Our clinical and discovery pipeline programs are centered on restoring immune homeostasis in patients with severe inflammatory and autoimmune diseases.
ADX-097: Phase 1 planned for 2021
The complement system is a first line of defense for fighting pathogens and clearing apoptotic cells. However, when hyperactivated, it is a driver of a variety of autoimmune and inflammatory diseases. Using a groundbreaking platform technology, Q32 Bio has generated a portfolio of first-in-class fusion proteins that provide potent and targeted regulation of complement directly to diseased tissues without long-term systemic blockade, minimizing the risk of serious infections and other complications. These molecules have therapeutic potential across numerous organ systems, including kidney, skin, liver and eye diseases.
ADX-097 is the lead candidate in Q32’s pipeline of complement-targeting therapies. ADX-097 has proven in vivo biodistribution to affected tissues/organs, durable tissue pharmacokinetics (PK)/pharmacodynamics (PD), robust in vivo efficacy, and possesses attractive drug properties. Q32 is currently conducting IND-enabling studies of ADX-097 and is also advancing the discovery of other complement-targeting fusion protein constructs.
ADX-914: Phase 1 planned for 2020
Activation of the interleukin-7 (IL-7) pathway can induce T-effector cell pathology, aberrant regulatory T cell suppression, and T cell-dependent autoantibody responses, resulting in autoimmune or inflammatory disease. The interleukin-7 receptor (IL-7R) is a cytokine receptor biologically and genetically implicated as a central mediator of T cell-mediated adaptive immune dysfunction and pathology. Based on this rationale, inhibition of IL-7R signaling has the potential to durably and safely restore healthy immune regulation in patients. Q32 Bio is developing a fully human antagonist antibody against IL-7R, ADX-914, with the aim of re-regulating adaptive immune function.
We believe ADX-914 is a powerful approach to attenuate pathology and re-establish healthy immune tolerance in multiple high unmet need indications. Our biomarker-enabled Phase 1 study of ADX-914, planned for late 2020, will provide an efficient path to demonstrate PK/PD and proof of mechanism/proof of concept.