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 focused on developing novel therapies for cancer, with a strong emphasis on acute myeloid leukemia (AML) and other hematologic malignancies. This news page aggregates company announcements, clinical updates, financial disclosures, and collaboration news related to SLS.
Readers can follow developments around SELLAS’ lead product candidate galinpepimut-S (GPS), a WT1-targeted peptide immunotherapy licensed from Memorial Sloan Kettering Cancer Center, which is being evaluated in the pivotal Phase 3 REGAL trial as a potential maintenance therapy in AML after second complete remission. News items include updates on the REGAL trial’s progress, Independent Data Monitoring Committee recommendations, and commentary from investigators and key opinion leaders.
The SLS news feed also covers SLS009 (tambiciclib), SELLAS’ highly selective CDK9 inhibitor. Articles highlight Phase 2 clinical data in relapsed or refractory AML with myelodysplastic syndrome-related changes (AML-MR) after prior venetoclax-based treatment, including reported response rates, survival outcomes, and safety findings for SLS009 in combination with azacitidine and venetoclax. Preclinical results in T-cell prolymphocytic leukemia (T-PLL) and mechanistic studies in AML cell lines are also featured in conference-related releases.
In addition to clinical and scientific news, this page includes corporate updates such as participation in investor conferences, warrant exercise transactions, and quarterly financial results as reported in press releases referenced by Form 8-K filings. Investors and followers of SLS can use this page to review the sequence of material events, from R&D days and conference presentations to financing activities and operational updates, in one organized stream of company-specific news.
SELLAS Life Sciences Group (NASDAQ: SLS) outlined key business objectives for 2025, highlighting two major upcoming milestones. The company expects an interim analysis of its Phase 3 REGAL study by an Independent Data Monitoring Committee in January 2025, which will determine whether to stop the trial early for efficacy, stop for futility, or continue without modification.
Additionally, full topline Phase 2 data for SLS009 (tambiciclib) in Acute Myeloid Leukemia (AML) and FDA regulatory review are expected in 1H 2025. The company reported positive 2024 results for SLS009, with median overall survival exceeding 7.7 months compared to historical 2.5 months, and a 56% Overall Response Rate in AML-MRC patients. The drug received multiple regulatory designations, including FDA Fast Track Designation for AML and EMA orphan drug designation for AML and peripheral T-cell lymphoma.
SELLAS Life Sciences Group (NASDAQ: SLS), a late-stage clinical biopharmaceutical company specializing in cancer therapy development, has announced a corporate update call scheduled for Wednesday, January 8, 2025, at 9:00 a.m. Eastern Time.
The call will feature Angelos Stergiou, MD, ScD h.c., President and CEO of SELLAS, who will present the company's 2025 outlook. He will be joined by Dr. Yair Levy, Director of Hematologic Malignancies at the Baylor University Medical Center and member of the REGAL Steering Committee.
The presentation will be accessible via webcast under the title '2025 Business Outlook'.
SELLAS Life Sciences Group (NASDAQ: SLS) announced reaching a critical milestone in its Phase 3 REGAL clinical trial of galinpepimut-S (GPS) for acute myeloid leukemia (AML). The study has achieved its pre-specified threshold of 60 events (deaths), triggering an interim analysis by the Independent Data Monitoring Committee (IDMC).
The IDMC will conduct a comprehensive review of the REGAL data in January 2025, assessing the efficacy, futility, and safety of GPS as a potential new treatment option for AML patients. The analysis represents a significant step in SELLAS's mission to develop novel cancer therapies.
SELLAS Life Sciences Group announced positive data from Phase 2 trial of SLS009, a CDK9 inhibitor, in relapsed/refractory acute myeloid leukemia (r/r AML). Key findings include:
- Median Overall Survival exceeding 7.7 months in the 30 mg BIW cohort for venetoclax-refractory patients (vs. historical 2.5 months)
- 56% Overall Response Rate in AML-MRC patients, surpassing the 33% target
- Well-tolerated safety profile with no new safety signals
The trial included 14 patients in Cohort 3 and 14 in Cohorts 4-5, with 9 evaluable patients at analysis. The study evaluates SLS009 in combination with venetoclax and azacitidine at different dose levels, focusing on ASXL1 mutated AML patients and those with myelodysplasia-related molecular abnormalities.
