SELLAS Life Sciences Group, Inc. announced 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). 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.

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).