Dizal to Showcase its Hematological Oncology Pipeline at the 2023 ICML

Golidocitinib Peripheral T-cell lymphoma (PTCL), a malignant subtype of non-Hodgkin lymphoma, remains an area with unmet medical needs given the lack of safe and effective treatment options. While anthracycline-based combination chemotherapy is the current standard of care for newly diagnosed PTCL patients, the response rates are suboptimal and relapse rates are high. Furthermore, patients with relapsed or refractory (r/r) PTCL face a particularly poor prognosis, with a 5-year survival rate of less than 30%. Golidocitinib is a first-in-class JAK1 only inhibitor currently being evaluated in a multinational, pivotal study in r/r PTCL (JACKPOT8). Golidocitinib demonstrated potent and durable anti-tumor efficacy, showing its potential as a new therapy for treating the disease.  The preliminary analysis results will be presented as an oral presentation at the coming 2023 ICML. It was selected as an oral presentation at the just-concluded 2023 ASCO conference. Abstract#43: Golidocitinib in Treating Refractory or Relapsed Peripheral T-Cell Lymphoma: Primary Analysis of the Multinational Pivotal Study Results (JACKPOT8) Golidocitinib demonstrated potent and durable anti-tumor efficacy in patients with PTCL In the efficacy analysis set of 88 patients, the objective response rate (ORR) was 44.3% (39/88) including 21 complete responses (CRR, 23.9%) assessed by independent review committee (IRC). Anti-tumor efficacy was observed across different PTCL subtypes. The mDoR has not been reached. The longest DoR was 16.8 months, and patients are still responding. In the safety analysis set of 116 patients, golidocitinib demonstrated a benign safety profile. Most treatment-related adverse events (TRAEs) were hematological in nature and amenable to monitoring and management in the clinical setting. The median relative dose intensity was 100%, and the longest treatment duration was 18 months.   DZD8586 Non-Hodgkin lymphoma (NHL) is the most common subtype of lymphoma, representing up to 90% of lymphoma cases, with B-cell NHL accounting for approximately 85% of NHL cases. Bruton's tyrosine kinase (BTK) inhibitors have transformed the treatment of multiple B-cell malignancies. However, resistance can arise through multiple mechanisms, including acquired mutations in BTK at residue C481 and non BTK-driven mutations. There is currently no targeted therapy available capable of addressing both resistance mechanisms, highlighting an urgent need for the development of a safe and effective treatment option for patients with relapsed or refractory B-cell non-Hodgkin lymphoma (r/r B-NHL). DZD8586 is a rationally designed, 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. A study of DZD8586 in healthy volunteer has been completed in the US to investigate safety, tolerability, and pharmacokinetics. Additionally, a global phase I/II study is currently underway to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor efficacy of DZD8586 in patients with r/r B-NHL. The trial includes patients with various subtypes of r/r B-NHL who have failed systemic therapy, including chronic lymphocytic leukemia (CLL) previously treated with BTK inhibitors, central nervous system lymphoma (CNSL), follicular lymphoma (FL), marginal zone lymphoma (MZL), and diffuse large B-cell lymphoma (DLBCL). Abstract #655: Treatment of B-cell malignancies with DZD8586 through overcoming both BTK-dependent and BTK-independent resistance DZD8586 showed promising preliminary anti-tumor efficacy and a benign safety profile in r/r B-NHL patients, indicating its great potential for overcoming BTK resistance DZD8586 exhibited equal potencies against wildtype and C481S mutant BTKs, as well as BTK mutations resistant to pirtobrutinib.   Similar PK characteristics were observed between patients and healthy subjects Safety profile was good, and no patients experienced ≥ grade 3 treatment-related adverse events (TRAEs)   About Golidocitinib (DZD4205) Golidocitinib is the first-in-class Janus kinase 1 (JAK1) only inhibitor currently being evaluated in a global, multicenter pivotal study in r/r PTCL. At the data cut-off date of February 16, 2023, Golidocitinib has demonstrated strong and durable anti-tumor activity, with an ORR of 44.3%. Over 50% of the patients with tumor remission achieved complete response. The longest duration of response (DoR) exceeded 16 months. Golidocitinib was granted Fast Track Designation for the treatment of r/r PTCL by US FDA in February 2022.   About DZD8586 DZD8586 is an in-house developed, 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 profile and 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 characteristics, good safety profile, and preliminary anti-tumor activity in patients with B-NHL.   About Dizal Dizal is a clinical-stage, biopharmaceutical company, dedicated to the discovery and development of differentiated therapeutics for the treatment of cancer and immunological diseases. 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. To learn more about Dizal, please visit www.dizalpharma.com, 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.   Contacts Investor Relations: [email protected] Business Development: [email protected]

The release as fetched from its publisher. dizalpharma.com ↗