secwatch.observer — SEC 8-K summary
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Issuer:     BICYCLE THERAPEUTICS PLC (BCYC)
CIK:        0001761612
Form:       8-K
Filed at:   2022-09-07T23:59:59+00:00
Accession:  0001104659-22-098037
Event type: other_material
Sentiment:  positive
Materiality: 0.70
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Bicycle Therapeutics reports BT5528 Phase I dose escalation results: ORR 22% in ovarian, 67% in urothelial cancers
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- Among 9 EphA2-positive ovarian patients, ORR 22% (1 CR, 1 PR), DCR 67%; median 4 prior therapies.
- In 3 EphA2-positive urothelial patients, ORR and DCR 67% (2 PRs).
- Safety differentiated from EphA2 ADCs: no treatment-related hemorrhage, low-grade neuropathy, rash, eye disorders.
- RP2D established at 6.5 mg/m2 every other week; expansion cohorts for ovarian, urothelial, and basket cancers ongoing.
- Enrollment ongoing in expansion cohorts of up to 56 patients; updates expected next year.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1761612/000110465922098037/0001104659-22-098037-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1761612/000110465922098037/tm2225232d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-22-098037

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