting chemotherapy (LDC) or lymphodepletion. After LDC, patients will receive a single injection of TAK-007 or three weekly injections of TAK-007 (multi-dose injection). After this, participants will regularly visit the clinic for check-ups.
Start Date12 Nov 2021 |
Sponsor / Collaborator |
100 Clinical Results associated with Sitocabnagene loxiveluecel
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100 Translational Medicine associated with Sitocabnagene loxiveluecel
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100 Patents (Medical) associated with Sitocabnagene loxiveluecel
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1
Literatures (Medical) associated with Sitocabnagene loxiveluecel01 Jun 2015·Bulletin du cancerQ4 · MEDICINE
Les nouvelles thérapies dans le cancer de la prostate métastatique
Q4 · MEDICINE
Review
Author: Thibault, Constance ; Massard, Christophe
Therapeutic arsenal in prostate cancer widens for several years. New hormonal therapies such as acetate abiraterone or enzalutamide were the first molecules to revolutionize the treatment of metastatic castration resistant prostate cancer. Several other treatments are on trial targeting different pathways: androgene pathway (TAK-007, ARN-509, ODM-201, TOK-001), immune system (sipuleucel, ipilimumab, PROSTVAC-V/F, tasquinimod), but also tumor cell (PARP inhibitor, cabozantinib). The treatment sequencing will therefore soon be problematic, raising the necessity to identify predictive markers of response to the new therapies.
10
News (Medical) associated with Sitocabnagene loxiveluecel19 Nov 2024
Systemic Lupus Erythematosus (SLE) is a chronic autoimmune disease characterized by inflammation and tissue damage across multiple organ systems, such as the skin, joints, kidneys, heart, and brain. The incidence of autoimmune diseases, including SLE, has been increasing globally, with a significant impact on demand for targeted and effective therapies.
LAS VEGAS, Nov. 19, 2024 /PRNewswire/ -- DelveInsight's
'
Systemic Lupus Erythematosus Pipeline Insight 2024
' report provides comprehensive global coverage of pipeline systemic lupus erythematosus therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the systemic lupus erythematosus pipeline domain.
Key Takeaways from the Systemic Lupus Erythematosus Pipeline Report
DelveInsight's systemic lupus erythematosus pipeline report depicts a robust space with
120+ active players working to develop
140+ pipeline therapies for systemic lupus erythematosus treatment.
Key systemic lupus erythematosus companies such as
Roche, ImmuPharma, UCB, Idorsia Pharmaceuticals, Biogen, AbbVie, Bristol-Myers Squibb, Vera Therapeutics, Beijing Mabworks Biotech Co., Ltd., BeiGene, Jiangsu Renocell Biotech Company, AstraZeneca, Pfizer, Red de Terapia Celular, Kira Pharmacenticals (US), LLC., Jemincare, Galapagos NV, Alumis, argenx, Gilead Sciences, Novartis, Zenas Biopharma, Horizon Therapeutics, Provention Bio, Janssen Research & Development, Eli Lilly and Company, Medsenic, Sanofi, Merck KGaA, Resolve Therapeutics, ILTOO, Janssen, Alpine Immune Sciences, Kezar Life Sciences, Neovacs, Kangpu Biopharmaceuticals, Cartesian Therapeutics, Apellis Pharmaceuticals, Inc., Alexion Pharmaceuticals, Inc., Q32 Bio Inc., Conduit