SELLAS Announces Positive Topline Data from the Phase 2a Study of SLS009 in r/r AML and Provides Steering Committee Update on Phase 3 REGAL Study
SELLAS Life Sciences Group, Inc. announces positive Phase 2a data for SLS009 in AML patients, with a 50% response rate exceeding the targeted 20%. The Phase 3 REGAL Study of GPS in AML has completed enrollment, with an imminent interim analysis. Median OS not reached in Phase 2a study, showcasing strong anti-leukemic activity and favorable safety profile.
Positive
Positive Phase 2a data for SLS009 in AML patients with a 50% response rate exceeding the targeted 20%
Completion of enrollment in the Phase 3 REGAL Study of GPS in AML, with an imminent interim analysis
Median OS not reached in Phase 2a study of SLS009, demonstrating strong anti-leukemic activity in ~70% of patients
First CR patient remains leukemia-free 9 months post-enrollment in Phase 2a study of SLS009
Toxicities observed with therapies used in control arm, but not with GPS arm in REGAL Study
The completion of enrollment for the Phase 3 REGAL study and the results from the Phase 2a study of SLS009 in AML patients represent significant milestones for SELLAS Life Sciences Group, potentially impacting its stock valuation. The Phase 3 study's progress is a critical step towards potential FDA approval, which can have substantial implications for the company's revenue and market share within the oncology sector. The reported 50% response rate in the Phase 2a study exceeds the targeted 20%, indicating a potentially efficacious treatment for AML patients resistant to venetoclax combination therapies. This could translate into a competitive advantage in the market, considering the high unmet medical need in AML CR2 maintenance settings.
Moreover, the identification of biomarkers with a 100% response rate at the optimal dose level suggests a precision medicine approach that could lead to better patient outcomes and more efficient healthcare spending. The favorable safety profile of SLS009, with no dose-limiting toxicities or treatment-related high-grade toxicities, further enhances its potential marketability. However, it is paramount to scrutinize the long-term safety data and overall survival rates, as these are critical factors for regulatory approval and market adoption.
The reported data from SELLAS Life Sciences indicates promising therapeutic potential for SLS009 in a subset of AML patients. The strong anti-leukemic activity and favorable safety profile are particularly noteworthy, as they suggest a viable treatment option for patients who have exhausted other therapies. The absence of intolerable toxicities is encouraging, given the toxicity profiles of existing AML treatments. The identification of biomarkers that correlate with a higher response rate could lead to more personalized and effective treatment strategies, which is a significant advancement in oncology.
However, the clinical significance of these findings will depend on the long-term outcomes, including overall survival and quality of life measures. The ongoing trials and subsequent peer-reviewed publications will be important in determining the true impact of SLS009 on AML treatment paradigms. It is essential to consider the broader context of AML treatment, where the introduction of new therapies can shift standard care practices and influence treatment guidelines.
The topline data from SELLAS' Phase 2a study and the update on the Phase 3 REGAL study are likely to be closely monitored by investors and could influence the company's stock performance. The high response rates and favorable safety profile of SLS009 are positive indicators that could lead to increased investor confidence and capital inflow, especially if the drug achieves regulatory approval. The potential for SLS009 to address a significant unmet medical need in AML could result in a substantial market opportunity for SELLAS.
However, investors should consider the inherent risks associated with clinical-stage biopharmaceutical companies, including the possibility of regulatory setbacks or unfavorable long-term data. The market's reaction to these updates will depend on the perceived likelihood of SLS009's commercial success and the company's ability to navigate the regulatory landscape. It is also important to assess the competitive landscape, as the introduction of new treatments by competitors could affect SELLAS' market position.
03/26/2024 - 07:35 AM
- Phase 3 REGAL Study of GPS in AML: Enrollment Completed; Steering Committee Guided Interim Analysis Imminent; IDMC Now Scheduled in Late April -
- Phase 2a study of SLS009 in r/r AML: 50% Response Rate in the Selected Optimal Dose of 30 mg BIW Exceeding the Targeted 20% ; 100% Response Rate in Patients with Identified Biomarkers to Date -
- Median OS Has Not Been Reached in the Phase 2a Study of SLS009; First CR Patient Continues on Study and Remains Leukemia-Free 9 Months Since Enrollment –
- SLS009 Exhibits Strong Anti-Leukemic Activity in ~70% of Patients with a Favorable Safety Profile at All Dose Levels -
- Company to Host Corporate Update Webinar Today, March 26, 2024, at 8:15 am ET-
NEW YORK, March 26, 2024 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS’’ or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today announces topline data from the Phase 2a study of SLS009 and provides an update on Phase 3 REGAL Study of GPS in AML. The Company will host a webinar to discuss the data and the REGAL update today at 8:15 am ET.
