Bicycle Therapeutics reports 65% ORR in Ph1 combo zelenectide plus pembro in 1L mUC; outlines 2025 milestones

BICYCLE THERAPEUTICS PLC

Updated Phase 1 Duravelo-1 data: 65% ORR (13/20 evaluable) in 1L cisplatin-ineligible mUC; 50% confirmed ORR.
Median duration of response not yet mature; 12 patients remain on treatment at data cut-off (Jan 3, 2025).
No Grade 4/5 TRAEs of clinical interest; no patients withdrew due to zelenectide TRAEs; low-grade peripheral neuropathy, skin/eye events.
Cash and equivalents $890.9M as of Sept 30, 2024; financial runway into 2H 2027.
2025 milestones: Phase 2/3 Duravelo-2 dose selection data in 2H; initiate Phase 1 trials in NECTIN4-amplified breast, lung, and multi-tumor cancers.

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