WOOHOO!
It’s on!
Heck, yeah, it is!
It’s on like freakin’ Donkey Kong.
We’re talking about a good old-fashioned, knock-down, drag-out, winner-take-all heavyweight slugfest between AdAPT-001 and soft tissue sarcoma (STS), for which a Phase 3 clinical trial has been written. A Phase 3 clinical trial is for all the marbles because if the data are positive in STS EpicentRx can request FDA approval to market AdAPT-001 with a checkpoint inhibitor.
By and large, checkpoint inhibitors (CIs) are largely ineffective against most STS subtypes of which there are over 100. The reason is that STS are mainly “cold,” immunosuppressed tumors, in part because of overexpression of immunosuppressive cytokines like transforming growth factor beta (TGFβ), which makes them resistant to CIs.
The fact that AdAPT-001 expresses a TGFβ trap, which binds to and neutralizes TGFβ suggested to us from the outset that it would make checkpoint inhibitor-resistant tumors like STS sensitive to checkpoint inhibitors. The data from the Phase 2 BETA PRIME clinical trial bear out this intuition since several sarcoma subtypes, which did not benefit from a checkpoint inhibitor in previous lines of therapy, responded — and responded durably for 6+ months — to the same checkpoint inhibitor in the presence of AdAPT-001. On top of these clinical observations, AdAPT-001 has been shown to increase the infiltration of T-cells in a syngeneic checkpoint-inhibitor resistant mouse tumor model and to boost the efficacy of CIs.
So, get ready, soft tissue sarcomas. The die is cast. The Rubicon has been crossed. A Phase 3 clinical trial of AdAPT-001 + a CI in STS is coming your way.
It’s about to go down, so cue the trash talk — and the fireworks. This is the “Thrilla in Manila” — on steroids. The run-up to V-Day has begun — the V stands for “virus,” “victory,” and for “vaffanculo,” an Italian obscenity directed at STS.
Oh, yes, everyone, it’s most definitely on!