Venetoclax

Supports capital-efficient expansion of the SLS009 clinical program into frontline AML, enabling broader U.S. and European patient enrollment U.S. enrollment evaluating SLS009 in combination with AZA/VEN in newly diagnosed AML with high-risk features is planned for Q1 2026, with European enrollment anticipated in Q2 2026 NEW YORK, Jan. 14, 2026 (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 it has entered into an agreement with IMPACT-AML, a European collaborative initiative dedicated to advancing innovative treatments for patients with acute myeloid leukemia (AML). Under the agreement, the IMPACT-AML network will conduct a clinical study evaluating SLS009, a highly selective CDK9 inhibitor, enabling access to multiple European clinical sites and patients. IMPACT-AML is a pan-European project and builds an inclusive clinical network (STREAM platform) that connects patients, clinicians, and researchers to test novel AML therapies and improve patient outcomes (https://impactaml.eu/). It is part of the prestigious EU Mission Cancer program and a top-tier scientific cluster. The IMPACT-AML project is led by a consortium of major research and clinical institutions in Europe, including IRST (IRCCS Istituto Romagnolo per lo Studio dei Tumori “Dino Amadori”), the University of Bologna, IIS LA FE (Health Research Institute Hospital La Fe), several European AML collaborative groups, and supranational organizations under the umbrella of the European Leukemia Net (ELN), as well as various university hospitals across Europe. By leveraging IMPACT-AML’s existing infrastructure and expertise, SELLAS expects to expand European patient access to SLS009 in a highly cost-efficient manner while supporting broader participation across the clinical program. “This is a highly meaningful milestone for SELLAS and for the SLS009 program,” said Angelos Stergiou, M.D., Sc.D., President and Chief Executive Officer of SELLAS. “Gaining access to the IMPACT-AML framework represents strong external validation of SLS009 and reflects the growing recognition of SLS009’s potential in addressing critical unmet needs in AML. Importantly, this collaboration allows us to efficiently expand our clinical program into Europe by leveraging an established infrastructure, significantly improving capital efficiency while supporting broader and faster patient enrollment as we advance the program into frontline AML.” The collaboration is expected to support the continued execution of the SLS009 clinical program as SELLAS advances into frontline AML. The study in Europe is planned to enroll approximately 40 patients to evaluate SLS009 in combination with azacitidine and venetoclax (AZA/VEN) in patients with newly diagnosed AML with high-risk features. Enrollment in the first part of the trial for newly diagnosed patients is expected to begin at U.S. sites in Q1 2026, followed by initiation at European sites in Q2 2026, subject to regulatory and site readiness. “IMPACT-AML is committed to accelerating access to promising new therapeutic approaches for patients with AML who face limited treatment options,” said IMPACT-AML Scientific Coordinator, Dr. Giovanni Martinelli. “We are pleased to collaborate with SELLAS and support the evaluation of SLS009 within our European network, consistent with our mission to facilitate efficient, high-quality clinical research in AML.” 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 John Fraunces Managing Director LifeSci Advisors, LLC jfraunces@lifesciadvisors.com

WASHINGTON, Jan. 14, 2026 /PRNewswire/ -- Blood Cancer United®, formerly The Leukemia & Lymphoma Society, announced today that the first patient has received treatment in a new sub-study of its Beat AML® Master Clinical Trial (Beat AML). In collaboration with AVEO Oncology, an LG Chem company, ("AVEO") the new sub-study is evaluating ficlatuzumab, a monoclonal antibody targeting hepatocyte growth factor (HGF), in combination with venetoclax and azacitidine in adults 60 years and older with newly diagnosed, untreated acute myeloid leukemia (AML). The new sub-study is open at the University of California San Francisco and The University of Kansas Medical Center. "The shift five years ago to venetoclax plus azacitidine as the standard of care for older adults with AML was practice-changing, but most patients still relapse, and long-term outcomes remain poor," said Blood Cancer United Chief Scientific Officer Lore Gruenbaum, Ph.D. "That's why we are actively investigating new triplet therapies like in this new sub-study. These combination therapies have the potential to improve survival and quality of life." New Triplet Sub-Study Builds on Beat AML Progress The latest sub-study is one of four that is currently open and is part of the Beat AML Master Clinical Trial, which tests multiple treatments for different subtypes under one master umbrella. Beat AML uses genomic testing to match patients with the most promising targeted treatment based on their unique genetic mutations. To date, more than 1,850 patients have received genomic testing within seven days of diagnosis, and more than 650 have enrolled in one of the Beat AML precision treatment sub-studies. Fourteen clinical sites are open in the United States, including recent additions at the University of Pittsburgh Medical Center and West Virgina University. Beat AML unites leading blood cancer experts, pharmaceutical partners, genomic testing firms, data specialists, clinical trial sites and regulators to break down silos and accelerate patient-focused discoveries. Two other sub-studies have recently achieved key milestones: Revumenib-Based Triplet Shows Strong Responses: An early phase Beat AML sub-study found that adding the menin inhibitor revumenib to ven/aza produced high rates of complete remission. The trial enrolled adults 60 and older with NPM1 mutations or KMT2A rearrangements. In the phase 1 trial, patients with KMT2A-rearranged AML who received the triplet combination had a median overall survival of 15.5 months. Historically, treatment with venetoclax and azacitidine alone results in a median overall survival of 2.5 months for these patients. Optimizing Shorter Treatment Cycles for Older AML Patients: Launched in June 2023, Opti-AML, a Beat AML sub-study, is studying whether a shorter duration of venetoclax treatment—14 days compared to the FDA-approved 28 days— combined with azacitidine can achieve a similar complete remission rate in newly diagnosed AML patients age 60 and older. The shorter duration is expected to speed blood count recovery, reduce infections, and lower the frequency of hospitalizations and blood transfusions. Patient enrollment in Opti-AML was completed in September 2025 with results expected in 2026. "Beat AML continues to exceed expectations and has evolved into what it is today, an extensive network of innovative therapeutic trials," says John Byrd, M.D., Beat AML Chief Medical Officer and UPMC Hillman Cancer Center Director. "Patients enrolled in a Beat AML treatment trial have achieved improved survival and better quality of life compared to those who received standard-of-care chemotherapy. As we approach 10 years, the master trial continues to advance the frontier of precision medicine in AML." About Blood Cancer United ® and the Beat AML ® Master Clinical Trial Blood Cancer United (formerly The Leukemia & Lymphoma Society) is the largest global nonprofit focused on blood cancer patient support, research, and advocacy. The organization's mission is to cure blood cancer and improve the quality of life of all patients and their families. To achieve it, Blood Cancer United brings together a community of people—patients and their families, volunteers, healthcare providers, scientists, staff, partners, fundraisers, and philanthropists—who believe all blood cancer patients deserve longer, fuller lives. For support and to learn more, visit . The Beat AML® Master Clinical Trial (NCT03013998), launched in 2016 by Blood Cancer United, is the first collaborative precision medicine clinical trial in a blood cancer. The trial uses advanced genomic technology to match patients to the most promising targeted treatment based on their unique genetic mutations. The trial tests multiple therapies in multiple sub-studies simultaneously and has already generated strong results, showing superior survival rates and better quality of life. Over the past decade, Beat AML has grown into a powerful ecosystem of pharma companies, genetic testing experts, data specialists, regulatory agencies, and other industry partners working toward better and safer treatments for patients with AML. For more information, visit Media Contact: Ryan McDonald Blood Cancer United [email protected] SOURCE Blood Cancer United® formerly The Leukemia & Lymphoma Society 21% more press release views with Request a Demo