---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-22-098037"
form_type: "8-K"
ticker: "BCYC"
cik: "0001761612"
company_name: "BICYCLE THERAPEUTICS PLC"
filed_at: "2022-09-07T23:59:59+00:00"
generated_at: "2026-06-23T14:24:38.694007+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# Bicycle Therapeutics reports BT5528 Phase I dose escalation results: ORR 22% in ovarian, 67% in urothelial cancers

## Summary
- 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.

## SEC filing metadata
- accession: 0001104659-22-098037
- form_type: 8-K
- ticker: BCYC
- cik: 0001761612
- company_name: BICYCLE THERAPEUTICS PLC
- filed_at: 2022-09-07T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1761612/000110465922098037/0001104659-22-098037-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1761612/000110465922098037/tm2225232d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-22-098037
- JSON: https://secwatch.observer/filing/0001104659-22-098037.json
- Plain text: https://secwatch.observer/filing/0001104659-22-098037.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.