Kech Biopharma's Global First-in-Class BCMA×CD19 Dual-Targeting CAR-T Therapy KQ-2003 Receives IND Approval for Relapsed/Refractory POEMS Syndrome

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On March 27, according to the CDE official website, "KQ-2003 Autologous Chimeric Antigen Receptor T-cell Injection" developed by Novatim Immune Therapeutics (Zhejiang) Co., Ltd. ("Novatim") has obtained clinical trial implied permission, for the indication of relapsed/refractory POEMS syndrome.

Multiple Myeloma (MM) is one of the most common blood cancers and is a malignant disease characterized by the abnormal clonal proliferation of plasma cells.For newly diagnosed multiple myeloma patients, commonly used first-line treatment drugs include proteasome inhibitors, immunomodulatory agents, and alkylating agents.For the majority of initial patients who respond effectively to treatment, after a period of disease stabilization, they will inevitably enter the relapse or refractory stage, and the remission rate and survival rate for relapsed/refractory multiple myeloma are low.Therefore, there are still unmet needs in this field.

KQ-2003 Autologous Chimeric Antigen Receptor T-Cell Injection is a next-generation CAR-T product that can simultaneously target two therapeutic targets: B-cell maturation antigen (BCMA) and CD19.BCMA is primarily expressed in mature B lymphocytes and plasma cells.One of its biggest characteristics is that it is expressed in all multiple myeloma cells, making it an ideal antigen target for the treatment of multiple myeloma.. AndCD19 is an antigen widely expressed in B-cell cancers, which can enhance B-cell receptor-mediated signaling pathways and support B-cell survival, making it one of the important targets for targeting B-cell cancers. BCMA/CD19 dual-target CAR-T productExpected to bring new treatment hope and deep, lasting therapeutic effects to more patients with relapsed/refractory multiple myeloma.

KQ-2003It is also the world's first CAR-T therapy targeting POEMS syndrome., marking the third innovative drug project from Novatim to enter the clinical stage.

Novatim Immune Therapeutics (Zhejiang) Co., Ltd. was founded in 2018 as a biopharmaceutical technology enterprise focused on the research and development of innovative drugs for cancer immunotherapy and their clinical applications, wholly owning and controlling Shanghai Novatim Pharmaceuticals Technology Co., Ltd. The company has established several R&D platforms, including a bispecific antibody platform, a nano-bispecific ADC platform, and an enhanced dual-target CAR-T platform, and has developed nearly 10 FIC/BIC products.