SELLAS Life Sciences Delivers Oral Presentation of SLS009 Phase 1 Data for Acute Myeloid Leukemia Patients at 2024 European School of Haematology (ESH) Conference
- Key study objectives met including pharmacokinetic, pharmacodynamic, safety, and clinical activity
- Complete remission achieved after three months of treatment with eight-month duration and one-year survival
- First-time CR achieved with CDK9 inhibition monotherapy in r/r AML patient
- Phase 2a data for r/r AML patients expected in March and Q2 2024
- Positive topline data for heavily pretreated AML patients with evidence of anti-tumor activity and no significant safety issues
- Dose-proportional anti-leukemic activity and favorable safety profile observed
- Establishment of recommended phase two dose (RP2D) for AML at 60 mg
- Highly selective CDK9 inhibitor SLS009 shows potential synergy with venetoclax and hypomethylating agents in AML treatment
- None.
Insights
The achievement of complete remission with CDK9 inhibition in a relapsed/refractory acute myeloid leukemia patient is a significant clinical milestone. CDK9 inhibitors target a specific enzyme that is crucial for the transcription of genes that promote cancer cell survival. The observed complete remission without minimal residual disease suggests that SLS009 could have a profound impact on patient outcomes, especially considering the poor median survival post-aza/ven therapy. The absence of dose-limiting toxicities and significant off-target adverse events is promising, as it may indicate a favorable risk-benefit profile for patients.
The potential synergy of SLS009 with venetoclax and hypomethylating agents could represent a substantial advancement in AML treatment protocols. This combinatory approach could potentially overcome resistance mechanisms to current therapies. As an oncologist, the favorable safety profile and strong inhibitory activity against key biomarkers such as MYC and MCL-1 are particularly encouraging, as these proteins are often implicated in the pathogenesis and progression of hematologic malignancies.
The pharmacokinetic and pharmacodynamic data presented are crucial for understanding the drug's behavior in the body and its interaction with the disease pathology. Pharmacokinetics involves how the body absorbs, distributes, metabolizes and excretes the drug, which is important for determining the appropriate dosing regimen. The reported dose-proportional pharmacokinetics and the establishment of the recommended phase two dose (RP2D) at 60 mg are key elements for the ongoing Phase 2a trial. The pharmacodynamic response, including the dose-proportional anti-leukemic activity and universal decrease of MYC and MCL-1, provides evidence of SLS009's mechanism of action and its therapeutic potential.
From a research perspective, the upcoming Phase 2a data will be instrumental in confirming these preliminary findings and potentially solidifying SLS009's role in AML treatment. The data will also be critical for future regulatory discussions and could impact the drug's development timeline and market potential.
The positive clinical trial results for SLS009 could have a significant impact on the market landscape for AML treatments. AML is a market with a high unmet need and the development of new therapies that can offer better outcomes is closely watched by investors and healthcare professionals alike. The ability to achieve complete remission in a heavily pretreated patient population is a notable differentiator that could position SLS009 favorably in the competitive landscape.
Investors will be particularly interested in the upcoming Phase 2a data release, as it will provide further evidence of efficacy and safety that could influence the stock performance of SELLAS Life Sciences. The potential for SLS009 to be used in combination with existing AML therapies expands its market potential and could lead to strategic partnerships or licensing agreements, which are common in the biopharmaceutical industry for promising oncology drugs.
- 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 -
NEW YORK, March 01, 2024 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS” or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today announced the delivery of an oral presentation of data for the cohort of patients with acute myeloid leukemia (AML) from the Phase 1 dose-escalation study of SLS009 (formerly GFH009) by Dr. Tapan Kadia, Professor at MD Anderson Cancer Center and the study’s primary investigator, at the 2024 European School of Haematology Acute Leukaemias (ESH) Conference: How to Diagnose and Treat Acute Leukaemias, taking place March 1-3, 2024, in Stockholm, Sweden.
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 Dragan Cicic, MD, Chief Development Officer at Sellas. “Its potential strong synergy with the standard regimen of venetoclax and hypomethylating agents could open up new avenues in the treatment of acute myeloid leukemia. We are looking forward to additional findings from the ongoing Phase 2a trial with the topline data from the initial 45 mg safety-dose level expected by the end of March and the 60 mg RP2D level in the second quarter of this year.”
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.
About SELLAS Life Sciences Group, Inc.
SELLAS is a late-stage clinical biopharmaceutical company focused on the development of novel therapeutics for a broad range of cancer indications. SELLAS’ lead product candidate, galinpepimut-S (GPS), is licensed from Memorial Sloan Kettering Cancer Center and targets the WT1 protein, which is present in an array of tumor types. GPS has potential as a monotherapy and combination with other therapies to address a broad spectrum of hematologic malignancies and solid tumor indications. The Company is also developing SLS009 , a small molecule, highly selective CDK9 inhibitor, which is licensed from GenFleet Therapeutics (Shanghai), Inc., for all therapeutic and diagnostic uses in the world outside of Greater China. For more information on SELLAS, please visit www.sellaslifesciences.com.
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 SELLAS and its development programs as set forth under the caption “Risk Factors” in SELLAS’ Annual Report on Form 10-K filed on March 16, 2023 and in its other SEC filings. Other risks and uncertainties of which SELLAS is not currently aware may also affect SELLAS’ forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated. The forward-looking statements herein are made only as of the date hereof. SELLAS undertakes no obligation to update or supplement any forward-looking statements to reflect actual results, new information, future events, changes in its expectations or other circumstances that exist after the date as of which the forward-looking statements were made.
Investor Contact
Bruce Mackle
Managing Director
LifeSci Advisors, LLC
SELLAS@lifesciadvisors.com
FAQ
What are the key study objectives met in the Phase 1 data for SLS009 in AML patients?
What was achieved after three months of treatment with SLS009 in an AML patient?
What is the recommended phase two dose (RP2D) for AML with SLS009?
What is the potential synergy of SLS009 with other agents in AML treatment?
When can we expect Phase 2a data for r/r AML patients?