“Completion of enrollment in the Phase 3 REGAL trial represents an important milestone in our goal to deliver GPS to AML patients,” said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. “We are extremely grateful to the patients, their families, and investigators who have helped us achieve this significant milestone. Additionally, we are pleased to share that the Steering Committee has reviewed the study as of the March 1, 2024, cutoff date. As of this evaluation, 123 patients were enrolled with 66 of them discontinuing the treatment. In the trial, patients are recorded as having stopped the study treatment in cases of death for any reason, relapse, intolerable toxicity, or treatment completion. Regarding the GPS arm, we are pleased to report that we have not observed any intolerable toxicities in any patient population across all our clinical studies thus far, although toxicities are commonly observed with therapies used in the control arm. Therefore, almost all patients who are off treatment may have most likely either relapsed or passed away. The most frequent cause of death in this patient population is relapse. As the study sponsors, we lack specific information on the outcomes of these 66 patients, hindering our ability to confirm whether the required number of events for interim analysis – 60 – has been reached. The determination of such outcomes, the primary endpoint of the trial, lies within the purview of the IDMC, which is now scheduled to meet by the end of April.”
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.
Dr. Stergiou continued: “We are extremely excited to share positive topline data from the Phase 2a trial of SLS009 in AML patients resistant to venetoclax combination therapies. In the selected optimal dose regimen of 30 mg BIW a 50% response rate was achieved, far surpassing the targeted 20% rate. Notably, we identified promising biomarkers and observed a 100% response rate at the optimal dose level and a 57% response rate across all the levels tested in patients with those biomarkers. The SLS009 aza-ven treatment was well-tolerated and evoked anti-leukemic effects in 67% of patients across all levels dosed. The first patient who achieved a complete response continues on the study and remains leukemia-free 9 months post-enrollment. These compelling results from the Phase 2a reinforce our belief that SLS009 represents a potential breakthrough for relapsed and/or refractory AML patients, addressing one of the most urgent unmet medical needs.”
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 (95% ) enrolled patients had adverse/high-risk cytogenetics and 1 patient (5% ) had intermediate cytogenetics Median age was 70 and 19/21 (90.5% ) 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 (DLT) at any of the studied dose levels and no treatment-related high-grade (≥G3) 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 (2 x 30 mg twice a week or 60 mg once a week)
10% response rate in the 45 mg QW safety cohort (dose level below the recommended Phase 2 dose, RP2D)20% response rate in the 60 mg QW cohort50% response rate in the 60 mg, 2 x 30 mg BIW cohortObserved 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 (CR) 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 (30 mg BIW)57% response rate across all dose levelsFurthermore, 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.
Corporate update call details are as follows:
Date: Tuesday, March 26, 2024 Time: 8:15 a.m. Eastern Time Dial-in (U.S.): 1-877-423-9813 International Dial-in: 1-201-689-8573 Webcast: SELLAS Update Call
About SELLAS Life Sciences Group, Inc.
SELLAS is a late-stage clinical biopharmaceutical company focused on the development of novel therapeutics for a broad range of cancer indications. SELLAS’ lead product candidate, galinpepimut-S (GPS), is licensed from Memorial Sloan Kettering Cancer Center and targets the WT1 protein, which is present in an array of tumor types. GPS has potential as a monotherapy and combination with other therapies to address a broad spectrum of hematologic malignancies and solid tumor indications. The Company is also developing SLS009 (formerly GFH009), a small molecule, highly selective CDK9 inhibitor, which is licensed from GenFleet Therapeutics (Shanghai), Inc., for all therapeutic and diagnostic uses in the world outside of Greater China. For more information on SELLAS, please visit www.sellaslifesciences.com .
Forward-Looking Statements
This press release contains forward-looking statements. All statements other than statements of historical facts are “forward-looking statements,” including those relating to future events. In some cases, forward-looking statements can be identified by terminology such as “plan,” “expect,” “anticipate,” “may,” “might,” “will,” “should,” “project,” “believe,” “estimate,” “predict,” “potential,” “intend,” or “continue” and other words or terms of similar meaning. These statements include, without limitation, statements related to the SLS009 clinical development program, including data therefrom, and regulatory strategy. These forward-looking statements are based on current plans, objectives, estimates, expectations and intentions, and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties with oncology product development and clinical success thereof, the uncertainty of regulatory approval, and other risks and uncertainties affecting SELLAS and its development programs as set forth under the caption “Risk Factors” in SELLAS’ Annual Report on Form 10-K filed on March 16, 2023 and in its other SEC filings. Other risks and uncertainties of which SELLAS is not currently aware may also affect SELLAS’ forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated. The forward-looking statements herein are made only as of the date hereof. SELLAS undertakes no obligation to update or supplement any forward-looking statements to reflect actual results, new information, future events, changes in its expectations or other circumstances that exist after the date as of which the forward-looking statements were made.
Investor Contact
Bruce Mackle
Managing Director
LifeSci Advisors, LLC
SELLAS@lifesciadvisors.com
What is the response rate for SLS009 in AML patients in the Phase 2a study?
The response rate for SLS009 in AML patients in the Phase 2a study was 50%, exceeding the targeted 20%.
What milestone has been achieved in the Phase 3 REGAL Study of GPS in AML?
The Phase 3 REGAL Study of GPS in AML has completed enrollment, with an imminent interim analysis.
What is the status of the first CR patient in the Phase 2a study of SLS009?
The first CR patient in the Phase 2a study of SLS009 remains leukemia-free 9 months post-enrollment.
What is the safety profile of SLS009 in AML patients?
SLS009 in AML patients has shown a favorable safety profile at all dose levels, with no dose-limiting toxicities observed.
What is the median OS in the Phase 2a study of SLS009?
The median OS has not been reached in the Phase 2a study of SLS009, indicating positive outcomes.
