On December 3, 2024, Shanghai Escugen Biotechnology Co., Ltd. (hereinafter referred to as "Escugen") announced that the company's independently developed innovative drug, ESG401 Injection, has received approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) to conduct its second Phase III clinical study (ESG401-302). This study focuses on the treatment of locally advanced, recurrent, or metastatic PD-L1 negative triple-negative breast cancer (TNBC) that has not previously been treated with systemic therapy. The study also received approval from the Ethics Committee of the Chinese Academy of Medical Sciences Cancer Hospital, the leading institution, on November 14, 2024. The first patient enrollment is expected to be completed in early January 2025.
Previously, ESG401 was designated as a Breakthrough Therapy by the CDE for the first-line TNBC indication on November 1, and this approved Phase III pivotal clinical study targets this indication.
Product Introduction
ESG401 is a key development product of Escugen, targeting the Trop-2 antigen with an ADC (Antibody-Drug Conjugate) drug. It features an innovative, stable, and degradable linker that significantly reduces off-target toxicity. Existing clinical data suggest 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
The Phase III clinical study ESG401-302 aims to evaluate the efficacy and safety of ESG401 Injection in patients with locally recurrent, inoperable, or metastatic TNBC who have not been previously treated. The study will compare ESG401 with TPC (Treaters' Preferred Chemotherapy). Led by Professor Ma Fei from the Chinese Academy of Medical Sciences Cancer Hospital, the study will be conducted at approximately 60 centers nationwide. This marks an important step in advancing the treatment of TNBC with ESG401 Injection.
New Hope for TNBC Patients
Professor Ma Fei, the national Leading PI (Principal Investigator) of the study from the Chinese Academy of Medical Sciences Cancer Hospital, said, "Triple-negative breast cancer (TNBC) is the most aggressive and difficult-to-treat subtype of breast cancer, accounting for 15%-20% of breast cancer patients. Metastatic TNBC progresses rapidly with a poor prognosis, and its five-year survival rate is less than 15%, significantly lower than the overall five-year survival rate of breast cancer (31%). This is a major challenge in the treatment of breast cancer. The approval of ESG401 Injection for Phase III clinical study as a first-line treatment for TNBC is an exciting development. We look forward to exploring the indications of ESG401 further through this study and providing more treatment options for patients with advanced TNBC."
Statement from Escugen
Dr. Zhou Qing, Founder, Chairman, and CEO of Escugen, said, "ESG401 is a key innovative product of Escugen and the first ADC product from our company to enter the clinical stage. In April 2024, we received CDE approval for the Phase III pivotal clinical trial of ESG401 for the treatment of second-line and above HR+/HER2- breast cancer, and we completed the first patient dosing in early July. Now, we have again received CDE approval for the Phase III pivotal clinical trial of ESG401 for first-line treatment of advanced TNBC. These milestones further demonstrate the continuous breakthroughs of ESG401 in the treatment of breast cancer and our confidence in the ongoing development of this product. Moving forward, we will fully and rapidly advance these two Phase III clinical studies to obtain trial data as soon as possible, with the goal of providing better treatment options for Chinese patients with HR+/HER2- breast cancer and TNBC, benefiting more patients."
About Escugen Biotechnology
Escugen is a clinical-stage ADC (Antibody-Drug Conjugate) new drug development company with a comprehensive new drug research and development capability and an ADC clinical pipeline. 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. Escugen has two new drugs in clinical studies and one entering pivotal clinical studies. The company has also established an independent intellectual property rights for its next-generation ADC platform technology, EZWi-Fit®, which surpasses international benchmark ADC technologies in multiple dimensions. Leveraging this ADC platform, Escugen is expanding its layout of "First-in-Class" and "Best-in-Class" ADC pipelines and has achieved external licensing of the technology platform. The company has also built a global business development network, establishing business and strategic cooperation with several top global biotech companies.
