Dizal Announces Pre-clinical and Clinical Results of Sunvozertinib (DZD9008) Published in Cancer Discovery

SHANGHAI, May 5, 2022 /PRNewswire/ -- Dizal Pharmaceutical Co., Ltd ("Dizal", SHEX: 688192) today announced the publication of the pre-clinical and early clinical data of sunvozertinib (DZD9008) for the treatment of non-small cell lung cancer with EGFR exon 20 insertion mutations in Cancer Discovery.

Due to the unique structural features of EGFR exon20ins proteins, most approved EGFR TKIs are not active against them. Sunvozertinib (DZD9008) was designed with the goal to address the limitations of existing therapies. It is an irreversible inhibitor targeting EGFR exon20ins as well as EGFR sensitizing, T790M and uncommon mutations while maintaining selectivity against wild-type EGFR. Sunvozertinib shows potent antitumor activity against EGFR exon20ins mutations at the enzymatic and cellular levels, and in patient-derived xenograft and transgenic animal models. These findings support the ongoing clinical development of sunvozertinib for the treatment of EGFR exon20ins NSCLC. Commenting on the findings, Prof. Pasi Jänne of Dana-Farber Cancer Institute and Harvard Medical School, a lead investigator of the study and the corresponding author of the paper, said "sunvozertinib was well tolerated in the study. Antitumor efficacy was observed at the doses of 100 mg and above in patients with EGFR exon20ins NSCLC across different subtypes, with prior amivantamab treatment as well as with baseline brain metastasis. Its best ORR was 48.4%." Based on the data, sunvozertinib has been granted Breakthrough Therapy Designation by US FDA and China CDE.

"This is yet another milestone achievement for the team. Like Breakthrough Therapy Designation from US and China, it reflects the quality of Dizal's science. The data published further demonstrated sunvozertinib's enormous potential for bringing meaningful benefits to lung cancer patients." said Dr. Xiaolin Zhang, CEO of Dizal. "At Dizal, we strive to bring differentiated therapies to treat devastating diseases. We have now established an internationally competitive portfolio with two leading assets in the global pivotal studies."

Paper Details:

• Journal: Cancer Discovery
• Title: Sunvozertinib, a selective EGFR inhibitor for previously treated non-small cell lung cancer with EGFR exon 20 insertion mutations
• Corresponding Author: Prof. Pasi A. Jänne, Dana-Farber Cancer Institute of Harvard Medical School.
• Joint Primary Authors: Prof. Mengzhao Wang, Chinese Academy of Medical Sciences & Peking Union Medical College and Prof. James Chih-Hsin Yang, Graduate Institute of Oncology of National Taiwan University

About Cancer Discovery

Cancer Discovery, a journal of the American Association for Cancer Research (AACR), publishes high-impact, peer-reviewed articles describing major advances in research and clinical trials ^[1]. As the premier cancer information resource, the Journal presents articles from the world-class universities and top-notch oncology research institutions.

About EGFR Exon20ins NSCLC

Lung cancer is the leading cause of cancer death in the world. It is classified broadly as non-small cell lung cancer (NSCLC), accounting for 85% lung cancer cases, and small cell lung cancer (SCLC). EGFR mutation is common in NSCLC. About 4–12% of all EGFR mutations are insertions at exon 20 (EGFR exon20ins) ^[2]. Patients with EGFR exon20ins generally don't respond to the currently available EGFR TKIs.

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.

Forward-Looking Statements

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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.

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Source

^[1] Cancer Discovery by American Association for Cancer Research (AACR). https://aacrjournals.org/cancerdiscovery.
^[2] Riess JW, Gandara DR, Frampton GM, et al. Diverse EGFR exon 20 insertions and co-occurring molecular alterations identified by comprehensive genomic profiling of NSCLC. J Thorac Oncol. 2018;13(10):1560–1568. doi: 10.1016/j.jtho.2018.06.019.

SOURCE Dizal Pharmaceutical