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SELLAS Life Sciences’ Licensee, 3D Medicines, Doses First Patient in Phase 1 Clinical Trial in China of Galinpepimut-S

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SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) announced that its partner, 3D Medicines Inc., has successfully dosed the first patient in a Phase 1 clinical trial for its lead candidate, galinpepimut-S (GPS), in China. This open-label trial aims to recruit 15 patients with specific hematologic malignancies who have had prior treatments. SELLAS views this milestone as critical for the global development of GPS. The company continues to progress with its focus on innovative cancer therapies, with GPS targeting the WT1 protein in various tumor types.

Positive
  • First patient dosed in Phase 1 clinical trial for GPS in China, indicating progress in global development.
  • Potential for GPS as a therapeutic option in various hematologic malignancies.
Negative
  • Trial is limited to only 15 patients, which may restrict data applicability.
  • Dependence on 3D Medicines for trial execution could pose risks if delays occur.

NEW YORK, Oct. 11, 2022 (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 announced that 3D Medicines Inc., SELLAS’ licensee for the development and commercialization of its lead clinical candidate, galinpepimut-S (GPS), in China, Hong Kong, Macau and Taiwan, has dosed the first patient in its Phase 1 clinical trial in China of GPS (3D189 in China).

The Phase 1 clinical trial is an open-label, single-arm, multi-center study in patients with acute myeloid leukemia in complete response, or patients with multiple myeloma, non-Hodgkin’s lymphoma or higher-risk myelodysplastic syndrome who have received at least first-line standard therapy and achieved a complete response or partial response. 3D Medicines plans to recruit fifteen patients for the study.

“The dosing of the first patient in 3D Medicines’ Phase 1 clinical trial for GPS, or 3D189, in China, marks an important milestone for GPS’ global clinical development. We are excited that 3D Medicines’ clinical program for GPS is proceeding on course, and we look forward to receiving the results from this study,” said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS.

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 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.

About 3D Medicines Inc.
3D Medicines Inc. is a commercial-stage biopharmaceutical company with a mission to help people with cancer live longer and better. Envisioning a future when cancer is managed as a chronic disease, 3D Medicines focuses on the development of differentiated next-generation immuno-oncology drugs, helping cancer patients live with prolonged survival time and a better quality of life. 3D Medicines has established a pipeline with both next-generation biological macromolecule and chemotherapeutic small-molecule drugs, as well as a professional team capable of global development, registration and commercialization operation.

For more information, please visit http://www.3d-medicines.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 global clinical development of GPS and the potential for GPS as a drug development candidate. 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 associated with the COVID-19 pandemic and its impact on the Company’s clinical plans and business strategy, risks and uncertainties associated 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 31, 2022 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
Allison Soss
KCSA Strategic Communications
Email: SELLAS@kcsa.com
Phone: 212.896.1267

Media Contacts
Raquel Cona / Michaela Fawcett
KCSA Strategic Communications
Email: SELLAS@kcsa.com
Phone: 212.896.1276


FAQ

What is the significance of the Phase 1 clinical trial for SLS?

The Phase 1 trial's commencement is a critical milestone for SELLAS, marking progress in global development for its lead candidate, galinpepimut-S.

What type of patients are being recruited for the GPS trial?

The trial is recruiting patients with acute myeloid leukemia in complete response, or those with multiple myeloma, non-Hodgkin’s lymphoma, or higher-risk myelodysplastic syndrome post-treatment.

How many patients will be involved in the GPS clinical trial?

The study plans to recruit a total of 15 patients.

What are the next steps for SELLAS Life Sciences after this trial?

SELLAS will await the results from the Phase 1 trial to inform future development strategies for galinpepimut-S and other therapies.

SELLAS Life Sciences Group, Inc.

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