ATLCAR.CD19

CAR T-cell therapy clinical trial pipeline constitutes 193+ key companies continuously working towards developing 450+ CAR T-cell therapies, analyzes DelveInsight LAS VEGAS, Nov. 7, 2022 /PRNewswire/ -- DelveInsight's ' CAR T-cell Therapy Competitive Landscape – 2022 ' report provides comprehensive global coverage of available, marketed, and pipeline CAR T-cell therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the CAR T-cell therapy competitive domain. Key Takeaways from the CAR T-cell Therapy Pipeline Report Over 193+ CAR T companies are evaluating 450+ CAR T-cell therapies in various stages of development, and their anticipated acceptance in the CAR T-cell therapy market would significantly increase market revenue. Leading CAR T companies such as Alnylam Pharmaceuticals, JW Therapeutics, Gilead Sciences, Janssen Pharmaceuticals, Innovent Biologics, Sorrento Therapeutics, Cartesian Therapeutics, CASI Pharmaceuticals, Juventas Cell Therapy, Novartis, Poseida Therapeutics,Shanghai Unicar-Therapy Bio-medicine Technology, Sinobioway Cell Therapy Co., Ltd., Tessa Therapeutics, Wuhan Bio-Raid Biotechnology, Miltenyi Biomedicine, Bristol-Myers Squibb, Autolus Limited, Beijing Immunochina Medical Science and Technology, Carsgen Therapeutics, Cellular Biomedicine Group, Chongqing Precision Biotech, Eureka Therapeutics, Formula Pharmaceuticals, Guangzhou Bio-gene Technology, Hebei Senlang Biotechnology, Mustang Bio, MolMed, Aurora BioPharma, Atara Biotherapeutics, Autolus, Bellicum Pharmaceuticals, Kecellitics Biotech Company Ltd, Yake Biotechnology, Minerva Biotechnologies, Allogene Therapeutics, PersonGen BioTherapeutics (Suzhou), Precision BioSciences, Pregene (ShenZhen) Biotechnology Company, Shanghai GeneChem, Shanghai Longyao Biotechnology, Shenzhen BinDeBio, and others are evaluating novel CAR T-cell Therapy drugs candidate to improve the treatment landscape. Key CAR T pipeline therapies in various stages of development include Breyanzi, Kymriah, CT103A, CEA CAR-T, Descartes-11, CNCT19, CTL119, P-BCMA-101, CD19/CD20/CD22/CD30 CAR T-cell therapy, CD19-targeted CAR T-cells, EPCAM-targeted CAR-T cells, TT11, CD19+CD22 CAR-T cell sequential therapy, CART-19/22, MB-CART2019.1, JCAR017, AUTO4, AUTO3, IM19 CAR-T, CSG-CD19, CT053, Descartes-08, Orvacabtagene autoleucel, CAR-T CD30, PCAR-19B, BCMA CAR-T cells, CD123 CAR-T cells, CD19 CAR-T cells, ET140202, CIK-CAR.CD19, BG-T19, Autologous CD19-targeting CAR T cells (Senl-001), MB-102, Autologous CAR-T CD44v6 cell therapy, AU101, ATA2271, AU105, AUTO1, BPX-601, Anti-CD22 CAR, CAR-T cells targeting CD19 and CD22, huMNC2-CAR44 CAR T-cells, CD19-CART, ALLO-501A, AUTO1/22, ET 1402L1-CART, BPX-603, CAR-CD44v6, MB-106 (CD20 CAR), Anti-MUC1 CAR-T cells, PCAR-019, PBCAR0191, PBCAR20A, PBCAR269A, BCMA CAR T-cells, CAR19 CAR T cells, MG7-CART Cells, GPC3 – CART Cells, Anti-CD19 and Anti-CD20 CAR-T Cells, Humanized CD19 CAR-T cells, Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy, Mesothelin CAR-T cell therapy, and others. In May 2022, Novartis announced the US Food and Drug Administration (FDA) had granted accelerated approval for Kymriah (tisagenlecleucel) for the treatment of adult patients with relapsed or refractory (r/r) follicular lymphoma (FL) after two or more lines of systemic therapy. Kymriah is now FDA-approved in three indications and remains the only CAR-T cell therapy approved in both adult and pediatric settings. In April 2022, the FDA approved axicabtagene ciloleucel (brand name Yescarta) for adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or relapses within 12 months of first-line chemoimmunotherapy. It is not indicated for treating patients with primary central nervous system lymphoma. In March 2022, JW Therapeutics announced that it had received the Investigational New Drug (IND) clearance from the National Medical Products Administration (NMPA) of China for a pivotal clinical trial of its anti-CD19 autologous chimeric antigen receptor T (CAR-T) cell immunotherapy product Carteyva (relmacabtagene autoleucel injection) in the treatment of second-line large B-Cell lymphoma. In February 2022, Fully human anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T-cell therapy (CT103A) received orphan drug designation (ODD) from the FDA for the treatment of relapsed and/or refractory multiple myeloma (R/R MM), according to a press release by IASO Biotherapeutics. In June 2021, based on ZUMA-3 study data, the US FDA accepted the supplemental Biologics License Application (sBLA) and granted Priority Review designation for Tecartus for the treatment of adult patients with relapsed or refractory B-cell precursor ALL. In April 2021, the Janssen Pharmaceutical Companies of Johnson & Johnson announced that they had submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval of cilta-cel for the treatment of patients with relapsed and refractory multiple myeloma. In March 2021, the FDA approved Abecma (idecabtagene vicleucel), a cell-based CAR T - Cell Therapy to treat adult patients with multiple myeloma who have not responded to or whose disease has returned after at least four prior lines (different types) of therapy. Abecma is the first cell-based CAR T - Cell Therapy approved by the FDA for treating multiple myeloma. Request a sample and discover the recent advances in CAR T therapies @ CAR T-cell Therapy Competitive Landscape Report CAR T-cell Therapy Overview Chimeric antigen receptors (CARs) are recombinant antigen receptors that redirect the specificity and function of T lymphocytes and other immune cells in a single molecule. Cancer Immunotherapy is one of the most promising approaches for treating severe diseases (including cancer, autoimmune diseases, and allergic-hypersensitivity reactions) because it uses and improves the immune system's standard capacity. CAR T-cells are proteins that are fusions of a specific monoclonal antibody's single-chain fragment variable and one or more T-cell receptor intracellular signaling domains. A CAR combines antigen-binding domains—most commonly, a single-chain variable fragment (scFv) derived from antibody variable domains—with TCR chain signaling domains and costimulatory domains from receptors such as CD28, OX40, and CD137. For more information about CAR T-cell therapy drugs; visit @ CAR T-cell Therapy Process CAR T-cell Therapy Pipeline Analysis: Drug Profile JWCAR029: JW Therapeutics JW Therapeutics drug JWCAR029 is a CAR-T cell product that targets CD19 and is intended to treat advanced lymphoma and leukemia (Second-line therapy or greater). The molecule is currently in phase II of development. JWCAR029 is initially being investigated for the treatment of B-cell malignancies, with a focus on relapsed and refractory DLBCL. The National Medical Products Administration ("NMPA") accepted for review its NDA for relma-cel as a third-line treatment for DLBCL in June 2020. KTE-X19: Gilead Sciences Gilead Sciences drug KTE-X19 is an autologous CD19 CAR T-cell therapy under investigation. The drug is manufactured using the XLP process, including T-cell selection and lymphocyte enrichment. Lymphocyte enrichment is required in certain B-cell malignancies for which KTE-X19 is being studied. KTE-X19 is currently in Phase II clinical trials for the treatment of both adult and pediatric acute lymphocytic leukemia. Brexucabtagene autoleucel (formerly KTE-X19; Tecartus) has been approved by the FDA for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL). A snapshot of the CAR T-cell Therapy Pipeline Drugs mentioned in the report: Learn more about FDA approved CAR T-cell therapy @ CAR T Clinical Trials Scope of the CAR T-cell Therapy Competitive Landscape Report Coverage: Global Key CAR T-cell Therapy Companies: Alnylam Pharmaceuticals, JW Therapeutics, Gilead Sciences, Janssen Pharmaceuticals, Innovent Biologics, Sorrento Therapeutics, Cartesian Therapeutics, CASI Pharmaceuticals, Juventas Cell Therapy, Novartis, Poseida Therapeutics,Shanghai Unicar-Therapy Bio-medicine Technology, Sinobioway Cell Therapy Co., Ltd., Tessa Therapeutics, Wuhan Bio-Raid Biotechnology, Miltenyi Biomedicine, Bristol-Myers Squibb, Autolus Limited, Beijing Immunochina Medical Science and Technology, Carsgen Therapeutics, Cellular Biomedicine Group, Chongqing Precision Biotech, Eureka Therapeutics, Formula Pharmaceuticals, Guangzhou Bio-gene Technology, Hebei Senlang Biotechnology, Mustang Bio, MolMed, Aurora BioPharma, Atara Biotherapeutics, Autolus, Bellicum Pharmaceuticals, Kecellitics Biotech Company Ltd, Yake Biotechnology, Minerva Biotechnologies, Allogene Therapeutics, PersonGen BioTherapeutics (Suzhou), Precision BioSciences, Pregene (ShenZhen) Biotechnology Company, Shanghai GeneChem, Shanghai Longyao Biotechnology, Shenzhen BinDeBio, and others Key CAR T-cell