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CStone Announces FDA Clearance of IND Application for Its Novel Trispecific Antibody CS2009 (PD-1/VEGF/CTLA-4) to Advance into Phase II Clinical Trial

CStone Pharmaceuticals announced that the U.S. FDA has cleared their IND application to start a Phase II clinical trial of their antibody CS2009 for advanced solid tumors.
Dr. Jason Yang, CEO of CStone, expressed satisfaction with the FDA clearance to begin the global Phase II clinical trial of CS2009.
The FDA reviewed Phase I data showing safety and antitumor activity and agreed on key Phase II study design elements, including dose optimization and expansion strategies.
CS2009 is a novel trispecific antibody targeting PD-1, VEGFA, and CTLA-4, and is currently being tested in a multi-cohort Phase II trial enrolling patients in Australia, China, and the U.S.

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The Berkshire Eagle

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CStone Announces FDA Clearance of IND Application for Its Novel Trispecific Antibody CS2009 (PD-1/VEGF/CTLA-4) to Advance into Phase II Clinical Trial

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pressreach.com

CStone Announces FDA Clearance of IND Application for Its Novel Trispecific Antibody CS2009 (PD-1/VEGF/CTLA-4) to Advance into Phase II Clinical Trial - PressReach

CS2009 (PD-1/VEGF/CTLA-4 trispecific antibody) has received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) to initiate a Phase II clinical trial in patients with advanced solid tumors. This marks a significant milestone in the global development of this innovative immunotherapy. The ongoing global multicenter Phase II trial is currently enrolling patients in Australia and China. The study design include…

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