CPACS: Research, Results, Market Comparisons, and Valuations, page-100

@TentCity CDx funding and development is a big task. As long as race design the trial so the relevant assays can be produced for a CDx I’m happy. Looking at other all comers trials they relied on a biomarker and a lot s such CDx will be required for all comers approval in this case m6A levels.

The immediate concern is whether the observations from historical data and research likely to translate to the clinic.

1) As we know Bisantrene is cardiotoxic and if paired with Dox cardiotoxicity should hypothetically increase. FTO inhibition also increases Dox induced cardiotoxicity so theoretically if Bisantrene is an FTO inhibitor we would expect even higher rather than lower cardiotoxicity in combo (in vitro). This may indicate self rescue / in combo cardio protection.

2) The question then becomes whether FTO inhibition can also translate. We can only go by Storms results, that it’s METTL3 inhibitor (m6A reader) has translated in vitro in vivo and into the clinic. So it is possible that m6A readers translate then potentially erasers could also.

3) The EMD results are potentially the results of Bisantrenes own FTO inhibition that removes treatment resistance. Otherwise other better performing Anthracenes / TopoII treatments should theoretically also treat EMD.

4) Therefore cardio protection could translate similar to results of Dexrazoxane. Also Storms results is the first in clinic m6A reader showing m6A can be a valid target. Plus broad acting synergy further supports FTO inhibition for a mediocre TopoII Anthracene.

My thoughts are that CPACS translates at clinically relevant dosing, but we will need to wait until clinical trials to confirm. DYOR.