SELLAS Announces Key Business Objectives for 2025
SELLAS Life Sciences Group (NASDAQ: SLS) outlined key business objectives for 2025, highlighting two major upcoming milestones. The company expects an interim analysis of its Phase 3 REGAL study by an Independent Data Monitoring Committee in January 2025, which will determine whether to stop the trial early for efficacy, stop for futility, or continue without modification.
Additionally, full topline Phase 2 data for SLS009 (tambiciclib) in Acute Myeloid Leukemia (AML) and FDA regulatory review are expected in 1H 2025. The company reported positive 2024 results for SLS009, with median overall survival exceeding 7.7 months compared to historical 2.5 months, and a 56% Overall Response Rate in AML-MRC patients. The drug received multiple regulatory designations, including FDA Fast Track Designation for AML and EMA orphan drug designation for AML and peripheral T-cell lymphoma.
SELLAS Life Sciences Group (NASDAQ: SLS) ha delineato gli obiettivi aziendali chiave per il 2025, evidenziando due importanti traguardi imminenti. L'azienda si aspetta un'analisi intermedia del suo studio di Fase 3 REGAL da parte di un Comitato Indipendente di Monitoraggio dei Dati nel gennaio 2025, che determinerà se fermare anticipatamente la sperimentazione per efficacia, fermarla per inutilità o continuare senza modifiche.
Inoltre, si prevede che i dati completi di fase 2 di SLS009 (tambiciclib) nella Leucemia Mieloide Acuta (AML) e la revisione regolatoria della FDA saranno disponibili nel primo semestre del 2025. L'azienda ha riportato risultati positivi per il 2024 riguardo a SLS009, con una sopravvivenza globale mediana che supera i 7,7 mesi rispetto ai 2,5 mesi storici, e un tasso di risposta globale del 56% nei pazienti con AML-MRC. Il farmaco ha ricevuto diverse designazioni regolatorie, tra cui la Designazione Fast Track FDA per AML e la designazione di farmaco orfano EMA per AML e linfoma a cellule T periferiche.
SELLAS Life Sciences Group (NASDAQ: SLS) ha delineado los principales objetivos empresariales para 2025, destacando dos hitos importantes que se avecinan. La compañía espera un análisis intermedio de su estudio de Fase 3 REGAL por parte de un Comité Independiente de Monitoreo de Datos en enero de 2025, que determinará si detener el ensayo anticipadamente por eficacia, detenerlo por futilidad o continuar sin modificaciones.
Además, se espera que los datos completos de la Fase 2 de SLS009 (tambiciclib) en Leucemia Mieloide Aguda (AML) y la revisión regulatoria de la FDA estén disponibles en el primer semestre de 2025. La compañía reportó resultados positivos para SLS009 en 2024, con una supervivencia global mediana que supera los 7,7 meses en comparación con los 2,5 meses históricos, y una tasa de respuesta global del 56% en pacientes de AML-MRC. El fármaco ha recibido múltiples designaciones regulatorias, incluyendo la Designación Fast Track de la FDA para AML y la designación de medicamento huérfano de la EMA para AML y linfoma de células T periféricas.
SELLAS Life Sciences Group (NASDAQ: SLS)는 2025년을 위한 주요 사업 목표를 개Outline하고 두 가지 주요 밀레니엄을 강조했습니다. 회사는 2025년 1월에 독립 데이터 모니터링 위원회에 의해 3상 REGAL 연구의 중간 분석이 실시될 것으로 예상하며, 이는 시험을 조기 종료할지, 무효로 종료할지, 아니면 수정 없이 계속할지를 결정하게 됩니다.
추가로, 2025년 상반기 내에 급성 골수 백혈병(AML)에 대한 SLS009 (탐비시클립)의 2상 전체 데이터와 FDA의 규제 검토가 있을 것으로 예상됩니다. 회사는 SLS009에 대한 2024년 긍정적인 결과를 보고했으며, 중위 생존 기간이 역사적인 2.5개월에 비해 7.7개월을 초과하고, AML-MRC 환자에서 56%의 전체 반응률을 기록했습니다. 이 약물은 AML에 대한 FDA의 신속 승인 제도와 AML 및 말초 T세포 림프종에 대한 EMA의 희귀의약품 지정을 포함하여 여러 규제 지정을 받았습니다.
SELLAS Life Sciences Group (NASDAQ: SLS) a défini les principaux objectifs commerciaux pour 2025, en mettant en lumière deux grands jalons à venir. La société s'attend à une analyse intermédiaire de son étude de phase 3 REGAL par un comité indépendant de surveillance des données en janvier 2025, qui déterminera s'il faut arrêter l'essai prématurément pour son efficacité, l'arrêter pour futilité ou continuer sans modification.
De plus, les données complètes de phase 2 pour SLS009 (tambiciclib) dans la leucémie myéloïde aiguë (AML) et l'examen réglementaire par la FDA sont attendus au premier semestre 2025. La société a rapporté des résultats positifs pour SLS009 en 2024, avec une survie globale médiane dépassant 7,7 mois par rapport aux 2,5 mois historiques, et un taux de réponse globale de 56% chez les patients AML-MRC. Le médicament a reçu plusieurs désignations réglementaires, y compris la désignation Fast Track de la FDA pour l'AML et la désignation de médicament orphelin de l'EMA pour l'AML et le lymphome à cellules T périphériques.
