SELLAS Reports 46% Response Rate for SLS009 in AML Treatment

Written by Emily J. Thompson, Senior Investment Analyst

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Source: Globenewswire

Updated: 11 hour ago

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Source: Globenewswire

Clinical Trial Results: SELLAS Life Sciences' SLS009 combined with AZA/VEN achieved a 46% overall response rate in relapsed/refractory acute myeloid leukemia (AML) patients, demonstrating significant efficacy in heavily pretreated patients, particularly those with ASXL1 and TP53 mutations, which reached response rates of 48% and 57%, respectively.
Survival Improvement: The median overall survival (mOS) for the least pretreated patients was 8.9 months, significantly exceeding the historical benchmark of 2.5 months, indicating the drug's potential in enhancing patient survival, especially in those previously treated with VEN.
Safety Validation: The SLS009 30 mg bi-weekly regimen combined with AZA/VEN showed no dose-limiting toxicities (DLTs), indicating good tolerability and laying a solid foundation for future clinical applications, thereby boosting confidence in the new therapy.
Future Research Plans: SELLAS plans to expand the study in Q1 2026 to evaluate SLS009 combined with AZA/VEN in newly diagnosed high-risk AML patients, further validating its efficacy and safety across different patient populations.

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Analyst Views on SLS

Wall Street analysts forecast SLS stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for SLS is 7.25 USD with a low forecast of 7.00 USD and a high forecast of 7.50 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.

2 Analyst Rating

2 Buy

0 Hold

0 Sell

Moderate Buy

Current: 1.740

Low

7.00

Averages

7.25

High

7.50

Current: 1.740

Low

7.00

Averages

7.25

High

7.50

Maxim

Buy

maintain

$4 -> $7

2025-07-16

Reason

Maxim

Price Target

$4 -> $7

2025-07-16

maintain

Buy

Reason

Maxim raised the firm's price target on Sellas Life Sciences to $7 from $4 and keeps a Buy rating on the shares. Shares have risen about 90% year-to-date as the company continues to execute across its Acute Myeloid Leukemia, or AML, programs, the analyst tells investors in a research note. Maxim further cites the company's galinpepimut-S in Phase 3 and yesterday's positive SLS009 data hitting all its endpoints, adding that its higher price target factors in SLS009 in first-line AML as a potential triplet combination with venetoclax/azacitidine.

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About SLS

SELLAS Life Sciences Group, Inc. is a late-stage clinical biopharmaceutical company. The Company is focused on the development of therapeutics for a range of cancer indications. The Company's product candidates are galinpepimut-S (GPS), a peptide immunotherapy directed against the Wilms tumor 1 (WT1), antigen, and SLS009, a selective small molecule cyclin-dependent kinase 9 (CDK9) inhibitor. GPS is a cancer immunotherapeutic agent licensed by Memorial Sloan Kettering Cancer Center (MSK), that targets the WT1 protein, which is present in an array of tumor types. GPS has potential as a monotherapy or in combination with other immunotherapeutic agents to address a broad spectrum of hematologic malignancies and solid tumor indications. The Company is developing SLS009, which is licensed by GenFleet Therapeutics (Shanghai), Inc., for all therapeutic and diagnostic uses in the world outside of mainland China, Hong Kong, Macau, and Taiwan.

About the author

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Emily J. Thompson

Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.