15 August 2022 - - US-based clinical stage biotechnology company Q32 Bio and Dublin-based Horizon Therapeutics plc (NASDAQ: HZNP) have entered into a collaboration and option agreement to develop ADX-914 for the treatment of autoimmune diseases, the companies said.

ADX-914 is a fully human anti-IL-7Rα antibody that re-regulates adaptive immune function by blocking signaling mediated by both IL-7 and TSLP. Q32 has 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.

Q32 expects to initiate a Phase 2 trial in atopic dermatitis later this year and is planning to initiate a Phase 2 trial in a second autoimmune disease next year.

Under the terms of the agreement, Horizon will fund development through completion of the two Phase 2 trials of ADX-914, with Q32 being operationally responsible for the conduct of all program-related activities.

Horizon will receive an option to acquire the ADX-914 program, exercisable through a period following completion of the Phase 2 trials.

During the option period, Q32 will receive USD55 m in the form of initial consideration and staged development funding, of which Horizon expects to recognize as R and D expenses approximately USD 32.5m in 3Q22, and the remainder in 2023.

These payments will be included in Horizon's non-GAAP financial measures, including adjusted EBITDA.

If Horizon exercises the option, Q32 may be eligible to receive up to an additional USD 645m in closing and milestone payments, as well as tiered royalties on net sales, less certain amounts payable under a pre-existing license agreement.

Q32 Bio is a clinical stage biotechnology company developing biologic therapeutics targeting powerful regulators of the innate and adaptive immune systems to re-balance immunity in severe autoimmune and inflammatory diseases.

Q32 Bio's lead programs, focused on the IL-7 / TSLP receptor pathways and complement system, address immune dysregulation to help patients take back control of their lives.

The company's most advanced program, ADX-914, is a fully human anti-IL-7Rα antibody that re-regulates adaptive immune function and is being initially developed to treat an immune-mediated dermatological disease.

The IL-7 and TSLP pathways have been genetically and biologically implicated in driving several T cell-mediated pathological processes in numerous autoimmune diseases.

Q32 Bio's lead program for innate immunity, ADX-097, is based on a pioneering approach enabling tissue-targeted regulation of the complement system without long-term systemic blockade a key differentiator versus current complement therapeutics.

Q32 Bio is currently conducting a first-in-human, Phase 1, ascending dose (SAD/MAD) clinical study of ADX-097 for the treatment of complement disorders.

Horizon is a global biotechnology company focused on the discovery, development and commercialization of medicines that address critical needs for people impacted by rare, autoimmune and severe inflammatory diseases.