Pharmaceuticals, Miltenyi Biomedicine GmbH, Kyverna Therapeutics, ImmPACT Bio, Genrix (Shanghai) Biopharmaceutical Co., Ltd., Gracell Biotechnologies (Shanghai) Co., Ltd., Cabaletta Bio, Tenet Medicines, Ascentage Pharma Group Inc., InnoCare, Eisai, Sorrento Therapeutics, Carna Bioscience, Yake Biotechnology, Equillium, Daiichi Sankyo Company, SinoMab Bioscience Ltd, Citryll BV, Sareum, Shanghai Junshi Biosciences, Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Millennium Pharmaceuticals, Inc., Takeda, Synthekine, Hangzhou Sumgen Biotech Co., Ltd., Sana Biotechnology, Hoffmann-La Roche, Guangdong Ruishun Biotech Co., Ltd, Shanghai Ming Ju Biotechnology Co., Ltd., Autolus Limited, Nkarta, Inc., Luminary Therapeutics, Kyowa Kirin Co., Ltd., Shanghai Ming Ju Biotechnology, IGM Biosciences, Inc., GlaxoSmithKline, Fate Therapeutics, Cugene Inc., Century Therapeutics, Inc., Cullinan Therapeutics Inc., Juno Therapeutics, Inc., EdiGene Inc., Atara Biotherapeutics, Annexon, Inc., Adicet Therapeutics, Bioray Laboratories, PersonGen BioTherapeutics (Suzhou) Co., Ltd., Juventas Cell Therapy Ltd., Nanjing Bioheng Biotech Co., Ltd., Pregene ShenZhen Biotechnology, Artiva Bio, KeyMed Biosciences, IASO, JW Therapeutics, ROME Therapeutics, Ventus Therapeutics, Allosite Therapeutics, iCell Gene Therapeutics, Caribou Biosciences, LongBio Pharma, Amytrx Therapeutics, Corestem, Eliem Therapeutics, SinoMab Bioscience Ltd., and others are evaluating new systemic lupus erythematosus drugs to improve the treatment landscape.
Promising systemic lupus erythematosus pipeline therapies such as
Obinutuzumab, Lupuzor (IPP-201101), Dapirolizumab pegol, Cenerimod, BIIB059, Upadacitinib, Deucravacitinib, Atacicept, MIL62, Zanubrutinib, RY_SW01 cell injection|Basic treatment, Ravulizumab, Rapcabtagene autoleucel, PF-06823859, Mesenchymal stem cells (MSC), KP104, JMKX000189, Iptacopan, GLPG3667, ESK-001, Elsubrutinib, Efgartigimod alfa, Edecesertib, Ianalumab, Obexelimab (XmAb5871), Daxdilimab (VIB7734), PRV-3279, Nipocalimab, ABBV 599, NKTR-358 (LY3471851), Arscimed, SAR441344, Enpatoran, RSLV-132, Aldesleukin, Daratumumab, Branebrutinib, BMS-986256, ALPN-101, KZR-616, IFNα kinoid, KPG 818, Descartes-08, CFZ533, APL-2, ALXN2050, ADX-097, AZD1656, MB-CART19.1, KYV-101, IMPT-514, GR1603, GC012F Injection, CABA-201, Budoprutug, APG-2575, ICP-022, E6742, ALPN-303, AC0058, Mosunetuzumab, AS-0871, CD19/BCMA CAR T-cells, PF-06835375, EQ001 (Itolizumab), DS-7011a, SM03, CIT-013, SDC-1801, UBP1213, TQB3702, TAK-079, TAK-007, SYNCAR-001, SG301, SC291, RO7507062, RJMty19 (CD19-CAR-DNT cells), Relma-cel, PIT565, Obecabtagene autoleucel (obe-cel), NKX019, LMY-920, KK4277, JWCAR201, Imvotamab, GSK4527363, GSK4347859, FT819, CUG252, CNTY-101, CLN-978, CC-97540, Belantamab, ATHENA CAR-T ATA3219, ANX009, ADI-001, BRL-301, T-cell injection targeting CD19 chimeric antigen receptor, CNCT19, RD06-04, PRG-2311, PRG-1801, AlloNK, CM313, CT103A, JWCAR 029, Research program: endogenous reverse transcriptase inhibitors, VENT 03, ONT01, BCMA-CD19 cCAR T cells, CB-010, LP-005, AMTX 100, CE211AT15, TN-119, SN1011, QX002N, RSLV-145, Recombinant human plasma gelsolin, LN-008, TST 008, IBL 100s, and others are under different phases of systemic lupus erythematosus clinical trials.
