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Novartis Presents Histology Data with Iscalimab Suggesting the Extended Survival of Transplanted Organs May Be Possible

Basel, June 6, 2019 – Novartis announced today new early stage histology data in kidney transplantation, suggesting that with investigational compound iscalimab (CFZ533) it may be possible to prolong the durability of transplanted kidneys as well as to potentially improve long-term outcomes for kidney transplant patients[1].

“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.”

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, 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[1]. Low CADI scores have been associated with improved long-term outcomes[4]. The findings, although in a limited number of patients, are to be confirmed in an ongoing Phase IIb trial (Cirrus I, NCT03663335).

About iscalimab (CFZ533)
Iscalimab is a new, fully human, monoclonal antibody preventing cluster of differentiation 40 (CD40) pathway signaling and activation of CD40+ cell types[1]. In a recent multicenter, randomized control trial (NCT02217410), with the primary endpoint of non-inferiority on the composite endpoint, iscalimab therapy showed non-inferiority on a composite clinical endpoint, improved renal function, reduced risk for new onset diabetes and similar safety compared with tacrolimus[5]. 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. A CADI of 1 or less was considered as ‘normal renal histology’. The average CADI at final biopsy was 1.6 ±0.6 for iscalimab and 5.1 ±0.8 for tacrolimus[1].

Disclaimer
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “expect,” “anticipate,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political and economic conditions; safety, quality or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Novartis
Novartis is reimagining medicine to improve and extend people’s lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world’s top companies investing in research and development. Novartis products reach more than 750 million people globally and we are finding innovative ways to expand access to our latest treatments. About 105 000 people of more than 140 nationalities work at Novartis around the world. Find out more at www.novartis.com.

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References
[1]           Farkash E, et al. Cni-free Therapy With Iscalimab (anti-cd40 Mab) Preserves Allograft Histology Compared To Standard Of Care After Kidney Transplantation. Presented at the American Transplant Congress (ATC). June 2019.
[2]           Hart A, et al. OPTN/SRTR 2016 Annual Data Report: Kidney. Am J Transplant 2018;18:1-96.
[3]           University of California San Francisco. The Kidney Project Key Statistics [online]. Available from: https://pharm.ucsf.edu/kidney/need/statistics [Last accessed: May 2019].
[4]           Yilmaz S, et al. Protocol Core Needle Biopsy and Histologic Chronic Allograft Damage Index (CADI) as Surrogate End Point for Long-Term Graft Survival in Multicenter Studies. J Am Soc Nephrol 2003;14:773-779.
[5]           Novartis data on file. May 2019.

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