Dizal Announces New Data from the Phase I/II Study of Golidocitnib in Refractory or Relapsed Peripheral T Cell Lymphoma Selected for Oral Presentation at 2022 EHA Annual Meeting

SHANGHAI, May 13, 2022 /PRNewswire/ -- Dizal (SSE: 688192) will present the data from an ongoing phase I/II study of golidocitnib, a selective JAK1 inhibitor, in refractory or relapsed peripheral T cell lymphoma (r/r PTCL) in oral session at the 27^th European Hematology Association 2022 (EHA2022) Hybrid Congress in Vienna, Austria, 12 June 2022.

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 first 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.

Key data (cutoff date: 31 May 2021) to be presented at EHA2022 include:

• 49 patients completed at least one post-treatment Lugano assessment, of whom 21 have achieved tumor response.
• The median duration of treatment (DoR) was not reached, and the longest DoR was >14months.
• 20 patients (39.2%) experienced grade 3 treatment emergence adverse events (TEAEs) possibly related to the drug. The majority of TEAEs were reversible or clinically manageable with dose modification.

The clinical data from the ongoing phase I/II study of golidocitnib shows good safety and promising anti-tumor efficacy in patients with r/r PTCL, providing an exciting potential treatment option for these patients. Golidocitnib received FDA Fast Track Designation for the treatment of r/r PTCL in February 2022.

Earlier results of this study were first presented on 22 June 2021 during an oral session at the 2021 International Conference on Malignant Lymphoma (ICML) Annual Meeting.

"We are thrilled to share the updated results from the phase I/II study of golidocitnib in patients with r/r PTCL at 2022EHA." said Dr. Xiaolin Zhang, Chief Executive Officer of Dizal. "This, along with FDA's recent decision to grant Fast Track designation, strengthens our belief that golidocitnib has enormous potential for PTCL patients."

Details of the oral presentations are as follows:

Title: A phase I/II study of golidocitinib, a selective JAK1 inhibitor, in refractory or relapsed peripheral T cell lymphoma
Session Title: Aggressive Lymphoma – Novel agents
Session date and time: Sunday, June 12 11:30 – 12:45 (CEST)
Session room: Hall C1
Final Abstract Code: S218
Presenting Author: Won-Seog Kim, Samsung Medical Center

About Dizal

Dizal is a clinical-stage, biopharmaceutical company, dedicated to 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.

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SOURCE Dizal Pharmaceutical