In
October 2024, the FDA approved the investigational new drug (IND) application for Cullinan Therapeutics' CLN-978 to treat systemic lupus erythematosus (SLE).
In September 2024, Cartesian Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation to Descartes-08 for the treatment of juvenile dermatomyositis (JDM).
In September 2024, Caribou Biosciences announced that the U.S. Food and Drug Administration (FDA) had granted fast-track designation to CAR T-cell therapy CB-010 for systemic lupus erythematosus (SLE).
In
September 2024, UCB and Biogen reported successful results from their Phase III clinical trial of the PHOENYCS GO study, which tested dapirolizumab pegol as a treatment for moderate-to-severe systemic lupus erythematosus.
In August 2024, Conduit Pharmaceuticals announced they will be conducting a Phase IIa clinical trial to evaluate AZD1656 for the treatment of multiple autoimmune diseases, including systemic lupus erythematosus (SLE).
In
July 2024, the first individual received the therapy Descartes-08 to treat systemic lupus erythematosus. This therapy has been previously administered to patients with myasthenia gravis, a long-term autoimmune disorder characterized by muscle weakness.
In
February 2024, Idorsia Pharmaceuticals formed a major global research and development partnership with Viatris to advance and commercialize two Phase III assets, selatogrel and cenerimod, on a global scale.
Request a sample and discover the recent advances in systemic lupus erythematosus treatment drugs @
Systemic Lupus Erythematosus Pipeline Report
The systemic lupus erythematosus pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage systemic lupus erythematosus drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the systemic lupus erythematosus clinical trial landscape.
Systemic Lupus Erythematosus Overview
Systemic lupus erythematosus (SLE) is a chronic autoimmune disease in which the immune system mistakenly attacks healthy tissues in various parts of the body. The exact cause of SLE is unknown, but it is believed to result from a combination of genetic, environmental, and hormonal factors. Common triggers include infections, sunlight exposure, and certain medications. Women, particularly of childbearing age, are more commonly affected.
Symptoms of SLE vary widely and can affect many organ systems, leading to a wide range of clinical presentations. Common symptoms include fatigue, joint pain, skin rashes, photosensitivity, and fever. More severe cases can affect the kidneys, heart, lungs, and central nervous system, potentially leading to life-threatening complications.
Diagnosis of SLE is based on a combination of clinical features and laboratory tests. The antinuclear antibody (ANA) test is a common initial screening tool, but additional tests like anti-double stranded DNA (anti-dsDNA) and anti-Smith antibodies, as well as assessments of kidney and liver function, are often necessary. Diagnosis can be challenging because SLE symptoms often mimic those of other diseases.
Treatment for SLE focuses on managing symptoms and preventing flares. Mild cases may be treated with nonsteroidal anti-inflammatory drugs (NSAIDs) and antimalarial drugs like hydroxychloroquine. More severe cases may require corticosteroids, immunosuppressive drugs such as azathioprine, methotrexate, or newer biologics like belimumab. Lifestyle modifications, such as avoiding excessive sun exposure and managing stress, are also essential in controlling the disease.
Find out more about systemic lupus erythematosus treatment drugs @
Drugs for
Systemic Lupus Erythematosus Treatment
A snapshot of the Systemic Lupus Erythematosus Pipeline Drugs mentioned in the report:
Learn more about the emerging systemic lupus erythematosus pipeline therapies @
Systemic Lupus Erythematosus Clinical Trials
Systemic Lupus Erythematosus Therapeutics Assessment
The systemic lupus erythematosus pipeline report proffers an integral view of the systemic lupus erythematosus emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration.
