SELLAS Life Sciences Announces First Pediatric AML Patient Dosed in the Ongoing Phase 2 Trial of SLS009 r/r AML
- First ASXL1 Pediatric Acute Myeloid Leukemia (AML) Patient Dosed at MD Anderson Cancer Center: Program Supported by Rare Pediatric Disease Designation (RPDD)
NEW YORK, May 15, 2025 (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 first pediatric AML patient has been dosed in the ongoing Phase 2 trial of SLS009 (tambiciclib), a highly selective CDK9 inhibitor, in relapsed/refractory acute myeloid leukemia (r/r AML).
'Building upon our promising Cohort 3 data, we are pleased to dose our first pediatric AML patient as part of the ongoing Phase 2 trial,' said Dragan Cicic, MD, Chief Development Officer of SELLAS. 'This milestone reflects our commitment to addressing critical unmet needs in hematologic disorders as we develop treatments for the most difficult to treat patients, particularly pediatric patients, with very few available options, including multi-hit TP53 mutation, failure of azacitidine and venetoclax, failure of transplant, and almost all available high-intensity chemotherapies. With the Rare Pediatric Disease Designation already in place, we are hopeful that our work will bring meaningful progress and potential regulatory advantages as we continue to advance this important program.'
SELLAS was granted the FDA RPDD for the treatment of pediatric AML in July 2024. If, in the future, a New Drug Application (NDA) for SLS009 for the treatment of pediatric AML is approved by the FDA, SELLAS will be eligible to receive a Priority Review Voucher (PRV) that could be redeemed to receive a priority review for any subsequent marketing application. PRVs may be used by the sponsor or sold to another sponsor for their use and have recently sold for approximately $100 million.
The Phase 2 clinical trial of SLS009 is an open-label, single-arm, multi-center study designed to evaluate the safety, tolerability, and efficacy of SLS009 in combination with venetoclax and azacitidine at two dose levels, 45 and 60 mg. In the 60 mg dose cohort, patients were treated at either a 60 mg dose once per week or a 30 mg dose two times per week. The trial was expanded to include two additional cohorts, one with ASXL1-mutated AML patients and one with patients with myelodysplasia-related molecular abnormalities other than ASXL1. The target response rate at the optimal dose level is 20% with a target median survival of at least 3 months. In addition, the study aims to identify biomarkers for the target patient population and enrichment for further trials. For more information on the study, visit clinicaltrials.gov identifier NCT04588922.
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, 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 the 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 (tambiciclib) - potentially the first and best-in-class differentiated small molecule CDK9 inhibitor with reduced toxicity and increased potency compared to other CDK9 inhibitors. Data suggests that SLS009 demonstrated a high response rate in AML patients with unfavorable prognostic factors including ASXL1 mutation, commonly associated with poor prognosis in various myeloid diseases. 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 GPS clinical development program, including the REGAL study and the timing of future milestones related thereto. 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 20, 2025 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
Hashtags

Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
13 minutes ago
- Yahoo
Jim Cramer Highlights That Dollar Tree (DLTR) Has 'More Trouble With the Tariffs'
We recently published a list of . In this article, we are going to take a look at where Dollar Tree, Inc. (NASDAQ:DLTR) stands against other stocks that Jim Cramer discusses. Discussing the impact of tariffs on Dollar Tree, Inc. (NASDAQ:DLTR), Cramer stated: 'Discount retailers tend to do better when the consumers' feeling stretched thin, and you know the consumer's feeling that way. But Dollar General and Dollar Tree have behaved very differently after reporting earnings over the past couple days… Then today, Dollar Tree reported what I also thought was a pretty good quarter, but its stock got eviscerated, down 8%. What explains the disparity here?… The difference between these two comes down to what they had to say about their ability to control costs and offset the impact of, you bet, go ahead, the president's tariffs… A shopper browsing through a discount retailers merchandise aisle filled with a wide variety of items. Dollar Tree (NASDAQ:DLTR) runs discount retail stores that carry a wide variety of products. The selection includes consumables, home essentials, seasonal items, apparel, and electronics. Overall, DLTR ranks 8th on our list of stocks that Jim Cramer discusses. While we acknowledge the potential of DLTR as an investment, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an extremely cheap AI stock that is also a major beneficiary of Trump tariffs and onshoring, see our free report on the best short-term AI stock. READ NEXT: 20 Best AI Stocks To Buy Now and 30 Best Stocks to Buy Now According to Billionaires. Disclosure: None. This article is originally published at Insider Monkey. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
15 minutes ago
- Yahoo
Sedalia announces end of Hot Air Balloon and Kite Festival
KANSAS CITY, Mo. — The Sedalia Chamber of Commerce made an unexpected announcement Friday, confirming the end of a popular event that attracted visitors from all over the state. According to a , the city will no longer be hosting the Hot Air Balloon and Kite Festival, which has been held in June for the past two years. 'World's Largest Rubber Duck' coming to Missouri State Fair 'We are so incredibly thankful for the generous support from our sponsors and the amazing community turnout over the past two years for the Hot Air Balloon and Kite Festival. It has been such a joy to see our community come together and make lasting memories at this special event,' the chamber of commerce said. The post said the event was canceled due to staffing limitations and a lack of resources. 'This was not an easy decision, and we truly appreciate your understanding and continued support and we focus on other ways to serve and celebrate our community,' the chamber said on Facebook. Despite this popular event ending, the city has a number of other events planned throughout the year. . Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
Yahoo
17 minutes ago
- Yahoo
Was Jim Cramer Right About Meta Platforms, Inc. (META)?
We recently published a list of . In this article, we are going to take a look at where Meta Platforms, Inc. (NASDAQ:META) stands against other stocks that Jim Cramer discusses. A viewer asked if Meta Platforms, Inc. (NASDAQ:META) still had technological upside, particularly under CEO Mark Zuckerberg's leadership. In that older segment, Cramer expressed strong long-term optimism, suggesting Meta was investing in something bigger than the public could yet see. He responded with: 'I think there is. I mean, I think that they're going to be in competition in something we don't know yet. They're buying too many of the Nvidia cards for me to think they're just going to continue to be just Instagram and Facebook and WhatsApp. I think there's much more in store for us and I think you got to stay long that stock. It is not an expensive stock.' Cramer was right to call it an inexpensive stock. It's now up +39.66% since those comments. Meta Platforms, Inc. (NASDAQ:META) is a technology company that owns Facebook, Instagram, and WhatsApp, and is investing heavily in AI and virtual reality platforms like the Metaverse. When asked about the stock again recently, Cramer gave his blessing to buy it, saying: 'I like your thinking very much. I think Meta's having a great quarter. I also think that they are without a doubt the best advertising bet. What happens if he actually starts, Mark Zuckerberg starts to want to, let's say, monetize WhatsApp? Do you know how much that darn thing's worth? I think you got horse sense. Good level to buy.' A team of developers working in unison to create the company's messaging application. Overall, META ranks 6th on our list of stocks that Jim Cramer discusses. While we acknowledge the potential of META as an investment, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an extremely cheap AI stock that is also a major beneficiary of Trump tariffs and onshoring, see our free report on the best short-term AI stock READ NEXT: 20 Best AI Stocks To Buy Now and 30 Best Stocks to Buy Now According to Billionaires. Disclosure: None. This article is originally published at Insider Monkey.