The CF33, Vaxinia and Oncarlytics Deal, page-22

It seems like everyone is forgetting about CHECKvacc?

It was the first CF33 drug into the clinic, is being trialled against TNBC, for which there is no effective treatment, and the trial is expected to enrol 78 patients and expected to be completed at the end of this year. If I was to wager a fiver, it would be that this will be the first CF33 drug to be licensed, and the first put up to the FDA for accelerated approval on the basis of safety and meeting an unmet need. However, that will obviously be determined by the results of the trial.

What will be interesting is whether or not there is differing efficacy between CHECKvacc and Vaxinia? The DOMINICA trial to assess CHECKvacc against solid tumours will provide valuable comparative data against the MAST trial to assess Vaxinia against metastatic solid tumours.

It’s hypothesised Vaxinia is a stronger agent because CHECKvacc was modified by the addition of the antiPDL1, but it is entirely possible it will be just as effective against both tumours with and without PDL1 expression. So, it may be a case of whoever licenses CHECKvacc gets first mover advantage.

Alternatively, if CHECKvacc and Vaxinia are seen to be comparative, it might be reasonable to think onCARlytics will be equally effective as a standalone drug, but with the benefit of creating a CD19 target in tumours it does not obliterate in the first instance.

So, if you were a BP exec looking for a breakthrough treatment against all solid tumours, would you licence CHECKvacc to get first mover advantage and have a drug that also has an antiPDL1 or would you sit back waiting to see the PH1 results of the onCARlytics trial and if it really can result in all solid tumours expressing a CD19 target?

Whilst it might not seem like there is currently any BP interest, it is almost certain there are several sitting on the side lines like the rest of us waiting for the first round of hard data and biopsy results.

The only deal done by IMU this year might be for HER-Vaxx as it is close to completing its second PH2 which is being run as a combo study, but you can almost guarantee if the CF33 platforms show they are anywhere close to being as good as what is being talked about by Professor Yuman Fong then we will almost certainly not only see a licensing deal but also an announcement for a confirmatory trial to be commenced followed by an announcement of an accelerated approval submission to the FDA.

I would expect there to be multiple contenders for a licensing deal which would allow IMU to negotiate a large upfront payment, followed by generous milestone payments followed by a sizeable royalty percentage if the drugs can make it all the way to market. CF33 should be a lot cheaper to manufacture relative to big name monoclonal antibody drugs so that should result in a higher royalty, as a lower amount from the sales would be needed to offset the cost
to manufacture the drugs.

I’ll leave it for others to guesstimate what the signing bonus could be and potential ranges for royalties, but I do think we will see deal/s being done before long before onCARlytics completes its PH1. The first deal might be for CHECKvacc or Vaxinia but it is also an outside chance someone will go all in and there will be a winner takes all agreement for all three drugs.

Regardless of how it all plays out, the next 6-18 months will almost certainly be a defining time in the Imugene story.