secwatch.observer — SEC 8-K summary
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Issuer:     BICYCLE THERAPEUTICS PLC (BCYC)
CIK:        0001761612
Form:       8-K
Filed at:   2024-09-19T23:59:59+00:00
Accession:  0001104659-24-101202
Event type: other_material
Sentiment:  positive
Materiality: 0.75
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Bicycle Therapeutics reports positive ESMO 2024 data: 45% ORR for zelenectide pevedotin in mUC
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- Zelenectide pevedotin monotherapy in mUC: 45% ORR (38 evaluable patients), 11.1 months median duration of response.
- BT5528 in mUC: 45% ORR in 6.5 mg/m² Q2W expansion cohort; EphA2 expression correlates with response.
- Low treatment-related peripheral neuropathy: 28% with zelenectide, 19% with BT5528; no Grade ≥3 events.
- BT7480 in advanced solid tumors: favorable safety, 13 of 39 patients stable disease, 2 unconfirmed PRs in cervical cancer.
- Global Phase 2/3 Duravelo-2 registrational trial for zelenectide pevedotin in mUC is enrolling.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1761612/000110465924101202/0001104659-24-101202-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1761612/000110465924101202/tm2424162d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-24-101202

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