Dizal Highlights Its Advances in Hematological Portfolio at 2023 ASH, Featuring Breakthroughs in Lymphoma Treatment

03 Nov 2023
www.biospace.com
Clinical ResultPhase 1Fast TrackPhase 2Priority Review
Oral presentation of global pivotal study of golidocitinib in relapsed or refractory peripheral T-cell lymphoma (r/r PTCL) Release of promising data from DZD8586 for the treatment of B-cell non-Hodgkin lymphoma (B-NHL) SHANGHAI--(BUSINESS WIRE)-- Dizal today announced that it will have four presentations from its hematological oncology pipeline, including golidocitinib and DZD8586, at the 65th American Society of Hematology Annual Meeting and Exposition (2023 ASH, San Diego). Its global multicenter pivotal study of golidocitinib (JACKPOT8 PARTB) has been selected for oral presentation. Golidocitinib Golidocitinib is the first and only Janus kinase 1 (JAK1) selective inhibitor in the NDA stage for the treatment of r/r PTCL. Dizal will release the latest results from two clinical studies: the full analysis of the multinational pivotal study of golidocitinib (JACKPOT8 PARTB) in r/r PTCL and a phase 2 study evaluating golidocitinib as a maintenance therapy in patients with PTCL after first-line systemic therapy (JACKPOT26). Golidocitinib monotherapy demonstrated superior efficacy and safety pro the full analysis of the JACKPOT8 PARTB study, which was consistent with the preliminary findings presented at 2023 ASCO. An IRC-assessed overall response rate (ORR) was 44.3%, nearly double the existing treatment options. The response was durable. The final data for duration of response (DOR), progression-free survival (PFS), as well as overall survival (OS) will be reported at the meeting. Approximately 40% of patients with complete response and 80% of patients with partial response have disease relapse within 2 years following first-line standard therapy, and the prognosis of relapsed patients was typically poor. According to the results of phase 2 study of golidocitinib as maintenance therapy in patients with PTCL after first-line systemic therapy (JACKPOT26), golidocitinib showed manageable safety pro promising efficacy in maintaining and enhancing tumor response in patients with PTCL post first-line therapies. DZD8586 DZD8586 is a rationally designed, oral, non-covalent, LYN and BTK dual inhibitor with excellent blood-brain barrier (BBB) penetration. Dizal will report its preclinical data as well as the ongoing clinical study results in B-NHL. While Bruton's Tyrosine Kinase (BTK) inhibitorsBruton's Tyrosine Kinase (BTK) inhibitors have been approved for the treatment of B-NHL, resistance can emerge due to various mechanisms, including acquired mutations at residue C481 of BTK and non BTK-driven mutations. Currently, there is no targeted therapy available to address both resistance mechanisms, highlighting an urgent need for a safe and effective treatment option for patients with r/r B-NHL. Preclinical studies have shown that DZD8586 can overcome resistance mutations observed with approved covalent and non-covalent BTK inhibitorsBTK inhibitors. DZD8586 has exhibited potent inhibition of cell growth by blocking both BTK-dependent and BTK-independent signaling pathways. Key highlights of DZD8586 are as follows: Potent inhibition of LYN and BTK, with good selectivity against other kinases. Significant inhibitory effects on mutations at residue C481 of BTK, as well as BTK mutations associated with resistance to Pirtobrutinib (LOXO-305). Potent cell growth inhibition observed in diffuse large B-cell lymphoma (DLBCL) cell lines. Excellent BBB penetration, as evidenced by a CSF-to-plasma concentration ratio (Kpuu,CSF) greater than 1 in animal models, suggesting potential effectiveness in humans. Currently, DZD8586 is conducting two global phase 1 studies (TAI-SHAN1 and TAI-SHAN5) for the treatment of r/r B-NHL. The preliminary results of the studies have shown encouraging pharmacokinetic (PK) properties, safety pro antitumor efficacy. The pooled analysis results from these two studies will be presented for the first time at 2023 ASH. Dizal’s Presentation at 2023 ASH Lead Author Abstract Title Presentation Details Prof. Yuqin Song Golidocitinib in Treating Refractory or Relapsed Peripheral T- Cell Lymphoma: Full Analysis of the Multinational Pivotal Study