SELLAS Life Sciences Group (NASDAQ: SLS) hat die wichtigsten Unternehmensziele für 2025 umrissen und dabei zwei große bevorstehende Meilensteine hervorgehoben. Das Unternehmen erwartet im Januar 2025 eine Zwischenanalyse seiner Phase-3-REGAL-Studie durch ein unabhängiges Datenüberwachungskomitee, das entscheiden wird, ob die Studie vorzeitig aus Wirkungsgründen abgebrochen, aus Bedeutungslosigkeit abgebrochen oder ohne Änderungen fortgesetzt wird.
Darüber hinaus werden die vollständigen Topline-Daten der Phase 2 für SLS009 (Tambiciclib) bei akuter myeloischer Leukämie (AML) sowie die regulatorische Prüfung durch die FDA im ersten Halbjahr 2025 erwartet. Das Unternehmen berichtete über positive Ergebnisse für 2024 zu SLS009, wobei die mediane Überlebenszeit 7,7 Monate über dem historischen Wert von 2,5 Monaten lag und eine Gesamtansprechrate von 56 % bei AML-MRC-Patienten erreicht wurde. Das Medikament erhielt mehrere regulatorische Auszeichnungen, darunter die FDA Fast Track-Designation für AML und die EMA-Orphan-Drug-Designation für AML und periphere T-Zell-Lymphome.
- SLS009 showed impressive median overall survival exceeding 7.7 months vs historical 2.5 months
- 56% Overall Response Rate in AML-MRC patients, exceeding pre-specified target of 33%
- Multiple regulatory designations received for both GPS and SLS009
- 97% of Phase 2a trial patients had adverse risk AML, demonstrating efficacy in difficult cases
- Phase 3 REGAL study faces potential early termination for futility in January 2025
- Final analysis will require 80 death events, indicating significant mortality risk in the study population
Insights
The Phase 3 REGAL study's upcoming interim analysis in January 2025 represents a critical inflection point for SELLAS's GPS program. The IDMC's recommendation could dramatically alter the company's trajectory, particularly if the trial is stopped early for efficacy in AML CR2 patients. The preliminary data from SLS009's Phase 2 trial showing median overall survival exceeding 7.7 months is remarkably promising, considering historical survival rates of about 2.5 months in this patient population.
The 56% objective response rate in AML-MRC patients significantly outperforms the pre-specified target of 33%, suggesting potential breakthrough efficacy in this difficult-to-treat subgroup. The identification of ASXL1 mutations as potential response predictors could enable a precision medicine approach, potentially increasing the likelihood of regulatory success.
The regulatory momentum for both GPS and SLS009 is substantial, with multiple designations including Fast Track and Rare Pediatric Disease Designations indicating accelerated development potential. The expansion into pediatric indications, particularly for SLS009, represents a strategic move into an underserved market with significant unmet needs.
The upcoming FDA feedback on SLS009's regulatory path in 1H 2025 could potentially expedite the development timeline. The 97% adverse risk AML patient population in the Phase 2a trial demonstrates efficacy in a particularly challenging subset, strengthening the potential regulatory case. The combination strategy with azacitidine and venetoclax shows promise in addressing resistance mechanisms.
- Independent Data Monitoring Committee to Perform Interim Analysis of Phase 3 REGAL Study in January 2025 -
- SLS009: Full Topline Phase 2 Data in Acute Myeloid Leukemia and FDA Regulatory Review Expected in 1H 2025 -
- Approval of “tambiciclib” as Recommended International Nonproprietary Name for SLS009 -
- Applied for Non-Dilutive Grant Funding to Expand SLS009 Development Into Frontline Setting in AML -
- Developing SLS009 Pediatric Programs in Hematological and Potentially Other Malignancies -
- Company to Host Corporate Update Webinar Today, January 8, 2025, at 9:00 am ET -
NEW YORK, Jan. 08, 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 provided a business update and will host a webinar at 9:00 am ET.
“We believe that 2025 will be a pivotal year for SELLAS as we continue to advance our clinical stage portfolio of novel therapeutics for hematologic malignancies,” said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. “We aim to build on the excellent progress achieved in 2024 and look forward to several, potentially transformative clinical milestones. Specifically, we anticipate full topline dataset from our Phase 2 trial of SLS009 in acute myeloid leukemia (AML) patients resistant to venetoclax combination therapies and FDA regulatory feedback around our SLS009 study, as well as the interim analysis from Phase 3 REGAL being conducted by the Independent Data Monitoring Committee (IDMC). Based on the results of this analysis, the IDMC will provide their recommendation in January to either stop the trial early for efficacy, stop for futility, or continue the study without modification. If the recommendation is to continue, the next and final analysis will take place upon reaching a total of 80 events, as predefined in the study protocol.”
