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SELLAS Life Sciences Group, Inc. - $SLS STOCK NEWS

Welcome to our dedicated page for SELLAS Life Sciences Group news (Ticker: $SLS), a resource for investors and traders seeking the latest updates and insights on SELLAS Life Sciences Group stock.

SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) is a late-stage clinical biopharmaceutical company dedicated to the development of novel therapeutics aimed at addressing a broad range of cancer indications. The company's core mission is to practice the medicine of tomorrow, today, by integrating innovative approaches that significantly impact the global healthcare landscape.

SELLAS' leading product candidate is galinpepimut-S (GPS), a peptide immunotherapy targeting the Wilms Tumor 1 (WT1) antigen. Licensed from Memorial Sloan Kettering Cancer Center, GPS is designed to treat various hematologic malignancies and solid tumors. Notably, GPS is currently undergoing a Phase 3 REGAL clinical trial for acute myeloid leukemia (AML), with promising safety and efficacy data observed so far.

Another pivotal asset in SELLAS' pipeline is SLS009 (formerly GFH009), a highly selective cyclin-dependent kinase 9 (CDK9) inhibitor. Licensed from GenFleet Therapeutics (Shanghai), Inc., SLS009 is being explored for its potential to treat relapsed/refractory acute myeloid leukemia (r/r AML) and other cancer types. Recent Phase 2a trial results show that SLS009 exhibits strong anti-leukemic activity, with favorable safety profiles and significant response rates, particularly in patients with identified biomarkers such as the ASXL1 mutation.

SELLAS is committed to advancing these therapeutics through rigorous clinical trials and strategic partnerships. The company collaborates with renowned scientists, healthcare professionals, and pharmaceutical executives to bring cutting-edge treatments to market. Recent collaborations include a clinical trial agreement with BeiGene Switzerland GmbH to study the combination of GFH009 and BRUKINSA® (zanubrutinib) in treating diffuse large B cell lymphoma (DLBCL).

Financially, SELLAS has shown resilience and growth, as evidenced by a successful $20 million registered direct offering in March 2024, bolstering their cash reserves for ongoing R&D activities. The company continues to report sound financial health, marked by a focused approach on strategic developments and clinical milestones.

For more information on SELLAS Life Sciences Group, Inc. and its innovative therapies, visit their official website at www.sellaslifesciences.com.

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SELLAS Life Sciences (NASDAQ: SLS) announced a positive recommendation from the Independent Data Monitoring Committee (IDMC) for its Phase 3 REGAL trial in acute myeloid leukemia (AML). The IDMC advised the trial to continue without modifications, citing no safety or futility concerns. The IDMC's review of unblinded data indicated a high level of confidence that an interim analysis will occur by Q4 2024. This recommendation strengthens SELLAS' confidence in GPS (galinpepimut-S) as a potential AML treatment. The REGAL trial targets AML patients in complete remission post-second-line salvage therapy, with the primary endpoint being overall survival.

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SELLAS has completed enrollment for its Phase 2a trial of SLS009 in relapsed/refractory acute myeloid leukemia (r/r AML) ahead of schedule. The trial includes 30 patients who have not responded to venetoclax-based regimens.

Initial results show promising efficacy with an overall response rate (ORR) of 33% and 50% in the 60 mg QW and 30 mg BIW dosing cohorts, respectively. Median overall survival (OS) was 5.4 months at the 45 mg QW dose, significantly higher than the 2.5 months standard of care. Notably, patients with ASXL1 mutations in the 30 mg BIW cohort achieved a 100% ORR. The trial will now proceed with two additional cohorts focusing on patients with specific genetic mutations, with further updates expected in Q3 2024.

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SELLAS Life Sciences (SLS) announced its Q1 2024 financial results, highlighting significant clinical and financial milestones. The Independent Data Monitoring Committee (IDMC) recommended the continuation of the Phase 3 REGAL study without modifications and confirmed the completion of patient enrollment. Positive Phase 2 data for SLS009 in AML patients showed a 100% response rate in those with the ASXL1 mutation at a 30 mg BIW dose. Financially, R&D expenses decreased to $5.1 million, while G&A expenses rose slightly to $4.5 million. The net loss narrowed to $9.6 million, with cash reserves at $18.4 million.

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SELLAS Life Sciences Group, Inc. announces positive Phase 2 preliminary data of SLS009 in relapsed/refractory acute myeloid leukemia (r/r AML), achieving a 100% response rate in patients with ASXL1 mutation at the optimal dose level. The company has filed IP protection related to the ASXL1 mutation, showing a highly significant market potential. SLS009 exhibits strong anti-leukemic activity with a favorable safety profile across all dose levels. Study enrollment is ongoing, with updates expected in Q3 2024.

