The partial clinical hold applies to all Gilead or investigator-sponsored trials of magrolimab in solid tumour indications. Image Credit: II.studio / Shutterstock.

Gilead Sciences had paused enrolment in the magrolimab solid tumour trials, with the FDA requesting a partial clinical hold on these studies.

Earlier this month, the US regulatory agency placed a full clinical hold on all the clinical trials of magrolimab for myelodysplastic syndromes (MDS) and acute myeloid leukaemia (AML).

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“Gilead will likely decide to deprioritise the magrolimab programme entirely,” said Sakis Paliouras, associate director for oncology research and analysis at GlobalData. Adding: “it is less likely, but still possible, that the company will come back from the clinical hold and continue the programme.”

GlobalData is the parent company of Pharmaceutical Technology.

The latest partial clinical hold affects the Phase II trials of magrolimabin multiple solid tumour conditions such as head and neck squamous cell carcinoma (NCT04854499), triple-negative breast cancer (NCT04958785), and colorectal cancer (NCT05330429). In addition to Gilead-sponsored trials, the partial clinical also applies to Investigator Sponsored Studies with magrolimab in solid tumours.

Paliouras said the blood cancer results for all CD47 products had been very disappointing and the field is shifting most of its interest in solid tumours.

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“Despite the failures, GlobalData’s PIC tracks over 50 clinical-stage CD47 products globally, so the industry’s interest in the target remains,” said Paliouras.

The CD47 targeting monoclonal antibody was a high-value bet for the company. Gilead acquired the drug as part of its $4.9bn acquisition of Forty Seven in 2020. However, since then the therapy has shown little clinical benefit in clinical trials. In July 2023, Gilead terminated a Phase III trial (NCT04313881) evaluating the efficacy and safety of magrolimab in combination with azacytidine in patients with MDS due to futility. In September 2023, the company terminated another Phase III trial (NCT04778397) for the therapy in AML patients with TP53 mutations.

Other CD47 products currently in Phase III clinical development include ALX Oncology’s evorpacept, I-Mab’s lemzoparlimab and Viego Therapeutics VY-1021. In October 2023, ALX reported positive interim results of combination treatment with evorpacept from a Phase II/III ASPEN-06 trial (NCT05002127) in patients with HER2-positive gastric/gastroesophageal junction cancer. The results showed that the confirmed overall response rate for the evorpacept combination treatment was 52% compared to 22% for the control treatment.