Bicycle Therapeutics: nuzefatide 40% ORR in EphA2+ mUC; Phase 2 PDAC trial dosed

BICYCLE THERAPEUTICS PLC

Nuzefatide + nivolumab in 14 mUC patients: 40% ORR in EphA2+ tumors; 100% ORR (3/3) in MMAE-naïve EphA2+ tumors.
Preferred monotherapy dose identified as 8mg/m2 Q2W; first patient dosed in Phase 2 trial for 2L+ pancreatic ductal adenocarcinoma.
Human imaging data with EphA2 BIA detected PDAC metastases in 15/18 patients; validates EphA2 as a novel target.
No Grade ≥3 TRAEs of clinical interest with combination; differentiated safety profile vs other EphA2-targeted agents.

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