Therapies in Pipeline: Breyanzi, Kymriah, CT103A, CEA CAR-T, Descartes-11, CNCT19, CTL119, P-BCMA-101, CD19/CD20/CD22/CD30 CAR T-cell therapy, CD19-targeted CAR T-cells, EPCAM-targeted CAR-T cells, TT11, CD19+CD22 CAR-T cell sequential therapy, CART-19/22, MB-CART2019.1, JCAR017, AUTO4, AUTO3, IM19 CAR-T, CSG-CD19, CT053, Descartes-08, Orvacabtagene autoleucel, CAR-T CD30, PCAR-19B, BCMA CAR-T cells, CD123 CAR-T cells, CD19 CAR-T cells, ET140202, CIK-CAR.CD19, BG-T19, Autologous CD19-targeting CAR T cells (Senl-001), MB-102, Autologous CAR-T CD44v6 cell therapy, AU101, ATA2271, AU105, AUTO1, BPX-601, Anti-CD22 CAR, CAR-T cells targeting CD19 and CD22, huMNC2-CAR44 CAR T-cells, CD19-CART, ALLO-501A, AUTO1/22, ET 1402L1-CART, BPX-603, CAR-CD44v6, MB-106 (CD20 CAR), Anti-MUC1 CAR-T cells, PCAR-019, PBCAR0191, PBCAR20A, PBCAR269A, BCMA CAR T-cells, CAR19 CAR T cells, MG7-CART Cells, GPC3 – CART Cells, Anti-CD19 and Anti-CD20 CAR-T Cells, Humanized CD19 CAR-T cells, Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy, Mesothelin CAR-T cell therapy, and others. Dive deep into rich insights for CAR T-cell therapy drugs; visit @ FDA-approved CAR T-cell Therapy Table of Contents For further information on the CAR T-cell therapy pipeline therapeutics, reach out @ CAR T-cell Therapy Clinical Trials Related Reports CAR T-cell Therapy for Acute Lymphoblastic Leukemia Market CAR T-cell Therapy for Acute Lymphoblastic Leukemia Market Insights, Epidemiology, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key CAR T-cell therapy for acute lymphoblastic leukemia companies, including Autolus, Pepromene Bio, Actinium Pharmaceuticals, among others. CAR T-cell Therapy for Multiple Myeloma Market CAR T-cell Therapy for Multiple Myeloma Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key CAR T-cell therapy for multiple myeloma companies, including Novartis, Yake Biotech, Celgene Corporation, among others. CAR T-cell Therapy for Non-Hodgkin's Lymphoma Market CAR T-cell Therapy for Non-Hodgkin's Lymphoma Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key CAR T-cell therapy for non-Hodgkin's lymphoma companies, including Juno Therapeutics, Allogene Therapeutics, Caribou Biosciences, among others. CAR T-cell Therapy for Acute Lymphoblastic Leukemia Pipeline CAR T-cell Therapy for Acute Lymphoblastic Leukemia Pipeline Insight – 2022 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key CAR T-cell therapy for acute lymphoblastic leukemia companies, including Autolus, Pepromene Bio, Actinium Pharmaceuticals, among others. CAR T-cell Therapy for Multiple Myeloma Pipeline CAR T-cell Therapy for Multiple Myeloma Pipeline Insight – 2022 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key CAR T-cell therapy for multiple myeloma companies, including Novartis, Yake Biotech, Celgene Corporation, among others. CAR T-cell Therapy for Non-Hodgkin's Lymphoma Pipeline CAR T-cell Therapy for Non-Hodgkin's Lymphoma Pipeline Insight – 2022 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key CAR T-cell therapy for non-Hodgkin's lymphoma companies, including Juno Therapeutics, Allogene Therapeutics, Caribou Biosciences, among others. 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NKarta Therapeutics is using engineered chimeric antigen receptor natural killer cells (CAR-NK cells) for allogeneic therapy, showing substantial benefits both in vitro and in vivo, according to James Trager, CSO, speaking Wednesday at the virtual CAR-TCR Summit – Europe. Specifically, one of NKarta’s two lead compounds, NKX019, “showed robust activity, longer half-life than non-engineered NK cells, faster onset of activity, and the production of fewer cytokines than CAR T cells. A first-in-human trial of NKX019 in B cell malignancies is planned for 2H 2021,” Trager said. “Natural killer cells are the cornerstone of innate immune surveillance,” Trager said. They offer allogeneic, “off-the-shelf” accessibility. NKarta’s engineering enhances their persistence and tumor targeting. “They are more potent when used allogeneically, and can be scaled to a large degree. They also can be cryopreserved, which lowers the cost of manufacturing,” Trager said. The company’s engineered NK cell program is based on four core technologies. For expansion, the program co-cultures cells with a stimulatory cell line to achieves high doses. Persistence is achieved by expressing membrane-bound