Ann: Partnership with QIMR Berghofer targets oesophageal cancer, page-7

Hi Pat,

Canafliglozin has received a further 2 indication approvals from the FDA in the USA being CKD/CVD in Diabetes. Looking at recent research in SGLT2 inhibitors & the improvement in renal and cardiovascular outcomes in diabetic patients, it actually makes sense that if you are going to apply for a CDx from the FDA, it will be for both indications of the drug minus glycaemic control (and in this drug class, there are now multiple drugs & Big Pharma awaiting priority review in these indications).

So the research collaboration that Janssen (J&J) & PIQ are doing with PromarkerD has now extended beyond DKD/CKD & looking at CVD outcomes now also on treatment with canafliglozin.

The PromarkerD test has been validated in Ph1 with ~3000 patients blood samples from the CANVAS trial (DM patients with CKD & CVD risk).

In ADDITION to the DKD outcomes in Ph2, PIQ/Janssen are now also looking at CVD outcomes for patients on treatment with canafliglozin.

The DKD/CKD trial was estimated to complete CY2020, CVD FY2021.

It does not mean that something significant won’t happen prior with DKD/CKD results, as all IP in relation to PromarkerD has CE Mark approval in EU & it is also possible that after this validation study on treatment with Canafliglozin, that there may be an FDA application for CDx for CKD/DKD as was first intended (plus being an International CLIA approved lab, the test can be used in the USA anyway in accredited laboratories, prior to FDA approval).

PIQ are doing everything right though, it’s just that the regulatory & International validation through peer reviewed evidence of large clinical trials is a hard slog & lengthy. I think it will all be worth the wait in the near term.

A lot has happened in the diabetes space over the last couple of years since this collaboration began, so the path has changed a little.

GLTAH