On July 11, 2024, Shanghai Escugen Biotechnology Co., Ltd. ("Escugen") announced that the first patient has been dosed in the Phase III clinical trial (ESG401-301) of its independently developed innovative drug, ESG401 Injection. This trial aims to treat hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) locally advanced or metastatic breast cancer that has previously received at least one line of systemic chemotherapy. This significant milestone marks another important achievement in the development process of ESG401 by Escugen.

Product Introduction

ESG401 is a key development product of Escugen, targeting the Trop-2 antigen with an antibody-drug conjugate (ADC) approach. It features an innovative stable and degradable linker that significantly reduces off-target toxicity. Clinical data to date indicate that ESG401 has a higher tolerable dose than other ADCs targeting the same antigen, with lower incidence and severity of off-target and on-target toxicities, demonstrating a clear safety advantage.

Project Introduction

This Phase III clinical trial (NCT06383767) aims to evaluate the efficacy and safety of ESG401 compared to investigator-selected chemotherapy regimens in the treatment of HR+/HER2- locally advanced or metastatic breast cancer that has previously received at least one line of systemic chemotherapy. The study is led by Professor Ma Fei from the Cancer Hospital of the Chinese Academy of Medical Sciences and is planned to be conducted at approximately 60 centers across the country, with an estimated enrollment of 378 patients with HR+/HER2- breast cancer. This trial is a pivotal registration study for ESG401 Injection.

Professor Ma Fei, the national principal investigator of this study from the Cancer Hospital of the Chinese Academy of Medical Sciences, stated: "Breast cancer is a malignant tumor that seriously endangers the health and lives of women in China, with HR+/HER2- breast cancer being the most common subtype. For patients with advanced disease who have failed endocrine therapy combined with targeted treatment, the treatment options are limited, and monotherapy chemotherapy is one of the most important choices. However, the response rate to monotherapy chemotherapy in advanced HR+/HER2- breast cancer is low, and the median progression-free survival is relatively short. Moreover, as the disease progresses, the treatment becomes even more challenging when visceral metastases (especially brain and liver metastases) occur. We urgently need more effective treatment options to help improve prognosis and increase patient survival benefits.

We are pleased to see that the first patient dosing in the Phase III clinical trial of ESG401 Injection has been successfully completed, and we hope that through this study, we can explore new effective treatment options for patients with this indication."

Dr. Zhou Qing, Founder, Chairman, and CEO of Escugen, said: "ESG401 is a key development product of Escugen and the first ADC product from our company to enter the clinical stage. We obtained IND approval from the CDE in July 2021 and first presented the early clinical trial results at the ASCO Annual Meeting in June 2023. In April 2024, the CDE approved the Phase III pivotal registration clinical trial for the second-line and above HR+/HER2- breast cancer indication. Just over two months later, we have completed the first patient dosing.

We are very much looking forward to the rapid advancement of the project to obtain the data from the pivotal registration clinical trial as soon as possible, in order to provide a better treatment option for Chinese patients with HR+/HER2- breast cancer. Escugen has completed the commercial process development of the ADC drug, and is well-prepared for the Phase III clinical trial. Moving forward, we will continue to drive innovation and bring more innovative drugs into the clinic as quickly as possible to benefit more patients."

About Escugen Biotechnology

Escugen is a clinical-stage ADC new drug development company with comprehensive new drug research and development capabilities. Established in 2017 in the Zhangjiang Hi-Tech Park, Pudong New District, Shanghai, the company was founded by veteran returnees with decades of R&D experience in both international and domestic biopharmaceutical companies. The team's expertise covers all aspects from laboratory to clinical research, including antibody engineering, antibody drug discovery, preclinical studies, bioconjugation, CMC, quality research, medical monitoring, clinical operations, data management, and pharmacovigilance. The company has two new drugs in clinical studies and one entering pivotal registration clinical studies. In addition, Escugen has established its next-generation ADC platform technology with independent intellectual property rights, EZWi-Fit®, which surpasses international benchmark ADC technologies in multiple dimensions. Escugen is leveraging this ADC platform technology to expand its pipeline of "First-in-Class" and "Best-in-Class" ADCs and has already licensed out the technology platform. The company has also built a global business development network, establishing business and strategic cooperation with several top global biotech companies.