Salarius Pharmaceuticals Inc. has received FDA clearance of its IND application to initiate a phase I trial with SP-3164 in patients with relapsed/refractory non-Hodgkin lymphoma (NHL).
Salarius Pharmaceuticals Inc. has completed two GLP toxicology studies with its targeted protein degrader SP-3164, with no unexpected safety findings reported. These results will be included in an IND application that the company plans to submit to the FDA this quarter.
Researchers from Salarius Pharmaceuticals Inc. have presented preclinical data on SP-3164, a novel cereblon (CRBN)-binding protein degrader intended for the treatment of lymphoma. SP-3164 bound to cereblon and consequently induced the degradation of hematological transcription factors Ikaros and Aiolos. The aim of their studies was to investigate the drug’s antitumor efficacy in preclinical models of diffuse large B-cell lymphoma (DLBCL).
Salarius Pharmaceuticals Inc. is joining the red-hot protein degradation space with an acquisition of a portfolio of oral small-molecule protein degraders and IP from Deuterx LLC it’s calling "transformative." The lead asset, SP-3164, is a cereblon-binding molecular glue that Salarius plans to move to the clinic in 2023 as a potential treatment for hematological cancers and solid tumors. Salarius paid Deuterx $1.5 million in cash and 1 million shares of restricted stock (NASDAQ:SLRX) up front, worth about $487,900 at market close on Jan. 13.
In a step toward what may become the new normal, at least for now, the Pediatric Oncology Subcommittee of the FDA’s Oncologic Drugs Advisory Committee is meeting virtually Wednesday and Thursday to review pediatric development plans for four cancer drugs.