- All key study objectives regarding pharmacokinetic, pharmacodynamic, safety, and clinical activity were met -
- Complete remission (CR) achieved after three months of treatment with duration of eight months and one year survival at the latest assessment -
- First time achievement of CR with CDK9 inhibition monotherapy in relapsed/refractory (r/r) acute myeloid leukemia (AML) patient –
- Phase 2a data in r/r AML patients expected in March and Q2 2024 -
Positive topline data for the heavily pretreated AML patients showed evidence of anti-tumor activity increasing with higher dose levels and no significant safety issues. Treatment with SLS009 resulted in a complete remission (CR) with no minimal residual disease (MRD) after three cycles as a monotherapy in an AML patient who had failed prior venetoclax plus azacytidine (aza/ven) therapy. The CR lasted eight months with the patient achieving one year survival at the latest assessment. This is the first time that a relapsed/refractory (r/r) AML patient achieved a CR with CDK9 inhibition monotherapy. Notably, the median survival for patients relapsed after aza/ven therapy is approximately 2.5 months.
All key study objectives regarding pharmacokinetic (PK), pharmacodynamic (PD), safety, and clinical activity were met. Presented findings included:
- No dose-limiting toxicities or significant off-target adverse events (AEs) at any dose level. Maximum tolerated dose was not reached due to a favorable safety profile.
- Dose-proportional anti-leukemic activity across all dose levels and administration regimens studied, including bone marrow blast reduction of greater than 50% in patients with high burdens of leukemic bone marrow blasts indicating a broad therapeutic index and meaningful cell killing activity.
- Durable CR was observed in one patient who had previously failed aza/ven therapy, after three months of treatment, lasting eight months and one-year survival at the most recent assessment.
- Strong inhibitory activity against key biomarkers with a dose-proportional response and universal decrease of MYC and MCL-1 in evaluable patients.
- Proportional and well-controlled pharmacokinetics at all dose levels and at different dosing regimens.
- The recommended phase two dose (RP2D) for AML was established at 60 mg.
- Favorable safety profile observed with a notable absence of higher-grade extramedullary toxicities which have been frequently observed with other CDK9 inhibitors in development.
“SLS009 is a highly selective CDK9 inhibitor with high specificity, only low grade off-target toxicity, confirmed efficacy on relevant biomarkers and clinical outcomes in hematologic malignancies,” said
The ongoing Phase 2a trial is designed to assess the safety and efficacy of SLS009 in combination with aza/ven in AML patients who stopped responding to standard aza/ven therapy and other venetoclax- based regimens. Patients are dosed at two SLS009 dose levels of 45 mg once a week and 60 mg either as a once-weekly dose or divided into two 30 mg doses weekly.
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Forward-Looking Statements
This press release contains forward-looking statements. All statements other than statements of historical facts are “forward-looking statements,” including those relating to future events. In some cases, forward-looking statements can be identified by terminology such as “plan,” “expect,” “anticipate,” “may,” “might,” “will,” “should,” “project,” “believe,” “estimate,” “predict,” “potential,” “intend,” or “continue” and other words or terms of similar meaning. These statements include, without limitation, statements related to the SLS009 clinical development program, including data therefrom, and the timing for release of additional data. These forward-looking statements are based on current plans, objectives, estimates, expectations and intentions, and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties with oncology product development and clinical success thereof, the uncertainty of regulatory approval, and other risks and uncertainties affecting
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