Innolake Biopharm announced that the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA) has accepted the company’s Investigative New Drug (IND) application to initiate a Phase I trial of ILB-2101 in patients with advanced malignant tumors.
ILB-2101 is a novel anti-CD40 monoclonal antibody. CD40 is a member of the tumor necrosis factor receptor (TNFR) superfamily and is an important connecting factor between the innate and adaptive immune responses. CD40 is mainly expressed on immune cells, including B cells, Dendritic Cells (DCs), macrophages, monocytes cells and on selected tumor cells. Studies have shown that CD40 agonists exert anti-tumor effects through multiple pathways. In the adaptive immune system, the binding of CD40 Ligands (CD40L) to CD40 activates antigen presenting cells (APCs) such as DCs, which in turn will activate cytotoxic CD8+ T cells and enable them to kill tumor cells. In the innate immune system, the binding of CD40L to CD40 expressed on macrophages will activate macrophages to kill tumor cells. In addition, the binding of CD40L to CD40 on tumor cells will lead to tumor cell apoptosis. As one of the most promising co-stimulatory immune targets, CD40 agonists combined with PD-(L)1 antibodies and chemotherapeutic drugs has attracted much attention and exploration with the goal of overcoming PD-(L)1 resistance and improving the effectiveness of cancer immunotherapy.
ILB-2101 is a novel, fully humanized IgG2 anti-CD40 agonist. Through innovative design, ILB-2101 targets a unique epitope, which reduces the effects of complement-dependent cytotoxicity （ADCC）and antibody-dependent cellular （CDC）toxicity. Compared to the benchmark product, ILB-2101 has increased safety and the therapeutic window. The preclinical data shows that ILB-2101 has superior pharmacological activity and lower risk of cytokine release. In CDX mouse model, ILB-2101 monotherapy showed significant anti-tumor activity and synergistic effect when combined with anti-PD-1 antibody and other immune checkpoint inhibitors.
Dr. Mingde Xia, Founder/Chairman/CEO of Innolake Biopharm
Dr. Mingde Xia said, " ILB-2101 is a biologics project that we accelerated from candidate molecule to IND application in a year. This is a testimony of our capabilities in CMC, preclinical development, clinical registration and project management at Innolake. The IND acceptance of ILB-2101 is another important milestone in the rapid development of Innolake. We look forward to working closely with industry peers and clinical leaders to accelerate its clinical development. With innovative approaches, we hope to bring new and better treatment options to patients in China and around the world.