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
Business Upturn
16 minutes ago
- Business Upturn
Krispy Kreme, Inc. Class Action: Levi & Korsinsky Reminds Krispy Kreme, Inc. Investors of the Pending Class Action Lawsuit with a Lead Plaintiff Deadline of July 15, 2025
NEW YORK, June 10, 2025 (GLOBE NEWSWIRE) — Levi & Korsinsky, LLP notifies investors in Krispy Kreme, Inc. ('Krispy Kreme, Inc.' or the 'Company') (NASDAQ: DNUT) of a class action securities lawsuit. CLASS DEFINITION: The lawsuit seeks to recover losses on behalf of Krispy Kreme, Inc. investors who were adversely affected by alleged securities fraud between February 25, 2025 and May 7, 2025. Follow the link below to get more information and be contacted by a member of our team: Krispy Kreme, Inc. Lawsuit Submission Form DNUT investors may also contact Joseph E. Levi, Esq. via email at [email protected] or by telephone at (212) 363-7500. CASE DETAILS: The filed complaint alleges that defendants made false statements and/or concealed that: (1) demand for Krispy Kreme products declined materially at McDonald's locations after the initial marketing launch; (2) demand at McDonald's locations was a driver of declining average sales per door per week; (3) the partnership with McDonald's was not profitable; (4) the foregoing posed a substantial risk to maintaining the partnership with McDonald's; (5) as a result, the Company would pause expansion into new McDonald's locations; and (6) as a result of the foregoing, defendants' positive statements about the Company's business, operations, and prospects were materially misleading and/or lacked a reasonable basis. WHAT'S NEXT? If you suffered a loss in Krispy Kreme, Inc. during the relevant time frame, you have until July 15, 2025 to request that the Court appoint you as lead plaintiff. Your ability to share in any recovery doesn't require that you serve as a lead plaintiff. NO COST TO YOU: If you are a class member, you may be entitled to compensation without payment of any out-of-pocket costs or fees. There is no cost or obligation to participate. WHY LEVI & KORSINSKY: Over the past 20 years, the team at Levi & Korsinsky has secured hundreds of millions of dollars for aggrieved shareholders and built a track record of winning high-stakes cases. Our firm has extensive expertise representing investors in complex securities litigation and a team of over 70 employees to serve our clients. For seven years in a row, Levi & Korsinsky has ranked in ISS Securities Class Action Services' Top 50 Report as one of the top securities litigation firms in the United States. CONTACT:Levi & Korsinsky, LLP Joseph E. Levi, Korsinsky, Esq.33 Whitehall Street, 17th FloorNew York, NY 10004 [email protected] Tel: (212) 363-7500Fax: (212) 363-7171
New York Times
21 minutes ago
- New York Times
What Makes a Food Ultraprocessed? The FDA Is About to Weigh In.
The federal government plans to develop a new definition of ultraprocessed foods, a wide-ranging group of snacks, meals and drinks that have become a cornerstone of the American diet. Nutrition researchers generally define ultraprocessed foods as industrially manufactured products that include ingredients you wouldn't find in your own kitchen, like high-fructose corn syrup or hydrogenated oils. The products also often contain artificial flavors, sweeteners and emulsifiers that make them appealing to consumers and can give them a longer shelf life. In crafting its own definition, the government could examine the chemicals and additives put in foods, the number of ingredients in a product or its overall nutritional content. That description could then be used to shape school lunch policy, regulate the foods available through federal services like the Supplemental Nutrition Assistance Program or make recommendations about limiting ultraprocessed food consumption in the U.S. dietary guidelines. The Food and Drug Administration, which is leading the effort in collaboration with the U.S. Department of Agriculture and other agencies, plans to seek public comment before setting a definition in the coming months. Dr. Marty Makary, the commissioner of the F. D.A., said he expected the definition would encourage companies to label foods as 'non-ultraprocessed' to entice customers, similar to how food manufacturers market their products as being free from added sugars. 'We do not see ultraprocessed foods as foods to be banned,' he said. 'We see them as foods to be defined so that markets can compete based on health.' The idea that consumers may go out of their way to avoid these items reflects growing concerns about the potential harms of ultraprocessed foods, which include many breakfast cereals, instant noodles, protein bars, meal-replacement shakes, flavored yogurts, hot dogs and more. Scientists have increasingly linked ultraprocessed foods to poor health outcomes, such as Type 2 diabetes, heart issues, some types of cancers and gastrointestinal issues. Want all of The Times? Subscribe.
