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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.

News

SELLAS Provides Corporate Updates and Highlights Key Upcoming Milestones

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SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) will host a corporate update webinar to discuss the positive clinical progress and upcoming milestones for their cancer therapy programs, Galinpepimut-S (GPS) and SLS009.
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SELLAS Life Sciences Reports Positive Follow-Up Immune Response and Survival Data in Completed Phase 1 Study of Galinpepimut-S Combined with Opdivo® in Advanced Malignant Pleural Mesothelioma

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SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) announced positive follow-up clinical/immune-response data from a Phase 1 trial of galinpepimut-S (GPS) combined with nivolumab in patients with relapsed malignant pleural mesothelioma. The study showed a 70.3 weeks median overall survival, a 208.3% increase in survival time for patients with GPS-specific immune response, and a 30% disease control rate.
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SELLAS Receives FDA Orphan Drug Designation for SLS009 for Treatment of Peripheral T-cell Lymphomas

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SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) announced that the U.S. FDA has granted Orphan Drug Designation for SLS009, a novel CDK9 inhibitor, for the treatment of r/r Peripheral T-cell Lymphomas. The drug showed a 36.4% clinical response rate, higher than the standard of care's 25.8%. The Phase 1b/2 study in PTCL is ongoing, with top-line data expected in 1H 2024.
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SELLAS Life Sciences Announces First Patients Enrolled in 60 mg Dose Cohort in Phase 2a Clinical Trial of SLS009 in Acute Myeloid Leukemia

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SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) has completed enrollment in the 45 mg safety cohort for its ongoing Phase 2a clinical trial of SLS009, a CDK9 inhibitor, in combination with venetoclax and azacitidine for patients with relapsed/refractory acute myeloid leukemia (AML). The Safety Monitoring Committee has recommended proceeding to the Phase 2 dose level of 60 mg, with early data expected around year-end 2023. The company reported significant anti-leukemic effects and no dose limiting toxicities in the 45 mg cohort, indicating important progress in the clinical advancement of SLS009.
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SELLAS to Host Corporate Update Webinar on January 3, 2024 at 8:30 am ET

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SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) will host a corporate update webinar on January 3, 2024, at 8:30 a.m. Eastern Time. Angelos Stergiou, MD, ScD h.c., President and CEO, will discuss the Company’s achievements in 2023 and provide an outlook for 2024. Key opinion leaders will discuss the Phase 3 registrational REGAL clinical trial of galinpepimut-S (GPS) in patients with acute myeloid leukemia and the clinical program for SLS009, the Company’s CDK9 inhibitor.
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SELLAS Life Sciences Announces Positive Recommendation from REGAL Independent Data Monitoring Committee of Galinpepimut-S in Acute Myeloid Leukemia

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SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) announced that the Independent Data Monitoring Committee (IDMC) recommended the continuation of the Phase 3 REGAL trial for galinpepimut-S (GPS) in acute myeloid leukemia (AML) without any modifications. The IDMC expressed satisfaction with the speed of enrollment and high study integrity, and will review the most current survival data at the next scheduled meeting in Q1 2024.
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SELLAS Life Sciences Reaches Target Enrollment ex-China in Phase 3 REGAL Trial of Galinpepimut-S in Acute Myeloid Leukemia

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SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) has reached target patient enrollment outside of mainland China in the ongoing Phase 3 REGAL trial of galinpepimut-S (GPS) in patients with acute myeloid leukemia (AML) who have achieved complete remission following second-line salvage therapy. The trial is designed to compare GPS monotherapy to the best available treatment in AML patients who are ineligible for or unable to undergo allogeneic stem-cell transplantation. The primary endpoint is overall survival, with secondary endpoints including leukemia-free survival, antigen-specific T-cell immune response dynamics, measurable residual disease, and assessments of AML clonal evolution and inflammasome molecular signatures in the tumor microenvironment. The interim analysis is expected by late 2023 or early 2024, with the final analysis on track to occur by the end of 2024. GPS has received Fast Track Designation in the United States and Orphan Drug Designation in both the United States and the European Union for AML.
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SELLAS Life Sciences Receives Favorable FDA Type C Meeting Feedback on Chemistry, Manufacturing, and Controls (CMC) Biologics License Application (BLA) Filing Strategy for Galinpepimut-S (GPS)

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SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) announced positive feedback from the FDA regarding their Chemistry, Manufacturing, and Controls (CMC) sections in a potential biologics license application (BLA) for their lead product candidate, galinpepimut-S (GPS). The FDA's favorable guidance is a crucial step in the approval pathway for GPS, a potential immunotherapy cancer vaccine for acute myeloid leukemia (AML). The Company has successfully completed various clinical development and CMC objectives, including manufacturing, process qualification, method validation, and stability monitoring. The FDA also agreed on the Company’s proposed stability data generation plan for the commercial presentation of GPS, making it more accessible for end-users.
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SELLAS Provides Business Update and Reports Third Quarter 2023 Financial Results

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NASDAQ: SLS - SELLAS Life Sciences Group, Inc. reports positive Phase 2a data of SLS009 in AML patients and regulatory milestones. Fast Track Designation by FDA for PTCL and Orphan Drug Designation for AML. Phase 3 REGAL Trial of Galinpepimut-S on track to complete enrollment ex-China in November 2023.
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SELLAS Life Sciences Presents Positive Key Immunobiological and Clinical Data from Phase 1/2 Trial of Galinpepimut-S (GPS) in Combination with Keytruda® in WT1+ Platinum-Resistant Advanced Ovarian Cancer at the International Gynecologic Cancer Society 2023 Annual Global Meeting

Rhea-AI Summary
SELLAS Life Sciences Group, Inc. announced final clinical and immunobiological data from the Phase 1/2 clinical trial of galinpepimut-S (GPS) in combination with pembrolizumab (Keytruda®) in Wilms’ tumor-1 (WT1)-positive platinum-resistant ovarian cancer. The combination showed a median overall survival of 18.4 months compared to 13.8 months with pembrolizumab alone. The combination also resulted in a 41% longer progression-free survival and a statistically significant difference. The trial included 16 evaluable patients.
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FAQ

What is the current stock price of SELLAS Life Sciences Group (SLS)?

The current stock price of SELLAS Life Sciences Group (SLS) is $1.22 as of November 21, 2024.

What is the market cap of SELLAS Life Sciences Group (SLS)?

The market cap of SELLAS Life Sciences Group (SLS) is approximately 85.2M.

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.

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SELLAS Life Sciences Group, Inc.

Nasdaq:SLS

SLS Rankings

#4490 Ranked by Market Cap
N/A Ranked by Dividends

SLS Stock Data

85.16M
70.23M
0.24%
7.36%
13.39%
Biotechnology
Pharmaceutical Preparations
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