NEW YORK – Salarius Pharmaceuticals on Tuesday said the US Food and Drug Administration has cleared its investigational new drug (IND) application allowing for the start of a Phase I trial of SP-3164 in patients with relapsed or refractory non-Hodgkin lymphoma.
In the trial, expected to begin in the second half of this year, Salarius will also evaluate a gene signature for selecting patients who may respond well to the second-generation targeted protein degrader SP-3164. The dose-escalation portion of the study will involve patients with non-Hodgkin lymphoma, and in a second portion of the study, researchers will assess the activity of the drug in patients with diffuse large B-cell lymphoma, Salarius CEO David Arthur said in a statement.
SP-3164 is designed to stave off cancer and modulate the immune system by degrading transcription factors IKZF1 and IKZF3, along with other proteins. Targeted protein degraders currently on the market in the US include Bristol Myers Squibb's Revlimid (lenalidomide) and Pomalyst (pomalidomide).
Arthur noted there's a lot of excitement around first-generation targeted protein degraders and estimated that Revlimid and Pomalyst together generated more than $16 million in 2021 sales. With its next-generation targeted protein degrader, Houston-based Salarius is hoping to build on the success of these first-generation products, he added.
Salarius' pipeline also includes the targeted protein inhibitor seclidemstat, which it is studying in a Phase I/II trial involving patients with Ewing sarcoma and FET-rearranged sarcomas and in earlier-stage studies in hematologic and gynecologic cancers.