On April 19, 2024, Shanghai Escugen Biotechnology Co., Ltd. ("Escugen") announced that its ESG401 (Trop-2 ADC) has received approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) to conduct a pivotal Phase III clinical trial for the indication of "HR+/HER2- metastatic breast cancer that has progressed after endocrine therapy or is unsuitable for endocrine therapy and has received at least one line of systemic chemotherapy in the metastatic setting." This decision was based on the overall excellent safety data from the ESG401-101 study and the consistent safety and highly competitive efficacy data obtained in the Phase Ib study for the same indication.
ESG401 is Escugen's first ADC in the clinical stage of development. It features an innovative stable and degradable linker that significantly reduces off-target toxicity. 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. The increased ADC treatment dose and in-body exposure have led to encouraging efficacy in patients with advanced, heavily pretreated triple-negative breast cancer and HR+/HER2- metastatic breast cancer that has progressed after endocrine therapy or is unsuitable for endocrine therapy and has received at least one line of systemic chemotherapy in the metastatic setting. ESG401 has also shown distinct advantages in treating visceral metastases and outstanding efficacy in treating brain metastases. Additionally, the ongoing ESG401 monotherapy first-line triple-negative breast cancer dose-expansion trial has accumulated a higher objective tumor response rate (ORR) than the combination of ADC competitors targeting the same antigen with immune checkpoint inhibitors.
Dr. Zhou Qing, Founder, Chairman, and CEO of Escugen, said: "ESG401 has demonstrated exciting efficacy evidence in clinical trials, with tumor responses observed across multiple breast cancer subtypes. The company will disclose clinical trial data at international professional academic conferences. Escugen has completed the commercial process development of the ADC drug and is well-prepared for the upcoming pivotal Phase III clinical trial. This approval from the CDE for ESG401 to conduct a pivotal clinical trial for HR+/HER2- metastatic breast cancer is an important milestone in Escugen's journey in ADC new drug development. We sincerely thank the participants and their families for their trust and cooperation, the clinical researchers and professional staff of the research institutions for their hard work, and our service providers and supplier partners for their strong support! All employees of the company will continue our research and development work with enthusiasm and a rigorous scientific attitude, and we eagerly look forward to our research results being applied to clinical practice to benefit patients as soon as possible."
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 currently has two clinical-stage projects, including ESG401. In addition to ESG401, which is about to enter late-stage clinical development, Escugen has also 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 simultaneously licensed out the technology platform.