Scope of the Systemic Lupus Erythematosus 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, Ophthalmic, Oral, Parenteral, Subcutaneous, Topical, Transdermal
Therapeutics Assessment
By Molecule Type: Oligonucleotide, Peptide, Small molecule
Therapeutics Assessment
By Mechanism of Action: Antibody-dependent cell cytotoxicity, Cell death inhibitors, Cell death stimulants, Immunomodulators, CD40 ligand inhibitors, Sphingosine 1 phosphate receptor modulators, Calcineurin inhibitors, Immunosuppressants, Janus kinase 1 inhibitors, TYK2 kinase inhibitors, B cell activating factor inhibitors, Tumour necrosis factor ligand superfamily member 13 inhibitors
Key Systemic Lupus Erythematosus Companies: Roche, ImmuPharma, UCB, Idorsia Pharmaceuticals, Biogen, AbbVie, Bristol-Myers Squibb, Vera Therapeutics, Beijing Mabworks Biotech Co., Ltd., BeiGene, Jiangsu Renocell Biotech Company, AstraZeneca, Pfizer, Red de Terapia Celular, Kira Pharmacenticals (US), LLC., Jemincare, Galapagos NV, Alumis, argenx, Gilead Sciences, Novartis, Zenas Biopharma, Horizon Therapeutics, Provention Bio, Janssen Research & Development, Eli Lilly and Company, Medsenic, Sanofi, Merck KGaA, Resolve Therapeutics, ILTOO, Janssen, Alpine Immune Sciences, Kezar Life Sciences, Neovacs, Kangpu Biopharmaceuticals, Cartesian Therapeutics, Apellis Pharmaceuticals, Inc., Alexion Pharmaceuticals, Inc., Q32 Bio Inc., Conduit Pharmaceuticals, Miltenyi Biomedicine GmbH, Kyverna Therapeutics, ImmPACT Bio, Genrix (Shanghai) Biopharmaceutical Co., Ltd., Gracell Biotechnologies (Shanghai) Co., Ltd., Cabaletta Bio, Tenet Medicines, Ascentage Pharma Group Inc., InnoCare, Eisai, Sorrento Therapeutics, Carna Bioscience, Yake Biotechnology, Equillium, Daiichi Sankyo Company, SinoMab Bioscience Ltd, Citryll BV, Sareum, Shanghai Junshi Biosciences, Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Millennium Pharmaceuticals, Inc., Takeda, Synthekine, Hangzhou Sumgen Biotech Co., Ltd., Sana Biotechnology, Hoffmann-La Roche, Guangdong Ruishun Biotech Co., Ltd, Shanghai Ming Ju Biotechnology Co., Ltd., Autolus Limited, Nkarta, Inc., Luminary Therapeutics, Kyowa Kirin Co., Ltd., Shanghai Ming Ju Biotechnology, IGM Biosciences, Inc., GlaxoSmithKline, Fate Therapeutics, Cugene Inc., Century Therapeutics, Inc., Cullinan Therapeutics Inc., Juno Therapeutics, Inc., EdiGene Inc., Atara Biotherapeutics, Annexon, Inc., Adicet Therapeutics, Bioray Laboratories, PersonGen BioTherapeutics (Suzhou) Co., Ltd., Juventas Cell Therapy Ltd., Nanjing Bioheng Biotech Co., Ltd., Pregene ShenZhen Biotechnology, Artiva Bio, KeyMed Biosciences, IASO, JW Therapeutics, ROME Therapeutics, Ventus Therapeutics, Allosite Therapeutics, iCell Gene Therapeutics, Caribou Biosciences, LongBio Pharma, Amytrx Therapeutics, Corestem, Eliem Therapeutics, SinoMab Bioscience Ltd., and others.
