Q32 Bio has signed a partnership and option agreement with Horizon Therapeutics for developing ADX-914 to treat autoimmune ailments.

According to the deal, Horizon will provide the funding to develop the therapy until the conclusion of its two Phase II clinical trials.

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Furthermore, Q32 will oversee the conduct of all programme-linked works. 

Under the agreement, Horizon will hold an option for the acquisition of the ADX-914 programme, which is exercisable through a period after concluding the Phase II trials. 

Q32 is entitled to get $55m as initial consideration and staged development funding during the option period.

Of this amount, Horizon plans to recognise research and development (R&D) costs of nearly $32.5m in the third quarter of this year and the remaining funds next year.

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On Horizon exercising the option, Q32 could be entitled to further receive up to another $645m in closing and milestone payments.

Q32 will also receive tiered royalty payments on net sales.

A fully human anti-IL-7Rα antibody, ADX-914 re-regulates adaptive immune function by hindering IL-7 and TSLP-facilitated signalling. 

Recently, Q32 concluded a Phase I clinical trial to evaluate the pharmacokinetics, pharmacodynamics and safety of ADX-914, which showed a pharmacological effect on T cells in healthy subjects. 

The company anticipates commencing a Phase II trial of the therapy for atopic dermatitis later this year and plans to begin a Phase II trial for another autoimmune disease next year.

Horizon research and development executive vice-president Elizabeth Thompson said: “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.”

In July, the US Food and Drug Administration (FDA) approved Horizon’s supplemental Biologics License Application for Krystexxa (pegloticase) plus methotrexate, to aid uncontrolled gout patients attain a complete response to treatment.

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