secwatch.observer — SEC 8-K summary
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Issuer:     Silexion Therapeutics Corp (SLXN)
CIK:        0002022416
Form:       8-K
Filed at:   2026-08-10T10:16:08+00:00
Accession:  0001178913-26-003966
Event type: other_material
Sentiment:  positive
Materiality: 0.80
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Silexion starts SIL204 Phase 2/3 in pancreatic cancer; FDA pre-IND expected Q1 2027
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- Phase 2/3 safety run-in for SIL204 in LAPC initiated July 2026; approved by Israel MoH and Germany BfArM.
- Early human data expected Q4 2026; IND application and US/EU expansion planned Q1 2027.
- SIL204 targets >74% of KRAS mutations in PDAC; sub-nanomolar IC50 across G12D/V/C/R and others.
- Preclinical data show tumor growth inhibition, synergy with FOLFIRI, and 11-fold safety margins.
- Toxicology package for marketing approval planned H2 2026; collaboration with Catalent and Axolabs for GMP supply.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/2022416/000117891326003966/0001178913-26-003966-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/2022416/000117891326003966/zk2635901.htm
  HTML page:      https://secwatch.observer/filing/0001178913-26-003966

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