Key Systemic Lupus Erythematosus Pipeline Therapies: Obinutuzumab, Lupuzor (IPP-201101), Dapirolizumab pegol, Cenerimod, BIIB059, Upadacitinib, Deucravacitinib, Atacicept, MIL62, Zanubrutinib, RY_SW01 cell injection|Basic treatment, Ravulizumab, Rapcabtagene autoleucel, PF-06823859, Mesenchymal stem cells (MSC), KP104, JMKX000189, Iptacopan, GLPG3667|Placebo, ESK-001, Elsubrutinib, Efgartigimod alfa, Edecesertib, Ianalumab, Obexelimab (XmAb5871), Daxdilimab (VIB7734), PRV-3279, Nipocalimab, ABBV 599, NKTR-358 (LY3471851), Arscimed, SAR441344, Enpatoran, RSLV-132, Aldesleukin, Daratumumab, Branebrutinib, BMS-986256, ALPN-101, KZR-616, IFNα kinoid, KPG 818, Descartes-08, CFZ533, APL-2, ALXN2050, ADX-097, AZD1656, MB-CART19.1, KYV-101, IMPT-514, GR1603, GC012F Injection, CABA-201, Budoprutug, APG-2575, ICP-022, E6742, ALPN-303, AC0058, Mosunetuzumab, AS-0871, CD19/BCMA CAR T-cells, PF-06835375, EQ001 (Itolizumab), DS-7011a, SM03, CIT-013, SDC-1801, UBP1213, TQB3702, TAK-079, TAK-007, SYNCAR-001, SG301, SC291, RO7507062, RJMty19 (CD19-CAR-DNT cells), Relma-cel, PIT565, Obecabtagene autoleucel (obe-cel), NKX019, LMY-920, KK4277, JWCAR201, Imvotamab, GSK4527363, GSK4347859, FT819, CUG252, CNTY-101, CLN-978, CC-97540, Belantamab, ATHENA CAR-T ATA3219, ANX009, ADI-001, BRL-301, T-cell injection targeting CD19 chimeric antigen receptor, CNCT19, RD06-04, PRG-2311, PRG-1801, AlloNK, CM313, CT103A, JWCAR 029, Research program: endogenous reverse transcriptase inhibitors, VENT 03, ONT01, BCMA-CD19 cCAR T cells, CB-010, LP-005, AMTX 100, CE211AT15, TN-119, SN1011, QX002N, RSLV-145, Recombinant human plasma gelsolin, LN-008, TST 008, IBL 100s, and others.
Dive deep into rich insights for new drugs for systemic lupus erythematosus treatment, visit @
Systemic Lupus Erythematosus Drugs
Table of Contents
For further information on the systemic lupus erythematosus pipeline therapeutics, reach out @
Systemic Lupus Erythematosus Treatment Drugs
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Phase 3Phase 2Fast TrackCell Therapy
11 Nov 2024
NK cell therapy is gaining momentum as a promising solution to unmet medical needs in cancer treatment, offering safer, targeted options for patients unresponsive to traditional therapies. Increased R&D investment, regulatory support, and successful clinical trials have bolstered confidence in these therapies, while technological advances in cell production are set to meet growing demand. Rising cancer rates and heightened public awareness further amplify market potential, making NK cell therapy a pivotal area of growth in oncology.
LAS VEGAS, Nov. 11, 2024 /PRNewswire/ -- DelveInsight's
'
NK Cell Therapy Pipeline Insight 2024
' report provides comprehensive global coverage of pipeline NK cell therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the NK cell therapy pipeline domain.
Key Takeaways from the NK Cell Therapy Pipeline Report
DelveInsight's NK cell therapy pipeline report depicts a robust space with
140+ active players working to develop
160+ pipeline NK cell therapies.
Key NK cell therapy companies such as
Amgen, Innate Pharma, Nektar Therapeutics, SMT bio Co., Ltd., Alphageneron Pharmaceuticals, XNK Therapeutics, ImmunityBio, Cellid, Cantargia, Affimed Therapeutics, Takeda, Artiva Biotherapeutics, Sanofi, Dragonfly Therapeutics, INmune Bio, NKGen Biotech, Asclepius Technology Company Group, Glycostem Therapeutics (IPD Therapeutic), Wugen, Celularity, VERAXA, GamidaCell, MiNK Therapeutics, Indapta Therapeutics, ImmunityBio, Inc., Allife Medical Science and Technology, Nkarta, Base Therapeutics, GT Biopharma, Athenex, Ambicion, Biohaven Pharmaceuticals, Acepodia, Bright Path Biotherapeutics, Nkarta Therapeutics, Qihan Biotech, Century Therapeutics, Fate Therapeutics, Chimeric Therapeutics, Senti Biosciences, GICELL, Deverra Therapeutics, Medigen Biotechnology Corporation, GlaxoSmithKline, CytoImmune Therapeutics, Nuwacell Biotechnologies Co., Ltd., and others are evaluating new NK cell therapies to improve the treatment landscape.