The Hill
35 minutes ago
- The Hill
Trump shouldn't import socialist price controls
Remember when Republican presidential candidate Donald Trump castigated 'Comrade Kamala' Harris, then the Democratic nominee, for supporting price controls? It wasn't that long ago — just last August. At a campaign rally in Pennsylvania, Trump told the crowd: 'In her speech yesterday, Kamala went full Communist … She wants to destroy our country. After causing catastrophic inflation, Comrade Kamala announced that she wants to institute socialist price controls.' Harris's price controls were largely aimed at food in grocery stores, though she also frequently touted the 2022 Inflation Reduction Act's backdoor price controls — under the guise of 'negotiations' — on a certain number of expensive drugs. Trump was right to criticize Harris for supporting price controls on food, as well as prescription drugs. And, given the election results, it seems the public agreed with him. Price controls are the progressive left's go-to solution for almost all economic problems. But price controls virtually always lead to unintended consequences: shortages of the price-controlled products or services; lower quality as manufacturers cut corners to meet government-imposed price points; less innovation, since companies don't know if they'll be allowed to recover their costs; and a black market where people pay more to get what they want or need. So it's puzzling to see Trump now proposing a version of drug price controls himself. It's not the first time, either. During his first term, Trump pushed for 'drug importation,' encouraging U.S. citizens to buy medicines from countries like Canada — even though the FDA has warned those drugs could be fake or substandard. The effort fizzled, and even Florida, which tried a state-level importation scheme, eventually abandoned its program. Trump's latest idea is called 'Most Favored Nation' pricing. Details are thin, but a recent executive order says, 'To the extent consistent with law, the Secretary of Health and Human Services (Secretary) shall facilitate direct-to-consumer purchasing programs for pharmaceutical manufacturers that sell their products to American patients at the most-favored-nation price.' That 'most-favored' country will almost certainly be one with government-run health care — that is, socialized medicine. These systems are known for price controls, which lead to shortages, long wait times, and limited access to cutting-edge treatments. The goal of Most Favored Nation is to lower prices on expensive drugs. Americans do pay more for brand-name drugs than patients elsewhere. But they also pay less for generics, which account for roughly 90 percent of all prescriptions. One reason for the disparity is the middlemen in our system, known as pharmacy benefit managers. Their job is to negotiate lower prices with drugmakers. But those savings often don't make it to patients. Instead, pharmacy benefit managers keep a big chunk for themselves — on average, $0.42 of every $1 spent on brand-name drugs in the commercial market, by one estimate. In many cases, those pharmacy benefit manager cuts are larger than the total price of the drug in Europe. It's clear our system could work better. 'Shark Tank' entrepreneur Mark Cuban launched the Cost Plus Drug Company in 2022 to bypass these middlemen. The Cost Plus website says, 'Our prices are the true cost to get each medication from the manufacturer to you. We cut out the pharmacy middlemen and negotiate directly with manufacturers to get the best possible price.' The company tacks on 15 percent for overhead and a $5 filling fee. While customers may not save much on some widely used generics, the discounted prices on more expensive brand name and generic drugs are significantly lower than what most people would experience at their local pharmacy. Cost Plus has hundreds of drugs for nearly 100 listed medical conditions, and it's looking to add new drugs all the time. It's only been in business a few years and is working to expand. We also shouldn't ignore the fact that Americans are subsidizing below-market prices abroad. The United States funds a disproportionate share of global pharmaceutical innovation, while other wealthy nations impose price caps and benefit from our investment. If Trump wants to stop other countries from taking advantage of us, he should take the approach he's using to get countries to pay more for defense. Cuban's Cost Plus experiment proves we don't need Most Favored Nation pricing. Let socialized systems keep their socialized prices, limited access and denial of care. Tweaking a line Trump likes to use and applying it to prescription drugs: We don't need a new law. We just don't need a middleman. Merrill Matthews is a public policy and political analyst and the co-author of 'On the Edge: America Faces the Entitlements Cliff.'
