Total mitigation rate up to 100%

     
       

        Nanjing, Dec.9,2019- Kingsley Biotechnology announces today that at the 61st annual meeting of the American Society of Hematology (ASH), its subsidiary, Legendary Biology, released for the first time the latest clinical trial data on the effectiveness and safety of the JNJ-68284528(JNJ-4528) study conducted by research-based BCMA CAR-T cell therapy in the United States. the results showed that the total remission rate (orr) reached 100% for the cell therapy for recurrent refractory multiple myeloma (r/rmm). Just a few days ago, the CAR-T cell therapy was recognized as a "breakthrough" by the Food and Drug Administration.

       

       The therapy is an anti-embellished antigen receptor (car) t cell therapy for targeting b cell maturation antigen (bcma) developed autonomously by legendary organisms. In June 2017, Legendary Biology was invited to attend the annual meeting of the American Society of Clinical Oncology (ASCO) and, after stunning with 100 percent of the objective remission rate, caused a huge international response, and received the first CAR-T clinical trial application (IND) approval from the National Drug Administration in 2018. this therapy is a structurally novel car-t cell therapy that contains a 4-1bb co-stimulatory domain and two bcma-targeted monodomain antibodies designed to increase antibody affinity for adult patients who have received treatment options that previously included proteasome inhibitors, immunomodulators, and anti-cd38 antibodies and recurrent or refractory multiple myeloma (mrr) progression during or after the last treatment.

     

       Clinical trials of legendary bioresearched bcm acar-t cell therapy have been conducted simultaneously in both china and the united states since 2018, and it has shown outstanding efficacy in the treatment of legend-2 clinical trials in chinese patients with recurrent/refractory multiple myeloma (r/rmm). This is the first time that legendary creatures have published the latest clinical trial data for the CARTITUTTE-1 study in the United States. The results were reported in an oral presentation at the annual meeting of the American Society of Hematology (ASH) and highlighted in the official ASH news program (Abstract 577). The results of the trial showed that JNJ-4528 showed excellent efficacy in the treatment of 29 R/RMM patients, reaching a total remission rate of 100% at the median follow-up time of 6 months. these patients received an average of 5 prophase therapies,68% were resistant to proteasome inhibitors (pi), immunomodulatory drugs (imid), and anti-cd38 antibody triple resistance,72% had received 5 treatments, and 31% were resistant to 5 treatments. 69% of patients achieved complete remission (cr) or better,86% achieved very good partial remission (vgpr) or better, and 14% achieved partial remission. In addition,66 per cent of patients had complete remission in a strict sense, meaning sensitive laboratory tests and microscopic examinations found no evidence of myeloma proteins or cells in the blood, urine and bone marrow.

       Notably, all assessable bone marrow microresidue assays in all patients who achieved complete remission or better efficacy showed negative results at a negative 5th-square detection sensitivity level of 10. after a median follow-up of 6 months,27 of the 29 patients maintained disease-free progression. Legendary creatures also released updated data on LGEND-2(NCT03090659) phase I/II, openness, and first-time use in human research in China at the ASH annual meeting. these updated data further show long-term remission, safety characteristics, and complete remission rates in patients with advanced relapsed or refractory multiple myeloma.
 

        In December 2017, Kingsley subsidiary Legend Biological signed a global cooperation and licensing agreement with Yang Sen to jointly develop and commercialize LCAR-B38M/JNJ-4828 for the treatment of multiple myeloma. Mr. yangundefineds $350 million down payment and subsequent milestone payment to mr. kingsley set the record for the largest down payment for foreign patent authorizations and the best terms of cooperation. Dr. Xu Yuan, CEO of Legendary Biology, said," in cooperation with Yang Sen, we are committed to the clinical development of LCAR-B38M/JNJ-4528 and strive to apply this experimental treatment to patients with multiple myeloma and provide a new treatment for it. Dr Zhang Fangliang, founder and CEO of Kingsley, said:" We are pleased to see the preliminary data from the CARTITUDE-1 study in the United States and the long-term follow-up data from the Chinese Legend-2 study.

        We also know that this is only a milestone on the path of innovation in biomedicine, and we will continue to race against time, fight against difficulties, and bring more hope to patients in China and the world. We will continue to accelerate the development of new drugs through local innovation and international cooperation, and it is incumbent upon all biomedical workers in the face of life. The Food and Drug Administration (FDA) has recently officially awarded Janssen Research