Promising NK cell therapies in the pipeline such as
Bemarituzumab, Monalizumab, NKTR-225, SMT-NK, Enkastim, CellProtect, ALT 803, BVAC-C, PD-L1.t-haNK, Nidanilimab, M ceNK, HER2 t-haNK, AFM-13, TAK-007, IPH4102, AB-101, KDS-1001, AB-201, DF9001, INKmune, IPH65, SNK01, IPH6101 (SAR443579), BCMA CAR-NK 92 cells, DF1001, Allogeneic Natural Killer Cell Therapy (oNKord), WU-NK-101, AFM24, CYNK-001, FLYSYN, GDA-201, AGENT-797, CYNK-101, SAR445514, IDP-023, DF6002, CD19.taNK, Anti-PSMA CAR NK cells, DF2001, NKX101, NK510, GTB-3550, KUR-501, RK-pulsed autologous antigen-presenting cells (APCs), BHV-1100, ACE1702, iPS NKT, Anti-CD19/CD22 CAR NK cell therapy, NKX019, KUR-502, BVAC-P, QN-019a, QN-030a, QN-023a, CNTY-101, FT576, CHM 0201, SENTI-202, AFM28, DF8001, FT522, SNK02, GIC-102, DVX201, Magicell®-NK, GSK4381562, CYTO NK-102, NCR300, and others are under different phases of NK cell therapy clinical trials.
In October 2024, Immunitybio announced that the first patients had been dosed in an initial trial studying the potential of the company's
CAR-NK cell therapy targeting CD-19 in the treatment of non-Hodgkin's lymphoma (NHL).
In July 2024, The U.S. Food and Drug Administration (FDA) gave Nkarta the green light to launch a clinical trial testing its cell therapy candidate
NKX019 in people with ANCA-associated vasculitis (AAV) and other autoimmune disorders.
In May 2024, KGen Biotech announced that its Safety Review Committee had cleared the Company's cryopreserved autologous, expanded, and enhanced
SNK01 to progress into Phase II clinical development.
In May 2024, Fate Therapeutics announced that a late-breaking abstract featuring preclinical data from its
FT522 program for autoimmune diseases will be featured at the American Society of Gene and Cell Therapy (ASGCT) 27th Annual Meeting.
In April 2024, Sanofi moved its natural killer (NK) cell engager candidate
SAR443579/IPH6101 to a Phase II trial evaluating the drug's use in treating a range of blood cancers.
In April 2024, the FDA granted orphan drug designation to the investigational therapy
IGNK001 (Gengleucel) for patients with acute myeloid leukemia (AML).
In February 2024, Indapta Therapeutics received FDA Fast Track Designation for its natural killer (NK) cell therapy
IDP-023 for patients with multiple myeloma (MM) and non-Hodgkin lymphoma (NHL).
Request a sample and discover the recent advances in the NK cell therapy segment @
NK Cell Therapy Pipeline Report
The NK cell therapy pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage NK cell therapies, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the NK cell therapy clinical trial landscape.
NK Cell Therapy Overview
Natural Killer (NK) cell therapy is an innovative approach in immunotherapy that harnesses the power of NK cells, a vital component of the innate immune system. Unlike T cells, which require prior sensitization to target cancer cells, NK cells can recognize and kill abnormal cells without prior exposure. This unique ability makes NK cell therapy a promising option for treating various cancers, including hematologic malignancies like leukemia and lymphoma, as well as solid tumors. By isolating and activating NK cells from a patient's blood or using engineered NK cells from healthy donors, researchers aim to enhance the immune response against tumors, leading to improved patient outcomes. Recent advancements in genetic engineering, such as the introduction of chimeric antigen receptors (CAR) into NK cells, are further enhancing their specificity and efficacy against cancer cells.
