BXQ-350 (Saposin C nanovesicle; sphingolipid “homeostasis” modulator) + mFOLFOX7/bevacizumab posts 61% ORR in 1L mCRC

BXQ-350 is a Saposin C nanovesicle designed to allosterically activate sphingolipid metabolism—reported here to lower GM3/GluCer/S1P and raise ceramides—combined with first-line mFOLFOX7 plus bevacizumab in a Phase 1b/2a dose-escalation study in newly diagnosed metastatic colorectal cancer (n=32 evaluable; NCT05322590). As of September 2025, disease control rate was 91% and ORR was 61% with median PFS 10.6 months; subgroup readouts were ORR 64.3% (male) vs 52.6% (female) and mPFS 9.1 vs 10.6 months, plus ORR 60% (right-sided) vs 52.9% (left/rectal) with mPFS 10.6 vs 10.8 months. Against typical first-line doublet chemo + bevacizumab benchmarks (often ~45–55% ORR and ~9–11 months mPFS across trials/regimens), 61% ORR with ~10.6-month mPFS looks broadly “in-family” rather than clearly additive, and the claim of unexpectedly strong right-sided/female performance is hard to validate without a concurrent control and with small subgroup denominators; safety was described as “safe and well tolerated,” but no Grade 3+ AE rates were provided.