BXQ-350 (saposin C nanovesicle; sphingolipid “homeostasis” modulator) + mFOLFOX7/bevacizumab shows 61% ORR with low severe CIPN in 1L mCRC

BXQ-350 is a saposin C–containing nanovesicle designed to allosterically shift dysregulated sphingolipid metabolism (↓GM3/GluCer/S1P; ↑ceramides) and was combined with first-line mFOLFOX7 + bevacizumab in a Phase 1b/2a dose-escalation study in newly diagnosed metastatic colorectal cancer (NCT05322590). In 32 evaluable patients (all completed the planned SoC schedule plus BXQ-350), the disease control rate was 91% and as of September 2025 the ORR was 61% with median PFS 10.6 months—numerically similar to historical first-line mFOLFOX6 + bevacizumab benchmarks (mPFS ~10.6 months in CALGB/SWOG 80405’s bevacizumab arm), so the efficacy signal reads more “within-range” than clearly additive on this small, early-phase dataset. The standout claim is neuropathy: 85% completed ≥8 oxaliplatin cycles, 58% completed all 12 cycles, only 2 stopped oxaliplatin before cycle 8 due to CIPN, and there were no Grade 4 and only three Grade 3 CIPN events (all after cycle 12)—suggesting a potential CIPN-mitigation effect that could preserve oxaliplatin dose intensity (though attribution is hard without a randomized control and with expected clinician-driven oxaliplatin de-escalation practices).