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Fly News Breaks for April 8, 2019
SLS
Apr 8, 2019 | 07:22 EDT
Alliance Global Partners analyst James Molloy initiated Sellas Life Sciences with a Buy and $4.50 price target.
News For SLS From the Last 2 Days
SLS
Mar 26, 2024 | 07:38 EDT
SELLAS Life Sciences Group announces topline data from the Phase 2a study of SLS009 and provides an update on Phase 3 REGAL Study of GPS in AML. The REGAL Steering Committee met on March 22, 2024, to discuss the study and believes the high number of patients who completed participation in the study signals that the interim analysis requiring 60 events may be imminent. The Committee also expressed its satisfaction with SELLAS' overall clinical study conduct and complimented SELLAS for addressing such a debilitating and high unmet medical need as no drugs are approved in the AML CR2 maintenance setting. Summary of Topline Data from Phase 2a data of SLS009 in AML: Patients Characteristics: As of March 15, 2024 data cutoff, 21 patients were treated; All patients were diagnosed with AML refractory to or relapsed after venetoclax containing regimens; 20 out of 21 enrolled patients had adverse/high-risk cytogenetics and 1 patient had intermediate cytogenetics; Median age was 70 and 19/21 of patients were older than 60. Safety: SLS009 in combination with aza/ven has been well-tolerated at all tested dose levels; No dose-limiting toxicities at any of the studied dose levels and no treatment-related high-grade toxicities were observed; Hematologic toxicities profile was consistent with aza/ven standalone treatment. Efficacy: A total of 21 patients were enrolled in the study as of March 15, 2024: 10 in the 45 mg safety cohort, 11 in the 60 mg cohort; 10% response rate in the 45 mg QW safety cohort; 20% response rate in the 60 mg QW cohort; 50% response rate in the 60 mg, 2 x 30 mg BIW cohort; Observed strong anti-leukemic activity, defined as 50% or more bone marrow blast reduction in 67% of patients across all dose levels; Median survival rate has not been reached in any of the dose levels; The first patient enrolled in the study who achieved a complete response continues on the study and remains leukemia-free 9 months after enrollment. Biomarkers: During the trial the Company identified potential biomarkers currently undergoing testing as predictive markers in the most recent portion of the study; Patients with the identified biomarkers exhibited significantly higher response rates: 100% response rate at the optimal dose level; 57% response rate across all dose levels; Furthermore, the Company has clarified the proposed biological basis and mechanism of action for SLS009 activity in patients with these biomarkers; The relevant biomarkers are present in multiple hematologic and solid cancer indications, with a substantial proportion of patients exhibiting them in additional indications, ranging up to ~50% of patients in some indications. The Phase 2a clinical trial of SLS009 is an open-label, single-arm, multi-center study designed to evaluate the safety, tolerability, and efficacy of SLS009 in combination with aza/ven at two dose levels, 45 and 60 mg. In the 60 mg dose cohort patients were randomized into either a 60 mg dose once per week or a 30 mg dose two times per week. The target response rate at the optimal dose level is 20% with a target median survival over 3 months. In addition, the study aims to identify biomarkers for the target patient population and enrichment for further trials.