IL-15 (mbIL15). For tight targeting, the cells are engineered to express optimized CARs. “Researchers can put on different targeting heads to change the tropism of the cells,” Trager said. Cryopreservation, the fourth technology, exacts no toll on the cells. Their effectiveness matches that of non-cryopreserved cells. Notably, NKarta expands the cells before transducing them. “This puts the expensive part of the process up front,” he explained. “Efficacy is much greater when cells are in a robustly proliferatively state, so the expansion and retroviral engineering occur during the first few days.” Although such early expansion is not necessarily easy to achieve, “working with small cell numbers lowers cost of goods.” “After that, we’re expanding in a bioreactor,” he continued, where continued expansion is driven by the expression of mbIL-15. This approach drives large-scale manufacturing, enabling NK cells to be expanded more than 1,000-fold (including viral transduction) in two weeks. Trager shared a chart showing the expansion level at 3,364 cells after 15 days. Projected cost estimates for commercial manufacturing, at 500 doses per batch, are approximately $2,000 per dose. “That’s very competitive in the cell therapy field,” Trager said. “A lot of work goes into this,” he pointed out, discussing NK cell engineering. “NK cells, even before we engineer them, provide initial control over tumor cells, but they lose control after a couple of challenges.” NKarta’s engineered, but-not-yet optimized CAR NK cells, in contrast, can withstand six to seven challenges. Optimized CAR-NK cells withstood more than seven challenges by tumor cells. “Cryopreservation is difficult to achieve while maintaining potency,” Trager noted, but NKarta seems to have succeeded. In a chart comparing the activity of cryopreserved and thawed CAR-NK cells to fresh and non-engineered NK cells, the differences in activity among fresh cells and three runs of frozen and thawed NKX101 cells were minuscule. The real difference was between engineered and non-engineered cells. Tumor activity was approximately three-fold lower for fresh and frozen/thawed CAR-NK cells than non-engineered NKs, and approximately six-fold lower than for controls, thus reinforcing the superiority of the engineered cells. As Trager said, NKX019, a CD-19-targeted CAR NK, provides “stunning potency” and “options for patients the point of need with, possibly, less risk or toxicity.” Others are reporting beneficial results, too. A trial at MD Anderson Cancer Center (published in the New England Journal of Medicine last year) involving Takeda’s CAR19-NK showed complete responses in more than half of patients with advanced B cell malignancies, and no instances of cytokine release syndrome, graft versus host disease, or neurotoxicity. NKarta’s studies in mice indicated that cryopreserved NKX019 inhibited tumor activity in lymphoma models, as well as prolonged persistence in tumor-naïve mice. Non-engineered NK cells “have a half-life of about nine days. We can roughly double that with engineering,” Trager elaborated. The goal of this therapy is to maintain the NK cells’ potency while delivering a large number of cells and to ensure acceptable safety profiles. In the case of NKX019, cytokine generation is one-to-two levels of magnitude lower than with unengineered CAR T cells so, Trager surmised, “there’s low risk of triggering cytokine release syndrome.” Additionally, NKX019 works swiftly, with a faster onset of activity and enhanced potency that combine to kill tumor cells faster than CAR19 T cells. NKarta also is exploring the synergy between NK and T cells for enhanced potency. “When we combine the two cell types, we see greater potency, and additive activity… that is greater than the sum of the individual components,” he said. That synergy between NK and T cells stimulated NK cell proliferation and depressed – but did not halt – T cell proliferation. Furthermore, combining CAR19-NK and CAR19-T cells lowered the accumulation of cytokines associated with cytokine release syndrome. “NK cells act as a sink for cytokines,” Trager pointed out. In mouse models, “The NK or T cells provided limited control but, when combined, survival extended to four months (and in one mouse, six months) before dying of natural causes. NKarta is eager to learn, later this year, whether such benefits translate to humans.