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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.
SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) announced that its partner, 3D Medicines Inc., has successfully dosed the first patient in a Phase 1 clinical trial for its lead candidate, galinpepimut-S (GPS), in China. This open-label trial aims to recruit 15 patients with specific hematologic malignancies who have had prior treatments. SELLAS views this milestone as critical for the global development of GPS. The company continues to progress with its focus on innovative cancer therapies, with GPS targeting the WT1 protein in various tumor types.
SELLAS Life Sciences Group (NASDAQ: SLS) has announced data from a bioequivalence study for GFH009, a selective small molecule inhibiting CDK9, presented at the Society of Hematologic Oncology. The study demonstrates that GFH009's formulation at pH 6.0 is less acidic than the previous pH 4.5 formulation, leading to improved patient tolerability during prolonged dosing. The study supports ongoing Phase 1 trials for relapsed/refractory hematologic cancers, indicating potential for better therapeutic strategies and reduced infusion reactions.
SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) announced a poster presentation at the Tenth Annual Meeting of the Society of Hematologic Oncology on September 28, 2022, showcasing preclinical pharmacokinetic profiles of GFH009. This selective CDK9 inhibitor, under development for various cancer types, demonstrates an important step in its clinical development.
The presentation will be led by Dragan Cicic, MD, and highlights two GFH009 formulations with distinct pH levels. SELLAS aims to advance therapeutic options targeting hematologic malignancies and solid tumors.
SELLAS Life Sciences Group (NASDAQ: SLS) announced that its CEO, Angelos Stergiou, will participate in the Cantor Oncology, Hematology, HemeOnc Conference on September 28, 2022, in New York City. Dr. Stergiou will be featured in the ‘Leukemia and MDS’ panel at 3:25 p.m. ET. SELLAS focuses on developing innovative therapies for various cancer types, with its lead candidate, GPS, targeting the WT1 protein associated with multiple tumors. The company also develops GFH009, a selective CDK9 inhibitor.
SELLAS Life Sciences Group (NASDAQ: SLS) will host a virtual investor symposium on September 15, 2022, focusing on its lead asset, galinpepimut-S (GPS), which targets acute myeloid leukemia (AML) patients. The event will include remarks from key executives, including CEO Angelos Stergiou, and will discuss GPS's commercial potential. Interested parties can access the live call or join via webcast. A replay will be available until September 29, 2022. SELLAS is also developing GFH009, a selective CDK9 inhibitor, licensed for global use outside Greater China.
SELLAS Life Sciences Group (NASDAQ: SLS) announces promising results from a preclinical study of its CDK9 inhibitor, GFH009, targeting neuroendocrine prostate cancer (NEPC). The study showed significant anti-tumor effects, with some samples showing complete inhibition of cancer cell growth at nanomolar concentrations. NEPC, often arising from advanced prostate cancer treatment, has a median survival of only 5.4 months. The findings suggest GFH009 could be a potential treatment option, marking a critical advance in addressing this aggressive cancer variant.
SELLAS Life Sciences Group has appointed Katherine Bach Kalin to its Board of Directors, bringing decades of experience in the life sciences and healthcare sectors. Kalin's extensive background includes leadership roles in strategy, business development, and sales at renowned companies like Celgene and Johnson & Johnson. With her expertise, SELLAS aims to advance its clinical programs, including galinpepimut-S (GPS) and GFH009, which target various cancer indications. This leadership change signifies a strategic move for SELLAS as it prepares for commercialization.
SELLAS Life Sciences Group, Inc. (SLS) reported a net loss of $8.4 million for Q2 2022, increasing from $4.6 million in Q2 2021. The company, focusing on cancer therapies, achieved milestones in its lead asset, Galinpepimut-S (GPS), with encouraging clinical results in trials combining GPS with KEYTRUDA and OPDIVO. The GFH009 program also showed promising results with no dose-limiting toxicities. As of June 30, 2022, SELLAS had cash reserves of $27 million, and plans to host a virtual investor symposium on September 15, 2022, to discuss GPS's potential.
SELLAS Life Sciences Group (NASDAQ: SLS) announced promising preclinical results for its CDK9 inhibitor, GFH009, showing significant anti-tumor effects across selected cancer cell lines. The studies indicated that GFH009 inhibited cancer growth by 90 to 100 percent in three out of four cell lines, including pediatric rhabdomyosarcoma and small cell lung cancer. Conducted at Translational Drug Development, these findings will guide the clinical development of GFH009. The company aims to leverage this data for future treatment strategies.
SELLAS Life Sciences Group announced an expansion in its ongoing global Phase 1 clinical trial for the CDK9 inhibitor GFH009, focusing on patients with advanced relapsed or refractory lymphoma and acute myeloid leukemia (AML). A new once-a-week dose cohort has been added, starting at 30 mg. Previous cohorts showed no significant toxicities at the 22.5 mg dose. With safety assessments underway for the twice-a-week regimen, the company aims to determine the optimal dosing for the upcoming Phase 2 study, potentially enhancing efficacy in these patient populations.
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