Anova Partners with Dizal (Jiangsu) Pharmaceuticals to Accelerate Development of DZD9008 for Patients with Advanced or Metastatic NSCLC with EGFR Exon20 insertion Mutation

• AnovaOS™ will be used to support site activation, patient identification and enrolment through just-in-time approach;
• AnovaOS™ will be used to support the delivery of two studies of DZD9008 for patients with advanced or metastatic NSCLC harboring EGFR Exon20 insertion mutation (Exon20ins) in a Phase III study study in a first-line setting and a Phase II study in ≥ 2^nd line setting;
• Patients with lung cancer and a epidermal growth factor receptor (EGFR) exon 20 insertion mutation meet study specific eligibility criteria can participate in the studies where they choose to receive care.

Anova Enterprises, Inc. (Anova), an organization dedicated to accelerating promising treatments to market with its transformative AnovaOS™ technology platform, and the industry’s first collaborative ‘learning system’, today announced a partnership with Dizal Pharmaceuticals (Dizal) to accelerate the development of DZD9008 for patients with EGFR Exon20ins mutant NSCLC.

Dizal is a commercial-stage biopharmaceutical company focused on the discovery and development of differentiated therapeutics for the treatment of cancer and immunological diseases. Dizal are evaluating DZD9008 in a Phase III study in a first-line setting and a Phase II study in a recurrent setting.

EGFR Exon20ins occur in about 2% patients with NSCLC. No target therapy has gained full approval for the treatment. Chemotherapy is the most commonly used in the first-line setting, but the treatment’s efficacy is not optimal. Therefore, there is an unmet medical need to develop more effective therapy.

“Advances in precision medicine have clearly helped patients with EGFR mutations survive longer. Anova and Dizal are committed to building upon recent success with DZD9008 following NDA approval of Sunvozernitib for the treatment of adult patients with locally advanced or metastatic NSCLC patients with EGFR Exon20ins by the National Medical Products Administration (NMPA) of China. We are identifying the underserved group of NSCLC cases that have EGFR Exon20ins mutations and giving them an opportunity to participate in research designed to benefit them.

“It is not enough to identify patients with rare tumor mutations and hope they can access a promising clinical trial,” said Martin Walsh, President at Anova. “AnovaOS™ provides a network that allows any patient to participate in research where they choose to receive care. Being able to deliver study opportunities in real time transforms the way research has been historically conducted.”

Research sites and physicians interested in participating in this study should register their profile at www.anovaevidence.com. NSCLC patients with EGFR Exon20ins mutations can e-mail Dizal@anovaevidence.com to find out more about the study and consider participation. To find out more contact Victor Sirippi, Project Lead at victor@anovaevidence.com

ENDS

About Anova

Anova Enterprises, Inc. (Anova) is accelerating clinical development with a technology platform (AnovaOS™) that brings participants in the clinical research process together to speed promising new treatments to market, at reduced cost and for a larger number of patients. We kickstart the development of new treatments through standardization and automation as no one else can do.

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About DZD9008 (sunvozertinib)

DZD9008 is an irreversible EGFR inhibitor discovered by Dizal scientists targeting a wide spectrum of EGFR mutations with wild-type EGFR selectivity. In August 2023, sunvozertinib received approval from NMPA for the treatment of advanced NSCLC with EGFR Exon20ins mutations after platinum-based chemotherapies. The approval is based on the results of WU-KONG6 study, the pivotal study of sunvozertinib in platinum-based chemotherapy pretreated NSCLC with EGFR Exon20ins mutations. As assessed by the Independent Review Committee (IRC), the primary endpoint of cORR at RP2D of 300mg QD reached 60.8%. Anti-tumor efficacy was observed across a broad range of EGFR Exon20ins subtypes, and in patients with pretreated and stable brain metastasis. In addition, sunvozertinib also demonstrated preliminary anti-tumor activity in NSCLC patients with EGFR sensitizing, T790M and uncommon mutations (such as G719X, L861Q, etc.), as well as HER2 Exon20ins mutations.

Sunvozertinib showed a well-tolerated and manageable safety profile in the clinic.

Pre-clinical and Phase I clinical results of sunvozertinib were published in peer-reviewed journal Cancer Discovery (IF:39.397) in April 2022.

About Dizal

Dizal is a 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 and one already launched.

To learn more about Dizal, please visit www.dizalpharma.com

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