Results (JACKPOT8) Abstract #305 Session Type: Oral Oral Abstract Session Date and Time: December 9, 2023, 5 PM PST Location: Hall B Prof. Jie Jin Phase 2 Study of Golidocitinib, a JAK1 Selective Inhibitor, As Maintenance Therapy in Patients with Peripheral T Cell Lymphomas after First-Line Systemic Therapy (JACKPOT26) Abstract #4430 Poster Session Date and Time: December 11, 2023, 6 PM – 8 PM PST Location: Hall G-H Dr. Yu Bai Preclinical Study of DZD8586, a Non-Covalent LYN/BTK Dual Inhibitor with Excellent BBB Penetration, for the Treatment of B-Cell Non-Hodgkin Lymphoma (B-NHL) Abstract #2822 Poster Session Date and Time: December 10, 2023, 6 PM – 8 PM PST Location: Hall G-H Prof. Yuqin Song First Report of Phase 1 Studies of DZD8586, a BBB Penetrant LYN/BTK Dual Inhibitor, in Patients with B-Cell Non-Hodgkin Lymphoma (B-NHL) Abstract #4465 Poster Session Date and Time: December 11, 2023, 6 PM – 8 PM PST Location: Hall G-H About golidocitinib (DZD4205) Golidocitinib is the first-in-class Janus kinase 1 (JAK1) only inhibitor currently being evaluated in a global, multicenter pivotal study (JACKPOT8 PARTB) in r/r PTCL. At the data cut-off date of February 16, 2023, Golidocitinib has demonstrated robust and durable anti-tumor activity, with an ORR of 44.3%. More than 50% of the patients with tumor remission achieved a complete response. The median relative dose intensity was 100%. Golidocitinib was granted Fast Track Designation by the U.S. FDA for the treatment of r/r PTCL in February 2022. In September 2023, the CDE accepted the NDA and granted the Priority Review status for the treatment of r/r PTCL. And the Phase I clinical data of golidocitinib for the treatment of r/r PTCL (JACKPOT8 PARTA) was published in Annals of Oncology (Impact Factor: 51.8). About DZD8586 DZD8586 is an orally available, highly selective small molecule inhibitor to target both BTK-dependent and BTK-independent B-cell receptor (BCR) signaling pathways, with full blood-brain barrier penetration. Pre-clinical research revealed that DZD8586 demonstrated good safety pro could effectively inhibit the growth of B-NHL cells. A healthy volunteer study of DZD8586 has been conducted to investigate the clinical safety and PK/PD correlation. Additionally, a global phase I/II study is ongoing to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor efficacy of DZD8586 in patients with r/r B-NHL. Preliminary results from the clinical trial suggest that DZD8586 exhibits favorable PK properties, good safety profile, and preliminary anti-tumor activity in patients with B-NHL. About Dizal Dizal is a biopharmaceutical company, dedicated to the discovery, development and commercialization of differentiated therapeutics for the treatment of cancer and immunological diseases. The company aims to develop first-in-class and groundbreaking new medicines, and further address unmet medical needs around the world. Deep-rooted in translational science and molecular design, it has established an internationally competitive portfolio of five clinical-stage assets with two leading assets in global pivotal studies and one already launched. To learn more about Dizal, please visit , or follow us at Linkedin or Twitter. Forward-Looking Statements This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words “anticipate”, “believe”, “estimate”, “expect”, and “intend” and similar expressions, as they relate to Dizal, are intended to identify certain forward-looking statements. Dizal does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections, and understandings of the management of Dizal with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties, and other factors, some of which are beyond Dizal’s control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Dizal’s competitive environment, and political, economic, legal, and social conditions. Dizal, the Directors, and the employees of Dizal assume (a) no obligation to correct or update the forward-looking statements contained on this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turnout to be incorrect. View source version on businesswire.com: Contacts Investor Relations: ir@dizalpharma.com Business Development: bd@dizalpharma.com Source: Dizal View this news release online at:
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