Skyline Therapeutics (Shanghai) Co. Ltd. has received FDA clearance for its IND application for a phase I/IIa trial of SKG-0106, a one-time intravitreally delivered recombinant adeno-associated virus (AAV) gene therapy for the treatment of neovascular age-related macular degeneration (wet AMD). A global phase I trial will be initiated soon.
Benitec Biopharma Inc. has received FDA clearance of its IND application for BB-301, its silence and replace gene therapy for the treatment of oculopharyngeal muscular dystrophy (OPMD)-related dysphagia.
Replay Holdings LLC and The University of Texas MD Anderson Cancer Center have announced that the FDA has cleared the IND application for NY-ESO-1 TCR/IL-15 NK, an engineered T-cell receptor natural killer (TCR-NK) cell therapy for advanced synovial sarcoma and myxoid/round cell liposarcoma.
TG Immunopharma Co. Ltd. has announced clearance by the FDA for a clinical trial of TGI-6, a bispecific antibody targeting unique tumor-associated antigens (TAA) and CD3 molecules simultaneously, for solid tumors.
Iaso Biotechnology Co. Ltd. has received FDA approval of the company’s IND application for IASO-782 injection for use in U.S. clinical trials for autoimmune hematological disorders, including primary immune thrombocytopenia (ITP) and warm autoimmune hemolytic anemia (AIHA).
Alentis Therapeutics AG has received FDA clearance of the company’s IND application for ALE.C04, a first-in-class monoclonal antibody developed to specifically target exposed Claudin-1 (CLDN1) on cancer cells.
Lantern Pharma Inc. has received IND clearance from the FDA for LP-184, which is being developed for advanced solid tumors and central nervous system (CNS) cancers.
Pipeline Therapeutics Inc. has received FDA clearance to initiate a phase I trial of PIPE-791 in healthy volunteers, with dosing expected to begin in the second half of this year. PIPE-791 is advancing toward clinical development for remyelination and neuroinflammation, with a leading indication of multiple sclerosis (MS).
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