Our Key Product AN1004 (pelareorep), with fast track designation from the FDA, is a registrational trial-stage, potential first-in-class intravenously delivered oncolytic virus for treating HR+/HER2- mBC.
AN1004 is also the clinically most advanced intravenous oncolytic virus that has completed a Phase II clinical trial and its safety profile has been proven in clinical trials with over 1,000 patients.
Phase II studies have shown an approximate doubling of OS in HR+/HER2-mBC patients who received AN1004. We received the approval from the NMPA in February 2019 for our initiation of an open-label, randomized, multi-center, Phase III clinical trial for AN1004 in combination with paclitaxel in patients with HR+/HER2-mBC. We initiated a bridging trial in China in March 2021 to assess the safety and tolerability of AN1004 in combination with paclitaxel for the Chinese patient population with HR+/HER2- mBC. We plan to initiate Phase III clinical trials in China in the first half of 2022.
Advanced/Metastatic Breast Cancer
Breast cancer is the most common cancer in women, with its incidence increasing year by year. Developed from breast tissue, BC may present as a lump in the breast, a change in breast shape, dimpling of the skin, fluid coming from the nipple, a newly inverted nipple, or a red or scaly patch of skin. Worldwide, the incidence of BC grew from approximately 2,002,000 in 2016 to 2,261,400 in 2020.
Among BC patients, approximately 6.0% of patients have metastatic breast cancer (“mBC”) when they are firstly diagnosed with BC. Approximately 50% of BC patients will eventually progress to advanced or metastatic BC with limited life span. Furthermore, it is estimated that 60% to 75% of mBC patients are with HR+/HER2- mBC.
The treatment and management of HR+/HER2- mBC is largely dependent on early diagnosis and timely medical intervention. Currently, the endocrine-based therapy in combination with a CDK4/6 inhibitor is the primary treatment for patients with HR+/HER2- mBC. However, after receiving chemotherapies or endocrine-based therapies, patients with HR+/HER2- mBC are provided with limited treatment.