The FDA has cleared an IND for a clinical trial in the U.S. of NBL-020, a fully human antibody drug independently developed by CSPC Pharmaceutical Group Ltd.'s subsidiary Novarock Biotherapeutics Ltd., for the treatment of advanced solid tumors.

Okyo Pharma Ltd. has received clearance of its...

Neurophth Therapeutics Inc. has received FDA clearance of its IND application for the in vivo gene replacement therapy NFS-02, a novel recombinant adeno-associated viral serotype 2 vector (rAAV2) containing a codon-optimized NADH-dehydrogenase subunit 1 (ND1) gene, for the treatment of Leber hereditary optic neuropathy (LHON) associated with ND1 mutation.

Invectys Inc. and CTMC, a joint venture between MD Anderson Cancer Center and National Resilience Inc., have announced FDA clearance of an IND application for a phase I/IIa study of IVS-3001, Invectys' lead engineered human leukocyte antigen A (HLA-G)-targeting chimeric antigen receptor (CAR) T-cell therapy for the treatment of solid tumors.

Clearmind Medicine Inc. has completed IND-enabling studies with its 5-methoxy-2-aminoindane (MEAI)-based lead compound, CMND-100, aimed at treating alcohol use disorder (AUD). The company is preparing for an IND submission early next year to the FDA and the Israeli Ministry of Health to start first-in-human phase I/IIa studies in the U.S. and Israel.

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).