Chinese biotechnology company GenFleet Therapeutics has received the US Food and Drug Administration (FDA) designations for its drug candidate SLS009 (GFH009).
The fast track and orphan drug designations have been awarded for GFH009 (highly selective CDK9 inhibitor) to treat adult patients with relapsed/refractory (r/r) peripheral T-cell lymphomas (PTCL) and r/r acute myeloid leukaemia (AML).
Currently, two Phase II studies are in progress in China and the US, targeting r/r PTCL and r/r AML, respectively.
Several subjects within the studies achieved complete or partial responses and safety and efficacy of GFH009 have been highlighted in previous research phases.
In China, GenFleet is conducting a multi-centre, open-label, single-arm study of the therapy for r/r PTCL treatment at nearly 40 sites.
This study is progressing into Phase II after a successful Phase Ib safety confirmation.
Early data from the Phase I dose escalation showed significant reductions in proto-oncogene expression and clinical responses were reported in four PTCL patients, with one patient receiving treatment for over 66 weeks.
In the US, GenFleet’s partner, Sellas Life Sciences, is undertaking 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 chief medical officer Yu Wang said: “Leading projects in GenFleet’s pipeline made significant strides in registrational efforts over the past year. GFH925 was granted with NDA acceptance, priority review and two breakthrough therapy designations in China; GFH009 received FDA fast track and orphan drug designations for two indications.
“The forward-thinking strategy in GenFleet’s pipeline buildup brings immense challenge as well as opportunities for our innovation. We appreciate recognition of supervisory bodies and collaborative efforts of business partners both in China and the US. As we step into new year, we are looking forward to more registrational advancements of our pipeline.”