Sellas Life Sciences Group Inc - SLS STOCK NEWS

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.

The press release from SELLAS Life Sciences Group (NASDAQ: SLS) details a clinical update on its Phase 1 trial of GFH009, a selective CDK9 inhibitor, aimed at treating advanced relapsed lymphoma and acute myeloid leukemia (AML). So far, no dose-limiting toxicities have been observed, with AML patients at the 22.5 mg dose showing significant anti-leukemic effects. The 30 mg dose has commenced, and early efficacy indications are positive in both lymphoma and AML groups. The release highlights ongoing safety assessments and responses from previous cohorts.

SELLAS Life Sciences Group reported promising clinical trial results for galinpepimut-S (GPS) combined with nivolumab in treating malignant pleural mesothelioma (MPM). Patients receiving this combination therapy exhibited a median overall survival of 45.7 weeks compared to approximately 28 weeks for standard care. The study involved eight patients, with 50% showing advanced Stage IV disease. Safety was consistent with nivolumab alone, noting no severe toxicities. SELLAS aims to further evaluate GPS's immunotherapy efficacy.

SELLAS Life Sciences Group (NASDAQ: SLS), a biopharmaceutical firm, will present at the JMP Securities Life Sciences Conference on June 15, 2022, at 11:00 a.m. ET. CEO Angelos Stergiou will lead the presentation at the Lotte New York Palace.

SELLAS focuses on developing novel cancer therapies. Its lead candidate, GPS, targets the WT1 protein in various tumors and could be used alone or with other treatments. Additionally, the company is developing GFH009, a selective CDK9 inhibitor licensed from GenFleet Therapeutics.

SELLAS Life Sciences Group (NASDAQ: SLS) has released top-line results from its Phase 1/2 trial of galinpepimut-S (GPS) in combination with Merck’s KEYTRUDA in patients with platinum-resistant advanced metastatic ovarian cancer. The overall response rate is 7.7%, while the disease control rate is 53.9%, significantly higher than the 37.2% achieved with checkpoint inhibitors alone. Median progression-free survival stands at 12 weeks. The trial included 15 patients, with further data expected by year-end. The safety profile aligns with pembrolizumab alone, and no serious adverse effects were reported.

SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) reported its financial results for Q1 2022, highlighting key milestones including the in-licensing of GFH009, a selective CDK9 inhibitor. The company raised $25 million through a public offering, enhancing its cash balance to $14.3 million as of March 31, 2022. Licensing revenue fell to $1 million, down from $5.7 million in Q1 2021. R&D expenses rose to $4.6 million. The net loss increased to $16.7 million, or $1.05 per share, from $2.4 million, or $0.16 per share, year-over-year. Major clinical trials, including the Phase 3 REGAL study for GPS, are ongoing.

SELLAS Life Sciences Group (NASDAQ: SLS) has launched a Pre-Approval Access Program for its lead immunotherapy asset, Galinpepimut-S (GPS), targeting patients with Acute Myeloid Leukemia (AML). This initiative responds to demand from physicians under the 21st Century Cures Act. GPS, which targets the WT1 protein, is currently in pivotal Phase 3 trials and has shown promise as a monotherapy and in combination with PD1 inhibitors. SELLAS aims to improve outcomes for AML patients seeking novel therapeutic options.

SELLAS Life Sciences Group (NASDAQ: SLS) has initiated the fifth dose level cohort of its clinical trial for GFH009, a selective CDK9 inhibitor, focusing on acute myeloid leukemia (AML). The first four dose levels reported no dose-limiting toxicities, with significant anti-leukemic effects noted at 9mg and 15mg doses. Approximately 35% of newly diagnosed AML patients are resistant to current treatments. SELLAS plans to advance to a Phase 2 trial, leveraging GFH009's potential to enhance the effectiveness of venetoclax and azacitidine in treating AML.

SELLAS Life Sciences Group has received approval from China's NMPA for an IND application to begin the first clinical trial of 3D189 (GPS) in China, scheduled for mid-2022. This milestone triggers a $1 million payment to SELLAS, which it expects in Q2 2022. The potential total milestone payments from the licensing agreement with 3D Medicines could reach $191.5 million, excluding future royalties. GPS targets the WT1 protein in various cancers, offering hope for improved patient outcomes.