I have written to our new CEO, pointing out that investors cannot make informed decisions if they are not told what is going on.
We all know that data trumps everything, so slow recruitment in IONIC, DARRT-2 and CEP-2 is particularly worrisome. It is inconceivable that nothing is happening on the Hudson Institute front, particularly regarding vaccine enhancement, so it would be nice to know whether Pfizer or Moderna has shown interest. But the first program I want to discuss is LuPIN.
There seems to be a perception that the lack of a partnership or licence with Novartis implies that LuPIN is dead. This is incorrect.
Novartis is focussed on getting Lu-PSMA approved and then into the market. It would not be a good look if Novartis said that they needed Veyonda to make it work and that it will take another 3-4 years to take the combination through Phase 3 and get it approved.
Lu-PSMA is going to be approved as a 4
th line therapy, worldwide, that is about a 25,000 patient market. Novartis wants to take Lu-PSMA into 1
st line therapy of mCRPC where there are 250,000 patients and where patients are more likely to respond. They will need to run a Phase 3 trial there first before they go looking at whether Veyonda is needed.
If not Novartis, then why isn’t another of the many theranostic companies all over us? The answer is that everyone else’s drug is experimental and you cannot run a registration study of two experimental drugs and expect approval of the combination. Those companies need to get their drugs approved first before they go looking at boosting their performance.
Does this mean that LuPIN is a lost cause? HELL NO!
The NOX 2021 AGM presentation noted that discussions were underway regarding a LuPIN-style trial in Europe. We know that GenesisCare has been using Veyonda since 2020 in their compassionate-care program, treating mCRPC patients who have exhausted their treatment options – including Lu-PSMA. They wouldn’t have continued this program unless treatment was successful, so my conclusion is that Veyonda plus LuPSMA has shown efficacy against patients who have
failed Lu-PSMA.
A small trial would conclusively show whether Veyonda performs better than Lu-PSMA, the Standard of Care. The hospital would then be able to offer Veyonda on a Compassionate basis, paying a fee to use our drug; and Noxopharm would be well placed to pursue an Accelerated Approval pathway for Veyonda.
The timing would be exquisite, given that Novartis has run into production problems with Pluvicto. See:
Novartis halts US production for cancer drugs Lutathera, Pluvicto (fiercepharma.com)Among other things, I suggested that Dr Mautner let shareholders know what was going on with this program.
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