CARsgen Therapeutics
United States
55 articles about CARsgen Therapeutics
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CARsgen Therapeutics Opens New U.S. cGMP Facility for CAR T Production
2/21/2022
CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies announced that its current Good Manufacturing Practices (cGMP) manufacturing facility located at the Research Triangle Park (RTP) in North Carolina, the United States of America ("The RTP Manufacturing Facility") has successfully passed the official inspections by local government.
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CARsgen Therapeutics to Celebrate the Completion of Its cGMP Commercial Manufacturing Facility with Design and Construction Partner, CRB
2/21/2022
CARsgen Therapeutics, a company mainly focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, announced today the grand opening of the newly completed 37,000-ft2 clinical and early-stage commercial manufacturing facility.
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CARsgen Presents Updated Research Results on BCMA CAR T-cell Product (CT053) at 2021 ASH Annual Meeting
12/13/2021
CARsgen Therapeutics Holdings Limited today announces that at the 2021 American Society of Hematology ("ASH") Annual Meeting, the Company presented two posters with study results for CT053, an autologous CAR T-cell product candidate against B-Cell Maturation Antigen (BCMA).
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CARsgen Receives CTA Authorization from Health Canada for CLDN18.2-targeted CAR T-cell Product CT041
11/22/2021
CARsgen Therapeutics Holdings Limited today announced that the Company has received a No Objection Letter from Health Canada in response to the Clinical Trial Application (CTA) of CT041.
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Appealing Data of CARsgen Therapeutics' CAR-T (CT041) in Advanced Gastric Cancer Presented at ESMO
9/20/2021
On September 19, 2021, CARsgen Therapeutics disclosed the latest progress of the investigator-initiated trial of Claudin18.2 CAR-T for the treatment of digestive system tumors.
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CARsgen is building a new $157 million CAR-T manufacturing facility in Durham, that is expected to create approximately 200 new jobs.
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CARsgen Therapeutics Receives Orphan Medicinal Product Designation from the European Medicines Agency for CT041 CLDN18.2 CAR T Cells for the Treatment of Gastric Cancers
3/1/2021
CARsgen Therapeutics Holdings Limited, a clinical-stage biopharmaceutical company, announced that the European Commission has granted orphan designation for CT041, CARsgen's first-in-class Claudin 18.2 targeted CAR-T product candidate for the treatment of gastric cancer.
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CARsgen Therapeutics Presents Updated Multiple Myeloma Cell Therapy Data at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition
12/6/2020
CARsgen Therapeutics, a clinical-stage biopharmaceutical company, announced updated safety and efficacy results from its ongoing global clinical studies of CT053, an investigational chimeric antigen receptor T-cell therapy for patients with relapsed and/or refractory multiple myeloma.
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CARsgen Therapeutics to Present Multiple Myeloma Cell Therapy Data at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition in December
11/20/2020
CARsgen Therapeutics announced that data from its global multiple myeloma program will be presented, including two oral presentations and one poster session, at the 62nd American Society of Hematology Annual Meeting and Exposition, taking place virtually December 5-8, 2020.
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Find out which biopharma companies are raking in the cash this week, as companies from around the globe provide updates on their financing rounds and IPOs.
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CARsgen Therapeutics Closes a USD 186 Million Series C Equity Financing to Accelerate Global Clinical Trials of its Cell Therapy Product Candidates
11/2/2020
CARsgen Therapeutics Holdings Limited, a leading biotechnology company focused on innovation and development of chimeric antigen receptor T-cell therapeutics, announced the completion of a USD 186 million Series C Equity Financing.
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CARsgen Therapeutics Granted Orphan Drug Designation by the US FDA for CT041 CLDN18.2 CAR-T Cells for the Treatment of Gastric and Gastroesophageal Junction Cancers
10/5/2020
CARsgen Therapeutics Co., Ltd., a clinical-stage biopharmaceutical company, announced that the United States Food and Drug Administration has granted orphan drug designation to one of CARsgen's first-in-class drug candidates, CT041, for the treatment of gastric and gastroesophageal junction adenocarcinoma.
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CARsgen Therapeutics Receives IND Clearance from the NMPA for CT041 CLDN18.2-CAR-T Cells
8/20/2020
CARsgen Therapeutics Co., Ltd. announced that the National Medical Products Administration has cleared its Investigational New Drug application for the first-in-class drug candidate CT041, autologous chimeric antigen receptor T cells for the treatment of claudin18.2-positive solid tumors.
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CARsgen Announces the Publication of a Novel CAR-T Technology that Improves the Efficacy of CAR-T cells Against Solid Tumors without Requiring Preconditioned Lymphodepletion
8/17/2020
CARsgen Therapeutics, a leader in developing novel CAR-T cell therapies against solid tumors, announced its publication of the 7×21 CAR-T technology in CLINICAL CANCER RESEARCH.
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CARsgen Therapeutics Receives IND Clearance from the US FDA for CT041 CLDN18.2-CAR-T Cells
5/18/2020
CARsgen Therapeutics Co., Ltd., a clinical-stage biopharmaceutical company, announced that one of its first-in-class drug candidates, CT041 humanized anti-claudin18.2 autologous Chimeric Antigen Receptor T Cells for the treatment of patients with claudin18.2-positive adenocarcinoma of the stomach, gastroesophageal junction, or pancreas, has received Investigational New Drug clearance from the United States Food and Drug Administration.
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CARsgen Therapeutics Receives Positive EMA Opinion on Orphan Drug Designation for Fully Human Anti-BCMA CAR-T Cells (CT053) for the Treatment of Multiple Myeloma
4/27/2020
CARsgen Therapeutics Co., Ltd. announced the European Medicines Agency Committee for Orphan Medicinal Products adopted a positive opinion on CARsgen's application for orphan designation of its investigational CT053 CAR T-cell therapy, fully human anti-BCMA autologous chimeric antigen receptor T cells for the treatment of multiple myeloma.
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CARsgen Appoints Yong Fan as Senior Vice President of Global Regulatory Affairs
1/6/2020
CARsgen Therapeutics, a clinical-stage company committed to developing Chimeric Antigen Receptor T cell therapies for cancer, announced appointment of Yong Fan, MD, as Senior Vice President, Global Regulatory Affairs.
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CARsgen Therapeutics Receives IND Clearance from the NMPA for AB011 Humanized Claudin18.2 Monoclonal Antibody
12/9/2019
CARsgen Therapeutics announced that one of its leading drug candidates, AB011 humanized claudin18.2 monoclonal antibody for the treatment of patients suffering from advanced gastric and pancreatic adenocarcinoma, has received Investigational New Drug clearance from the National Medical Products Administration in China.
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CARsgen Announces Investigational CAR-T Therapy CT053 Granted RMAT Designation by the U.S. FDA for R/R Multiple Myeloma
10/28/2019
CARsgen Therapeutics Co. Ltd., a clinical-stage biopharmaceutical company announced that the United States Food and Drug Administration has granted Regenerative Medicine Advanced Therapy designation to its investigational CT053 CAR-T cell therapy.
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CARsgen Announces Investigational CAR-T Therapy CT053 Granted PRIME Eligibility by the European Medicines Agency
9/23/2019
CARsgen Therapeutics Inc., a clinical-stage biopharmaceutical company announced the European Medicines Agency has granted PRIority MEdicines eligibility to its investigational CAR-T cell therapy fully human anti-BCMA autologous chimeric antigen receptor T Cells for the treatment of relapsed or refractory multiple myeloma.