October 11, 2023

SELLAS Life Sciences Group, Inc. (Nasdaq: SLS) has reported two significant milestones this week as it pursues development of its drug candidate, SLS009 for hematological malignancies.

“SLS009 is a novel and highly selective CDK9 inhibitor which, to date, has shown tremendous therapeutic promise across multiple blood cancers.”

Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS

The company has dosed the first patient in a Phase Ib/II trial evaluating SLS009 (GFH009) in relapsed/refractory Peripheral T-cell Lymphomas (PTCL). SELLAS has also received Orphan Drug Designation (ODD) for SLS009, a novel and highly selective CDK9 inhibitor, for the treatment of acute myeloid leukemia (AML).

Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS, said, “We are pleased with the initiation of the Phase Ib/II trial of SLS009 in the underserved PTCL patient population. We are also honored to receive the ODD from the FDA. This designation underscores the potential of SLS009 to address a significant unmet medical need for patients with AML.”

Highlights – Acute Myeloid Leukemia

SLS009 is a highly selective CDK9 inhibitor that has already demonstrated a favorable safety profile, strong initial efficacy signals, and evidence of anti-tumor activity. It is currently being evaluated in an open-label, single-arm, multi-center Phase 2a study in patients with relapsed or refractory AML. Top-line data are expected by the end of this year.

ODD provides benefits to drug developers including assistance in the drug development process, tax credits for qualified clinical costs, exemptions from certain FDA fees and seven years of marketing exclusivity.

Highlights – Peripheral T-cell Lymphomas

SELLAS’ Phase Ib/II study is an open-label, single-arm trial of up to 95 patients, evaluating safety and efficacy. The study is fully funded by GenFleet and is being conducted in China.

The company stated that collaborating with GenFleet amplifies the potential of its highly selective CDK9 inhibitor in multiple indications and reflects the companies’ joint commitment to delivering this groundbreaking treatment to cancer patients globally.

SELLAS and GenFleet Therapeutics (Shanghai), Inc. have entered into an exclusive license agreement that grants rights to SELLAS for the development and commercialization of SLS009 (GFH009), a highly selective small molecule CDK9 inhibitor, across all therapeutic and diagnostic uses worldwide outside of Greater China (mainland China, Hong Kong, Macau, and Taiwan).

About SELLAS Life Sciences: 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.