Vincerx Pharma Inc. has received FDA clearance of its IND application for VIP-236, a small molecule-drug conjugate (SMDC) for the treatment of advanced solid tumors. A first-in-human study for advanced or metastatic solid tumors is expected to start in the first quarter of next year.
Erasca Inc. has received FDA clearance of its IND application for ERAS-3490, an orally available small-molecule KRAS G12C inhibitor designed to have high central nervous system (CNS) penetration for the treatment of KRAS G12C-mutated solid tumors, including non-small-cell lung cancer (NSCLC).
1st Biotherapeutics Inc. has received clearance from the FDA for its IND application to evaluate FB-849, a small-molecule hematopoietic progenitor kinase 1 (HPK1) inhibitor, in patients with advanced solid tumors.
Carina Biotech Pty Ltd. has submitted an IND application to the FDA to conduct a first-in-human phase I/IIa trial of CNA-3103, its LGR5-targeted chimeric antigen receptor T-cell (CAR-T) therapy candidate, in patients with advanced colorectal cancer.
Vertex Pharmaceuticals Inc. has received clearance from the FDA for its IND application for VX-522, a messenger ribonucleic acid (mRNA) therapy targeted at treating the underlying cause of cystic fibrosis (CF).
Sionna Therapeutics Inc. has received FDA clearance of its IND application for SION-638, a small molecule designed to target the first nucleotide-binding domain (NBD1) of the cystic fibrosis transmembrane conductance regulator (CFTR) protein. A phase I study is now dosing healthy volunteers.
Sparingvision SAS has obtained FDA clearance for its IND application for SPVN-06, its lead gene-independent therapy for the treatment of retinitis pigmentosa (RP). SparingVision has also submitted a clinical trial authorization (CTA) application to the French regulator (ANSM), which is currently under review.
Opus Genetics Inc. has received FDA clearance for its IND application for a first-in-human phase I/II trial of OPGX-001 in patients with Leber congenital amaurosis (LCA) resulting from biallelic mutations in the LCA5 gene (LCA5). The trial is due to start in the U.S. early next year (ClinicalTrials.gov Identifier NCT05616793).