On June 2, 2022, Shanghai Escugen Biotechnology Co., Ltd. ("Escugen") announced that it has formally submitted a First-in-Human (FIH) clinical trial application for ESG206 to the Bellberry Human Research Ethics Committee (Bellberry HREC) in Australia, for the treatment of malignant B cell lymphoma and chronic lymphocytic leukemia.
ESG206 specifically targets an undisclosed B cell-specific antigen. No drugs targeting this antigen have been approved for clinical use by regulatory authorities domestically or internationally. ESG206 is innovative in its target and has the potential to be a First-in-Class therapy. This humanized monoclonal antibody has been glycosylated to enhance antibody-dependent cellular cytotoxicity (ADCC). Although there are numerous drugs currently approved for the treatment of malignant B cell diseases, and the prognosis for these diseases is relatively better compared to other malignancies, resistance and recurrence are still very common in clinical practice, indicating a significant unmet clinical need. ESG206 has demonstrated significant and durable tumor suppression in tumor models resistant to existing treatments such as CD20 antibodies, BTK inhibitors, and CAR-T therapies, inducing long-term and high-rate tumor remission, making it a highly promising candidate for the treatment of B cell malignancies. In non-human primate repeat-dosing safety evaluation experiments, ESG206 has also shown good tolerability, with a maximum non-severe toxicity dose (HNSTD) as high as 100 mg/kg. The above preclinical studies fully support ESG206 entering the FIH study phase, and it is anticipated that the excellent preclinical data of ESG206 will be confirmed in human clinical trials.
The clinical indications for ESG206 can also be expanded to many B cell-related autoimmune diseases, offering broad market expansion prospects.
Escugen is currently engaging in pre-IND consultations with the National Medical Products Administration (NMPA) and the Center for Drug Evaluation (CDE) and has received some positive feedback. The company plans to formally submit an IND application to the NMPA/CDE in the near future.
Currently, ESG206 has successfully completed the production of multiple batches of clinical samples at Thousand Oaks Biologics (Nantong) Co., Ltd.
About Escugen Biotechnology
Founded in 2017 in Shanghai, Escugen Biotechnology is a clinical-stage biotechnology company. The company has completed a Series A financing round of over 100 million yuan. Escugen focuses on the development of new drugs based on monoclonal antibodies and innovative antibody-drug conjugates (ADCs). The company was founded by veteran returnees with decades of R&D experience in both international and domestic biopharmaceutical companies. The founding team has accumulated rich and successful R&D experience in leading biopharmaceutical companies both domestically and internationally, with capabilities covering antibody discovery, conjugation technology, process development and quality research, preclinical and clinical studies. The company continuously tracks new technologies, targets, and processes in the field of antibody drugs, explores innovative uses of new technologies, and has built a series of product pipelines with distinct competitive advantages targeting unmet clinical needs. ESG401, a Trop-2 ADC with multiple competitive advantages in safety, efficacy, and process stability, has entered the clinical study phase and has achieved encouraging early data. ESG206 is the second pipeline from Escugen to enter the clinical stage. The company will continue to introduce multiple innovative product pipelines into clinical trials.
