On January 3, 2024, the company Novatim Immune Therapeutics (Zhejiang) Co., Ltd. submitted an IND application for its new-generation CAR-T product KQ-2003, an autologous chimeric antigen receptor T-cell injection (for the treatment of POEMS syndrome) to the National Medical Products Administration's Drug Evaluation Center (CDE). The application has been accepted (application number: CXSL2400005). KQ-2003 is the world's first CAR-T cell injection for the treatment of POEMS syndrome to be accepted by CDE, and it is also the third innovative drug project of Novatim to enter the clinical stage.
Regarding POEMS syndrome
POEMS syndrome is a rare paraneoplastic syndrome characterized by multiple peripheral neuropathy (P), organ enlargement (O), endocrine disorders (E), monoclonal plasma cell disorder or M protein (M), and skin lesions (S). The pathogenesis of POEMS syndrome is still unclear at present. It usually presents with multiple neurological symptoms as the initial symptom, and the elevated level of vascular endothelial growth factor (VEGF) in the serum is considered to be the main pathogenic mechanism of POEMS syndrome.
Regarding KQ-2003
KQ-2003 Autologous Chimeric Antigen Receptor T-cell Injection is a new-generation CAR-T product independently developed. It can target both B-cell maturation antigen (BCMA) and CD19 as therapeutic targets. In the future, it will bring new treatment hope and long-lasting therapeutic effects to more patients with relapsed/refractory multiple myeloma and POEMS syndrome.
Regarding Novatim
Novatim Immune Therapeutics (Zhejiang) Co., Ltd. was established in 2018. It is a biopharmaceutical technology enterprise specializing in the research and clinical application of innovative drugs for tumor immunotherapy. Based on clinical needs and its focus on tumor immunotherapy, the company has established research platforms such as dual-function antibodies, bispecific ADC, and CAR-T, and has developed nearly 10 FIC/BIC products.
The first core product independently developed by Novatim, the targeted PD-1 mutant IL-2 fusion protein - KY-0118 injection, features a unique design concept that plays the role of a new-generation agonist. It is known that the research progress of this product in the same field is on par with that of Roche. Currently, it is undergoing clinical trials at the General Hospital of the People's Liberation Army of China. The preliminary clinical trial data have demonstrated good safety and significant efficacy.
