Novartis’ iscalimab results hint at extended survival of transplanted organs

Novartis has presented first-of-its-kind histology data with iscalimab (CFZ533), suggesting that it may be possible to prolong the durability of transplanted kidneys as well as to potentially improve long-term outcomes for kidney transplant patients.

The data, presented at the American Transplant Congress (ATC) examines whether calcineurin-free treatment with iscalimab preserves the quality of transplanted kidney grafts.

In this analysis, the drug demonstrated lower chronic allograft damage index (CADI) scores compared with the current standard of care, tacrolimus, and normal renal histology was seen in three of five patients (60%) on iscalimab vs. none of the seven on tacrolimus.

Low CADI scores have been associated with improved long-term outcomes and the findings, although in a limited number of patients, are to be confirmed in an ongoing Phase IIb trial.

Iscalimab is a new, fully human, monoclonal antibody preventing cluster of differentiation 40 pathway signaling and activation of CD40+ cell types.

"Extending the life of transplanted kidneys would mean fewer patients going back on dialysis or needing a second transplant - relieving pressure on waiting lists that in the US are already three-to-five years long," said Eric Hughes, global development unit head, Immunology, Hepatology and Dermatology.

"In our journey to reimagine care for patients, I'm excited about the potential of durable transplants becoming a reality."

Currently, a kidney transplant does not last for ever. The average life-span of a transplanted kidney is 12 years for a deceased donor kidney, and about 15 years for a living related transplant. The average for a living unrelated transplant is somewhere between the two.

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