China-based Hanx Biopharmaceuticals Co., Ltd has announced that its self-developed anti PD-1/CD47 bispecific antibody drug, HX009, has received a clinical trial notice from the National Medical Products Administration (NMPA) on October 30, 2019 (Acceptance Number: CXSL1900098). This follows the drug’s ethical review approval in Australia in July, where Phase I clinical trials have already commenced.
HX009: A New Generation of Immuno-Oncology Therapy
HX009 is a new generation of anti-tumor immunotherapy drugs, developed by Hanx Bio using its unique bispecific antibody and fusion protein platform. The PD-1/PD-L1 signaling pathway plays a pivotal role in tumor immunity, and blocking this pathway can prevent tumor cells from inhibiting the immune system’s primary force, T cells. While the development of anti PD-1 and anti PD-L1 antibodies has become a hot research direction in tumor immunotherapy, current treatment efficacy rates vary from 15% to 50%. Research evidence suggests that successful cancer immunotherapy depends on triggering a broader systemic immune response rather than just a local effect on the tumor itself. Stimulating the immune system to produce a more systematic response is expected to significantly increase the effectiveness of immunotherapy. CD47 is widely expressed on various tumor cells, and tumor cells can escape macrophage immune surveillance through the CD47-SIRPα signaling pathway. Therefore, blocking the binding of CD47 with SIRPα with a CD47 antibody can activate macrophages to engulf tumors and enhance the immune presentation of tumor-specific antigens, activating specific T cells to kill tumor cells. HX009, targeting both PD-1 and CD47, can simultaneously activate innate and acquired immune responses, making it a new generation of dual-function immune checkpoint inhibitors.
Global Clinical Research conducted simultaneously
Currently, HX009 is conducting clinical research in both Australia and China, marking it as the world’s first anti-PD-1/CD47 non-specific antibody to enter clinical trials. This highlights Hanx Bio’s drug development capabilities and indicators that its non-specific antibody platform technology has been developed, ready for clinical development of new drugs. In Hanx Bio’s pipeline, the PD-1 monoclonal antibody (HX008) has begun Phase III clinical studies and has laid out multiple solid cancer indicators Moving forward, Hanx Bio will continue to conduct clinical studies on multiple immunotherapies, both monotherapies and combination therapies, for various malignant tumors, striving to bring products to market as soon as possible to provide high-quality Chinese-made drugs to cancer patients worldwide. Additionally, a series of new tumor immunotherapies based on PD-1 antibodies and built using Hanx Bio’s unique dual-function antibody fusion protein platform will also enter international multicenter clinical research phases.
About HX009
HX009 is a self-developed anti PD-1/CD47 bispecific antibody drug by Hanx Biopharmaceuticals that targets both PD-1 and CD47, significantly enhancing their ability to activate the immune system for the treatment of malignant tumors such as liver, stomach, and colorectal cancer. PD-1 antibodies can cause exhausted T cells to replicate again, while CD47 antibodies can block the “do not eat me” signal by binding with CD47, allowing macrophages to exert their phagocytic action. HX009 activates both innate and acquired immune responses to curb tumor immune evasion and release immune checkpoint suppression for synergistic antitumor effects.-Fineline Info & Tech
