HuL001 is a humanized monoclonal antibody directed against ENO1 (enolase 1) for the treatment of multiple sclerosis (MS) and potentially other autoimmune diseases.
HuL001 is currently in preparation for IND submission in USA for clinical investigation in patients with multiple sclerosis. HuL001 is developed from the ENO1-targeting technology originated in Development Center for Biotechnology and National Health Research Institute in Taiwan. HuL001 is designed to target monocyte and macrophage for the treatment of immune disorder. We believe that HuL001 offers a safe alternative with novel mechanism for MS patients beside current therapy.
Mode of action
ENO1 is a 47 kd intracellular protein, a key enzyme in glycolysis. It also functions as a plasminogen receptor on cell surface of activated monocytes, which makes ENO1 as an ideal and novel target for antibody-based therapeutics in immune disorder.
HuniLife has pioneered in the ENO1 targeting therapeutics. HuL001 is a humanized monoclonal antibody, which targets a unique epitope of ENO1. HuL001 is designed to bind ENO1 and block its plasmin-dependent activity, including cell migration and invasion, cytokine production, and so on. By this mechanism of action (MOA), HuL001 is able to prevent the activated ENO1-bearing monocyte from entering the nervous system to perform its culprit role in immune-related diseases.
Indication: Multiple Sclerosis and potential other indications
Multiple sclerosis is a demyelinating disease in which the insulating covers of nerve cells in the brain and spinal cord are damaged. This damage could disrupt the ability of the nervous system related to communication and mobility, resulting in a wide range of symptoms, including physical, mental, and psychiatric problems. Current therapy can only control of slow the disease progression of MS, which is designed to target at T lymphocyte, B lymphocyte, or modulation of the immune system.
Infiltration of monocyte into the central nervous system (CNS) is a hallmark of MS patients and is commonly used to facilitate the diagnosis of MS. The presence and critical role of monocyte in CNS was demonstrated in EAE (Experimental autoimmune encephalomyelitis) mouse models of multiple sclerosis. ENO1 is expressed on activated monocytes or macrophages. With this unique feature, we believe HuL001 can offer a safe and novel profile of therapeutic, compared to current therapy, to treat multiple sclerosis.
It is generally believed that the presence and potential role of monocyte/macrophage could be involved in the pathogenesis of many autoimmune and inflammatory diseases, such as rheumatoid arthritis (RA), psoriasis, inflammatory bowel disease (IBD), atherosclerosis, and chronic lung inflammation. We are currently testing this hypothesis in animal models. Indeed, HuL001 has demonstrated its clinical potential in RA and IBD so far.
The preclinical development of HuL001 has been completed. US IND submission is pending for 2019Q2 for clinical investigation in patients with multiple sclerosis.