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    Home > Medical News > Latest Medical News > Boshengji Pharma's CAR-T therapy for neuroblastoma has been granted orphan drug designation by the FDA

    Boshengji Pharma's CAR-T therapy for neuroblastoma has been granted orphan drug designation by the FDA

    • Last Update: 2022-04-25
    • Source: Internet
    • Author: User
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    Transfer from | Medicine Guanlan

    On March 20, Boshengji Pharmaceutical Technology (Suzhou) Co.
    , Ltd.
    (hereinafter referred to as "Boshengji Medicine") announced that the company developed a chimeric antigen receptor (CAR)-T cell injection targeting B7-H3.
    (R&D code: TAA06 injection) has recently been granted orphan drug status by the US FDA for the treatment of neuroblastoma

    .

    The advent of CAR-T cell therapy is an important breakthrough in the field of cancer
    .
    Several CAR-T cell therapy products have been approved worldwide, bringing new options to many blood cancer patients

    .
    However, in the field of solid tumor treatment, CAR-T cell therapy products have not yet achieved breakthroughs

    .
    According to a press release from Boshengji Pharmaceuticals, the main reasons for the poor efficacy of CAR-T products in the field of solid tumors are that the heterogeneity of solid tumors easily leads to treatment escape, and the tumor immunosuppressive microenvironment hinders T cell homing and infiltration.

    .

    Neuroblastoma is one of the most common extracranial solid tumors in children with insidious onset and strong heterogeneity
    .
    Among them, high-risk neuroblastoma is called "the king of childhood tumors" because of its low cure rate

    .
    Because neuroblastoma is a low-immunogenic tumor, the effect of immunotherapy has been poor, and new treatment methods are urgently needed in clinical practice

    .

    In order to solve the above challenges, the R&D team of Boshengji Pharmaceuticals has developed TAA06 injection in a targeted manner
    .
    This is a CAR-T cell injection targeting B7-H3

    .
    B7-H3, a transmembrane protein of the B7 family, is frequently overexpressed in a variety of cancers including lung cancer, prostate cancer, breast cancer, etc.
    , and its overexpression is associated with poor prognosis of patients, which makes B7-H3 a an interesting anticancer target

    .

    According to the press release, Boshengji Medicine intends to develop TAA06 injection for the treatment of neuroblastoma
    .
    In preclinical studies, the drug candidate has achieved good pharmacodynamic and safety data

    .
    In addition, Boshengji Pharmaceutical also stated in the press release that the company has successfully developed a highly optimized fully automatic preparation process, which can effectively control the cost of the product, and improve the access of ordinary children to innovative CAR-T cell drugs.
    Accessibility creates the conditions

    .
    The orphan drug designation granted by the FDA this time is an important research progress for TAA06 injection

    .

    Note: Content has been deleted

    Original title: Boshengji CAR-T product obtained FDA orphan drug designation, targeting neuroblastoma!

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