Dizal to Demonstrate the Strength and Rapid Acceleration of its Clinical Portfolio at ASCO 2022

Sunvozertinib (DZD9008) shows superior efficacy in NSCLC patients harboring EGFR exon 20 insertion mutations after platinum and anti-PD(L)1 treatment failures

Golidocitinib (DZD4205) demonstrates enormous potential for peripheral T-cell lymphoma

DZD1516 exemplifies full BBB-penetration in patients with HER2 positive metastatic breast cancer

Further data will highlight the clinical pharmacokinetic/pharmacodynamic relationship of DZD2269, a potent and selective A2aR antagonist designed to overcome high levels of adenosine induced immunosuppression

SHANGHAI, May 27, 2022 /PRNewswire/ -- Dizal will present clinical results and updates from its four therapeutic candidates in solid tumors and hematologic malignancies at the 2022 Annual Meeting of the American Society of Cancer Oncology (ASCO) being held on June 3-7, 2022. New data from Dizal's investigational cancer medicines demonstrate the rapid progression of its oncology pipeline.

Clinical portfolio to be presented include:

• Sunvozertinib (DZD9008), which was granted Breakthrough Therapy Designation by US FDA and China CDE, is a rationally designed, oral, potent EGFR Ex20ins inhibitor, with wild-type EGFR selectivity. Results from the Phase 1/2 trial of sunvozertinib, which is evaluating the efficacy and safety of sunvozertinib in previously treated NSCLC patients with EGFR Ex20ins, showed sunvozertinib yielded a best ORR of 48.4% and DCR of 90.3%. It also demonstrates superior efficacy in patients after platinum and anti-PD(L)1 treatment failures, indicating sunvozertinib has the potential to provide the patient with a new and much improved targeted therapy.
• Golidocitinib (DZD4205), which was granted Fast Track Designation by US FDA, is an oral, potent, JAK1 specific inhibitor. Results from the Phase 1/2 trial, which is evaluating the efficacy and safety of golidocitinib in patients with r/r PTCL, showed golidocitinib yielded an ORR of 42.9% and longest DoR of > 14 months. This data was also accepted as an encore presentation at EHA 2022 and will be presented orally.
• DZD1516 is an oral, potent, reversible HER2-specific TKI with full blood-brain barrier (BBB) penetration. Results from the Phase 1 trial, which is evaluating the safety and tolerability of DZD1516 in patients with metastatic HER2 positive breast cancer, showed DZD1516 was well tolerated at doses < 300mg, BID. And no EGFR-related AEs have been reported, which is consistent with its high selectivity. In patients, Kpuu, _CSF of DZD1516 and its metabolite DZ2678 was around 2.13 and 0.66, respectively, suggesting good CNS penetration.
• DZD2269 is a potent and selective A2aR antagonist designed to overcome high levels of adenosine induced immunosuppression. Results from the Phase 1 healthy volunteer trial, which is evaluating the safety, PK, and effect on biomarkers, showed DZD2269 was safe and well tolerated from 5 mg to 160 mg, with no ≥ grade 3 TEAE or SAE reported. Approximately 90% pCREB inhibition could be achieved by a single dose of 80mg for 24 hours, indicating that DZD2269 could effectively reverse high adenosine induced immunosuppression.

"We are thrilled to have such a robust presence at this year's ASCO. These data presentations reflect the quality of our science and our important work to deliver innovative therapies for hard-to-treat diseases." said Dr. Xiaolin Zhang, CEO of Dizal, "Building on our extensive expertise in translational science and blood brain barrier research, we have established an internationally competitive portfolio of five clinical-stage assets with two leading assets at global pivotal studies."

Dizal's Presentations at ASCO 2022

About Dizal

Dizal Pharmaceutical is a clinical stage, biopharmaceutical company. At Dizal we aspire to discover and develop differentiated therapeutics for the treatment of cancer and immunological diseases. Building on our extensive expertise in translational science and molecular design, we have established an internationally competitive portfolio with two leading assets at 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", "intend" and similar expressions, as they relate to Dizal, are intended to identify certain of such 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 in 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]

SOURCE Dizal Pharmaceutical

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