Back to basics:
The strategy is still a four pronged approach.
1. AML (specifically EMD AML), which has unmet clinical needs. That said, SoC doesn’t recognise EMD for a standalone treatment option -presently. This recruitment is an issue as AML clinical trials are highly competitive.
Plan to progress with EMD recruitment.
(i) change in trial design to accept AML patients even if not AML.
(ii) expand sites to Europe and Australia to x10 sites. Europe PETscan is SoC but delays due to EMA regulation changes are hindering all trials in EUR.
(iii) MD Anderson donation for EMD incidence PETscan trial in the US to change KOL approach to treating AML
So whilst 505(2)(b) accelerated pathway may be available it seems it’s seems other factors will delay. Can they drop the trial, short answer NO as it is too symbolic to the Pillar 1 strategy.
Can we partner and expand to US, possibly the same issue with Australia recruitment will be observed in the US and thus the MD Anderson donation. So what to do other that persevere.
2. Cardio protect was identified well after FTO and already into P2 and KOLs knocking on the door. For those that have not read the Primary Research report, >$5b annual revenue opportunity and little or no competitors with such a clinically advanced solution.
As Zantrene is a repurposed drug, cost or development is reduced, cardio protect and anti cancer already observed, previously approved in France so significantly derisked.
Industry sees the need for cardio protect anti-cancer, but the reformulation is critical. Will we see delays or issues with manufacture… For me once we get the green light on reformulation it’s full steam ahead.
I think we will see this overtake EMD AML and be the new pathway to approval.
BUT, I would like to see an IND opened shortly after reformulation (think we need patient data first) and then breakthrough designation.
Will Race go the full hog to approval under license / partnership? Firstly we will need the cash, alternatively would need capital raise , which would fit nicely into the new players on the Race team.
3. FTO, the bigger of the biggest pillars. It took Big Pharma with unlimited resources and teams of 200+ to accelerate Keytruda. We can’t do this. If we sell or partner before proof of concept validated in the clinic then value will be lost.
Instead I see a phased exit, Cardio protect followed by EMD AML potentially scrapped post cardio transaction or sold to Astex. Giving cashflow to pursue FTO.
Will we see an FTO primary research report on the horizon, I believe so based on Dani’s comments in the cardio protect report. It just can’t be pursued yet until the Dominissini data is out and 100+ cancer panel review.
Side note, there is more scientific research on FTO than Bisantrene cardio protect, so I am more comfortable with FTO than Cardio. Science can throw some curves balls so need the data to prove.
I hold my breath on an FTO transaction and it may be licensed post cardio protect to same Pharma if selected wisely.
Final thought if FTO is the bigger whale, just double and add a bit more to Cardio values, including time taken to prove up. It won’t be 2 years IMO.
4. Pillar 4 for the home run, a bit of insurance against there being another FTO inhibitor on the same level as Zantrene that already exists. Plus finding a non-cytotoxic version for a quick flick diabetes program or retirement plan. There is also the ALKBH5 eraser program. License early for a development.
Value of all four is mind blowing. Still want the team to be beefed up with aa big name from the Pharma industry. Want to see all four pillars proceed and the team see it through, taking RACE from a biotech to pharma, cash, time and expertise / sticking through the strategy (before moving on) are some of the speed bumps I see ahead.
Best of luck and enjoy the ride!
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