Dizal Announces Clinical Data of Golidocitinib Presented at the 2022 ASH Annual Meeting

New Orleans, December 12, 2022—Dizal today announces new analysis on the Phase I/II JACKPOT8 trial of golidocitinib for the treatment of relapsed/refractory Peripheral T-cell Lymphoma (r/r PTCL) presented at the 64th American Society of Hematology (2022 ASH) Annual Meeting and Exposition. As of May 31, 2021, a total of 51 patients with r/r PTCL (21 PTCL-NOS, 20 AITL, 4 ALCL-, 4 NKTCL, 2 MEITL) were enrolled to receive golidocitinib at 150 mg (n = 35) or 250 mg (n = 16). Efficacy analyses were performed on the 49 patients who completed at least one post treatment investigator-based efficacy assessment. And the key findings are as follows: 21 achieved tumor response (ORR: 42.9%), including 11 complete responses (CR rate: 22.4%). Tumor responses were observed in AITL, PTCL-NOS, ALK- ALCL and NKTCL subtypes. Among 14 patients who received HDAC inhibitors in the prior anti-lymphoma regimens, 6 of them achieved tumor remission on golidocitinib (ORR: 42.9%). One patient who underwent an EZH2 inhibitor in the prior anti-lymphoma regimens achieved CR on golidocitinib. For the safety profile, the most common (≥10%) ≥ grade 3 TEAEs (treatment-emergent adverse events) were neutropenia (29.4%), thrombocytopenia (15.7%) and pneumonia (11.8%). Most TEAEs were reversible or clinically manageable with dose modifications. Based on the pSTAT3 IHC analysis of 20 patients’ tumor samples, a trend of correlation between clinical response and high pSTAT3 expression was observed. This exemplifies that golidocitinib could be an effective treatment for T-cell malignancies by inhibiting JAK-STAT Pathway. PTCL is a heterogeneous group of clinically aggressive diseases associated with poor outcome. Currently there is no consensus on the standard treatment for r/r PTCL. Patients with PTCL face an extremely high risk of disease relapse even if they achieved tumor remission following 1L conventional therapy. And the response rates to commonly used 2L agents are below 30%. Hence, there is an urgent unmet need for patients diagnosed with r/r PTCL. A couple of years ago, Dizal firstly identified that JAK/STAT may mediate the pathogenesis of PTCL and launched clinical studies to test the hypothesis. Golidocitnib is an orally available, potent JAK1 inhibitor with >200 – 400-fold selectivity over other JAK family members. The agent is currently being studied in the global pivotal clinical trial for the treatment of r/r PTCL.   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.   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 turn out to be incorrect.   Contacts Investor Relations: [email protected] Business Development: [email protected]

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