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SELLAS Life Sciences to Present Final Data from Phase 1/2 Study of Galinpepimut-S in Combination with Keytruda® (pembrolizumab) in Patients with WT1+ Platinum-Resistant Advanced Ovarian Cancer at the International Gynecologic Cancer Society 2023 Annual Global Meeting

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SELLAS Life Sciences Group, Inc. to present topline clinical data from Phase 1/2 trial of galinpepimut-S in combination with pembrolizumab at the 2023 IGCS Annual Global Meeting.
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  • SELLAS planning submission of full-length manuscript to peer-reviewed journal based on data presented
  • Galinpepimut-S has shown promising activity as maintenance therapy in combination with checkpoint blockade in patients with advanced ovarian cancer
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NEW YORK, Oct. 17, 2023 (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 the topline clinical data from the final analysis of the Phase 1/2 clinical trial of galinpepimut-S (GPS) in combination with pembrolizumab (Keytruda®) in Wilms’ tumor-1 (WT1)-positive platinum-resistant ovarian cancer (NCT03761914) will be presented at an e-Poster session at the 2023 International Gynecologic Cancer Society (IGCS) Annual Global Meeting taking place November 5-7, 2023, in Seoul, South Korea.

The multicenter study was sponsored by SELLAS and conducted under a Clinical Trial Collaboration and Supply Agreement with Merck & Co., Inc., Rahway, N.J., USA (known as MSD outside the United States and Canada). Based on data in this e-Poster presentation, SELLAS is planning the submission of a full-length manuscript to a peer-reviewed journal during the first half of 2024.

Abstract Publication and Poster presentation details:

Title: Phase 1/2 study of galinpepimut-S plus pembrolizumab combination in patients with WT1+ platinum-resistant ovarian cancer in 2nd/3rd line of therapy.

Galinpepimut-S (GPS) is an HLA-unrestricted heteroclitic peptide vaccine against WT1, an antigen highly expressed in ovarian cancer. GPS has previously shown promising activity as maintenance therapy in combination with checkpoint blockade in patients with advanced ovarian cancer in 2nd/3rd remission. The clinical trial investigated the effects of GPS plus pembrolizumab in patients with measurable WT1+ platinum-resistant ovarian cancer relapsed after or refractory to 1st/2nd -or later- line of therapy.

Abstract Embargo Release Date and Time: The abstract reporting the key results of this study will become public today at 5 pm Korean Standard Time (4 am EDT US) and available for access via the IGCS 2023 website: https://igcsmeeting.com/abstract-publications/. The abstract does not include follow-up assessments performed and further key outcomes which have been included in the e-Poster.

E-Poster Session Date and Time: The e-Poster for this study (# EP294) will be available for viewing to all registered delegates via the IGCS 2023 mobile application, IGCS 360 Educational Portal, and onsite (at the congress venue) at the e-Poster stations on November 5, 2023, at 8:30 am Korean Standard Time (November 4, 2023 at 7:30 pm EDT US) and throughout the duration of the meeting. The e-Poster is accompanied by a brief audio review of the data by the lead author.

Lead (Presenting) Author: Roisin E. O’Cearbhaill, M.D., Research Director, Gynecologic Medical Oncology Service; Clinical Director, Solid Tumor, Cellular Therapy Service; and Associate Attending Physician Memorial Sloan Kettering Cancer Center, New York, NY, USA.

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, 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.

Keytruda® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA and is not a trademark of SELLAS. The manufacturer of this brand is not affiliated with and does not endorse SELLAS or its products.

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 GPS clinical development program and the timing for achievement of milestones. 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


FAQ

What is SELLAS Life Sciences Group, Inc. focused on?

SELLAS is a late-stage clinical biopharmaceutical company focused on the development of novel therapies for cancer.

What is galinpepimut-S?

Galinpepimut-S is an HLA-unrestricted heteroclitic peptide vaccine against WT1, an antigen highly expressed in ovarian cancer.

What is the purpose of the Phase 1/2 clinical trial?

The trial investigated the effects of galinpepimut-S plus pembrolizumab in patients with platinum-resistant ovarian cancer.

When will the topline clinical data be presented?

The data will be presented at the 2023 IGCS Annual Global Meeting on November 5, 2023.

Who is the lead author of the study?

The lead author is Roisin E. O’Cearbhaill, M.D., from Memorial Sloan Kettering Cancer Center.

SELLAS Life Sciences Group, Inc.

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About SLS

σellas life sciences is a healthcare-oriented global group of companies with a unique and innovative vision, which is ambitious, yet clear: to practice the medicine of tomorrow, today. in other words, we incorporate innovation throughout all our activities aiming at breakthroughs that will have a significant impact on the thinking and practicing of healthcare worldwide. our international team of acknowledged scientists, doctors and health professionals along with a seasoned and highly experienced pharmaceutical executive management form the core of σellas. we strive to improve patients' quality of life through developing and commercializing cutting-edge drugs, medical devices and innovative therapies.