Recently, the Investigator Meeting for the "Phase I/IIa Clinical Study to Evaluate the Safety, Tolerability, Preliminary Efficacy and Pharmacokinetic Characteristics of KQ-2003 CAR-T Cell Injection in Patients with Relapsed/Refractory Multiple Myeloma" was held in Anji, Zhejiang Province, hosted by Novatim Immune Therapeutics (Zhejiang) Co., Ltd.
This research meeting was chaired by Dr. Li Jian, the director of the Department of Hematology at Peking Union Medical College Hospital and a doctoral supervisor. Nearly 20 researchers from five clinical trial centers, including Peking Union Medical College Hospital, Peking University First Hospital, Shanghai Fourth People's Hospital, the First Affiliated Hospital of Nanchang University, Henan Cancer Hospital, and Shanxi Cancer Hospital, as well as experts from Tongji Medical College Union Hospital of Huazhong University of Science and Technology and the Institute of Hematology of the Chinese Academy of Medical Sciences, the team from Novatim, and representatives from the contract research organization (CRO) Tigermed Company participated in the meeting both online and offline.
This meeting conducted a detailed analysis of the safety and efficacy data of the KQ-2003 CAR-T cell injection in the investigator-initiated clinical study (IIT) for the treatment of relapsed/refractory multiple myeloma. It also organized experts to have in-depth discussions on the clinical trial protocols and specific operational issues for relapsed/refractory multiple myeloma, thereby better ensuring the scientific nature of the clinical trials.
Dr. Wu Guoxiang, the founder and chairman of Novatim, extended a warm welcome and sincere gratitude to all the experts and the support from various research centers. KQ-2003, as the world's first CAR-T cell injection drug to have its IND application accepted by CDE for treating POEMS syndrome and also for treating relapsed/refractory multiple myeloma (RRMM) with dual indications, will surely bring more new hope to the treatment of hematological system tumors after its future launch.
Regarding KQ-2003
KQ-2003 is a new-generation CAR-T product independently developed. It can target both B-cell maturation antigen (BCMA) and CD19 as therapeutic targets simultaneously. In the future, it will bring new treatment hope and profound and lasting therapeutic effects to more patients with relapsed/refractory multiple myeloma and POEMS syndrome.
As of the meeting date, there were 18 evaluable patients in the IIT study of KQ-2003 CAR-T cell injection for the treatment of relapsed/refractory multiple myeloma. Among these 18 evaluable patients, the overall response rate (ORR) was 94.4%, with 14 achieving complete remission (sCR/CR), and the complete remission rate was 77.8%. 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.
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, nano-bispecific ADC, and CAR-T, and has developed nearly 10 FIC/BIC products.
The first core product independently developed at the source 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 Roche and is among the top globally. 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.
