secwatch.observer — SEC 8-K summary
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Issuer:     BICYCLE THERAPEUTICS PLC (BCYC)
CIK:        0001761612
Form:       8-K
Filed at:   2022-11-08T23:59:59+00:00
Accession:  0001104659-22-115679
Event type: other_material
Sentiment:  positive
Materiality: 0.70
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

BT8009 Phase II expansion first patient dosed; Phase I dose escalation complete
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- Phase I dose escalation complete; RP2Ds: 5 mg/m2 weekly and 7.5 mg/m2 (2 on, 1 off) selected.
- Confirmed RECIST responses in UC and NSCLC; median duration of response not yet reached.
- First patient dosed in Phase II expansion; includes cohorts evaluating BT8009 with CPI.
- Priority indication: first-line metastatic UC in cisplatin-ineligible patients combined with CPI.
- Updated Phase I data from 49 patients to be presented at medical meeting in 1H 2023.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1761612/000110465922115679/0001104659-22-115679-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1761612/000110465922115679/tm2229927d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-22-115679

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