Ningetinib Tosylate

SHANGHAI, Dec. 12, 2022 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, announces that at the 2022 American Society of Hematology (the "ASH") Annual Meeting, the Company presented a poster with the results of the phase II LUMMICAR STUDY 1 clinical trial of zevorcabtagene autoleucel ("zevor-cel", R&D code: CT053, an autologous CAR T-cell product candidate against BCMA) in Chinese patients with relapsed/refractory multiple myeloma (R/R MM). This poster reports for the first time the pivotal phase II safety and efficacy data of LUMMICAR STUDY 1. Poster: Phase Ⅱ Study of Fully Human BCMA-Targeted CAR T Cells (Zevorcabtagene Autoleucel) in Patients with Relapsed/Refractory Multiple Myeloma Zevor-cel, a fully human autologous CAR T-cell product targeting B-cell maturation antigen (BCMA), is being evaluated for patients with R/R MM in LUMMICAR STUDY 1 (NCT03975907), an ongoing phase I/II clinical trial in China. Results for the 14 subjects treated in phase I of LUMMICAR STUDY 1 showed a well-tolerated safety profile, plus deep and durable responses with an objective response rate (ORR) of 100% and a complete response/stringent complete response (CR/sCR) rate of 78.6%. A total of 102 patients with R/R MM were treated with zevor-cel at the dose of 150×106 CAR+ T cells. The patients had a median age of 59.5 years, the median time from diagnosis was 3.6 years, and the median prior lines of therapy was 4 (range, 3–15). Of the treated patients, 39 (38.2%) had International Staging System stage III disease; 46 (45.1%) patients had high-risk cytogenetic abnormalities, defined as del(17p), t(4; 14), t(14; 16), t(14; 20); and 24 (23.5%) patients had received autologous stem cell transplantation. The lymphodepletion regimen comprised cyclophosphamide at 300 mg/m2 and fludarabine at 25 mg/m2 daily for 3 days before zevor-cel treatment. Safety Zevor-cel was well tolerated with manageable safety profile. The treatment-related adverse events (AEs) were reported for 102 patients, and the AEs mainly comprised the lymphodepletion-related hematologic toxicities. A total of 92 (90.2%) patients experienced cytokine release syndrome (CRS) with 7 (6.9%) at grade 3 or 4, and all patients recovered from CRS. No grade 3 or higher neurotoxicity was identified. Two immune effector cell-associated neurotoxicity syndrome (ICANS) events (both grade 1) occurred, and the patients recovered without the use of tocilizumab or steroids. Treatment-related serious adverse events (SAEs) occurred in 38 (37.3%) patients, mainly comprising hematologic toxicities and infections. No AE led to discontinuation of zevor-cel infusion. One treatment-related death occurred 5 months post CAR T-cell infusion from severe pneumonia in a patient who had a history of chronic pneumonia. Efficacy At the update cut-off date of August 16, 2022, 102 patients had at least 3 months follow-up or early withdrawal, among whom 60 patients had at least 6 months follow-up or early withdrawal. For all 102 patients, the median follow-up was 9 months (range, 0.4–17.8 months), the ORR was 92.2% (95% CI, 85.13, 96.55), the rate of very good partial response (VGPR) or better was 85.3%, and the CR/sCR rate was 45.1%. Further, among the first 60 patients treated in the current study with a median follow-up of 12.1 months (0.4–17.8 months), the CR/sCR rate was 56.7%. The median DOR and median PFS were not reached. At 9 months median follow-up, the DOR rate was 86.1% and the PFS rate was 84.6%. Minimal residual disease (MRD) status was assessed in patients achieving VGPR or better. The MRD negativity rate (sensitivity of <10−5 nucleated cells) was 100% in patients with CR/sCR and 96.3% in patients with VGPR or better. Conclusion Preliminary results of the pivotal phase II LUMMICAR STUDY 1 showed that zevor-cel delivered deep and durable responses in patients with heavily pre-treated R/R MM. Dr. Raffaele Baffa, Chief Medical Officer of CARsgen Therapeutics, said: "We are delighted to present the pivotal phase II data from the LUMMICAR STUDY 1 of zevor-cel at the ASH Annual Meeting this year. The data highlighted the promising safety and efficacy of zevor-cel in patients with heavily pre-treated relapsed/refractory multiple myeloma. The New Drug Application for zevor-cel has been accepted by NMPA and is currently under priority review. We look forward to the approval of zevor-cel in China and will continue to accelerate the global development to benefit patients worldwide." About Zevor-cel Zevor-cel (CT053) is a fully human, autologous BCMA CAR T-cell product candidate for the treatment of R/R MM. The New Drug Application (NDA) for zevor-cel based on the phase I/II data from LUMMICAR STUDY 1 in China has been accepted by NMPA. CARsgen is conducting the phase 1b/2 LUMMICAR STUDY 2 clinical trial in North America to evaluate the safety and efficacy of zevor-cel for R/R MM in that population. The Company also plans to conduct additional clinical trials to develop zevor-cel as an earlier line of treatment for multiple myeloma. Zevor-cel received Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug designations from the U.S. FDA in 2019, as well as the Priority Medicines (PRIME) and Orphan Medicinal Product designations from the European Medicines Agency (EMA) in 2019 and 2020, respectively. Zevor-cel also received Breakthrough Therapy designation from the NMPA in 2020. The Company believes that zevor-cel is well positioned to potentially reshape the treatment paradigm for multiple myeloma and become a foundational treatment for multiple myeloma patients. About CARsgen Therapeutics Holdings Limited CARsgen is a biopharmaceutical company with operations in China and the U.S. and is focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors. The Company has built an integrated cell therapy platform with in-house capabilities that span target discovery, antibody development, clinical trials, and commercial-scale manufacturing. CARsgen has internally developed novel technologies and a product pipeline with global rights to address major challenges of CAR T-cell therapies, such as improving the safety profile, enhancing the efficacy in treating solid tumors and reducing treatment costs. The Company's vision is to become a global biopharmaceutical leader that brings innovative and differentiated cell therapies to cancer patients worldwide and makes cancer curable. Contact Us For more information, please visit SOURCE CARsgen Therapeutics

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. 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