---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-23-067033"
form_type: "8-K"
ticker: "SLS"
cik: "0001390478"
company_name: "SELLAS Life Sciences Group, Inc."
filed_at: "2023-06-01T23:59:59+00:00"
generated_at: "2026-06-14T09:10:50.990853+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# SELLAS to begin Phase 2a AML trial of CDK9 inhibitor GFH009; Phase 1 showed complete response in monotherapy

## Summary
- Phase 2a single-arm trial to enroll up to 20 R/R AML patients previously failed venetoclax/azacitidine; primary endpoints: composite CR rate, duration of response, safety.
- Trial expected to open June 2023 with top-line data by end of 2023; GFH009 dosed at 45 or 60 mg weekly in combination with standard aza/ven.
- Phase 1 produced the first known complete response (MRD-negative, >6 months) from a CDK9 inhibitor monotherapy in R/R AML; no DLTs observed.
- GFH009 targets MCL1 transcription, synergizing with BCL2 inhibitor venetoclax; triple combo may overcome venetoclax resistance by hitting both anti-apoptotic pathways.
- GPS Phase 3 REGAL AML IDMC meeting set for Q3 2023; interim analysis expected by year-end 2023 or early 2024.

## SEC filing metadata
- accession: 0001104659-23-067033
- form_type: 8-K
- ticker: SLS
- cik: 0001390478
- company_name: SELLAS Life Sciences Group, Inc.
- filed_at: 2023-06-01T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1390478/000110465923067033/0001104659-23-067033-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1390478/000110465923067033/tm2317574d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-23-067033
- JSON: https://secwatch.observer/filing/0001104659-23-067033.json
- Plain text: https://secwatch.observer/filing/0001104659-23-067033.txt

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