Duality Biologics (Suzhou) Co. Ltd. has presented data describing the discovery and preclinical results of DB-1303, an antibody-drug conjugate containing a trastuzumab biosimilar targeting HER2 (BAT0606), an exatecan derivative payload with topoisomerase I inhibitory activity (P1003) and an enzymatic ally cleavable tetrapeptide-maleimide-linker (payload-linker named L101P1003).
Wall Street nicked shares of Karyopharm Therapeutics Inc. after the firm offered top-line results from the 263-subject phase III study with Xpovio (selinexor) in advanced or recurrent endometrial cancer (EC). Shares (NASDAQ:KPTI) closed at $8.19, down $2.05, or 20%, having dropped as low as $7.66.
The FDA has approved Roche AG’s Ventana MMR Rxdx panel for patients with advanced or recurrent endometrial cancer. The companion diagnostic is the first to identify patients who are eligible for treatment with Glaxosmithkline plc’s (GSK’s) Jemperli (dostarlimab-gxly) monotherapy. The PD-1 antibody immunotherapy received FDA approval on Thursday.
Another PD-1 antibody is about to hit the U.S. market, following the FDA’s accelerated approval of dostarlimab (TSR-042) from partners Anaptysbio Inc. and Glaxosmithkline plc. But dostarlimab, branded Jemperli, will be only one of two PD-1 drugs indicated for endometrial cancer, going up against Merck & Co. Inc.’s Keytruda (pembrolizumab).
DUBLIN – Glaxosmithkline plc and Anaptysbio Inc. were able to get over some of the disappointment arising from a delayed FDA decision on their PD-1 inhibitor, dostarlimab, earlier this month, as the EMA came through Feb. 26 with a positive recommendation for the drug in endometrial cancers that are deficient in DNA mismatch repair or that are categorized as having high microsatellite instability.