U.S. Food & Drug Administration (FDA) Approves Investigational New Drug (IND) Application for Myrio's Lead Product (PHOX2B PC-CAR T) for the Treatment of Neuroblastoma
MELBOURNE, Australia, June 13, 2025 /PRNewswire/ -- On 7 May 2025, the FDA approved an IND application enabling Myrio's lead product (PHOX2B PC-CAR T) to enter human trials. Myrio, in collaboration the leading children's hospital in Philadelphia...
IND Application for NTS071, Nutshell Therapeutics' p53 Y220C Allosteric Reactivator, Received US FDA clearance
SHANGHAI, May 4, 2025 /PRNewswire/ -- On April 23, 2025, Nutshell Therapeutics ( Shanghai ) Co., LTD. received IND clearance from the FDA to initiate P hase 1 clinical trial in the United States for its NTS071, a novel small molecule allosteric...
Onward Therapeutics Announces IMPD Approval for Its Subsidiary Emercell to Start Clinical Investigation of Allogeneic NK Cell Therapy OT-C001 in Combination with Rituximab
EPALINGES, Switzerland and PARIS, April 22, 2025 /PRNewswire/ -- Onward Therapeutics SA, a biotechnology company dedicated to advancing innovative cancer immunotherapies, announced that its subsidiary, Emercell SAS, has received Investigational...
GC Cell Initiates First Patient Dosing in Phase 1 Clinical Trial for GCC2005, a Promising T‑Cell Lymphoma CD5 CAR-NK Therapy
YONGIN, South Korea, March 13, 2025 /PRNewswire/ -- GC Cell (KRX:144510), under the leadership of CEO Sungyong Won, announced today the initiation of its domestic Phase 1 clinical trial for GCC2005 (AB‑205), a novel CD5 CAR‑NK cell therapy. This...
ImmunoForge Receives IND Approval for Phase 2 Clinical Trial of 'Pemziviptadil' for DMD Cardiomyopathy Treatment from FDA, and KF1601, a chronic myeloid leukemia treatment, phase 1 clinical trial IND approved by MFDS
SEOUL, South Korea, Jan. 14, 2025 /PRNewswire/ -- ImmunoForge announced that it has received approval for the Phase 2 clinical trial IND for 'Pemziviptadil (development code name PF1804),' a treatment for DMD (Duchenne Muscular Dystrophy)...
Hanx Biopharmaceuticals, Ltd. Announces First Patient Dosing in First-in-Human Phase 1 Clinical Trial of HX044
WUHAN, China, Jan. 3, 2025 /PRNewswire/ -- Hanx Biopharmaceuticals, CO. Ltd, an innovative biotechnology company developing next-generation immunotherapies to address the challenges of unmet medical need diseases, today announced the first patient...
CYP-006TK Demonstrates Safety and Efficacy in DFU Clinical Trial
MELBOURNE, Australia, Dec. 5, 2024 /PRNewswire/ -- Cynata Therapeutics Limited (ASX: "CYP", "Cynata", or the "Company"), a clinical-stage biotechnology company specialising in cell therapeutics, has successfully completed its Phase 1 clinical trial...