After the recent approval and launch of twice-yearly HIV prophylactic Yeztugo, Gilead is cleaning up its R&D pipeline. The Bay Area company has dropped two early-stage cancer candidates and a Novo Nordisk-partnered combination treatment for metabolic dysfunction-associated steatohepatitis (MASH).
The two culled oncology assets are a DGKα inhibitor called GS-9911 and an MCL1 inhibitor called zamzetoclax or GS-9716, according to an Aug. 7 earnings presentation.
Both were being tested out in phase 1 trials, with GS-9911 being tested alone and in combination with an anti-PD-1 monoclonal antibody in patients with advanced solid tumors, and zamzetoclax alone or with other chemotherapies in patients with advanced solid malignancies. Gilead did not respond to Fierce Biotech's questions about the current status of the trials.
The other dropped program was evaluating two Gilead assets, cilofexor and firsocostat, either alone or with Novo's semaglutide for the treatment of MASH, a serious liver disease that used be called nonalcoholic steatohepatitis (NASH). A phase 2 trial with 457 patients wrapped up in December 2024, but Gilead has yet to publicly disclose any data from the study.
“Our portfolio is under constant review to ensure we are progressing the most promising and potentially impactful programs,” a Gilead spokesperson told Fierce.
At the time of publication, Novo Nordisk had not responded to Fierce's request for comment.
Gilead acquired cilofexor and firsocostat from buyouts of the biotechs, Phenex and Nimbus, respectively. The pair proved capable of improving MASH symptoms in a small trial of 20 patients, but several grade 3 adverse events occurred. The California biotech teamed up with Novo in April 2019 to see if adding semaglutide to the mix could boost the duo’s potential.
The partners launched the Wayfind trial in 2021 after some early phase 2a data showed a hint of potential efficacy.
In December 2019, cilofexor and firsocostat failed to improve liver scarring in a phase 2 MASH trial run by Gilead, either alone or with Gilead’s ASK1 inhibitor selonsertib.
With the Novo collaboration dropped, Gilead’s fibrotic disease pipeline is now entirely empty.