Ann: Lead Antibody Effective in Rare Chronic Kidney Disease, page-2

CELLMID’S LEAD ANTIBODY EFFECTIVE IN RARE CHRONIC KIDNEY DISEASE 

Cellmid’s lead antibody, CAB102, reduced kidney injury and preserved renal function in an experimental model of Focal Segmental Glomerulosclerosis (FSGS)

Research in collaboration with the Westmead Research Institute and funding from the Australian Government’s Innovation Connections Grant

 Results presented at the 54th Annual meeting of the Australian and New Zealand Society of Nephrology

 Preclinical efficacy in the rare kidney disorder FSGS allows for Orphan Drug application with FDA and EMA to commence

SYDNEY: Wednesday, 12 September 2018, Cellmid Limited (ASX: CDY) advises on positive efficacy results from its lead anti-midkine antibody, CAB102, in the rare kidney disease, FSGS. The humanised antibody reduced the area of kidney injury 3-fold compared to vehicle treated control mice with FSGS (p<0.05), while renal function was improved (p<0.05).

The study performed at the Westmead Institute confirmed previous findings, that blocking midkine alleviates damage to the kidney and prevents ensuing defects in renal function. Furthermore, it demonstrated that a humanised antibody targeting midkine, CAB102, is equally as effective as its murine precursor.

This is a critical step in progressing Cellmid’s antibody assets towards clinical trials in kidney patients. Demonstrating efficacy of the humanised midkine antibody in the rare kidney disorder FSGS enables Cellmid to apply to the US FDA and European EMA for Orphan Drug Designation for CAB102, as foreshadowed in the Company’s previous ASX releases earlier this year.

Midkine has been identified as a contributor in several kidney disorders and blocking the action of midkine has previously been shown to improve disease outcomes in animal models. In previous studies it was shown that Cellmid’s murine antibody, IP14, preserved renal structure and function (ASX announcement, 18 January 2017).

CAB102 represents the humanised form of the murine antibody and has been developed to pre-GMP quality. Cellmid received an Australian Government DIIS Innovation Connection Grant to support research projects carried out in the laboratories of Associate Professor Vincent Lee at the Westmead Institute.

The Westmead group not only provided expertise in performing experiments to enable the study of kidney disease, but also contributed valuable clinical and physiological insights into the disease processes involved. The collaboration enabled the testing of Cellmid’s lead antibody assets in a complex preclinical rodent model, providing vital proof of concept that blocking midkine in this manner will protect the kidney from injury in FSGS patients.

The benefits of Orphan Drug status include tax credits for costs of clinical trials, fee waiver and eligibility for seven years of marketing exclusivity. These incentives would represent a major boost to Cellmid’s clinical development programs. “We are excited that engagement with some of the leading renal clinicians and researchers in the field of CKD globally has lead us one step closer to clinical deployment of our anti-midkine assets” said Cellmid’s CEO Maria Halasz.