The FDA requires all investigational new drugs paired with approved drugs pass a simple P1 dose-escalation phase to determine the maximum tolerated dose (MTD) of the combination. Because an FTO inhibitor is a new drug class with no clinical or commercial competitors it has never been paired with an Anthracycline, so the optimum dose of the combination is unknown. For another example, CF33 couldn't progress to a combination study without first passing safety as a single agent.
You did know all of this, right?
Bisantrene has already been used in combination twice with excellent efficacy (46% CR / 40% ORR) and tolerable safety, so establishing the MTD should be a rather smooth process. Bisantrene is a phase III asset - all that's missing is in-human data linking clinical efficacy to m6A levels, which comes within the next 12-months.
Why IMU is a multi multi bagger, page-24231
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