SELLAS Rises On Positive Phase 2 Data Of SLS009 In Relapsed/Refractory AML-MR

(RTTNews) - Shares of SELLAS Life Sciences Group Inc. (SLS) are up nearly 7% at $1.86 in premarket trading, following promising clinical data from its ongoing Phase 2 study of SLS009 in relapsed/refractory acute myeloid leukemia (AML) with myelodysplastic syndrome-related changes.

The phase 2 study is evaluating SLS009 in combination with azacitidine (AZA) and venetoclax (VEN) for the treatment of patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with myelodysplastic syndrome-related changes (AML-MR) after prior VEN-based treatment.

The data from 35 evaluable patients across three cohorts in the phase 2 expansion study were presented at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition yesterday.

According to the study results, SLS009 in combination with AZA/VEN achieved a 46% overall response rate across all cohorts, a 58% overall response rate in patients with one prior line of therapy and encouraging survival outcomes in heavily pretreated AML-MR following prior VEN-based treatment.

The median overall survival was 8.9 months in the least pretreated patients. For those who received one prior therapy, median overall survival has not yet been reached, compared with a historical benchmark of about 2.5 months.

The company plans to expand the Phase 2 study in Q1 2026 to evaluate SLS009 in combination with AZA/VEN in newly diagnosed AML patients with high-risk features.

SLS closed Friday's trading at $1.74.