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OSS, Netherlands, Dec. 15, 2020 /PRNewswire/
Glycostem Therapeutics B.V., a leading clinical-stage company focused on the development of therapeutic off-the-shelf Natural Killer (NK) cells, today announced that the first patient has been dosed in its pivotal phase I/IIa trial of oNKord
® for the treatment of Acute Myeloid Leukemia (AML). The WiNK trial will enroll 33 AML patients at eight clinical sites based in five European countries. oNKord
® is the company s first-generation off-the-shelf allogeneic NK cellular immunotherapy product. Glycostem is furthermore developing a range of second (CAR-NK) and third generation (TCR-NK) NK products in-house. We are thrilled about the first patient being dosed in this pivotal trial. This important milestone potentially paves the way for a positive impact on the lives of patients with AML who are at high risk of relapse. The preliminary efficacy data obtained with oNKord
Investegate |Junshi Biosciences Announcements | Junshi Biosciences: CHOICE-01 Phase III Study of Toripalimab at the Interim Analysis Met Pre-Specified Primary Endpoint of Progression-Free Survival at the First-Line Treatment of Advanced NSCLC
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CHOICE-01 Phase III Study of Toripalimab at the Interim Analysis Met Pre-Specified Primary Endpoint of Progression-Free Survival at the First-Line Treatment of Advanced NSCLC – IT Business Net
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CHOICE-01 Phase III Study of Toripalimab at the Interim Analysis Met Pre-Specified Primary Endpoint of Progression-Free Survival at the First-Line Treatment of Advanced NSCLC
December 13, 2020 19:00 ET | Source: Junshi Biosciences Junshi Biosciences Shanghai, CHINA
SHANGHAI, China, Dec. 14, 2020 (GLOBE NEWSWIRE) Junshi Biosciences (HKEX: 1877; SSE: 688180), an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies, is pleased to announce that the Independent Data Monitoring Committee (IDMC) has determined that Toripalimab (product code: JS001) in combination with standard chemotherapy as the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) has reached its pre-specified primary endpoint of Progression Free Survival (PFS) at the interim analysis of a randomized, double-blind, multi-center, phase III clinical study “CHOICE-01
(2)
SHANGHAI, China, Dec. 14, 2020 (GLOBE NEWSWIRE) Junshi Biosciences (HKEX: 1877; SSE: 688180), an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies, is pleased to announce that the Independent Data Monitoring Committee (IDMC) has determined that Toripalimab (product code: JS001) in combination with standard chemotherapy as the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) has reached its pre-specified primary endpoint of Progression Free Survival (PFS) at the interim analysis of a randomized, double-blind, multi-center, phase III clinical study CHOICE-01 (Clinicaltrial.gov identifier: NCT03856411). The Company will initiate the process to submit a supplemental New Drug Application (NDA) to the National Medical Products Administration (NMPA) in the near future.