Q32 Bio and Horizon Therapeutics have entered into a collaboration and option agreement to develop ADX-914 for the treatment of autoimmune diseases.
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.
“Horizon is a leader in the autoimmune and inflammatory disease space and brings to this collaboration both the resources and experience of a pharmaceutical company and the speed and agility of a biotech,” said Michael Broxson, Chief Executive Officer of Q32 Bio. “We’re very excited to combine our strengths and expertise to continue to advance ADX-914 for autoimmune diseases, an area that is underserved by existing therapeutics and one where we hope to deliver life-changing medicines for patients in need.”
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 $55 million in the form of initial consideration and staged development funding, of which Horizon expects to recognize as R&D expenses approximately $32.5 million in the third quarter of 2022, 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 $645 million in closing and milestone payments, as well as tiered royalties on net sales, less certain amounts payable under a pre-existing license agreement.
“We are very pleased to begin our collaboration with Q32 to advance ADX-914 through the next phase of clinical development,” said Elizabeth H.Z. Thompson, Ph.D., executive vice president, research and development, Horizon. “By targeting the IL-7 and TSLP pathways, which are biologically and genetically implicated as central mediators of T cell-mediated pathologies, ADX-914 represents a novel approach to targeting a number of autoimmune diseases with the potential to restore healthy immune regulation.”