SHANGHAI, August 27, 2021 – Congratulations to our partner, Nanjing Immunophage Biotech, for receiving Investigational New Drug (IND) approval from the US Food and Drug Administration (FDA) to initiate clinical trials for their small molecule inhibitor, IPG1094. IPG1094 is a targeted MIF (Macrophage Migration Inhibitory Factor) inhibitor, and potentially novel treatment for solid tumors, hematomas, psoriasis and multiple sclerosis.Bioduro-Sundia assisted Immunophage in completing the API CMC portion of their IND application, including toxicological batch preparation, process optimization and scale-up, process validation, non-GMP and GMP API production. The partnership also supported analytical method development and verification, drug analysis services, polymorph screening, and pre-clinical IND application support.
The collaboration provided comprehensive integrated IND services throughout the development process for IPG1094, which accelerated Immunophage’s novel drug R&D program.
“It was an exemplary cooperation which enabled us to efficiently complete the US FDA PIND meetings and new IND approvals in such a short period of time”, said Dr. Jianfei Wang, Chief Scientific Officer of Immunophage, who expressed his gratitude to BioDuro-Sundia and other key partners. “It truly witnessed everyone’s trust, hard work, cooperation and persistence during the project implementation. My hope is that we will continue to work hard, strengthen cooperation and accomplish even greater achievements.”
“We are very pleased to see that the IND application for IPG1094 has been approved by the US FDA. This has the potential to benefit patients around the world, and we are very happy to be part of this success ” said Dr. Jim Li, President of BioDuro-Sundia Development and Manufacturing, APAC. “BioDuro-Sundia is committed to providing global partners with a full range of integrated services and technical support to advance novel drug research and development. We look forward to the future success of Immunophage, and hope to jointly develop many more innovative drugs that benefit patients around the world.”
MIF is a classic pro-inflammatory factor that participates in the regulation of innate and adaptive immune responses. A large number of studies have shown that the expression of MIF is significantly increased in a variety of tumor tissues, promoting tumor growth, metastasis, angiogenesis, and inducing the formation of a tumor-promoting immune microenvironment. In view of the important role of MIF in tumorigenesis and development, targeting MIF is considered a potential strategy for tumor treatment.
At present, there is no MIF target drug on the market globally, and the MIF projects under development are all in the preclinical stage. Preclinical studies of IPG1094 have shown that it has extremely high safety, with a safety window greater than 40 times, and rarely has no significant side effects. Its Phase I clinical trial in Australia showed good tolerability and safety.
“MIF small molecule inhibitors are the world’s leading new drug development project. Obtaining clinical approval from the US FDA is an important milestone in the development of the company,” said Dr. Guohuang Fan, Founder and CEO of Immunophage. “It is also a recognition and encouragement for the innovation capability of Immunophage. We are very much looking forward to the launch of clinical trials in the US, which will provide a wealth of clinical experience for Immunophage in the exploration of tumor immunotherapy.”
Founded in 2016, Nanjing Immunophage Biotech Co. Ltd. is an innovative drug research and development company based on the world’s leading targets. The company is committed to the development and commercialization of small molecule or large molecule novel drugs for major diseases such as malignancies, autoimmune diseases, metabolic diseases and neurodegenerative diseases. The company established a Shanghai R&D center in 2018 and a wholly-owned subsidiary in Australia in 2021, and plans to establish a wholly-owned subsidiary in the United States in the second half of 2021 to achieve a global layout. The company’s core management team is comprised of GSK senior executives and a group of middle-level technical backbones from well-known pharmaceutical companies such as GSK and Pfizer to form a new drug R&D team with strong competitiveness. The core technology team starts from the world’s leading targets and develops drugs based on disease cell phenotypes. At present, it has established more than 10 global innovative research and development pipelines, of which 2 products have completed IND applications and entering clinical trials.
BioDuro-Sundia, an Advent International portfolio company, is a leading contract research, development and manufacturing organization (CRDMO) that provides biopharmaceutical partners with fully integrated services to support drug discovery, development and manufacturing for both drug substance and drug product. The company is the industry’s third largest, with major operations in China and the US—featuring more than 2,000 employees and10 global sites.
Core expertise includes small and large molecule discovery, development and scale up, support for IND submission, and unique technology platforms such as bioavailability enhancement of insoluble compounds. The company has research sites, as well as GMP manufacturing facilities in both China and the US. The one-stop-shop operation helps biopharma partners across the globe to significantly accelerate discovery and de-risk development to create higher value outcomes.