Keyi Pharma's Dual-Target CAR-T Therapy KQ-2003 Receives CDE Approval for Clinical Trial in Relapsed/Refractory Multiple Myeloma with Promising IIT Results
VCBeat has learned that on August 21, 2023, the Investigational New Drug (IND) application for KQ-2003, a next-generation CAR-T product independently developed from scratch by Shanghai Keqi Pharmaceutical Technology Co., Ltd., a wholly-owned subsidiary of Keyi (Zhejiang) Pharmaceutical Technology Co., Ltd., was officially approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). The Phase I clinical trial of this autologous chimeric antigen receptor T-cell injection will soon be conducted at Peking Union Medical College Hospital, primarily targeting patients with relapsed/refractory multiple myeloma who have received three or more prior lines of therapy.
As of the approval date, 10 efficacy-evaluable patients have been enrolled in the investigator-initiated trial (IIT) of KQ-2003 CAR-T cell infusion for the treatment of relapsed/refractory multiple myeloma. Among these 10 patients, the overall response rate (ORR) was 100%, with 5 patients achieving complete response (CR) and 5 achieving very good partial response (VGPR). The longest progression-free survival (PFS) was maintained for 21 months. No grade 3 or higher cytokine release syndrome (CRS) occurred. Existing preliminary data indicate that KQ-2003 CAR-T cell infusion has a favorable safety and efficacy profile.
Dr. Wu Guoxiang, Founder and Chairman of Keyi Pharmaceutical, stated: “KQ-2003 CAR-T Cell Injection is a CAR-T product designed for patients with relapsed/refractory multiple myeloma. In the ongoing investigator-initiated trials (IIT), it has demonstrated an overall response rate (ORR) of 100% in patients with relapsed/refractory multiple myeloma, showcasing excellent therapeutic efficacy. The recent approval of the Investigational New Drug (IND) application fully reflects the Center for Drug Evaluation’s (CDE) high recognition of the existing clinical trial data and this product. In the future, Keyi Pharmaceutical will continue to explore and develop more first-in-class or best-in-class candidate products in the field of tumor immunotherapy, providing patients with additional treatment options.”
KQ-2003 Autologous Chimeric Antigen Receptor T-Cell Injection is a next-generation CAR-T product independently developed from the ground up. It simultaneously targets two therapeutic antigens, B-cell maturation antigen (BCMA) and CD19, and is poised to bring new hope and deep, durable therapeutic benefits to more patients with relapsed/refractory multiple myeloma.
Keyi (Zhejiang) Pharmaceutical Technology Co., Ltd. was established in 2018 as a biopharmaceutical technology enterprise focused on the research, development, and clinical application of innovative drugs for cancer immunotherapy. It is a wholly-owned subsidiary of Shanghai Keqi Pharmaceutical Technology Co., Ltd. Guided by clinical needs and its strategic focus on cancer immunotherapy, the company has established R&D platforms for bispecific antibodies, dual-target ADCs/dual-epitope ADCs, and CAR-T therapies, and is developing nearly 10 first-in-class (FIC) or best-in-class (BIC) product candidates.
Keyi Pharma’s first independently developed core product from the ground up, KY-0118 Injection—a mutant IL-2 fusion protein targeting PD-1—leverages a unique design concept to function as a next-generation agonist. Reportedly, this product ranks second globally in development progress within its field, trailing only Roche. Clinical trials are currently underway at the Chinese PLA General Hospital, with preliminary data demonstrating favorable safety and significant efficacy.