secwatch.observer — SEC 8-K summary
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Issuer:     SELLAS Life Sciences Group, Inc. (SLS)
CIK:        0001390478
Form:       8-K
Filed at:   2023-06-01T23:59:59+00:00
Accession:  0001104659-23-067033
Event type: other_material
Sentiment:  positive
Materiality: 0.75
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1390478/000110465923067033/0001104659-23-067033-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1390478/000110465923067033/tm2317574d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-23-067033

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