SELLAS Advances Blood Cancer Treatment with “Tremendous Therapeutic Promise”

SELLAS Life Sciences Group, Inc. (Nasdaq: SLS) has reported two significant milestones this week as it pursues development of its drug candidate, SLS009, a novel and highly selective CDK9 inhibitor,  for hematological malignancies.

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 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

Data for SLS009, a highly selective CDK9 inhibitor, 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 can provide certain 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 Therapeutics (Shanghai), Inc 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 potential groundbreaking treatment to cancer patients globally.

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SELLAS Advances Blood Cancer Treatment with “Tremendous Therapeutic Promise”

Catie Corcoran

Biotech Editor