China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) provided updates on the clinical development of its drug candidates, DZD8586 and the JAK1 inhibitor golidocitinib (DZD4205), at the 65th American Society of Hematology (ASH) annual meeting. The event showcased the latest findings from the company’s research and development efforts in the field of hematology.
Clinical Development of Golidocitinib (DZD4205)
The Part B of the international, multi-center regulatory JACKPOT8 study for DZD4205 in recurrent or refractory (r/r) peripheral T-cell lymphoma (PTCL) reached its primary endpoint, demonstrating a 44.3% objective response rate (ORR) and a favorable safety and tolerability profile. Additionally, a Phase II study for the drug as maintenance therapy for first-line systematic follow-up of PTCL patients indicated that golidocitinib was safe and effective as a maintenance/consolidation treatment after the first remission upon first-line induction therapy in PTCL patients.
Pre-Clinical and Clinical Studies of DZD8586
DZD8586, a non-covalent LYN/BTK inhibitor capable of completely penetrating the blood-brain barrier, saw the results of one pre-clinical study and two clinical studies published at the ASH meeting. Preclinical studies showed that DZD8586 strongly inhibited LYN and BTK targets with good selectivity, exhibiting significant inhibitory effects on both C481S mutations and Pirtobrutinib (LOXO-305) resistant BTK mutations, and effectively inhibiting the proliferation of diffuse large B-cell lymphoma (DLBCL) cells. In animal models, the Kpuu and CSF (ratio of free drug concentration in cerebrospinal fluid to plasma) of DZD8586 were greater than 1, confirming its ability to fully penetrate the blood-brain barrier. Two Phase I clinical trials (TAISHAN1 and TAI-SHAN5) for the drug targeting r/r B-NHL globally are underway, with preliminary results suggesting that DZD8586 has good pharmacokinetic (PK) characteristics, safety, and anti-tumor activity.-Fineline Info & Tech