The clinical applications of NK cell therapy are expanding rapidly, supported by a growing body of research and early-phase clinical trials. These studies have shown promising results, demonstrating the ability of NK cell therapy to induce durable remissions in patients with refractory cancers. Furthermore, the off-the-shelf nature of certain NK cell therapies allows for quicker treatment deployment compared to traditional CAR-T cell therapies, which require a personalized approach. Challenges remain, including optimizing NK cell expansion, persistence, and overcoming the immunosuppressive tumor microenvironment. However, ongoing research into combination therapies, such as pairing NK cell therapy with checkpoint inhibitors or monoclonal antibodies, is expected to enhance the therapeutic potential of NK cells and provide new hope for cancer patients.
Find out more about NK cell therapy @
Novel
NK Cell Therapies
A snapshot of the Pipeline NK Cell Therapies mentioned in the report:
Learn more about the emerging NK cell therapies @
NK Cell Therapy Clinical Trials
NK Cell Therapy Therapeutics Assessment
The NK cell therapy pipeline report proffers an integral view of the emerging NK cell therapies segmented by stage, product type, molecule type, and route of administration.
Scope of the NK Cell Therapy 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: Oral, Intravenous, Subcutaneous, Parenteral, Topical
Therapeutics Assessment
By Molecule Type: Vaccines, Monoclonal antibody, Peptides, Polymer, Small molecule
Key NK Cell Therapy Companies: Amgen, Innate Pharma, Nektar Therapeutics, SMT bio Co., Ltd., Alphageneron Pharmaceuticals, XNK Therapeutics, ImmunityBio, Cellid, Cantargia, Affimed Therapeutics, Takeda, Artiva Biotherapeutics, Sanofi, Dragonfly Therapeutics, INmune Bio, NKGen Biotech, Asclepius Technology Company Group, Glycostem Therapeutics (IPD Therapeutic), Wugen, Celularity, VERAXA, GamidaCell, MiNK Therapeutics, Indapta Therapeutics, ImmunityBio, Inc., Allife Medical Science and Technology, Nkarta, Base Therapeutics, GT Biopharma, Athenex, Ambicion, Biohaven Pharmaceuticals, Acepodia, Bright Path Biotherapeutics, Nkarta Therapeutics, Qihan Biotech, Century Therapeutics, Fate Therapeutics, Chimeric Therapeutics, Senti Biosciences, GICELL, Deverra Therapeutics, Medigen Biotechnology Corporation, GlaxoSmithKline, CytoImmune Therapeutics, Nuwacell Biotechnologies Co., Ltd., and others.
Key Pipeline NK Cell Therapies: Bemarituzumab, Monalizumab, NKTR-225, SMT-NK, Enkastim, CellProtect, ALT 803, BVAC-C, PD-L1.t-haNK, Nidanilimab, M ceNK, HER2 t-haNK, AFM-13, TAK-007, IPH4102, AB-101, KDS-1001, AB-201, DF9001, INKmune, IPH65, SNK01, IPH6101 (SAR443579), BCMA CAR-NK 92 cells, DF1001, Allogeneic Natural Killer Cell Therapy (oNKord), WU-NK-101, AFM24, CYNK-001, FLYSYN, GDA-201, AGENT-797, CYNK-101, SAR445514, IDP-023, DF6002, CD19.taNK, Anti-PSMA CAR NK cells, DF2001, NKX101, NK510, GTB-3550, KUR-501, RK-pulsed autologous antigen-presenting cells (APCs), BHV-1100, ACE1702, iPS NKT, Anti-CD19/CD22 CAR NK cell therapy, NKX019, KUR-502, BVAC-P, QN-019a, QN-030a, QN-023a, CNTY-101, FT576, CHM 0201, SENTI-202, AFM28, DF8001, FT522, SNK02, GIC-102, DVX201, Magicell®-NK, GSK4381562, CYTO NK-102, NCR300, and others.
