SELLAS Receives EMA Orphan Drug Designation for SLS009 for Treatment of Peripheral T-cell Lymphomas
SELLAS Life Sciences Group (NASDAQ: SLS) has received Orphan Drug Designation (ODD) from the European Medicines Agency (EMA) for SLS009, a novel CDK9 inhibitor, for treating relapsed/refractory peripheral T-cell lymphomas (PTCL). This follows recent FDA Orphan Drug and Fast Track Designations for SLS009 in PTCL. In the Phase 1 trial, SLS009 showed promising results with a 36.4% response rate in PTCL patients, surpassing the current standard of care. The drug demonstrated favorable safety and efficacy in various hematological malignancies. This designation highlights the potential of SLS009 in addressing the urgent need for new therapies in aggressive lymphomas with treatment options.
Il gruppo SELLAS Life Sciences (NASDAQ: SLS) ha ricevuto la Designazione di Farmaco Orfano (ODD) dall'Agenzia Europea per i Medicinali (EMA) per SLS009, un nuovo inibitore del CDK9, per il trattamento dei linfomi periferici a cellule T (PTCL) in recidiva/rifrangenti. Questo segue le recenti designazioni di Farmaco Orfano e Fast Track da parte della FDA per SLS009 nei PTCL. Nella fase 1 dello studio, SLS009 ha mostrato risultati promettenti con un tasso di risposta del 36,4% nei pazienti con PTCL, superando l'attuale standard di cura. Il farmaco ha dimostrato una buona sicurezza ed efficacia in diverse neoplasie ematologiche. Questa designazione evidenzia il potenziale di SLS009 nel rispondere all'urgenza di nuove terapie per i linfomi aggressivi con opzioni di trattamento limitate.
El grupo SELLAS Life Sciences (NASDAQ: SLS) ha recibido la designación de medicamento huérfano (ODD) de la Agencia Europea de Medicamentos (EMA) para SLS009, un nuevo inhibidor de CDK9, para el tratamiento de linfomas periféricos de células T (PTCL) en recaída/resistente. Esto sigue a las recientes designaciones de medicamento huérfano y de vía rápida por parte de la FDA para SLS009 en PTCL. En el ensayo de fase 1, SLS009 mostró resultados prometedores con una tasa de respuesta del 36,4% en pacientes con PTCL, superando el estándar actual de atención. El fármaco demostró una buena seguridad y eficacia en diversas malignidades hematológicas. Esta designación resalta el potencial de SLS009 para abordar la urgente necesidad de nuevas terapias en linfomas agresivos con opciones de tratamiento.
SELLAS Life Sciences Group (NASDAQ: SLS)는 유럽의약청(EMA)으로부터 희귀의약품지정(ODD)을 받았습니다 SLS009, 새로운 CDK9 억제제를 재발/내성이 있는 말초 T세포 림프종(PTCL) 치료에 대해. 이는 PTCL에 대한 SLS009의 FDA 희귀의약품 및 패스트트랙 지정 이후의 일입니다. 1상 시험에서 SLS009는 PTCL 환자에서 36.4%의 응답률을 보이며 현재 표준 치료를 초과하는 유망한 결과를 나타냈습니다. 이 약물은 다양한 혈액 악성종양에서 안전성과 효능이 우수한 것으로 입증되었습니다. 이 지정은 공격적인 림프종에 대한 새로운 치료법의 긴급한 필요성을 충족하는 데 있어 SLS009의 잠재력을 강조합니다.
Le groupe SELLAS Life Sciences (NASDAQ: SLS) a reçu la désignation de médicament orphelin (ODD) de l'Agence européenne des médicaments (EMA) pour SLS009, un nouvel inhibiteur de CDK9, pour le traitement des lymphomes périphériques à cellules T (PTCL) en rechute/réfractaires. Cela fait suite aux récentes désignations de médicament orphelin et de voie rapide par la FDA pour SLS009 dans les PTCL. Lors de l'essai de phase 1, SLS009 a montré des résultats prometteurs avec un taux de réponse de 36,4 % chez les patients atteints de PTCL, dépassant le standard actuel de soins. Le médicament a démontré une sécurité et une efficacité favorables dans diverses malignités hématologiques. Cette désignation met en évidence le potentiel de SLS009 pour répondre au besoin urgent de nouvelles thérapies dans les lymphomes agressifs avec des options de traitement.
