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    Home > Medical News > Latest Medical News > The total remission rate reached 100%. Legendary biology, a subsidiary of Kingsley, first released car-t clinical trial data in the United States

    The total remission rate reached 100%. Legendary biology, a subsidiary of Kingsley, first released car-t clinical trial data in the United States

    • Last Update: 2019-12-10
    • Source: Internet
    • Author: User
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    Nanjing, December 9, 2019 / Meitong news agency / -- Kingsley biotechnology announced today that at the 61st annual meeting of the American Society of Hematology (ash), legendary biology, a subsidiary of Kingsley biotechnology, announced for the first time the latest clinical trial data of IB / II cartitute-1 research on the effectiveness and safety of research-based bcmacar-t cell therapy in the United States The results showed that the overall remission rate (ORR) of the cell therapy for relapsed refractory multiple myeloma (R / RMM) was 100% Recently, the car-t cell therapy has just been recognized as "breakthrough therapy" by the US Food and Drug Administration (FDA) This therapy is an anti chimeric antigen receptor (car) T cell therapy targeting B cell mature antigen (BCMA) independently developed by legendary biology In June 2017, legendary biology was invited to attend the annual meeting of the American Society of Clinical Oncology (ASCO) and stunned the audience with 100% objective remission rate, which caused great international repercussions In 2018, legendary biology obtained the first car-t clinical trial application (ind) approval from the National Drug Administration This is a novel car-t cell therapy, which contains 4-1BB costimulatory domain and two BCMA targeted single domain antibodies It is designed to increase antibody affinity It is used to receive previous treatment plans including proteasome inhibitors, immunomodulators and anti-CD38 antibodies, and recurrent or refractory multiple myeloma (RRMM) adults who develop disease progression during or after the last treatment Patient Since 2018, the clinical trial of legendary biological research bcmacar-t cell therapy has been carried out in China and the United States at the same time It has shown excellent efficacy in the legend-2 clinical trial for the treatment of relapsed / refractory multiple myeloma (R / RMM) patients in China This is the first time that legend has published the latest clinical trial data of cartitute-1 study in the United States The results were presented orally at the annual meeting of the American Society of Hematology (ash) and highlighted in the official ash news program (Abstract 577) The results showed that jnj-4528 showed excellent efficacy in 29 patients with R / RMM, and reached a total remission rate of 100% at a median follow-up of 6 months On average, these patients received 5 kinds of pre-treatment, 68% of them were triple resistant to proteasome inhibitor (PI), immunomodulator (IMID), and anti-CD38 antibody, 72% of them received 5 kinds of treatment, 31% of them were resistant to 5 kinds of treatment 69% achieved complete remission (CR) or better, 86% achieved very good partial remission (vgpr) or better, and 14% achieved partial remission In addition, 66% of the patients had complete remission in a strict sense, which means no evidence of myeloma protein or cells in blood, urine and bone marrow was found in sensitive laboratory and microscopic examination It should be noted that in all patients with complete remission or better efficacy, all evaluable bone marrow microresidue tests showed negative results at the sensitivity level of the negative 5th power of 10 After a median follow-up of 6 months, 27 of 29 patients remained disease-free Legend biology also released the updated data of legend-2 (nct03090659) I / II, open and first used in human research in China at the ash annual meeting These updated data further show long-term remission, safety features, and complete remission rates in patients with advanced relapsed or refractory multiple myeloma In December 2017, legend biology, a subsidiary of Kingsley, signed a global cooperation and license agreement with Janssen company to jointly develop and commercialize lcar-b38m / jnj-4828 for multiple myeloma Yang Sen paid $350 million in down payment and subsequent milestone payment to Kingsley, setting a record of the largest down payment of foreign patent authorization of Chinese pharmaceutical enterprises at that time and the best conditions for cooperation "With the cooperation of Yang Sen, we are committed to the clinical development of lcar-b38m / jnj-4528, and strive to apply this experimental treatment method to patients with multiple myeloma and provide a new treatment method for them," said Dr Xu Yuan, CEO of legendary biology "We are very pleased to see the preliminary data of cartitude-1 study in the United States and the long-term follow-up data of legend-2 study in China," said Dr Zhang Fangliang, founder and CEO of Kingsley We also know that this is only a milestone on the road of biomedical innovation We still need to constantly race against time and difficulties to bring more hope to patients in China and even in the world We will continue to accelerate the development of new drugs through local innovation and international cooperation In the face of life, this is the bounden duty of all biopharmaceuticals Recently, the U.S Food and Drug Administration (FDA) has officially awarded Janssen Research & development, LLC (Janssen) the breakthrough therapy certification (BTD) of jnj-68284528 (jnj-4528) This is also another international authoritative recognition of the product after it obtained FDA Orphan Drug Certification and European Drug Administration priority Drug Certification (prime) qualification in February and April this year This has also become another example of the continuous important innovation power of Chinese Biomedical enterprises to the world after a Chinese drug from Baiji Shenzhou was officially approved for listing in the United States recently In the future, more and more Chinese Biomedical innovative forces will emerge on the world stage, inject new vitality into the industry development, and bring more hope to patients around the world *Lcar-b38m is the code of the experimental drug studied in China, jnj-68284528 (jnj-4528) is the code of the experimental drug under study in the United States / European Union, both of which represent the same car-t cell therapy