secwatch.observer — SEC 8-K summary
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Issuer:     ONCOLYTICS BIOTECH INC (ONCY)
CIK:        0001129928
Form:       8-K
Filed at:   2026-09-28T13:32:06+00:00
Accession:  0001129928-26-000057
Event type: other_material
Sentiment:  positive
Materiality: 0.50
Item codes: 8.01, 9.01
LLM model:  deepseek-v4.1-flash:cloud@v2

Oncolytics: REO 033 CRC study sites nearly all activated; interim Part A data due year-end 2026
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- Part A of randomized REO 033 to enroll ~60 patients with second-line RAS-mutant MSS metastatic colorectal cancer; ORR is primary endpoint, with PFS, OS, safety and biomarkers.
- Interim Part A data expected by year-end 2026, based on number of evaluable patients enrolled by end of October; multiple patients now on study.
- REO 022 prior data: ORR 33% vs ~6-11% historical benchmark; median PFS 16.6 months vs ~5.7; median OS 27.0 months vs ~11.2; median duration of response 19.5 months.
- FDA alignment on pivotal Part B expansion: potential accelerated approval on objective response rate; progression-free survival basis for full approval; Part A data to inform Part B.
- RO 033 tests pelareorep plus FOLFIRI and bevacizumab versus FOLFIRI and bevacizumab; COO John McAdory cites strong enrollment momentum.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1129928/000112992826000057/0001129928-26-000057-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1129928/000112992826000057/oncy-20260928.htm
  HTML page:      https://secwatch.observer/filing/0001129928-26-000057

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