DZD4205 (Golidocitinib) is a selective JAK1 inhibitor in relapsed/refractory peripheral T-Cell lymphoma.
The orally available, JAK1-specific inhibitor has showed that 21 (42.9%) out of the 49 patients have achieved tumour response, according to the initial data from an ongoing Phase I/II study conducted in r/r PTCL patients.
The company is conducting the Phase II pivotal clinical studies in Australia, South Korea, China, the US as well as other countries and regions.
Dizal Pharmaceutical CEO Dr. Xiaolin Zhang said: “Relapsed or refractory peripheral T-cell lymphoma is an aggressive and rare type of non-Hodgkin lymphoma.
“Patients with r/r PTCL are often associated with poor prognosis. Couple years ago, our translational science team first identified JAK1 as a potential target for PTCL treatment. Based on the finding, we launched clinical studies to test the hypothesis.
“The FDA Fast Track Designation for DZD4205 is an important milestone and we look forward to working closely with the U.S. FDA to potentially bring this treatment to our patients.”
Last month, the company secured breakthrough therapy designation from the US FDA for its DZD9008 (Sunvozertinib) to treat locally advanced or metastatic non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) exon20 insertion mutations.
The drug is a rationally designed irreversible, selective, new EGFR inhibitor, which showed antitumor efficacy in pre-treated NSCLC patients with EGFR exon20 insertion mutations, in global Phase I/II studies.