Die SELLAS Life Sciences Group (NASDAQ: SLS) hat die Orphan Drug Designation (ODD) von der Europäischen Arzneimittelagentur (EMA) erhalten für SLS009, einen neuen CDK9-Hemmer zur Behandlung von rezidivierenden/refraktären peripheren T-Zell-Lymphomen (PTCL). Dies folgt auf die kürzlichen Orphan Drug- und Fast-Track-Designationen der FDA für SLS009 in PTCL. Im Phase-1-Studie zeigte SLS009 vielversprechende Ergebnisse mit einer Antwortquote von 36,4% bei PTCL-Patienten, die den aktuellen Standard der Versorgung übertrifft. Das Medikament zeigte eine günstige Sicherheit und Wirksamkeit bei verschiedenen hämatologischen Malignomen. Diese Auszeichnung hebt das Potenzial von SLS009 hervor, den dringenden Bedarf an neuen Therapien bei aggressiven Lymphomen mit begrenzten Behandlungsmöglichkeiten zu decken.
- EMA granted Orphan Drug Designation for SLS009 in PTCL treatment
- SLS009 achieved a 36.4% response rate in PTCL patients in Phase 1 trial
- SLS009 demonstrated favorable safety/tolerability in Phase 1 trial
- One PTCL patient remained in continuous treatment for over 56 weeks
- SLS009's response rate surpassed current standard of care (belinostat) in similar patient population
- None.
Insights
The EMA's Orphan Drug Designation (ODD) for SLS009 in peripheral T-cell lymphomas (PTCL) is a significant development for SELLAS Life Sciences. This designation, along with the FDA's ODD and Fast Track status, underscores the potential of SLS009 in addressing an unmet medical need.
The Phase 1 trial results are particularly noteworthy, with a
The ODD could provide SELLAS with regulatory benefits and market exclusivity in the EU, potentially accelerating SLS009's development and commercialization. This could be a game-changer for PTCL patients, given the treatment options currently available.
The EMA's Orphan Drug Designation for SLS009 is a positive catalyst for SELLAS Life Sciences (NASDAQ: SLS). This designation, coupled with the FDA's similar recognition, enhances the market potential of SLS009 and could lead to faster regulatory approvals and extended market exclusivity.
Investors should note that PTCL is part of a broader oncology portfolio for SLS009, including AML and ALL indications. This diversification could mitigate risk and expand revenue potential. However, as a clinical-stage company, SELLAS faces significant R&D expenses and regulatory hurdles before potential commercialization.
The company's ability to advance SLS009 through clinical trials efficiently will be important for its financial outlook. While the news is promising, investors should remain cautious and monitor upcoming trial results and the company's cash position to fund ongoing development.
NEW YORK, Aug. 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 that the European Medicines Agency (EMA) has granted Orphan Drug Designation (ODD) for SLS009, a novel, and highly selective CDK9 inhibitor, for the treatment of relapsed/refractory (r/r) peripheral T-cell lymphomas (PTCL).
“We are pleased to announce the EMA’s granting of ODD for SLS009, highlighting another important milestone following recent FDA’s Orphan Drug and Fast Track Designations for SLS009 in PTCL,” said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. “PTCL is an aggressive form of lymphoma with limited treatment options, underscoring the urgent need for new and effective therapies. We are delighted that the potential of SLS009 has been recognized by both regulatory agencies and across multiple indications including acute myeloid leukemia (AML), pediatric AML, and pediatric acute lymphoblastic leukemia (ALL). This additional orphan drug designation also highlights our strong internal regulatory expertise, and we look forward to advancing the SLS009 development and our overall clinical programs to deliver its potential benefits to cancer patients.”
In the completed dose-escalation portion of the Phase 1 trial in relapsed/refractory hematological malignancies, SLS009 demonstrated favorable safety/tolerability and promising clinical efficacy. Complete or partial responses were observed in AML and lymphoma patients, with a
Orphan Designation is granted to therapies aimed at the treatment, prevention, or diagnosis of life-threatening or chronically debilitating diseases that affect no more than five in 10,000 persons in the European Union (EU) and for which no satisfactory therapy is available. The treatment must also provide significant benefit to those affected by the condition1.
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’ other 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
References:
1. European Medicines Agency (2023). "Orphan Designation." https://www.ema.europa.eu/en/human-regulatory-overview/orphan-designation-overview
FAQ
What is the significance of EMA's Orphan Drug Designation for SELLAS's SLS009?
How did SLS009 perform in the Phase 1 trial for PTCL patients?
What other indications is SELLAS (SLS) exploring for SLS009?
What were the key findings from the Phase 1 trial of SLS009 by SELLAS (SLS)?
