On July 21, 2021, Shanghai Escugen Biotech Co., Ltd. announced that it has officially received the approval notice from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for the clinical trial application (IND) of its recombinant humanized anti-Trop2 monoclonal antibody-SN38 conjugate (acceptance number CXSL2101069).
The Trop-2 ADC (code ESG-401) is jointly developed by Shanghai Escugen Biotech Co., Ltd. and Levena (Suzhou) Biopharmaceutical Co., Ltd. Both parties jointly own the domestic and international patents of this ADC and share the rights to product development.
ESG-401 has distinct advantages in terms of safety, efficacy, and process robustness. The conjugate uses an innovative, highly stable, degradable linker that releases minimal free toxin in circulation, highly accumulates in tumor tissues, and rapidly internalizes, effectively killing tumor cells and inhibiting tumor growth. In a series of preclinical studies, ESG-401 demonstrated excellent safety, with no observed off-target toxicity or on-target off-tumor toxicity in high-dose repeated administration non-human primate GLP safety evaluations. ESG-401 showed significant anti-tumor activity in various Trop-2 expressing tumor models, with low effective doses and prolonged tumor growth inhibition. ESG-401 addresses the highly unmet needs in the treatment of multiple solid tumors, such as triple-negative breast cancer and urothelial carcinoma.
The approval of the CDE clinical trial application marks the transition of Escugen Biotech from early-stage drug development to clinical development. The company looks forward to validating the excellent safety and efficacy characteristics demonstrated by ESG-401 in preclinical development in clinical trials, bringing the product to benefit patients as soon as possible.
The GMP filling of ESG-401 clinical samples and antibody production are entrusted to TOT Biopharm Co., Ltd. and Beijing Yizhuang International Protein Drug Technology Co., Ltd., respectively. Escugen Biotech also expresses its heartfelt gratitude to all CROs and CDMOs that provided high-quality services for the development of ESG-401.
About Escugen Biotech
Shanghai Escugen Biotech Co., Ltd. was established in Shanghai in 2017, focusing on the development of innovative monoclonal antibody-based new drugs. The company was founded by experienced "returnee" scientists with decades of R&D experience in both foreign and domestic biopharmaceutical companies. The entrepreneurial team has accumulated rich and successful R&D experience in leading biopharmaceutical companies at home and abroad, with R&D capabilities covering antibody discovery, process development and quality research, preclinical research, and clinical research. The company aims at "First-in-class" and "Best-in-class" product positioning, continuously tracking new technologies, new targets, and new processes in the field of antibody drugs, and exploring the innovative use of new technologies. It has built a series of product pipelines with distinct competitive advantages, including ADCs with "best-in-class" potential and innovative antibodies targeting "first-in-class" targets. The company will successively have multiple innovative product pipelines entering clinical trials.
About Levena (Suzhou) Biopharmaceutical Co., Ltd.
Levena (Suzhou) Biopharmaceutical Co., Ltd. was established in Suzhou in 2016 and is a wholly-owned subsidiary of Sorrento Therapeutics, a NASDAQ-listed company in the United States. Headquartered in Suzhou, it has R&D centers in Nanjing and San Diego, California. As a leading company in antibody-drug conjugates (ADCs), Levena Biopharmaceutical has been committed to the development and industrialization of ADC drugs. The company owns globally leading next-generation site-specific antibody-drug conjugate patents and collaborates with domestic and international pharmaceutical companies on new drug development. The company has a mature and professional core technology platform, covering small molecule drug and linker research and production, as well as high-level conjugation technology. The world's first ADC new drug STI-6129, with independent intellectual property rights, for the treatment of amyloidosis and multiple myeloma, received FDA approval for clinical trials in 2020. The company will continue to strengthen its pipeline construction and expand cooperative development to launch more innovative ADC drugs to benefit society.
