FDA Approves IND for ADG-106 Study

Adagene has received notification from the FDA to proceed on its Investigational New Drug (IND) application to study its lead product (ADG-106) in patients with advanced solid tumors and non-Hodgkin lymphoma.

CD137 or 4-1BB, a member of the tumor necrosis factor (TNF) receptor superfamily is a promising immune-oncology target. Ligation of CD137 induces a co-stimulatory signal on activated CD8+ T cells and natural killer (NK) cells, resulting in proliferation, increased pro-inflammatory cytokine secretion and, cytolytic function. CD137 is also thought of as an attractive target for autoimmune disease as T regulatory cells (Tregs) also express 4-1BB. ADG-106 is a fully human agonistic mAb targeting a novel epitope of CD137. Adagene will investigate the safety and efficacy of ADG-106 therapy as a single agent across a range of solid tumor and non-Hodgkin lymphoma patients in a Phase I clinical study expected to commence in the second half of 2018.

"ADG-106 is targeting a different epitope of CD137 compared with the other two therapeutic antibodies against this target in early clinical trials", said Peter Luo, CEO and Co-Founder of Adagene. "Our proprietary Dynamic Precision Library was able to generate an antibody that targets a unique epitope with cross-reactivity, enabling robust translational studies in both efficacy and safety. ADG-106 is the only monoclonal antibody against this target that has demonstrated potent single agent efficacy in multiple tumor models with intact immune system and work in synergy with other therapeutics, while maintaining an excellent safety profile at extremely high dose. We look forward to starting our clinical trial in the United States soon."

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