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SELLAS Life Sciences Group, Inc. announced a positive review by the Independent Data Monitoring Committee (IDMC) of the Phase 3 REGAL clinical trial of galinpepimut-S (GPS) in acute myeloid leukemia (AML). The IDMC recommended the trial continue without modifications based on efficacy and safety data, with the next assessment scheduled for June 2024. The trial aims to develop a novel therapy for AML patients who have achieved complete remission following second-line salvage therapy, with overall survival as the primary endpoint.

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SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) reported positive results from the Phase 2a study of SLS009 in r/r AML, showing a 50% response rate in the selected optimal dose of 30 mg BIW, exceeding the targeted 20%. The company completed enrollment in the Phase 3 REGAL study of Galinpepimut-S in AML, with a potential imminent interim analysis. SLS009 also demonstrated promising results in relapsed/refractory peripheral T-cell lymphoma patients, with top-line data expected in the first half of 2024.
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GenFleet Therapeutics collaborates with BeiGene Switzerland for a combination study in DLBCL patients, aiming to provide innovative therapies for relapsed/refractory cases. The agreement involves a phase Ib/II trial of GFH009 and BRUKINSA® targeting DLBCL, a prevalent form of non-Hodgkin's lymphoma in China. The trial marks the first combination study by a Chinese biotech in this field, with promising results from previous trials of GFH009 in other lymphomas.
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SELLAS Life Sciences Group, Inc. announces positive Phase 2a data for SLS009 in AML patients, with a 50% response rate exceeding the targeted 20%. The Phase 3 REGAL Study of GPS in AML has completed enrollment, with an imminent interim analysis. Median OS not reached in Phase 2a study, showcasing strong anti-leukemic activity and favorable safety profile.
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SELLAS Life Sciences Group, Inc. (SLS) completes a registered direct offering of common stock and warrants, raising approximately $20 million for research and development activities.
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SELLAS Life Sciences Group, Inc. provides an update on the Phase 3 REGAL Clinical Trial of GPS in Acute Myeloid Leukemia (AML) and the Phase 2a Clinical Trial of SLS009 in relapsed/refractory AML. The company will host a corporate update call on March 26, 2024, to discuss the latest developments.
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FAQ

What does SELLAS Life Sciences Group, Inc. specialize in?

SELLAS Life Sciences Group, Inc. focuses on the development of novel therapeutics for a broad range of cancer indications.

What is GPS in SELLAS' product pipeline?

GPS, or galinpepimut-S, is a peptide immunotherapy targeting the WT1 antigen, designed to treat various cancers and currently in a Phase 3 clinical trial for AML.

What is SLS009?

SLS009 is a highly selective CDK9 inhibitor licensed from GenFleet Therapeutics, being tested for effectiveness in treating relapsed/refractory AML and other cancers.

How is SELLAS contributing to cancer research?

SELLAS advances cancer research through clinical trials of innovative therapies like GPS and SLS009, aiming to address unmet medical needs in oncology.

Who are SELLAS' key partners?

SELLAS collaborates with Memorial Sloan Kettering Cancer Center, GenFleet Therapeutics, and BeiGene Switzerland GmbH for its clinical trials and therapeutic developments.

What financial milestone did SELLAS achieve in 2024?

In March 2024, SELLAS completed a $20 million registered direct offering, enhancing their financial position for ongoing research and development activities.

What recent clinical trial advancements has SELLAS made?

SELLAS recently completed enrollment in the Phase 3 REGAL trial for GPS in AML and reported positive Phase 2a results for SLS009 in r/r AML.

What is the significance of the ASXL1 mutation in SELLAS' research?

The ASXL1 mutation is linked to poor prognosis in myeloid diseases, and SELLAS' SLS009 has shown promising response rates in patients with this mutation, indicating potential for targeted therapy.

Where can I get more information about SELLAS Life Sciences Group, Inc.?

For more details, visit SELLAS Life Sciences Group, Inc.'s official website at www.sellaslifesciences.com.

What is the focus of the collaboration between SELLAS and BeiGene Switzerland GmbH?

The collaboration focuses on a clinical trial combining GFH009 (CDK9 inhibitor) and BRUKINSA® (zanubrutinib, BTK inhibitor) to treat diffuse large B cell lymphoma.

SELLAS Life Sciences Group, Inc.

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