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Lymphoma and Leukaemia Treatment GFH009 Receives FDA Fast Track and Orphan Drug Designations

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The highly selective CDK9 inhibitor GFH009 has been granted fast track and orphan drug designations for adult patients with relapsed/refractory (r/r) peripheral T-cell lymphomas (PTCL) and acute myeloid leukaemia (AML). Currently, two Phase II studies are underway in China and the US, focusing on r/r PTCL and r/r AML, respectively.

Previous research phases have demonstrated the safety and efficacy of GFH009, with several subjects in the studies achieving complete or partial responses. GenFleet, the company behind the drug, is conducting a multi-center, open-label, single-arm study of the therapy for r/r PTCL treatment across approximately 40 sites in China.

This study has advanced to Phase II following a successful Phase Ib safety confirmation. Early data from the Phase I dose escalation revealed significant reductions in proto-oncogene expression. Clinical responses were observed in four PTCL patients, with one patient undergoing treatment for over 66 weeks.

Advancing Lymphoma and Leukaemia Treatment with Promising Clinical Outcomes

In the US, GenFleet’s partner, Sellas Life Sciences, is conducting a Phase II trial of SLS009 in combination with venetoclax and azacitidine for r/r AML patients. The first patient achieved a complete response without any dose-limiting toxicities, and a significant number of subjects experienced a substantial decrease in bone marrow blasts.

GenFleet’s chief medical officer, Yu Wang, expressed satisfaction with the progress of their projects. He noted the significance of GFH009 receiving FDA fast-track and orphan drug designations for two indications. He also acknowledged the challenges and opportunities that come with the company’s forward-thinking pipeline strategy.

Lymphoma and Leukaemia

Advancements in Pipeline and Potential for Disease Treatment Transformation

Wang expressed his appreciation for the recognition of supervisory bodies and the collaborative efforts of business partners in both China and the US. Looking ahead, he said that the company is eagerly anticipating more registrational advancements in its pipeline in the coming year.

The development and testing of GFH009 has shown promising results for the treatment of PTCL and AML, with significant reductions in proto-oncogene expression and a substantial decrease in bone marrow blasts in some patients. The drug’s fast track and orphan drug designations highlight the potential it has to change the treatment landscape for these diseases.

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