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SELLAS Announces Positive Overall Survival and Overall Response Rate Data from the Phase 2 Trial of SLS009 in r/r AML

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SELLAS Life Sciences Group announced positive data from Phase 2 trial of SLS009, a CDK9 inhibitor, in relapsed/refractory acute myeloid leukemia (r/r AML). Key findings include:

- Median Overall Survival exceeding 7.7 months in the 30 mg BIW cohort for venetoclax-refractory patients (vs. historical 2.5 months)
- 56% Overall Response Rate in AML-MRC patients, surpassing the 33% target
- Well-tolerated safety profile with no new safety signals

The trial included 14 patients in Cohort 3 and 14 in Cohorts 4-5, with 9 evaluable patients at analysis. The study evaluates SLS009 in combination with venetoclax and azacitidine at different dose levels, focusing on ASXL1 mutated AML patients and those with myelodysplasia-related molecular abnormalities.

SELLAS Life Sciences Group ha annunciato dati positivi dal trial di Fase 2 di SLS009, un inibitore di CDK9, nella leucemia mieloide acuta recidivante/resistente (r/r AML). I principali risultati includono:

- Una sopravvivenza globale mediana superiore a 7.7 mesi nel gruppo da 30 mg BIW per pazienti refrattari a venetoclax (rispetto ai 2.5 mesi storici)
- Tasso di risposta globale del 56% nei pazienti AML-MRC, superando l'obiettivo del 33%
- Profilo di sicurezza ben tollerato senza nuovi segnali di sicurezza

Lo studio ha incluso 14 pazienti nel Coorte 3 e 14 nei Coorti 4-5, con 9 pazienti valutabili nell'analisi. La ricerca valuta SLS009 in combinazione con venetoclax e azacitidina a diversi livelli di dose, concentrandosi su pazienti con AML mutata ASXL1 e su quelli con anomalie molecolari correlate alla mielodisplasia.

SELLAS Life Sciences Group anunció datos positivos del ensayo de Fase 2 de SLS009, un inhibidor de CDK9, en leucemia mieloide aguda recidivante/resistente (r/r AML). Los hallazgos clave incluyen:

- Supervivencia global mediana superior a 7.7 meses en el grupo de 30 mg BIW para pacientes refractarios a venetoclax (frente a los 2.5 meses históricos)
- Tasa de respuesta global del 56% en pacientes AML-MRC, superando el objetivo del 33%
- Perfil de seguridad bien tolerado sin nuevas señales de seguridad

El ensayo incluyó 14 pacientes en el Cohorte 3 y 14 en los Cohoortes 4-5, con 9 pacientes evaluables en el análisis. El estudio evalúa SLS009 en combinación con venetoclax y azacitidina a diferentes niveles de dosis, centrando la atención en pacientes con AML mutada ASXL1 y aquellos con anomalías moleculares relacionadas con mielodisplasia.

SELLAS Life Sciences Group는 재발/난치 급성 골수 백혈병(r/r AML)에서 SLS009라는 CDK9 억제제의 2상 임상시험에서 긍정적인 데이터를 발표했습니다. 주요 결과는 다음과 같습니다:

- 30 mg BIW 집단에서 venetoclax에 내성이 있는 환자의 전체 생존 중위수가 7.7개월을 초과함 (역사적 2.5개월 대비)
- AML-MRC 환자에서 전체 반응률 56%, 목표인 33%를 초과함
- 새로운 안전성 신호가 없는 잘 견디는 안전성 프로필

이번 시험에는 Cohort 3에 14명, Cohorts 4-5에 14명이 포함되었으며, 분석 시 9명의 평가 가능한 환자가 미리 평가되었습니다. 이 연구는 SLS009를 venetoclax 및 azacitidine과 다른 용량 수준에서 병용하여 평가하며, ASXL1 변이가 있는 AML 환자와 골수형성이상 관련 분자 이상이 있는 환자에 중점을 두고 있습니다.

SELLAS Life Sciences Group a annoncé des données positives provenant de l'essai de phase 2 de SLS009, un inhibiteur de CDK9, dans le cas de leucémies aiguës myéloïdes récurrentes/résistantes (r/r AML). Les principaux résultats comprennent :

- Une survie globale médiane dépassant 7,7 mois dans le groupe de 30 mg BIW pour les patients réfractaires au venetoclax (contre 2,5 mois historiques)
- Un taux de réponse global de 56 % chez les patients AML-MRC, dépassant l'objectif de 33 %
- Un profil de sécurité bien toléré sans nouveaux signaux de sécurité

L'essai a inclus 14 patients dans le Cohorte 3 et 14 dans les Cohortes 4-5, avec 9 patients évaluables lors de l'analyse. L'étude évalue SLS009 en combinaison avec le venetoclax et l'azacitidine à différents niveaux de doses, en se concentrant sur les patients atteints de leucémie aiguë myéloïde mutée ASXL1 et ceux présentant des anomalies moléculaires liées à la myélodysplasie.

SELLAS Life Sciences Group hat positive Daten aus der Phase-2-Studie zu SLS009, einem CDK9-Inhibitor, bei rückfälligen/refraktären akuten myeloischen Leukämien (r/r AML) veröffentlicht. Wichtige Ergebnisse sind:

- Medianer Gesamtüberleben von über 7,7 Monaten in der 30 mg BIW Kohorte für venetoclax-refraktäre Patienten (im Vergleich zu historischen 2,5 Monaten)
- 56 % Gesamtansprechrate bei AML-MRC-Patienten, über dem Ziel von 33 %
- Gut verträgliches Sicherheitsprofil ohne neue Sicherheitssignale

Die Studie umfasste 14 Patienten in Kohorte 3 und 14 in den Kohorten 4-5, mit 9 evaluierbaren Patienten zur Analyse. Die Studie bewertet SLS009 in Kombination mit Venetoclax und Azacitidin auf unterschiedlichen Dosierungsstufen und konzentriert sich auf Patienten mit ASXL1-Mutationen und solche mit mielodysplasiebasierten molekularen Anomalien.

