- The study focuses on patients unlikely to benefit from azacitidine/venetoclax or showing early resistance.
- SLS009 showed strong Phase 2 results in relapsed/refractory AML, surpassing 20% overall response rate.
- Topline data for the trial is expected by Q4 2026.
SELLAS Life Sciences Group, Inc. (SLS) on Thursday said it has enrolled its first patient in a Phase 2 trial of SLS009 (tambiciclib), a selective CDK9 inhibitor for patients with acute myeloid leukemia (AML).
The trial aims to assess efficacy in first-line AML treatment and will enroll approximately 80 patients across two high-need cohorts.
Trial Design and Technology Integration
The study, identified as NCT04588922, targets patients predicted to respond poorly to standard azacitidine/venetoclax (aza/ven) therapy based on molecular profiling, as well as those who show early resistance after two treatment cycles.
“By targeting molecularly defined subgroups and those demonstrating early non-response, we aim to address a critical need in frontline AML and position SLS009 for potential registrational development.”
-Angelos Stergiou, President and CEO, SELLAS
Following the update, SELLAS Life Sciences stock traded over 1% higher in Thursday’s premarket.
SLS009 previously demonstrated promising results in relapsed/refractory AML, exceeding the 20% overall response rate (ORR) threshold in Phase 2 studies. Notably, patients receiving the recommended 30 mg twice-weekly dose achieved an overall ORR of 40%.
Study Timeline And Global Reach
The trial is planned across sites in the United States and Europe, with topline data expected by Q4 2026. By expanding SLS009 into newly diagnosed AML populations, SELLAS aims to broaden its therapeutic impact beyond relapsed/refractory cases, aligning with FDA guidance.
If successful, SLS009 could offer a new targeted option for patients with limited treatment prospects, particularly those with predictive biomarkers indicating poor response to conventional therapies.
What Are Stocktwits Users Saying?
On Stocktwits, retail sentiment around the stock remained in ‘bullish’ territory amid ‘high’ message volume levels.
A bullish Stocktwits user expressed optimism about the trial.
Another user called the stock ‘safest investment’.
SLS stock has gained 358% in the last 12 months.
For updates and corrections, email newsroom[at]stocktwits[dot]com.