On August 21, 2023, Shanghai Tinova Immune Therapeutics Co., Ltd., a wholly-owned subsidiary of Novatim Immune Therapeutics (Zhejiang) Co., Ltd., successfully obtained approval from the Drug Evaluation Center (CDE) of the National Medical Products Administration for the clinical trial application of its new-generation CAR-T product KQ-2003, an autologous chimeric antigen receptor T-cell injection. The Phase I clinical study will be conducted at Peking Union Medical College Hospital, focusing on patients with relapsed/refractory multiple myeloma who have received three or more lines of treatment.
As of the approval date, there have been 10 evaluable patients in the IIT study of KQ-2003 CAR-T cell injection for the treatment of relapsed/refractory multiple myeloma. Among these 10 patients, the overall response rate (ORR) was 100%, with 5 achieving complete remission (CR) and 5 achieving very good partial remission (VGPR). The longest progression-free survival (PFS) was maintained for 21 months. No grade 3 or above cytokine release syndrome (CRS) occurred. The preliminary data available indicate that KQ-2003 CAR-T cell injection is safe and effective.
Dr. Wu Guoxiang, the founder and chairman of Novatim, stated: "KQ-2003 CAR-T cell injection is a CAR-T product specifically for patients with relapsed/refractory multiple myeloma. In the ongoing IIT clinical study, the ORR for patients with relapsed/refractory multiple myeloma was 100%, demonstrating excellent therapeutic effects. The approval of this IND also fully indicates the CDE's high recognition of the existing clinical trial data and this product. Novatim will continue to explore and develop more candidate products in the field of tumor immunology that are first-in-class or best-in-class, providing more treatment options for patients." “
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 profound and lasting therapeutic effects to more patients with relapsed/refractory multiple myeloma.
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. It wholly owns
Shanghai Tinova Immune Therapeutics Co., Ltd. Based on clinical needs and its focus on tumor immunotherapy, the company has established research platforms for dual-function antibodies, bispecific ADC, and CAR-T, and has developed nearly 10 FIC/BIC products.
The first core product independently developed by Novatim, a targeted PD-1 mutant IL-2 fusion protein - KY-0118 injection, features a unique design concept that functions as a new-generation agonist. It is known that the research progress of this product in the same field ranks second globally, only after 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 shown good safety and significant effectiveness.
