Kech Biopharma's KQ-2003, the World’s First CAR-T Therapy for POEMS Syndrome, Receives CDE IND Clearance

On March 27, 2024, according to the announcement on the CDE's official website, KQ-2003 Autologous Chimeric Antigen Receptor T-cell Injection (for the treatment of POEMS syndrome), a next-generation enhanced dual-target CAR-T product independently developed by Novatim Immune Therapeutics (Zhejiang) Co., Ltd., has received tacit approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for clinical trials. The clinical trial for treating relapsed/refractory POEMS syndrome will soon be conducted at Peking Union Medical College Hospital.KQ-2003 is the world's first CAR-T cell injection for the treatment of POEMS syndrome.It is also the third innovative drug project of Novatim to enter the clinical stage.

POEMS SyndromePOEMS 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), involving multiple systems with abnormal proliferation of plasma cells. Currently, the pathogenesis of POEMS syndrome remains unclear. It often presents with polyneuropathy as the initial symptom, and elevated serum levels of vascular endothelial growth factor (VEGF) are considered the main pathogenic mechanism of POEMS syndrome.

KQ-2003The autologous chimeric antigen receptor T-cell injection is a next-generation enhanced dual-target CAR-T product independently developed from the ground up. It can simultaneously target two therapeutic targets: B-cell maturation antigen (BCMA) and CD19. In the future, it will bring new treatment hope and deep, lasting therapeutic effects to more patients with relapsed/refractory multiple myeloma and relapsed/refractory POEMS syndrome. Currently, clinical trials for the treatment of relapsed/refractory multiple myeloma and relapsed/refractory POEMS syndrome are being conducted with Peking Union Medical College Hospital as the central unit.

Novatim Immune Therapeutics (Zhejiang) Co., Ltd.Novatim Immune Therapeutics (Zhejiang) Co., Ltd., established in 2018, is a biopharmaceutical technology enterprise focused on the research and development of innovative drugs for cancer immunotherapy and their clinical applications. It wholly owns Shanghai Novatim Pharmaceutical Technology Co., Ltd. Based on clinical needs and its corporate positioning in cancer immunotherapy,Layout of bispecific antibody platform, nano-bispecific ADC platform, and enhanced dual-target CAR-T platformand other R&D platforms.Based on the hierarchical breakthrough of key technologies,Develop nearly 10 FIC/BIC products.

Novatim's first core product independently developed from the source —— KY-0118 Injection, a mutated IL-2 fusion protein targeting PD-1, features a unique design concept that harnesses the role of a new generation of agonists. It is a novel targeted IL-2 product that specifically activates CD8+T cells. Reportedly, the R&D progress of this product ranks in the first tier alongside Roche in the same field. Currently, clinical trials are being conducted with the PLA General Hospital as the central unit. Preliminary clinical trial data obtained so far has shown good safety and significant efficacy.