Kingsley affiliate Legend has again released CAR-T clinical data with a total remission rate of 97 percent, and researchers expect to use it for more front-line treatments

Legendary Bio (NASDAQ: LEGN), a subsidiary of Hong Kong-listed Kingsley Bio, has released the latest data from Cilta-cel's CARTITUDE-1 study (NCT03548207).
CARTITUDE-1 is a phase 1b/2 clinical study of chime antigen-subject T-cell (CAR-T) therapy (CAR-T) that targets B-cell mature antigens (BCMA).
results show a consistently high total mitigation rate (ORR), which deepens over time.
12.4 months of medium follow-up time, 97% of patients were relieved and 67% received strict total remission (sCR).
the data was reported orally at the 62nd annual meeting and exhibition of the American Society of Hematology (ASH) #177.
Legendary Bio, a global biopharmaceutical company in the clinical stage that specializes in the development of innovative cell therapy products focused on tumors and other allergies, was listed on the NASDAQ market in June this year and is known as the first CAR-T market in China.
Sidaki Oronse is a new class 1 drug used in the treatment of bio-products by Legendary Bios, a chime antigen-treated T-cell (CAR-T) therapy, and a number of clinical studies are currently under way to treat patients with relapsed or refractic multiple myeloma and more front-line patients, consisting of two single-domain antibodies targeting BCMA with a differentiated structure of CAR-T.
December 2017, Legendary Bio signed an exclusive global license and cooperation agreement with Janssen Bio for the development and commercialization of Sidaki Orensai.
it is understood that Sidaki Orensa was not only recognized as a breakthrough therapy in the United States in December 2019, but also as a priority drug by the European Commission in April 2019 and as a breakthrough therapy in China in August 2020.
addition, the FDA in February 2019 and the European Commission in February 2020 awarded Sidaki Orensai orphan drug qualification.
Deepu Madduri, M.D., lead researcher in the CARTITUDE-1 study at the Tisch Cancer Institute's School of Hematology and Oncology at Mount Sinai in New York, said, "Considering that patients generally had lower rates of previous treatment before receiving Sidaki Orensay treatment, the 97 percent remission rate was extraordinary."
In view of the rapid, deep and continuous remission and controlled safety of Sidaki Orensay after low-dose return, we look forward to further exploring Sidaki Orensay's outpatient treatment for patients with more front-line multiple myeloma.
" study found that 97 patients were treated with Sidaki Orensai, and all of the patients' CAR-T cells were successfully prepared.
rate (ORR) assessed by the Independent Review Board reached 97 per cent.
study also showed that the safety of Sidaki Orensa was controllable at the recommended dose of phase 2, which supported the potential for Sidaki Orense outpatient drug use. "We are encouraged by the strong results of the CARTITUDE-1 study, which demonstrates the potential of our leading research and development product, Sidaki Orense, to be a transformative treatment option for patients with relapsed or recurring multiple myeloma," said Dr. Ying Huang, CEO and Chief Financial Officer of legendary biology at
.
we look forward to advancing this potentially life-saving treatment for patients in need.
Dr. Zhenyu Liu, CEO of Kingsley Bio-Rotation, said, "Kingsley has been focusing on innovation and research and development for 18 years, and has established four platforms, including the Life Sciences Trust Research Institute (CRO) platform, the Biopharmaceutical Contract Research and Development (CDMO) platform, the cell therapy platform and the Industrial Synthesis Products Platform.
, Kingsley's incubated cell therapy legend was listed on NASDAQ in June, becoming china's first CAR-T-listed stock.
In the future, Kingsley will continue to increase its investment in the four business sections in the core capabilities of talent pool, innovative research and development, hardware facilities, etc., in order to continuously build up potential to help China's biotechnology industry in the international competition to achieve corner oversized.
"Cilta-cel, LCAR-B38M CAR-T cell self-refrasecting agent" internationally recognized overview: December 2017 declared the country's first cell therapy product drug clinical trial application (IND), and in March 2018 obtained drug clinical trial approval.
obtained FDA IND license in May 2018 February 2019 FDA granted JNJ-4528 orphan drug eligibility April 3, 2019 European Medicines Agency (EMA) grant Priority Drug (PRIME) qualification, becoming the first CAR-T product in China to qualify for the European Medicines Agency (EMA) Priority Drug (PRIME) december 2019 U.S. FDA Award for Breakthrough Therapy Recognized as National in December 2019" Major New Drug Creation "Major Special Support for Science and Technology On August 13, 2020 included in China's list of breakthrough therapeutic varieties on CARTITUDE-1CARTITUDE-1 (NCT03548207) is an ongoing 1 b / Phase 2, an open-label multi-center study designed to assess the safety and effectiveness of Sidaki Orense treatment in adult patients with relapsed or refractic multiple myeloma, of which 99% were resistant to the most recent treatment and 88% were The patients were triple resistant (at least 1 immunomodulant (IMiD), 1 protease inhibitor (PI) and 1 anti-CD38 antibody).
the primary goal of phase 1b (29 patients) of this study was to assess safety and confirm the dose of Sidakio, based on supporting data from the first human study of LCAR-B38M CAR-T cells (LEGEND-2).
the study phase II clinically included another 68 patients, with a total remission rate of the main endpoint to assess the efficacy of Sidaki Orensay.
is that multiple myeloma is a blood tumor that is currently incurable and whose tumor cells originate in the bone marrow and are characterized by excessive proliferation of plasma cells.
current treatment can provide relief, patients may relapse.
Recurring myeloma refers to a condition in which the initial treatment is alleviated and then recurs and does not meet the definition of incurableness, and the refraped multiple myeloma refers to a patient who is unresponsive to the most recent treatment or progresses within 60 days of treatment.
Although some patients with multiple myeloma do not develop symptoms until the advanced stages of the disease, most patients are diagnosed with symptoms such as bone-related events, low blood cell counts, elevated blood calcium, kidney problems, or infections, and patients who return after standard treatment, including protease inhibitors and immunomodulants, have poor prognosis and few available treatment options.
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