SELLAS Announces Publication of Preclinical Data on its Highly Selective CDK9 Inhibitor, SLS009, in Oncotarget
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Insights
The recent findings on SLS009, a CDK9 inhibitor, are significant in the field of oncology, particularly for the treatment of hematologic malignancies. CDK9 plays a critical role in the transcription of genes that regulate cell cycle progression and apoptosis. The ability of SLS009 to selectively inhibit CDK9 and induce apoptosis in cancer cells provides a promising therapeutic strategy. This targeted approach could potentially result in fewer side effects compared to traditional chemotherapy, which is less selective and often affects healthy cells. The dose-dependent induction of apoptosis observed in early-stage trials suggests a favorable therapeutic window for SLS009. However, it is essential to monitor for potential resistance mechanisms that might emerge with CDK9 inhibition, as seen with other targeted therapies.
The preclinical research publication for SLS009 underscores the importance of robust pharmacodynamic studies in drug development. Understanding the mechanistic underpinnings of a drug's action can significantly de-risk the clinical development process. With SLS009 showing superior kinome selectivity, there is a potential for reduced off-target effects, which is a common challenge in the development of kinase inhibitors. As the drug progresses through clinical trials, the data will be crucial in determining the optimal dosing regimen and patient population. Furthermore, the research may pave the way for combination therapies that could further enhance the efficacy of SLS009 by targeting complementary pathways involved in hematologic malignancies.
The advancement of SLS009 into later-stage clinical trials represents a significant milestone for SELLAS Life Sciences Group. The market for hematologic cancer treatments is highly competitive, with numerous established therapies and others in development. The success of SLS009 in clinical trials could position SELLAS favorably in this market, especially if the drug's selectivity translates into a strong safety profile. Investors should monitor the upcoming release of topline data from the Phase 2a and Phase 1b/2 studies closely, as positive results could lead to an increase in the company's valuation and investor interest. Conversely, any setbacks in the clinical trials could have a negative impact on the company's prospects. It's also important to consider the potential for strategic partnerships or licensing agreements that could arise if SLS009's clinical data is compelling.
NEW YORK, Feb. 06, 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 a publication in Oncotarget revealing the underlying mechanisms of action behind the anti-proliferative effects of SLS009 (formerly GFH009), its potent, highly selective CDK9 small molecule inhibitor, in various hematologic malignancies.
The publication, entitled, “The pharmacodynamic and mechanistic foundation for the antineoplastic effects of GFH009, a potent and highly selective CDK9 inhibitor for the treatment of hematologic malignancies”, is available online at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10732257/.
The research provides a robust pharmacodynamic and mechanistic foundation for the antiproliferative effects of SLS009 in hematologic cancers. SLS009 has exhibited significant anti-tumor activity in various human hematological malignancies in early-stage clinical trials and has demonstrated its potential in tumor growth inhibition with a dose-dependent induction of apoptosis. The research shows that through rapid CKD9 inhibition, SLS009 depletes the protective anti-apoptotic proteins produced downstream of CKD9. The Company believes that this induced cancerous cell apoptosis is a key mechanism behind SLS009's robust anti-cancer activity.
“The study establishes CKD9 as a targetable vulnerability in various human hematological malignancies highlighting the potential for SLS009 superior kinome selectivity compared to other inhibitors,” said Dragan Cicic, MD, Senior Vice President, Chief Development Officer, of SELLAS. “These findings provide a strong rationale for ongoing clinical trials and underscore SLS009's potential as a highly selective and effective treatment for hematological malignancies.”
Dr. Cicic added, “We are encouraged by the ongoing clinical progress of SLS009 and excited to see how the preclinical data seamlessly translates into clinical settings. We look forward to reporting topline data from our Phase 2a clinical trial of SLS009 in relapsed and/or refractory acute myeloid leukemia patients this quarter and next, and topline data from the Phase 1b/2 study of SLS009 in peripheral t-cell lymphomas (PTCL) by the end of the second quarter.”
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 SLS009 pre-clinical research and clinical development programs, including data therefrom, and expected milestones. 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
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