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Cell TherapyOrphan DrugFast TrackImmunotherapyPhase 2
11 Jul 2024
According to Takeda's 2023 fiscal year business report, the company's annual total revenue reached 4,263.8 billion yen, an increase of 5.9% year-over-year. However, net profit declined by 54.6% to 144.1 billion yen. This decline was primarily attributed to the loss of exclusivity for Azilva (a hypertension drug) and Vyvanse (used to treat ADHD and binge eating disorder), as well as the failed development of Alofisel (a stem cell therapy for Crohn's disease) and Exkivity (a lung cancer tyrosine kinase inhibitor).
Faced with these challenges, Takeda has announced a corporate restructuring to improve profitability in the coming years. The company expects to incur a one-time restructuring cost of 140 billion yen (around $9 billion) in 2024. Takeda stated that the restructuring measures will involve employee optimization, cost-cutting, and pipeline adjustments, with the goal of increasing the core profit margin by 1% to 2.5% annually, ultimately reaching a level of 30%.
As part of the pipeline adjustments, Takeda has discontinued a total of 18 products, including several cancer treatment products such as Exkivity (lung cancer), TAK-981 (cancer therapy), TAK-007 (cell therapy), TAK-573 (multiple myeloma and solid tumors), TAK-102/TAK-103 (solid tumors), and TAK-940 (multiple myeloma).
Following the restructuring, Takeda plans to fill the gaps by introducing high-quality products. Orserdulatinib, a third-generation oral BCR-ABL tyrosine kinase inhibitor already approved in China, has been selected as an acquisition target. The drug is used to treat chronic myeloid leukemia with the T315I mutation and patients who are resistant and/or intolerant to first- and second-generation TKIs. According to a report by Asieris Pharmaceuticals, the cumulative sales of orserdulatinib have already exceeded 300 million RMB, and its sales growth has been significant after being covered by medical insurance, indicating its vast market potential.
On the other hand, AbbVie's acquisition strategy has been focused on its strengths in the immunology field. Humira, once the world's best-selling drug, has ceded its "drug king" status to Merck's Keytruda (pembrolizumab) due to patent expiration and biosimilar competition. Analysts note that pharmaceutical companies need to adjust their strategies in a timely manner to address the rise of new "drug kings" and the challenges posed by upcoming patent expirations.
Currently, the acquisition of biotech companies to supplement product pipelines has become a common strategy among multinational pharmaceutical companies. While ensuring alignment with their own strategic goals, these companies conduct in-depth assessments of biotech companies' pipeline assets and innovation value to optimize their industrial layouts. Analysts emphasize that for large multinational pharmaceutical companies, acquiring "external innovation" through mergers and licensing is just as critical as "internal R&D." Approximately one-third of global innovative drug revenue comes from internal R&D, while two-thirds comes from mergers and collaborations. However, some companies' reliance on external innovation is significantly higher than the average, reaching 60% to 70%.
Analysts further note that since 2023, innovative products from China have frequently appeared in transactions involving multinational pharmaceutical companies, indicating that domestic Chinese pharmaceutical companies and their products are gradually gaining international recognition, a positive sign.
AcquisitionCell TherapyImmunotherapyDrug Approval
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| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| B-cell lymphoma refractory | Phase 2 | United States | 12 Nov 2021 | |
| Lupus Nephritis | Phase 1 | United States | 13 Jun 2025 | |
| Scleroderma, Systemic | Phase 1 | United States | 13 Jun 2025 |
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| Study | Phase | Population | Analyzed Enrollment | Group | Results | Evaluation | Publication Date |
|---|
NCT05020015 (ASH2024) Manual  | Phase 2 | 27 | (LBCL) | eqsbndralm(koabgikzlk) = All 26 pts who received TAK-007 experienced ≥1 TEAE. Among non-hematological (heme) TEAE events, 77% were grade 1–2; 18 (69%) pts had grade ≥3 non-heme TEAEs. The most common grade ≥3 TEAEs (heme + non-heme) included neutropenia (73%), leukopenia (50%), anemia (38%), thrombocytopenia (38%), sepsis (27%), and febrile neutropenia (12%). djinkitwyv (tgclionkfh ) View more | Positive | 07 Dec 2024 | |
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