NovImmune Initiates Phase I Clinical Study with First-in-Class Anti-TLR4 Monoclonal Antibody

NovImmune Initiates Phase I Clinical Study with First-in-Class Anti-TLR4 Monoclonal Antibody

Jack Barbut, +41 22 839 71 41CEO14 Chemin des Aulx1228 Plan-les-Ouates, GenevaSwitzerland

NovImmune SA initiated dosing in a Phase I clinical trial of NI-0101, a monoclonal antibody drug candidate targeting toll-like receptor-4 (TLR4).

NI-0101 was discovered and developed by NovImmune, and has broad potential applications. NovImmune has demonstrated efficacy of TLR4 blockade in a range of preclinical models of arthritis, respiratory inflammation, organ injury, as well as other autoimmune and inflammatory conditions. The first-in-human study in healthy volunteers will generate information for pharmacokinetic and pharmacodynamic properties as well as safety and tolerability data.

NovImmune’s Chief Medical Officer, Cristina de Min, said, "Data generated during this Phase I program, coupled with the information from pre-clinical experiments in relevant animal models for human diseases, will build a solid foundation to advance NI-0101 into Phase II studies.”

TLR4 is a well characterized toll-like receptor with extensive publications outlining its role as a key mediator of acute and chronic inflammation. Along with other receptors, TLR4 normally plays a role to fight invasion by responding to bacterial lipopolysaccharide as a pro-inflammatory stimulus. However, when the body has continuing inflammation, damage occurs, and products from damaged cells send pro-inflammatory signals via TLR4, causing a self-perpetuating loop of damage and inflammation that underlies many diseases, which NI-0101 is designed to interrupt.

NI-0101 is the first anti-TLR4 antibody drug candidate to enter development. By inhibiting the ability of the subunits of the receptor complex to function together, NI-0101 inhibits TLR4 signaling regardless of the pro-inflammatory signal, making it an attractive drug candidate for a range of applications.

NovImmune is a drug discovery and development company focused on the creation of antibody-based drugs to benefit patients with autoimmune and inflammatory diseases, and cancer. The Company’s pipeline is a balance of preclinical and clinical candidates for validated and novel targets. NovImmune has established a next-generation antibody drug discovery platform that includes novel bispecific antibody drug capabilities.

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