SELLAS Life Sciences Receives FDA Fast Track Designation for SLS009 for Treatment of Relapsed/Refractory Acute Myeloid Leukemia and Provides Updated Data for Phase 2a Study of SLS009 in Relapsed/Refractory Acute Myeloid Leukemia Patients
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The recent Fast Track Designation for SLS009, a CDK9 inhibitor, represents a significant step forward in the treatment of relapsed/refractory acute myeloid leukemia (r/r AML), a condition with limited therapeutic options and poor prognosis. The clinical outcomes observed with SLS009 in combination with venetoclax and azacitidine are particularly noteworthy, given the high percentage of patients showing significant anti-leukemic effects and the extended overall survival times, which are markedly better than the median OS typically seen with standard care. The durable complete response observed in the Phase 1 study further supports the drug's potential efficacy.
From a medical standpoint, the combination therapy's ability to induce responses in patients resistant to venetoclax regimens could signal a paradigm shift in AML treatment. Furthermore, the favorable safety profile and absence of dose-limiting toxicities to date could mean a more tolerable treatment for patients, which is critical in managing a disease as debilitating as AML.
The Fast Track Designation by the FDA is an indicator of SLS009's potential to address an unmet medical need in the treatment of r/r AML. The designation is likely to expedite the drug's development and review process, possibly leading to a quicker path to market. The initial positive data from the Phase 2a study, particularly the high survival rates and the complete remission in one patient, are promising for the drug's future prospects.
It's important to note that the study is still in its early stages and the long-term efficacy and safety of SLS009 remain to be fully established. However, the absence of significant safety issues and the achievement of a durable complete response in the Phase 1 study are encouraging signs. The ongoing enrollment in the higher 60 mg dose cohort will provide additional data that could further validate the drug's efficacy and safety profile.
The implications for SELLAS Life Sciences Group in terms of market potential are substantial. The Fast Track and Orphan Drug Designations could provide SELLAS with developmental incentives, including tax credits for clinical testing and potential market exclusivity upon approval. This could position SLS009 favorably in the competitive landscape of AML treatments, especially considering the current limitations of venetoclax-based therapies.
The market response to these positive developments could be reflected in investor optimism, potentially influencing SELLAS's stock performance. The full data readouts expected in the coming quarters will be critical milestones that the market will be watching closely. Positive results could lead to increased investor confidence, while any setbacks might have the opposite effect.
- Phase 2a Enrollment Completed in 45 mg Safety Cohort: Median Overall Survival (OS) Not Reached;
- First Enrolled Patient in Phase 2a Study Achieved Complete Remission and Continues on Study With Full Recovery and in Seventh Month of Survival; Second Enrolled Patient Continues on Study in Sixth Month of Survival; Median OS in Relapsed/Refractory (r/r) Acute Myeloid Leukemia (AML) Patients Treated with Standard of Care is Approximately 2.5 Months -
- Fast Track Designation Accelerates SLS009's Path for U.S. Regulatory Submission for Treatment of r/r AML -
NEW YORK, Jan. 09, 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 that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to SLS009 (formerly GFH009), its novel and highly selective CDK9 inhibitor, for the treatment of relapsed/refractory (r/r) acute myeloid leukemia (AML). The Fast Track Designation is intended to facilitate the development and review of drugs to treat serious conditions and fill an unmet medical need.
“Receiving Fast Track Designation for SLS009 for r/r AML, following the recent Orphan Drug Designation for the same indication, underscores the potential for SLS009 and highlights the critical unmet need for patients with AML who face a poor prognosis due to the progressive nature of the disease,” said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. “The initial positive topline Phase 2a data at the 45 mg (safety) dose level demonstrate that SLS009 in combination with venetoclax and azacitidine (aza/ven) exhibits anti-leukemic effects with a favorable safety profile in AML patients resistant to venetoclax combination therapies. Importantly, as of the last follow-up, eight of the nine patients enrolled in the 45 mg cohort were alive. The first patient enrolled in the study achieved a complete response (CR) and continues on study in the seventh month with full peripheral blood recovery. The second enrolled patient is in the sixth month of treatment, further underscoring the potential benefit of adding CDK9 inhibition to the aza/ven regimen. We have now also enrolled several patients in the ongoing 60 mg dose cohort. Our team is committed to advancing the development of SLS009 with the goal of providing effective solutions to patients in need of viable treatment options.”
Dr. Stergiou continued, “SLS009 continues to emerge as a promising treatment for hematologic malignancies, and we are pleased by the FDA’s recognition of its potential by the grant of Fast Track and Orphan Drug Designations for AML. These designations position us to accelerate SLS009 clinical development with the goal of delivering this potentially groundbreaking treatment to AML patients in need.”
A total of nine patients have been enrolled at the 45 mg safety dose level. Eight patients (
The Phase 2a clinical trial of SLS009 is an open label, single arm, multi-center study that is designed to evaluate safety, tolerability, and efficacy at two dose levels, 45 mg and 60 mg, in combination with aza/ven. In the 60 mg dose cohort, patients are being randomized to one of two groups, 60 mg flat (fixed) dose once per week and 30 mg fixed dose two times per week. Each group will enroll 5 – 10 patients. In addition to safety and tolerability of SLS009 in combination with aza/ven, the primary endpoints are composite complete response rate (CRc) and duration of response (DOR). Additional endpoints include event free survival (EFS), OS, and pharmacokinetic (PK) and pharmacodynamic (PD) assessments. Venetoclax combinations with hypomethylating agents are a commonly used regimen in this target population but despite high efficacy (up to ~
The Company expects to report additional data from the fully enrolled 45 mg (safety dose level) cohort and initial data from the 60 mg (recommended Phase 2 dose level) cohort in the first quarter of 2024 and expects the 60 mg cohort to be analyzed in the second quarter of 2024.
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 (formerly GFH009), 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 regulatory matters related thereto and the timing for receipt of additional data from the clinical program. 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
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