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 --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,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

Lead Author

Abstract Title

Presentation details

Prof. Pasi A. Janne

Antitumor activity of

sunvozertinib in NSCLC

patients with EGFR Exon20

insertion mutations after

platinum and anti-PD(L)1

treatment failures

Abstract #9015

Poster Discussion Session

Lung Cancer—Non-Small Cell

Metastatic | Hall D1

Session Date and Time: June 6,

2022,13:00 CDT

Poster Session

Lung Cancer—Non-Small Cell

Metastatic | Hall A

Session Date and Time: June 6,08:00 CDT

Prof. Won Seog

Kim

A phase I/II study of

golidocitnib,a selective JAK1

inhibitor,in refractory or

relapsed peripheral T-cell

lymphoma

Abstract #7563

Poster Session

Hematologic Malignancies –

Lymphoma and Chronic

Lymphocytic Leukemia | Hall A

Session Date and Time: June 4,08:00 CDT

Prof. Xichun Hu

Early clinical safety and

pharmacokinetics data

of DZD1516,an BBB-penetrant

selective HER2 inhibitor for the

treatment of HER2-positive

metastatic breast cancer

Abstract #1038

Poster Session

Breast Cancer—Metastatic | Hall A

Session Date and Time:

Monday,June 6,2022,08:00 CDT

Ziyi Liu PhD

Clinical pharmacokinetic /

pharmacodynamic relationship

of DZD2269,a potent and

selective A2aR antagonist

designed to overcome high

levels of adenosine induced

immunosuppression

Abstract #e15106

Online publication

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.

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Contacts

Investor Relations:ir@dizalpharma.com

Business Development:bd@dizalpharma.com

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