FDA clearance
Agencies and drugmakers are struggling to generate consistent standards and regulatory criteria for evaluating autologous cell therapies.
Lion TCR to Begin Phase Ib/II Trial of Autologous Liver Cancer T-Cell Receptor Therapy
The FDA has cleared an investigational new drug application for Lion's LioCyx-M004 for advanced hepatitis B virus-related hepatocellular carcinoma patients.
Instil Bio to Begin Phase II Trial of TIL Therapy for Advanced Melanoma
The firm expects data from the trial to support regulatory filings for its autologous tumor-infiltrating lymphocyte treatment in the US and EU.
InnoCare Pharma to Launch US Trial of ICP-723 for NTRK Fusion-Positive Solid Cancers
The US Food and Drug Administration has cleared an investigational new drug application for InnoCare's second-generation pan-TRK inhibitor.
FDA Clears IND for Anixa Biosciences, Moffitt Cancer Center's CER-T Therapy for Ovarian Cancer
Anixa and Moffitt will begin evaluating their autologous product, which targets the follicle stimulating hormone receptor, for advanced ovarian cancer patients.