On October 11, 2023 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, reported that its partner GenFleet Therapeutics (Shanghai), Inc. has dosed the first patient in a Phase Ib/II trial evaluating SLS009 (GFH009) in relapsed/refractory Peripheral T-cell Lymphomas (PTCL) (Press release, Sellas Life Sciences, OCT 11, 2023, View Source [SID1234635858]). The open-label, single-arm trial will enroll up to 95 patients to evaluate safety and efficacy and, based on the results, may serve as a registrational study. This initial PTCL study is fully funded by GenFleet and is being conducted in China.
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"SLS009 is a novel and highly selective CDK9 inhibitor which, to date, has shown tremendous therapeutic promise across multiple blood cancers," said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. "We are pleased with the initiation of the Phase Ib/II trial of SLS009 in the underserved PTCL patient population. Collaborating with GenFleet amplifies the potential of our highly selective CDK9 inhibitor in multiple indications and reflects our joint commitment to delivering this groundbreaking treatment to cancer patients globally. While our primary efforts are focused on acute myeloid leukemia (AML) in the United States, we remain fully supportive and deeply involved in the PTCL study and will make further development decisions for this indication as we obtain initial data for this Phase Ib/II study from our partner."
SLS009 demonstrated favorable safety/tolerability and promising clinical efficacy in the recently completed dose-escalation portion of the Phase I trial in relapsed/refractory hematological malignancies. Complete or partial responses were observed in AML and lymphoma patients among which four PTCL patients (36.4%) achieved clinical responses.
In March 2022, SELLAS and GenFleet Therapeutics (Shanghai), Inc. 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).