SELLAS Life Sciences Group announced promising preclinical study results showing ASXL1 mutations as a key predictor of SLS009 response in solid cancers. The study revealed high efficacy in 67% of ASXL1 mutated solid cancers compared to 0% in non-ASXL1 mutated cancers. In colorectal cancer (CRC MSI-H), ASXL1 mutations were found in 58% of cases, with high efficacy in 57% of mutated cell lines. In non-small cell lung cancer (NSCLC), 100% efficacy was observed in ASXL1 mutated cell lines. SLS009 outperformed the positive control in 5 out of 9 cell lines, positioning it as a promising therapeutic candidate.
SELLAS Life Sciences Group (NASDAQ: SLS) reported Q3 2024 financial results and pipeline updates. The company's Phase 3 REGAL study interim analysis for AML treatment remains on track for Q4 2024. Their drug candidate SLS009 showed promising results in Phase 2a trials, with a 31% overall response rate in relapsed/refractory AML patients. Financial highlights include Q3 R&D expenses of $4.4M (down from $5.8M in 2023), G&A expenses of $3.0M (down from $3.5M), and a net loss of $7.1M ($0.10 per share). Cash position stands at $21M as of September 30, 2024.
SELLAS Life Sciences (NASDAQ: SLS) announced promising results from its Phase 2a trial of SLS009, a CDK9 inhibitor, in treating relapsed/refractory acute myeloid leukemia (r/r AML). The findings will be presented at the 66th ASH Annual Meeting in December 2024.
The trial, involving 30 patients, demonstrated a 50% response rate at the optimal dose level of 30 mg twice weekly. Notable outcomes include a median overall survival of 5.5 months at 45 mg once weekly, compared to less than 2.5 months with standard care. The treatment showed particular effectiveness in patients with AML-myelodysplasia-related changes, especially those with ASXL1 mutations, achieving a 56% response rate in this group.
SELLAS Life Sciences Group (NASDAQ: SLS) has received Rare Pediatric Disease Designation (RPDD) from the FDA for Galinpepimut-S (GPS) in treating pediatric acute myeloid leukemia (AML). GPS, an immunotherapeutic targeting Wilms Tumor-1, is currently in a Phase 3 REGAL trial for adult AML patients, with an interim analysis expected in Q4 2024.
The RPDD makes GPS eligible for a Priority Review Voucher (PRV) upon marketing approval, which can be transferred or sold, with recent valuations around $100 million. GPS has shown promise in clinical settings, particularly in younger patients. In a Phase 2 trial with adult AML patients, GPS demonstrated a median overall survival of 67.6 months across all ages, with even better outcomes in younger patients.
AML prognosis in refractory/relapsed pediatric patients remains poor, with a 5-year overall survival rate of 33% for all patients, and only 15.7% for those whose remission lasted less than 12 months. About 50% of children with pediatric AML relapse, highlighting the need for new treatment options.
SELLAS Life Sciences Group (NASDAQ: SLS), a late-stage clinical biopharmaceutical company, announced its participation in the 2024 Maxim Healthcare Virtual Summit. Dr. Angelos Stergiou, President and CEO of SELLAS, will engage in a fireside chat on Tuesday, October 15, 2024, at 9:00 am EDT.
The virtual summit will be hosted on the M-Vest platform, where investors can register to watch the fireside chat and schedule one-on-one meetings. SELLAS focuses on developing novel therapies for a broad range of cancer indications, positioning itself as a key player in the oncology therapeutics sector.
SELLAS Life Sciences Group (NASDAQ: SLS) reported Q2 2024 financial results and provided a corporate update. Key highlights include:
1. The IDMC recommended continuing the Phase 3 REGAL study in AML without modifications, with interim analysis expected by Q4 2024.
2. Positive preliminary data from the Phase 2a trial of SLS009 in r/r AML, showing ORRs of 33%, 50%, and 100% in different cohorts.
3. SLS009 received EMA Orphan Drug Designations and FDA Rare Pediatric Disease Designations.
4. $21 million raised in August 2024 at a premium to market.
5. Q2 2024 financial results: R&D expenses $5.2M, G&A expenses $2.4M, net loss $7.5M ($0.13 per share).
6. Cash position: $9.1M as of June 30, 2024, bolstered by the subsequent $21M offering.