On March 27, 2024, according to the official website of the Center for Drug Evaluation (CDE), KQ-2003, an autologous chimeric antigen receptor T-cell injection developed independently by Novatim Immune Therapeutics (Zhejiang) Co., Ltd. for the treatment of POEMS syndrome, has been granted the approval for clinical trials by the Center for Drug Evaluation of the National Medical Products Administration (NMPA). It is about to start clinical trials at Peking Union Medical College Hospital for the treatment of relapsed/refractory POEMS syndrome. KQ-2003 is the world's first CAR-T cell injection for the treatment of POEMS syndrome and is also the third innovative drug project of Novatim to enter the clinical stage.
Regarding POMES Syndrome
POEMS syndrome is a rare paraneoplastic syndrome characterized by polyneuropathy (P), organomegaly (O), endocrinopathy (E), monoclonal plasma cell disorder or M protein (M), and skin changes (S). Currently, the pathogenesis of POEMS syndrome remains unclear. It often presents with polyneuropathy as the initial symptom, and the elevation of vascular endothelial growth factor (VEGF) levels in serum is considered the main pathogenic mechanism of POEMS syndrome.
Regarding KQ-2003
KQ-2003 autologous chimeric antigen receptor T-cell injection is a new-generation enhanced dual-target 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 lasting therapeutic effects to more patients with relapsed/refractory multiple myeloma and relapsed/refractory POEMS syndrome. Currently, clinical trials for treating relapsed/refractory multiple myeloma and relapsed/refractory POEMS syndrome are being conducted under the leadership of Peking Union Medical College Hospital.
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. The company, based on clinical needs and its focus on tumor immunotherapy, has established research platforms such as the dual-function antibody platform, the nano-bispecific ADC platform, and the enhanced dual-target CAR-T platform. Through breakthroughs at the level of key technologies, it has developed nearly 10 FIC/BIC products.
The first core product independently developed by Novatim from the source, the targeted PD-1 mutant IL-2 fusion protein - KY-0118 injection, features a unique design concept that enables the function of a new generation of agonists. It is a new type of targeted IL-2 product that specifically activates CD8+ T cells. It is known that in the same field, the research progress of this product is on par with Roche and is at the forefront of the first tier. Currently, clinical trials are being conducted at the General Hospital of the People's Liberation Army as the central unit. The preliminary clinical trial data have demonstrated good safety and significant effectiveness.
