On October 21, 2022, Shanghai Escugen Biotechnology Co., Ltd. ("Escugen") and InxMed (Nanjing) Co., Ltd. ("InxMed") jointly announced that their co-developed antibody drug INES103 has been formally accepted by the Center for Drug Evaluation (CDE) for IND application, with the acceptance number CXSL-2200537.
INES103 is a humanized single-domain antibody (VHH)-Fc fusion protein targeting a tumor immune-related antigen, intended for the treatment of various hematologic malignancies and solid tumors. The antibody was initially developed by Escugen based on its single-domain antibody technology platform and holds the molecular patent. Leveraging the unique species origin and structure of VHH, Escugen developed a VHH antibody that selectively binds to the tumor-associated epitope of the target antigen, significantly enhancing tumor specificity and safety. Due to the VHH-Fc fusion protein's molecular weight being only half that of a classic IgG, the molecule retains a longer plasma half-life while offering excellent tumor tissue penetration. This unique molecular design provides INES103 with a significant advantage in treating solid tumors.
The treatment of gastrointestinal tumors will be a key focus for the subsequent development of INES103. Through a series of translational medicine studies on the target antigen and diseases jointly conducted by Escugen and InxMed, INES103 in combination with a first-in-class ADC from InxMed has demonstrated excellent synergistic effects in treating certain high-incidence and poor-prognosis gastrointestinal tumors in China. Pharmacodynamic studies have proven that the combination therapy significantly outperforms monotherapy, rapidly reducing the volume of large tumors in various target solid tumor PDX mouse models to complete disappearance, with no recurrence after discontinuation of treatment.
Escugen and InxMed have jointly completed the process and preclinical development of INES103. In the safety evaluation experiments of repeated dosing in non-human primates, INES103 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 INES103 entering the First-in-Human (FIH) study phase.
Currently, INES103 has successfully completed the production of multiple batches of clinical samples at Thousand Oaks Biologics (Nantong) Co., Ltd.
Dr. Zhou Qing, Founder and CEO of Escugen, said: "The IND application of INES103 is the result of complementary advantages and win-win cooperation between Escugen and InxMed. Escugen's antibody technology provides a novel and unique antibody optimized for immunological, pharmacological, and toxicological characteristics, while the combination therapy with InxMed's pipeline offers us significant potential and differentiated clinical development pathways in the treatment of refractory gastrointestinal tumors and specific organ metastases."
Dr. Wang Zaiqi, Founder and CEO of InxMed, said: "InxMed focuses on the treatment of drug resistance and metastasis in solid tumors. Through in-depth research of disease biology, we explore and discover better treatment solutions and actively seek collaborations with domestic and international pharmaceutical companies to accelerate the clinical translation of our research results and meet patients' treatment needs. This collaboration with Escugen to develop INES103 fully reflects InxMed's overall strategy of starting from clinical diseases, conducting preclinical research based on translational medicine, and returning to clinical drug development. We hope that INES103 will achieve more breakthroughs in refractory gastrointestinal tumors and benefit more patients in the future."
INES103 is planned for simultaneous development in China and the United States. In addition to applying for IND in China, InxMed is expected to submit an IND application to the US FDA on behalf of the sponsor in the near future.
About Escugen Biotechnology
Founded in 2017 in Shanghai, Escugen Biotechnology is a clinical-stage biotechnology company. The company completed a Series A financing round of over 100 million yuan in September 2021. 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 Phase Ib/II study stage and has achieved encouraging early data. ESG206 is the second pipeline from Escugen to enter the clinical stage, targeting new targets for the treatment of B-cell malignancies and autoimmune diseases. INES103 is the third pipeline from Escugen to be advanced to the clinical stage.
About InxMed
Founded in 2018, InxMed is a global clinical-stage biotechnology company. The company focuses on and leads the development of innovative drugs for the treatment of drug resistance and metastasis in solid tumors, using translational medicine as the source of innovation and leveraging strong clinical capabilities to build an efficient platform from disease biology mechanism research to innovative drug discovery and clinical translation and proof of concept, aiming to become a global new drug development company. The company has established teams in Shanghai, Beijing, and Nanjing in China and has a high-level translational medicine and clinical development team spanning China, the United States, Canada, and Australia. The company has built a unique and synergistic global development pipeline through independent innovation, product introduction, and joint development. The first drug, FAK (focal adhesion kinase) small molecule inhibitor IN10018, has received Fast-track Designation from the US Food and Drug Administration and Breakthrough Therapy Designation from the National Medical Products Administration of China, and has initiated patient dosing in a pivotal clinical trial.
