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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 the acceptance of an abstract for a poster presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting, scheduled for June 2-6, 2023, in Chicago. The poster will detail a study on the efficacy and safety of galinpepimut-S (GPS) maintenance therapy for patients with acute myeloid leukemia (AML) who have achieved complete remission after second-line therapy. The study, led by Dr. Omer Jamy, Principal Investigator, will be presented on June 5, 2023. Additionally, SELLAS is advancing its cancer therapies, notably GPS, targeting the WT1 protein across various malignancies, and GFH009, a CDK9 inhibitor licensed from GenFleet Therapeutics.
SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) has announced promising results from its Phase 1 trial of GFH009, a selective CDK9 inhibitor for patients with acute myeloid leukemia (AML). The trial achieved safety and efficacy objectives, with no dose-limiting toxicities reported. Key findings include a complete response at an intermediate dosage and a significant reduction in leukemic cell blasts. SELLAS is set to initiate a Phase 2a clinical trial in 2Q 2023, combining GFH009 with venetoclax and azacitidine for AML patients who have relapsed. Topline data from this trial is expected in Q4 2023. The favorable pharmacokinetic profile supports the potential for once-weekly dosing, indicating a significant advancement in addressing AML treatment challenges.
SELLAS Life Sciences Group (NASDAQ: SLS) reported a positive review from the Independent Data Monitoring Committee (IDMC) of its ongoing Phase 3 REGAL clinical trial for galinpepimut-S (GPS) targeting acute myeloid leukemia (AML). The IDMC assessed unblinded data and recommended the trial's continuation without modifications, also endorsing the addition of clinical sites in China. This milestone is critical as SELLAS aims for interim analysis by late 2023 or early 2024. The REGAL trial evaluates overall survival in AML patients who achieved complete remission after second-line salvage therapy. Galinpepimut-S is designed to target the WT1 protein found in various tumors, and is being developed as both monotherapy and in combination with other therapies.
SELLAS Life Sciences Group reported progress in its clinical programs and financials for 2022. Their Phase 3 REGAL AML study is on track for interim analysis in late 2023/early 2024, with milestone payments from 3D Medicines expected to total $13 million in H1 2023. The company raised $20 million in February, enhancing its cash position to $37.1 million. Negative trends include a net loss of $41.3 million, a sharp increase from 2021's loss of $20.7 million, and a significant drop in licensing revenue from $7.6 million to $1 million. Research and development expenses rose to $20.3 million, partly due to higher clinical trial costs.
SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) announced the publication of Phase 1 trial results combining galinpepimut-S (GPS) with nivolumab in treating relapsed WT1-expressing ovarian cancer. The study, published in Cancers, revealed that 70% of patients achieved one-year progression-free survival, significantly higher than historic rates of 55%. Notably, 91% of patients exhibited WT1-specific T-cell responses, indicating robust immunologic activity. The results suggest GPS may provide substantial clinical benefits and delay disease relapse compared to salvage chemotherapy alone.
SELLAS Life Sciences Group, Inc. (Nasdaq: SLS) announced a public offering of 7,220,217 shares of common stock at $2.77 per share, including warrants with the same exercise price. The offering, expected to raise $20 million prior to expenses, is anticipated to close on February 28, 2023. Cantor Fitzgerald & Co. is the sole book-running manager. All securities are being sold by SELLAS under a previously declared effective shelf registration. The company focuses on developing novel cancer therapies, with lead candidate GPS targeting various tumors.
SELLAS Life Sciences Group, Inc. (Nasdaq: SLS) announced an underwritten public offering of shares and warrants to purchase its common stock. All securities in this offering will be sold by the company, with Cantor Fitzgerald & Co. acting as the sole book-running manager. The offering is subject to market conditions, and its terms are yet to be finalized. This initiative is in accordance with a previously filed shelf registration statement with the SEC. SELLAS focuses on developing novel cancer therapies, including its lead candidate, GPS, targeting the WT1 protein found in various tumors, and a CDK9 inhibitor, GFH009.
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