Dr. Stergiou continued, “We are also pleased that the potential of both of our assets has been recognized by the regulatory agencies. During 2024, GPS was granted FDA Rare Pediatric Disease Designation for pediatric AML and SLS009 was granted RPDD for pediatric AML and pediatric acute lymphoblastic leukemia, FDA Fast Track Designation for AML, and EMA orphan drug designation for AML and peripheral T-cell lymphoma. These designations underscore the significant unmet medical needs which our therapies aim to address and reinforce the confidence of regulatory authorities in our innovative approach to treating a broad range of cancer indications.”
Expected Milestones in 2025:
Galinpepimut-S (GPS): Wilms Tumor-1 (WT1) targeting immunotherapeutic
- Phase 3 REGAL study in AML:
The interim analysis from the ongoing REGAL global Phase 3 registrational clinical trial of GPS in patients with AML who have achieved complete remission following second-line salvage therapy (CR2 patients) is expected in January 2025. Based on the results of this analysis, the IDMC will provide recommendations to either stop the trial early for efficacy, stop for futility, or continue the study without modification. If the recommendation is to continue without modification, the next and final analysis will take place upon reaching a total of 80 events, as predefined in the study protocol.
SLS009: highly selective CDK9 inhibitor
- Phase 2 clinical trial in AML: Full topline data from expansion cohorts which include AML-MRC patients with ASXL1 mutation (cohort 4) and mutations and cytogenic changes other than ASXL1 (cohort 5) are expected in 1H 2025.
- FDA feedback on regulatory path for r/r AML study expected in 1H 2025.
2024 Key Achievements:
Galinpepimut-S (GPS): Wilms Tumor-1 (WT1) targeting immunotherapeutic
- Phase 3 REGAL study of GPS in AML reached pre-specified threshold of 60 events (deaths) initiating the interim analysis being conducted by the Independent Data Monitoring Committee (IDMC).
SLS009: highly selective CDK9 inhibitor
- The World Health Organization (WHO) has approved “tambiciclib” as the recommended International Nonproprietary Name (INN) for SLS009
- Reported positive data from the ongoing Phase 2 trial of SLS009 in r/r AML in Q4 2024. The median overall survival (mOS) has not been reached but exceeds 7.7 months at the latest follow-up, marking a significant milestone for patients in this setting, where the expected mOS is historically around 2.5 months. In expansion cohorts in patients with AML-myelodysplasia-related changes (AML-MRC) with ASXL1 mutation and mutations and cytogenic changes other than ASXL1, the ORR was
56% in 9 evaluable for efficacy patients, exceeding pre-specified target response rate of33% . - Presented data from Phase 2a trial of SLS009 in r/r AML at the 66th American Society of Hematology (ASH) Annual Meeting & Exposition 2024. Treatment with SLS009 in combination with azacitidine and venetoclax was well tolerated and led to a
50% response rate in the selected optimal dose level of 30 mg twice a week. Clinical activity was even higher in patients with AML-MRC and in particular, those with ASXL1 mutations, suggesting that this subset of patients may exhibit preferential sensitivity to SLS009. In the safety dose of 45mg once a week, SLS009 showed a mOS of 5.5 months. - Completed enrollment in Phase 2a Trial of SLS009 in r/r AML: 30 patients relapsed after or refractory to venetoclax-based regiments were enrolled ahead of schedule in 5 centers across the US. Except for one, all patients in the Phase 2a trial had adverse risk AML (
97% ) and were treated with continued venetoclax–azacytidine combination therapy after having failed it or similar venetoclax-based combinations, often more than once. - Opened enrollment in additional Phase 2 cohorts in venetoclax combinations in r/r AML. Development of SLS009 continues with the opening of two new cohorts - AML MRC with ASXL1 mutations and AML with myelodysplasia related changes other than ASXL1 mutations. These new cohorts are also open for enrollment of certain pediatric patients.
- Announced positive preclinical data indicating ASXL1 mutations as predictors of response to SLS009 in solid cancers.
- Published in Oncotarget, revealing the underlying mechanisms of action behind the anti-proliferative effects of SLS009 in various hematologic malignancies.
- Continued National Cancer Institute (NCI) Pediatric Preclinical in Vivo Testing (PIVOT) Program in pediatric tumor.
Regulatory:
- Received multiple regulatory designations: for GPS: FDA Rare Pediatric Disease Designation (RPDD) for pediatric AML, for SLS009: RPDD for pediatric AML, pediatric acute lymphoblastic leukemia (ALL), FDA Fast Track Designation for AML, and EMA orphan drug designation (ODD) for AML and peripheral T-cell lymphoma (PTCL).
To access the webinar, please use the following information:
Date: Wednesday, January 8, 2025
Time: 9:00 a.m. Eastern Time
Webcast: 2025 Business Outlook
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 (formerly GFH009) - 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 28, 2024 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
Media Contact
Michael Fitzhugh
LifeSci Communications
mfitzhugh@lifescicomms.com
FAQ
What are the key milestones expected for SELLAS (SLS) in 2025?
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