secwatch.observer — SEC 8-K summary
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Issuer:     BICYCLE THERAPEUTICS PLC (BCYC)
CIK:        0001761612
Form:       8-K
Filed at:   2026-04-20T23:59:59+00:00
Accession:  0001104659-26-045198
Event type: other_material
Sentiment:  positive
Materiality: 0.70
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1761612/000110465926045198/0001104659-26-045198-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1761612/000110465926045198/tm2612166d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-26-045198

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer