Yang Sen / Nanjing legend car-t therapy is recognized by FDA as a breakthrough therapy for multiple bone marrow

Today, Janssen, a subsidiary of J & J group, announced that the FDA of the United States has awarded the company a breakthrough treatment of car-t therapy jnj-4528 targeting B cell antigen (BCMA) for the treatment of multiple myeloma patients Breakthrough therapy identification will speed up the development and evaluation of this innovative therapy Jnj-4528, also known as lcar-b38m, is an innovative car-t therapy jointly developed by Nanjing legend company and YANGSEN company Multiple myeloma (mm) is an incurable blood cancer that affects the plasma cells in the bone marrow The cancerous plasma cells proliferate rapidly and replace the normal cells in bone marrow with cancer cells It is estimated that in 2019, more than 32000 patients will be diagnosed with mm Symptoms of MM patients include fracture or bone pain, decreased red blood cell count, fatigue, kidney problems, and infection Jnj-4528 is a car-t therapy with structural differences Its antibody fragment contains two protein domains targeting BCMA Jnj-4528 was originally designed and developed by Nanjing legend company In December 2017, YANGSEN company and Nanjing legend reached a global cooperation to jointly develop and promote jnj-4528 for MM patients In China, phase 2 clinical trial cardifan-1, jointly conducted by Nanjing legend and Yang Sen, is recruiting patients to further evaluate the efficacy of jnj-4528 in the treatment of late relapsed / refractory MM patients This therapy has obtained the orphan drug qualification granted by FDA and the prime Drug Certification granted by EU EMA The award of the breakthrough treatment was supported by phase 1B / 2 clinical trial data called cartitude-1 In this open label, patients with multiple myeloma in a multicenter clinical trial have received at least three types of pre-treatment, or developed resistance to proteasome inhibitors (PI) and an immunomodulatory therapy (IMID) They have been treated with PI, IMID and anti-CD38 antibodies, but the disease continues to progress Preliminary data for cartitude-1 will be released at the annual meeting of the American Society of Hematology (ash), which opens this weekend The summary of the ash meeting showed that of the 21 patients who were able to assess the efficacy, the tumor burden of all patients decreased Jnj-4528 achieved 91% of the total remission rate, of which 4 patients achieved strict complete response, 2 patients achieved complete remission, 7 patients achieved very high partial remission, and 6 patients achieved partial remission ▲ change of tumor burden in cartitude-1 trial (picture source: reference [2]) "The award of breakthrough therapy recognition is an important milestone in our cooperation with Nanjing legend to accelerate the development of this innovative car-t therapy," said Sen, vice president of oncology clinical development, Yang Sen "We look forward to working closely with the US FDA to promote the clinical development of jnj-4528 and eventually bring this BCMA targeted immunotherapy to multiple myeloma patients who need new treatment options," said Dr Zhuang reference material: [1] Janssen Announces BCMA CAR-T Therapy JNJ-4528 Granted U.S FDA Breakthrough Therapy Designation for the Treatment of Relapsed or Refractory Multiple Myeloma Retrieved December 6, 2019, from https:// [2] Results from CARTITUDE-1: A Phase 1b/2 Study of JNJ-4528, a CAR-T Cell Therapy Directed Against B-Cell Maturation Antigen (BCMA), in Patients with Relapsed and/or Refractory Multiple Myeloma (R/R MM) Retrieved December 6, 2019, from https://ash.confex.com/ash/2019/webprogram/Paper121731.html A kind of