Overview of international recognition of legendary biological research bcmacar-t cell therapy institute: in 2017, it was accepted by the State Food and Drug Administration (formerly the State Food and Drug Administration) for clinical trial application (ind), and in March 2018, it was approved by the China food and Drug Administration for confirmatory clinical trial; In December 2017, legend biology and Janssen reached a global cooperation and licensing agreement to jointly develop and commercialize bcmacar-t products Yang Sen paid $350 million in down payment and subsequent milestone payment to Kingsley, setting a record of the largest down payment of foreign patent authorization of Chinese pharmaceutical companies at that time and the best conditions for cooperation; in 2018, he was approved by the FDA of the United States; in February 2019, the FDA awarded Janssen's jnj-4528 orphan drug qualification; On April 3, 2019, jnj-68284528 (lcar-b38m) obtained the European Drug Administration (EMA) priority drug recognition (prime) qualification and became the first car-t product in China to obtain the European Drug Administration (EMA) priority drug recognition (prime) qualification Recently, jnj-68284528 (lcar-b38m) obtained the US FDA breakthrough therapy recognition About legend-2 legend-2 (nct03090659), an ongoing one arm, open 1 / 2-phase study, 74 subjects were enrolled in four centers in China to evaluate the efficacy and safety of lcar-b38m in the treatment of relapsed / refractory multiple myeloma About cartitude-1 In the United States, the 1B / 2 cartitude-1 (mmy2001, nct03548207) registration study is studying jnj-4528 for the treatment of multiple myeloma patients who have received at least 3-line treatment or dual resistance to PI and IMID ®, and who have received one PI, one IMID and anti-CD38 monoclonal antibody treatment, and who have the disease progression proved by the examination data within 12 months after the latest treatment About legendary biotechnology legendary biotechnology is a biopharmaceutical company entering the clinical stage, dedicated to the discovery and development of new cell therapies for blood / tumor, infectious diseases and autoimmune diseases Legend is a subsidiary of Kingsley Biotechnology (HKEx: 1548), which operates in the US, mainland China, Hong Kong and Ireland In December 2017, legend and Yang Sen reached a global cooperation and authorization agreement to jointly develop and commercialize jnj-4528 / lcar-b38m for the treatment of multiple myeloma For more information, please visit www.legendbiotech.com About Kingsley Biotechnology Co., Ltd Kingsley Biotechnology Co., Ltd (Stock Code: hk01548) is a global biotechnology group company The group is rooted in the leading gene synthesis technology, and its business scope covers four major fields: biological medicine cdmo, cell therapy, life science services and products, and industrial synthetic biological products Kingsley was founded in 2002 and listed on the main board of Hong Kong Stock Exchange in 2015 Its operating entities are located in Greater China, North America, Europe and Asia Pacific Based on this, Kingsley provides quality, convenient and reliable services and products to more than 300000 customers in more than 160 countries and regions around the world At present, Kingsley has more than 3000 employees in the world, of which more than 34% have master's or doctor's degrees Kingsley has a number of intellectual property rights and technical secrets, including more than 100 authorized patents and more than 270 patent applications As of June 30, 2019, over 40300 international peer-reviewed academic journals cited Kingsley's services and products Adhering to the corporate mission of "making people and nature healthier with biotechnology", Kingsley will continue to be committed to becoming the most trusted biotechnology company For more information, please visit Kingsoft's official website https://www.genscript.com.cn/ notes on forward-looking statements This information constitutes a forward-looking statement in relation to the business of legendary biotechnology, Inc., Nanjing legendary biotechnology, Inc and legendary biotechnology, Inc., Ireland ("legendary"), including a discussion, express or implied, of potential new products, potential new adaptations or potential future revenue from any such products These forward-looking statements reflect legendary management's current views on future events and involve known and unknown risks, uncertainties and other factors that may cause the actual results to differ materially from any and future results, performance or achievements expressed or implied in the statement The safety and efficacy of the study drug itself and its use have not been determined There is no guarantee that these preparations will be approved by the health authorities, or that the purpose of the study can be approved for commercial application in any country, or that these preparations can reach any specific level of income as products This information is true and accurate at the date of publication Legend has no responsibility to update the information reflecting the subsequent development Readers should not rely on the information on this page as being up-to-date or accurate after the publication date In particular, legend's expectations may be affected by the following factors: uncertainty of new drug development; unexpected clinical trial results, including additional analysis of existing or unexpected new clinical data; unexpected regulatory actions or delays or overall government regulation; legend's ability to obtain or maintain patent or other proprietary intellectual property protection, including the U.S litigation process Order uncertainty; general competition; government, industry, public pricing and other political pressures If one or more of these risks or uncertainties become a reality, or the underlying assumptions prove to be wrong, the actual results may differ materially from the expectations, confidence, estimates or assumptions described herein Source: Kingsley biotechnology related link: https://www.genscript.com.cn/penicillin this article is the content reprinted by yaozhi.com The copyright belongs to the original author The purpose of reprinting is to transmit more information, which does not represent the view of this platform If the content, copyright and other issues of the work are involved, please contact the message on this website, and we will delete it as soon as possible
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