– All major research goals regarding pharmacokinetics, pharmacodynamics, safety and clinical activity were met –
– Complete remission (CR) achieved after 3 months of treatment with duration of 8 months and survival of 1 year at latest evaluation –
~First CR achieved with CDK9 inhibition monotherapy in relapsed/refractory (r/r) acute myeloid leukemia (AML) patients~
– Phase 2a data for R/R AML patients expected in March and Q2 2024 –
NEW YORK, March 1, 2024 (GLOBE NEWSWIRE) — SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS” or the “Company”) is a late-stage clinical biopharmaceutical company focused on developing novel therapeutics. It's a company. Today we announced an oral presentation of data from an acute myeloid leukemia (AML) patient cohort from a Phase 1 dose escalation study of SLS009 (formerly GFH009) by Dr. Tapan Kadia in a wide range of cancer indications. 2024 European School of Hematology Acute Leukemia (ESH) Conference to be held in Stockholm, Sweden, March 1-3, 2024: How to Diagnose and Treat Acute Leukemia He took the stage as a principal researcher.
Positive topline data for heavily pretreated AML patients showed evidence of increased antitumor activity at higher dose levels, with no significant safety issues. Treatment with SLS009 resulted in a complete response (CR) without minimal residual disease (MRD) after 3 cycles as monotherapy in his AML patient in whom previous venetoclax and azacitidine (aza/ven) therapy had failed . CR lasted for 8 months, and at the latest evaluation the patient achieved her 1-year survival. This is the first time that a patient with relapsed/refractory (r/r) AML achieved CR with CDK9 inhibition monotherapy. Notably, the median survival time for patients who relapse after aza/ven therapy is approximately 2.5 months.
All major study objectives regarding pharmacokinetics (PK), pharmacodynamics (PD), safety, and clinical activity were met. The findings presented include:
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There were no dose-limiting toxicities or significant off-target adverse events (AEs) at any dose level. The maximum tolerated dose was not reached as the safety profile was favorable.
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Dose-proportional antileukemic activity across all dose levels and dosing regimens studied included greater than 50% reduction in myeloblasts in patients with high leukemic myeloblast burden, with a broad therapeutic index and Significant cell-killing activity has been demonstrated.
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In one patient who had previously failed Aza/Ven therapy, a durable CR was observed after 3 months of treatment, lasting 8 months, with a survival of 1 year at the latest evaluation.
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Potent inhibitory activity against important biomarkers. It exhibits a dose-proportional response with universal reductions in MYC and MCL-1 in evaluable patients.
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Proportional and well-controlled pharmacokinetics at all dose levels and various dosing regimens.
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The recommended phase 2 dose (RP2D) for AML was set at 60 mg.
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A favorable safety profile was observed with a notable absence of high-grade extramedullary toxicity frequently observed with other CDK9 inhibitors in development.
“SLS009 is a highly selective CDK9 inhibitor with high specificity, only low-grade off-target toxicity, and confirmed efficacy on relevant biomarkers and clinical outcomes in hematological malignancies,” said Seras. said Dragan Sisic, MD, Chief Development Officer. “The potential strong synergy between venetoclax and standard regimens of hypomethylating agents could open new avenues in the treatment of acute myeloid leukemia. We look forward to additional results from the ongoing Phase 2a study, including topline data from an initial 45 mg safe dose level and a 60 mg RP2D level in the second quarter of this year.”
An ongoing Phase 2a study is investigating the safety and efficacy of SLS009 in combination with Aza/Ven in patients with AML who have become unresponsive to standard Aza/Ven therapy or other venetoclax-based regimens. is designed to evaluate. Patients will receive two SLS009 dose levels: 45 mg once weekly, 60 mg once weekly, or 30 mg twice weekly.
About SELLAS Life Sciences Group, Inc.
SELLAS is a late-stage clinical biopharmaceutical company focused on developing new treatments for a wide range of cancer indications. SELLAS' lead product candidate, galinpepimut S (GPS), is licensed from Memorial Sloan Kettering Cancer Center and targets his WT1 protein, which is present in a variety of tumor types. GPS has the potential to address a wide range of hematologic malignancies and solid tumor indications, both as monotherapy and in combination with other treatments. The company is also developing SLS009, a small molecule, highly selective CDK9 inhibitor, licensed from GenFleet Therapeutics (Shanghai), Inc. for all therapeutic and diagnostic applications worldwide outside of Greater China. Masu. For more information about SELLAS, please visit www.sellaslifesciences.com.
Forward-looking statements
This press release contains forward-looking statements. All statements other than statements of historical fact are “forward-looking statements”, including statements regarding future events. In some cases, forward-looking statements include “plans,” “expects,” “anticipates,” “may,” “might,” “will,” “should,” It can be identified by terms such as “anticipate,” “think,” and “think.” “estimate,” “anticipate,” “may,” “intend,” or “continue” and other words or terms of similar meaning. These statements include, without limitation, statements relating to the SLS009 clinical development program (including data therefrom) and the timing of the 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 may differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties. These include, but are not limited to, risks and uncertainties related to the development and clinical success of cancer therapeutics and regulatory uncertainties; the approvals affecting SELLAS and its development programs as described under the “Risk Factors” caption in SELLAS' Annual Report on Form 10-K and other SEC filings filed on March 16, 2023; and other risks and uncertainties. Other risks and uncertainties not currently known to SELLAS may also affect SELLAS' forward-looking statements and could cause actual results or the timing of events to differ materially from expectations. The forward-looking statements herein are made only as of the date hereof. SELLAS does not intend to update or update any forward-looking statements to reflect actual results, new information, future events, changes in expectations, or other circumstances after the date on which the forward-looking statements are made. We are not obligated to provide supplementary information.
Investor contact information
bruce muckle
President
Lifecy Advisors LLC
SELLAS@lifesciadvisors.com