Aug. 15 Quick Takes: April PDUFA for Carvykti in earlier stage MM

FDA has set a PDUFA date of April 5, 2024, for an sBLA seeking approval of Carvykti ciltacabtagene autoleucel from the Janssen Pharmaceuticals unit of Johnson & Johnson (NYSE:JNJ) to treat multiple myeloma patients after 1-3 lines of therapy; the BCMA-targeting CAR T was approved in the fourth-line setting in 2022. Partner Legend Biotech Corp. (NASDAQ:LEGN) said EMA also accepted an application for earlier-line treatment of MM, and that the two regulatory filings triggered $35 million in milestone payments from Janssen. Last week, FDA granted accelerated approval to Janssen’s first-in-class CD3 X GPRC5D bispecific Talvey talquetamab to treat fifth-line MM.

Impilo Therapeutics Inc. launched Tuesday to treat solid tumors with nucleic acid-based therapies such as antisense oligonucleotides, siRNAs, mRNAs and in vivo gene editing. Led by CEO David Slack, the San Diego-based biotech aims to overcome the challenges of effectively delivering therapies past the tumor stroma by tethering a tumor-targeted tissue penetrating peptide to a nucleic acid therapy. The platform, dubbed Tumor-Penetrating Nanocomplex (TPN Platform), has its roots in the work of scientific founder and Sanford Burnham Prebys Medical Discovery Institute professor Erkki Ruoslahti. Impilo’s technology is derived from a deal with Lisata Therapeutics Inc. (NASDAQ:LSTA) for the targeted delivery of nucleic acid-based medicines. ...