Ann: Phase 1 CF33 VAXINIA Study Update - Positive Early Signals, page-162

Wow!

I'm late to today's party. This Ann dropped at 1am in my current time zone, and I started reading it at 4am. An hour later and I'm still wading through everyone's comments but I've read the Ann three times and started on the Poster and my first thoughts echo what so many here have already said:

• Outstanding result for patients who have failed at least two prior lines of treatment (a requirement for eligibility to enter the study).
• This data includes patients who started on the initial "teeny tiny dose" mandated by the FDA (Yuman Fong's words)
• The complete response would have been regarded as "Progressive Disease" initially (49% increase in tumour)after two cycles, but ended up completely cancer free. There is a very good chance that some - and maybe many - of the stable disease patients (or even the progressive disease patients) will ultimately show a partial or complete response. This is a biological process of the immune system, and it takes time.
• Amaaaazing that we are also seeing some clinical benefit from IV treatment
• The expansion with Bile Duct cancer shows where they are going for a potential FDA "Breakthrough Drug" designation. I would suggest they may also chase "Orphan Drug" designation - because there are no effective treatments for BDC. Orphan Drug would give them 7 years of market exclusivity after approval.
• But BDC would be just the start. We are seeing clinical benefit across a wide range of solid tumours.
• Then we will see what happens with combo with Keytruda
• AND we are yet to see what happen with OnCARlytics. omg.....

So although this is fabulous news, my final comment for now is:


Best wishes to all, particularly those living with cancer, or loving someone with cancer, or grieving the loss of someone from cancer - and that's probably most of us.

Dave