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    Home > Active Ingredient News > Antitumor Therapy > The third-generation CAR-T of Mustang Biotech obtains US FDA approval for IND application to initiate clinical research | Yimai Meng broke the news

    The third-generation CAR-T of Mustang Biotech obtains US FDA approval for IND application to initiate clinical research | Yimai Meng broke the news

    • Last Update: 2021-05-21
    • Source: Internet
    • Author: User
    Search more information of high quality chemicals, good prices and reliable suppliers, visit www.echemi.com
    Recent popular reports by Yimike ★ CD70 CAR-NK for treatment of solid tumors! CRISPR Therapeutics and Nkarta reached a global partnershipYimai Meng broke the news ★ miRNA treats diabetes! Different from the mechanism of traditional drugs, has the era of super drugs come? MedMed broke the news on May 12, 2021/MedClub News/--Recently, Mustang Bio announced that the US FDA has accepted the IND application for its CD20 CAR-T candidate product MB-106.
    Initiated phase 1/2 clinical research to develop the safety, tolerability and safety of MB-106 for the treatment of relapsed or refractory B-cell non-Hodgkin’s lymphoma (B-NHL) and chronic lymphocytic leukemia (CLL) Effectiveness.

    MB-106 is an autologous CAR-T cell targeting CD20, which is optimized as the third-generation CAR of fully human antibody.

    MB-106 was developed by Fred Hutchinson Cancer Research Center (Fred Hutch) and was exclusively licensed to Mustang Bio in 2017.

    At the 62nd Annual Meeting of the American Society of Hematology (ASH), Wild Horse Biology announced the Phase 1/2 clinical trial of MB-106 for relapsed or refractory B-cell non-Hodgkin’s lymphoma (NHL) sponsored by Fred Hutch (NCT03277729) research data.

    The data showed that among the 9 evaluable patients, the overall response rate (ORR) was 89%, and the complete response rate (CR) was 44%; in patients with follicular lymphoma (n=7), the ORR was 85%.
    The CR is 57%.Recommended reading: ASH 2020: Mustang Bio-CD20 CAR-T has achieved positive research results in the treatment of B-NHLYMeng broke the news, Mustang Bio-President and CEO Manuel Litchman said: "We are very pleased that the US FDA has accepted our MB-106 IND.
    Application, it is gratifying that we received a response only 28 days after submitting the IND.

    We are committed to finding better treatment options for cancer patients and look forward to launching our multi-center Phase 1/2 later this year For clinical trials, the research will be headed by Mazyar Shadman, associate professor of Fred Hutch's clinical research department.

    "CAR-T update iteration has experienced decades of development, and CAR-T cell technology has matured.
    The current CAR structure has developed to the fourth generation.
    Fifth Generation.

    The first generation CAR is composed of extracellular binding domain, hinge domain, transmembrane domain and signal domain.

    There is only one intracellular signal transduction domain (mainly CD-3ζ or FcRγ), which only express single-chain antibodies on T cells and target tumor cell surface antigen molecules, but its short duration limits its effectiveness.

    The second-generation CAR adds functional domains of costimulatory molecules, such as CD28 or 4-1BB.

    This can promote cell proliferation, secretion of cytokines, prolong the survival time in the body, and resist apoptosis.

    The third-generation CAR adds more costimulatory domains, such as CD28-4-1BB or CD28-OX40, to improve the viability of T cells.

    The fourth generation CAR, also called armored CAR, adds more functional domains, which can be derived from ligands of IL-2, IL-5, IL-12 or costimulatory molecules, in an immunosuppressive tumor microenvironment , By releasing pro-inflammatory factors to recruit and activate more immune cells, causing a wider anti-tumor immune effect.

    The fifth-generation allogeneic CAR-T, by knocking out genes that may cause immune rejection from allogeneic T cells, provides the possibility for the large-scale production and immediate application of CAR-T therapy.

    Novartis’ Kymriah and Gilead/Kite’s Yescarta, both of which have CAR structures belong to the second generation.

    At present, a good clinical remission rate has been achieved in hematoma.

    However, the curative effect of CAR-T treatment still needs to be optimized.
    The existing difficulties include high recurrence rate, poor treatment effect of solid tumors, long autologous product preparation cycle and other application difficulties; as well as side effects such as cytokine release syndrome and off-target toxicity.

    Based on this, the industry is also actively seeking breakthroughs and vigorously developing innovative technologies to further promote the all-round development of CAR-T cell therapy.

    In the second quarter of 2021, Medical Microbiology Class and Thermo Fisher Scientific will launch a series of online seminars on "Decoding Cellular Immunotherapy, Striving for the Present and the Future".
    At that time, you are welcome to communicate and learn online! The third course will be launched at 20:00 on the evening of May 20th.
    Zhang Jiqin, vice president of Shanghai Bangyao Biotechnology Co.
    , Ltd.
    , and Zhou Jing, an expert on cell and gene therapy products from Thermo Fisher, will bring the "Next Generation of New CAR-T Wonderful sharing of R&D and Commercialization Total Solution.

    Reference materials: 1.
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