Novartis presents first-of-its-kind histology data with iscalimab

Novartis presents first-of-its-kind histology data with iscalimab

Novartis has announced first-of-its-kind histology data with iscalimab (CFZ533), suggesting the extended survival of transplanted organs may be possible.

The early stage data suggest that with investigational compound iscalimab 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), examine whether calcineurin-free treatment with iscalimab preserves the quality of transplanted kidney grafts.

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

Low CADI scores have been associated with improved long-term outcomes. The findings, although in a limited number of patients, are to be confirmed in an ongoing Phase IIb trial (Cirrus I, NCT03663335).

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

The analysis presented at the ATC included patients from this study that underwent either routine biopsies or biopsies as part of a follow-up protocol. The data was reviewed and scored by a blinded pathologist using the established Banff criteria and CADI.

Less than half of donated kidneys last 10 years, so durability is a significant unmet need for patients who are living with or waiting for a transplant. More than 100,000 patients are on the US transplant waiting list with a chronic shortfall of donors.

Eric Hughes, Global Development Unit Head, Immunology, Hepatology and Dermatology, said: “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.

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