Positive
  • Median Overall Survival exceeding 7.7 months vs historical 2.5 months
  • 56% Overall Response Rate achieved, significantly above 33% target
  • Well-tolerated safety profile maintained with expanded patient enrollment
Negative
  • None.

Insights

The Phase 2 trial results for SLS009 demonstrate remarkable efficacy in a challenging patient population. The median Overall Survival exceeding 7.7 months in venetoclax-resistant patients represents a significant improvement over the historical 2.5-month survival. The 56% Overall Response Rate in AML-MRC patients substantially surpasses the predetermined threshold of 33%, indicating strong therapeutic potential. These results are particularly noteworthy given the trial targets heavily pretreated patients who have treatment options. The drug's favorable safety profile, with no new concerns emerging, further strengthens its clinical potential. The expansion cohorts' data in patients with specific genetic mutations (ASXL1) suggests potential for a targeted therapeutic approach, which could lead to more personalized treatment strategies in AML.

This clinical data represents a significant value driver for SELLAS, potentially expanding their market opportunity in the lucrative AML treatment space. The impressive survival benefit and response rates could position SLS009 as a leading therapy for venetoclax-resistant patients, a growing market segment. The positive safety profile enhances the drug's commercial potential and could expedite regulatory pathways. The rapid enrollment in expansion cohorts indicates strong physician interest and unmet medical need, suggesting robust market demand if approved. For a company with a $77.4M market cap, successful development of SLS009 could substantially impact valuation, particularly given the high-value nature of oncology assets and the potential for accelerated approval pathways based on these encouraging results.

- Median Overall Survival (mOS) Not Yet Reached, Now Exceeds 7.7. Months at Latest Follow-Up in the 30 mg BIW Cohort in Patients Relapsed or Refractory to Venetoclax-Based Regimens -

- Overall Response Rate (ORR) of 56% Achieved to Date in Patient with Acute Myeloid Leukemia with Myelodysplasia Related Changes (AML MRC) Prospectively Enrolled in Two Expansion Cohorts; Exceeding Prespecified Target Response Rate of 33% -

NEW YORK, Dec. 09, 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 additional data from the expansion cohorts in the Phase 2 trial of SLS009, a highly selective CDK9 inhibitor, in relapsed/refractory acute myeloid leukemia (r/r AML).

“We are highly encouraged by the emerging data, which continue to show the potential of SLS009 to transform outcomes of these heavily pretreated AML patients,” said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. “In the Cohort 3, the optimal dosing regimen of 30 mg BIW, in patients relapsed or refractory to venetoclax-based regimens, the median overall survival has not been reached but exceeds 7.7 months at latest follow-up, marking a significant milestone for patients in this setting, where the expected mOS is historically around 2.5 months. In addition, we are seeing more than 50% ORR to date in our expansion cohorts in patients with AML-myelodysplasia-related changes (AML-MRC) with ASXL1 mutation and mutations and cytogenic changes other than ASXL1, similar to the previously reported ORR in Cohort 3. We set up an aggressive threshold of 33% response rate before the trial started, and to date we achieved 56% in 5/9 evaluable patients. The rapid enrollment in the expansion cohorts further highlight the critical need for new treatments for our target patient population. These results support the potential of SLS009 to become an important new therapeutic option for this underserved patient population.”

Key Highlights from the updated topline data:

  • As of December 4, 2024, data cutoff, 14 patients were enrolled in Cohort 3 and 14 in Cohort 4 and 5, of which 9 were evaluable at the time of analysis.
  • At latest follow-up, the mOS has not been reached yet but has exceeded 7.7 months in Cohort 3. This is particularly significant as the expected mOS for patients in this setting is typically 2.5 months.
  • In expansion cohorts 4 and 5, in patients with AML-myelodysplasia-related changes (AML-MRC) with ASXL1 mutation (cohort 4) and mutations and cytogenic changes other than ASXL1 (cohort 5) the ORR was 56% in 9 evaluable for efficacy patients.
  • SLS009 was well-tolerated with no new safety signals observed to date as the regimen remains safe in additional patients enrolled to date.

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 randomized into 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. In addition to response and survival analyses, the study aims to identify biomarkers for the target patient population and enrichment for further trials. For more information on the study, visit clinicaltrial.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 (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 latest survival results for SLS009 Phase 2 trial in r/r AML?

The median Overall Survival has exceeded 7.7 months in the 30 mg BIW cohort for venetoclax-refractory patients, compared to historical survival of 2.5 months.

What is the Overall Response Rate (ORR) for SLS009 in AML-MRC patients?

The Overall Response Rate is 56% in AML-MRC patients (5/9 evaluable patients), exceeding the prespecified target response rate of 33%.

How many patients were enrolled in the SLS009 Phase 2 trial expansion cohorts?

The trial enrolled 14 patients in Cohort 3 and 14 patients in Cohorts 4-5, with 9 patients evaluable for analysis as of December 4, 2024.

SELLAS Life Sciences Group, Inc.

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