Shanghai-based Elpiscience Biopharmaceuticals Inc. has announced receiving Investigational New Drug (IND) approval in China to initiate a Phase I clinical trial for its bispecific antibody (BsAb) ES014 in patients with advanced solid tumors. ES014 is a potential first-in-class anti-CD39 x TGF-beta immunotherapeutic designed to activate T cells and overcome resistance to standard immune checkpoint inhibitors such as PD-1s. This approval follows a US FDA IND nod issued in May 2022.
Mechanism of Action and Development
Solid tumors frequently express TGF-beta, which suppresses T cell activation and induces CD39 expression. Elpiscience’s BsAb targets CD39 to guide the molecule to the tumor microenvironment (TME), where the anti-TGF-beta activity promotes direct T cell targeting of the cancer. The anti-CD39 activity aims to reverse TME immunosuppression by reducing suppressive adenosine while maintaining high levels of immune-stimulatory extracellular ATP. This dual action to remove immune suppression and stimulate the immune system has been shown to offer efficacy in PD-1 antibody-resistant animal models.
Company Background and Pipeline
Elpiscience is based in Shanghai’s Zhangjiang High-Tech Park and has sites in Suzhou, as well as Maryland in the United States. The firm is backed by leading investors including Lilly Asia Ventures, GL Ventures, and Hyfinity Investments. ES014 is the firm’s sixth pipeline candidate to reach the clinical stage, with the anti-VEGF/DLL4 molecule ES104 being the most advanced, currently in Phase II trials.
Future Prospects and Strategic Implications
The IND approval for ES014 marks a significant milestone for Elpiscience in advancing its innovative immunotherapeutic pipeline. By targeting key pathways in the tumor microenvironment, ES014 has the potential to address significant unmet medical needs in the treatment of advanced solid tumors. This approval positions Elpiscience to further explore the therapeutic potential of ES014 and contribute to the development of next-generation cancer treatments.-Fineline Info & Tech
