SELLAS Life Sciences Sets Ambitious Goals for 2025

SELLAS Life Sciences Sets Ambitious Goals for 2025

- Independent Data Monitoring Committee to Perform Interim Analysis of Phase 3 REGAL Study Soon -

- SLS009: Full Topline Phase 2 Data in Acute Myeloid Leukemia and FDA Regulatory Review Expected in Early 2025 -

- Approval of “tambiciclib” as the 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 Other Malignancies -

NEW YORK, SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) is a late-stage clinical biopharmaceutical company that centers its efforts on developing novel cancer therapies. Recently, SELLAS provided major business updates and announced an upcoming corporate webinar.

"We believe the year ahead will be pivotal for SELLAS, as we advance our portfolio of clinical therapeutics aimed at hematologic cancers," expressed Angelos Stergiou, MD, ScD h.c., the President and CEO of SELLAS. "We are excited to build on the remarkable progress achieved in 2024 while anticipating several clinical milestones vital for our growth. Notably, we expect to receive the full topline dataset from our Phase 2 trial of SLS009 targeting acute myeloid leukemia (AML) resistant to current therapies. Additionally, our Phase 3 REGAL study expects an interim analysis, which will guide our next steps based on the findings by the Independent Data Monitoring Committee (IDMC)."

Furthermore, Dr. Stergiou highlighted the recognition from regulatory bodies in 2024 when the FDA granted the Rare Pediatric Disease Designation for both GPS and SLS009 for pediatric AML, enhancing their potential impact on treating unmet medical needs. These designations validate our objectives and show the confidence the regulatory agencies have in our innovative cancer therapies.

Key Expected Milestones for SELLAS in 2025

Galinpepimut-S (GPS): Targeting Wilms Tumor-1 (WT1)

The anticipated interim analysis from the ongoing Phase 3 REGAL global clinical trial in AML patients achieving complete remission after second-line salvage therapy is projected for early 2025. The IDMC will make recommendations based on the analysis results, determining whether to continue the trial or halt it based on efficacy or futility.

SLS009: Selective CDK9 Inhibitor Innovations

SELLAS expects to disclose full topline data from the Phase 2 trial of SLS009 in AML throughout early 2025. This includes insights into AML-MRC patients harboring ASXL1 mutations. Furthermore, we anticipate feedback from the FDA concerning the regulatory pathway for the aforementioned study.

Highlights from 2024

Key Achievements in Galinpepimut-S (GPS)

In 2024, the Phase 3 REGAL study achieved a critical milestone by reaching a pre-specified threshold of 60 events, triggering the ongoing interim analysis by the IDMC.

Significant Developments in SLS009

Notably, SLS009 was officially designated as “tambiciclib” by the World Health Organization (WHO). Positive preliminary data from the ongoing Phase 2 trials indicated an impressive median overall survival exceeding 7.7 months, moving beyond the 2.5-month expectation for patients in similar conditions. Enrollment for the Phase 2a trial, which included patients failing venetoclax-based treatments, completed ahead of schedule.

SELLAS' portfolio for 2024 also saw the opening of new Phase 2 cohorts, along with the success of achieving the Rare Pediatric Disease Designation and other regulatory designations for both GPS and SLS009.

About SELLAS Life Sciences Group, Inc.

SELLAS is at the forefront of developing cutting-edge therapies for an extensive range of cancer types. The lead candidate, GPS, is a pioneering immunotherapy in collaboration with Memorial Sloan Kettering Cancer Center, aiming to tackle various tumor types expressively. Furthermore, SLS009, recognized for its potential as a groundbreaking small molecule CDK9 inhibitor, seeks to improve treatment outcomes for AML patients, including those with high-risk prognostic configurations like ASXL1 mutations.

Frequently Asked Questions

What are the primary objectives for SELLAS in 2025?

SELLAS aims to make significant advancements in their clinical trials, especially regarding SLS009 and further develop their pediatric programs targeting hematological malignancies.

How does SLS009 differ from other treatments?

SLS009 is being developed as a unique CDK9 inhibitor with reduced toxicity and increased efficacy compared to traditional therapies, specifically for AML patients.

What designations has SELLAS received from regulatory bodies?

SELLAS has achieved various regulatory designations, including FDA Rare Pediatric Disease Designations for both GPS and SLS009, highlighting their commitment to addressing critical medical needs.

What is the significance of the interim analysis from the REGAL study?

The interim analysis will guide the decision-making process for the continuation of the REGAL study, potentially determining the future direction of the treatment under investigation.

How can interested parties learn more about SELLAS?

For further details about SELLAS and their innovative cancer therapies, individuals can visit the company’s website at www.sellaslifesciences.com.

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