The pipeline changes leave the IRAK4 inhibitor GS-5718 only continuing on in lupus.
With so many Big Pharmas reportIRAK4 inhibitorIRAK4heir full-yGS-5718nings yesterday, it waslupusurprise that drugmakers used the occasion as an excuse to slip out some pipeline changes. Gilead was no exception, removing a solid tumor candidate from its early-stage lineup along with two of the three indications for its IRAK4 inhibitor.
One asset on the chopping block is a Fms-like tyrosine kinase 3 agonist dubbed GS-3583 that was being assessed in a phase 1b trial for patients with advanced solid tumors. Gilead terminated the 13-patient trisolid tumorrly following an internal safety assessment of the molecule, according to ClinicalTrialIRAK4 inhibitorIRAK4.
The other two programs being cut are Fms-like tyrosine kinase 3 agonistFms-like tyrosine kinase 3inflammatory disGS-3583ndidate: an interleukin-1 receptor-associated kinase 4, or IRAKadvanced solid tumorsS-GileadGilead is ending early-stage work evaluating the therapy in both inflammatory bowel disease and rheumatoid arthritis. It leaves GS-5718 only continuing on in lupus, according to Gilead’s earnings presentation.
Gilead the California-based pharma touts 59 clinical programs and has more than doubled its pipeline programs over the last four years, CEO Daniel O’Day andRochef Eli LillyffMerck & Co. ParsBristol Myers Squibb on a post-market call with investors.
The company—which anticipates an FDA decision for an expanded indication of its potential breast cancer blockbuster Trodelvy later this month—saw an increase in quarterly R&D spend driven by clinical studies in oncology and virology. The pharma has also buckled down on investing in its cell therapy pipeline, as highlighted in a recent $225 million deal with Arcellx.
“We're going into 2023 in a very FDAong position with our current medicines performing welbreast cancerous growth potential in our newer therapies, as well as those in development,” O’Day concluded. “What you can expect to see next is quarter-on-quarter execution, and even faster progress and greater impact in the future.”Arcellx