BCMA car-t therapy made in China! Clinical data of Xinda biological / reindeer medical cooperative product ibi326 was presented at ash annual meeting, with a total remission rate of 100%!

December 12, 2019 news / BIOON / -- Xinda biopharmaceutical Co., Ltd is a biopharmaceutical company dedicated to R & D, production and sales of innovative drugs for the treatment of major diseases such as tumor, autoimmune and metabolic diseases Recently, the company announced that it and Nanjing reindeer Medical Technology Co., Ltd (reindeer medical) jointly reported the latest clinical data of BCMA car-t (Xinda biological R & D Code: ibi326; reindeer medical R & D Code: ct103a) jointly developed by the two sides in the 61st annual meeting of American Hematology (ash) for the treatment of relapsed / refractory multiple myeloma (Abstract) The title of the speech is: "the efficacy and safety of all human BCMA car-t cells in the treatment of relapsed / refractory multiple myeloma." The conference will be held in Orlando, Florida from December 7 to 10, 2019 An IIT study carried out in Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of science and technology showed the safety, effectiveness and response durability of ibi326 products In the 18 classic phase I climbing trials completed, 17 patients could be evaluated, and the objective response rate (ORR) was 100% In addition, 70.6% patients achieved complete remission (SCR / Cr), 88.2% patients achieved very good partial remission (vgpr) or better efficacy The cytokine release syndrome (CRS) occurred in 17 / 18 patients (72.2% (13 cases), 16.7% (3 cases) and 5.6% (1 case) in grade 1-2), but it was controllable and neurotoxic Even in the lowest dose group (1 * 106 cells / kg), ibi326 remained 100% orr, of which 78% patients achieved good partial remission (vgpr) or better efficacy The study also included four patients who had previously experienced relapse after anti BCMA car-t treatment Their overall performance showed that ibi326 could also provide effective treatment options for relapsed patients after car-t treatment Dr Zhou Hui, vice president of biomedical science and strategic Oncology Department of Cinda, said: "this year's reports on ASCO, EHA and ash indicate that Cinda biology and caribou medicine have achieved exciting results in the field of cell therapy in this year We are very pleased to see that patients have a very high response rate to this treatment and have extended the time for remission We are very looking forward to our phase II clinical trial early next year, which will bring hope for more patients to be cured " On September 10, 2019, the ind of the ibi326 Ib / phase II chimeric scheme was implicitly approved by the National Drug Administration (nmpa), and phase II clinical trials are expected to start in early 2020 Multiple myeloma is a fatal hematologic tumor Due to bone marrow infiltration and abnormal immunoglobulin production, anemia, renal failure, infection, fracture and hypercalcemia are the most common hematologic problems The incidence rate is 2/100000 after Hodgkin's lymphoma For the patients with primary multiple myeloma, the common first-line treatment drugs include proteasome inhibitors, immunomodulators and alkylating agents For the majority of patients, the common first-line treatment can make the patient's condition stable for 3-5 years, but there are also a few patients in the initial treatment for primary drug resistance, the condition can not be effectively controlled Relapsed patients: patients who have achieved complete remission after treatment and the disease reappears The refractory patients are: Patients with primary drug resistance; after standard first-line treatment, the disease can not be alleviated or the patients with disease progress within 60 days after achieving minor remission For most of the first-time patients, after 3-5 years of stable disease, they will inevitably enter the stage of relapse and difficult treatment For these patients, the overall effective rate of the existing second-line treatment is about 40% to 70%, and the remission time is short About ibi326 (BCMA car-t) ibi326 is an innovative car-t cell therapy product jointly developed by Cinda biology and caribou medical Previous studies have shown that patients with recurrent / refractory multiple myeloma (R / RMM) treated with high-dose BCMA car-t cells may get better remission, but the adverse events are more serious In addition, once the disease worsens again, the re transfusion of car-t cells is ineffective The development of ibi326 is expected to overcome this problem The car contains all human scFv, CD8a hinge and transmembrane, 4-1BB co stimulation and cd3z activation domains Based on strict screening and comprehensive in vitro and in vivo functional evaluation, ibi326 car-t product has strong and rapid efficacy and outstanding response durability Source: Xinda biology