Our clinical and discovery pipeline programs are centered on restoring immune homeostasis in patients with severe inflammatory and autoimmune diseases.
IL-7 and TSLP Receptor Program
ADX-914: Phase 1 completed (NCT04485481); Phase 2 program to initiate in 2022
The IL-7 and TSLP receptor pathways have been genetically and biologically implicated in driving several T cell-mediated pathological processes in numerous autoimmune diseases. Based on this rationale, inhibition of IL-7 and TSLP receptor signaling has the potential to durably and safely restore healthy immune regulation in patients. Q32 Bio is developing a fully human anti-IL-7/TSLP receptor antibody, 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. Q32 Bio recently completed a biomarker-enabled Phase 1 study characterizing pharmacokinetics, pharmacodynamics and safety of ADX-914 that demonstrated pharmacological effect on T cells in healthy volunteers. In partnership with Horizon Therapeutics, we expect to initiate a Phase 2 trial in atopic dermatitis this year, and to initiate a Phase 2 trial in a second autoimmune disease in 2023.
ADX-097: Phase 1 in progress
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 an innovative 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. These molecules have therapeutic potential across numerous organ systems, including kidney, skin, lung 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 a first-in-human, Phase 1, ascending dose (SAD/MAD) clinical study of ADX-097 for the treatment of complement disorders and is also advancing the discovery of other complement-targeting fusion protein constructs.