【2024 ASH】HealZen Therapeutics Presents Multiple Clinical Data on CK1ε&PI3Kδ Inhibitor HZ-H08905 at the 2024 American Society of Hematology (ASH) Annual Meeting
TIME:
Dec 10,2024
The 66th American Society of Hematology (ASH) Annual Meeting took place from December 7th to 10th, 2024, in San Diego. HealZen Therapeutics' independently developed dual-target inhibitor of CK1ε&PI3Kδ, HZ-H08905, a novel, highly selective, and potent inhibitor, is currently undergoing a multicenter Phase III registration clinical trial in China. The latest clinical research data were presented and exchanged in the form of posters, covering the fields of B-cell lymphoma and T/NK-cell lymphoma, with the full abstracts available on the ASH official website.

Publication Number: 3057
Abstract Title:Preliminary Efficacy and Safety of the CK1ε/PI3Kδ Dual Inhibitor HZ-H08905 in Patients with Relapsed and/or Refractory Peripheral T-Cell Lymphomas: Results from the Phase 1 HZ-H08905-101 Study
Category:625. T Cell, NK Cell, or NK/T Cell Lymphomas: Clinical and Epidemiological: Poster II
Time:6:00 PM-8:00 PM, Sunday, December 8, 2024
Contents:
This study enrolled 50 patients with relapsed/refractory (R/R) peripheral T-cell lymphoma (PTCL), with doses ranging from 100mg to 450mg QD, without any dose-limiting toxicity (DLT) events or reaching the maximum tolerated dose (MTD). As of June 28, 2024, with a median follow-up of 13 months, the objective response rate (ORR) and complete response rate (CRR) for PTCL subjects were 64.0% and 30.0%, respectively. At the recommended dose of 200mg, the ORR for angioimmunoblastic T-cell lymphoma (AITL) and PTCL-not otherwise specified (PTCL-NOS) patients were 68.8% and 66.7%, respectively, with CRR of 31.3% and 33.3%, respectively. For AITL and PTCL-NOS patients previously untreated with chidamide, the CRR were 60.0% and 80.0%, respectively. The study indicates that HZ-H08905 monotherapy exhibits good tolerability and outstanding efficacy in treating R/R PTCL patients.

Publication Number: 3015
Abstract Title:Preliminary Efficacy and Safety of the CK1ε/PI3Kδ Dual Inhibitor HZ-H08905 in Patients with Relapsed and/or Refractory B-Cell Lymphomas: Results from the Phase 1 HZ-H08905-101 Study
Category:623. Mantle Cell, Follicular, Waldenstrom’s, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster II
Time:6:00 PM-8:00 PM, Sunday, December 8, 2024
Content:
This study enrolled 24 patients with relapsed/refractory (R/R) B-cell lymphoma (BCM), with doses ranging from 50mg to 300mg QD, without any dose-limiting toxicity (DLT) events or reaching the maximum tolerated dose (MTD). As of June 28, 2024, with a median follow-up of 8.3 months, the objective response rate (ORR) and complete response rate (CRR) for BCM patients were 70.8% and 33.3%, respectively. Among the 12 subjects with follicular lymphoma (FL), the ORR and CRR were 93.3% and 50%, respectively. The study suggests that HZ-H08905 monotherapy shows good tolerability and outstanding efficacy in treating R/R BCM patients.
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The innovative drug HZ-H08905 tablets of Hangzhou HealZen Therapeutics Co., Ltd has been approved for a pivotal Phase III clinical trial for the treatment of recurrent or refractory peripheral T-cell lymphoma
Hangzhou HealZen Therapeutics Co., Ltd recently announced that its independently developed Class 1 innovative drug, HZ-H08905 (CK1ε&PI3Kδ dual-target inhibitor), has been officially approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA), China, to conduct a pivotal registration Phase III clinical trial for the treatment of recurrent or refractory peripheral T-cell lymphoma (R/R PTCL).
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