— Q32 Bio now wholly owns development and commercialization rights to the anti-IL-7Rα antibody, currently being evaluated in two Phase 2 trials for atopic dermatitis (AD) and alopecia areata (AA) —

— Re-acquisition bolsters Q32 Bio’s autoimmune product portfolio and broadens strategic opportunities —

WALTHAM, MA, USA I November 16, 2023 I Q32 Bio, a clinical stage biotechnology company developing biologic therapeutics to restore immune homeostasis, today announced that it will regain full development and commercial rights to bempikibart (previously known as ADX-914) from Amgen.

In 2022, Q32 Bio and Horizon Therapeutics (Horizon) entered into a collaboration and option agreement to develop bempikibart in autoimmune diseases. Under the terms of the agreement, Q32 Bio received $55 million in initial consideration and staged development funding for the completion of the two ongoing Phase 2 trials, subsequent to which Horizon had an option to acquire the program at a prespecified price. Following the recent closing of Amgen’s acquisition of Horizon earlier this quarter, Q32 Bio has entered into an agreement to re-acquire all of Horizon’s rights to bempikibart.

Bempikibart is a fully human anti-IL-7Rα antibody that re-regulates adaptive immune function by blocking signaling mediated by both IL-7 and TSLP and is currently being evaluated in two Phase 2 trials, with one clinical trial evaluating the use in atopic dermatitis (AD) and one evaluating the use in alopecia areata (AA). All data from the Phase 2 trials remain blinded and Q32 Bio remains on track to report topline Phase 2 results in the second half of 2024.

“We are very excited to regain rights to bempikibart as we advance the program in the ongoing Phase 2 programs,” said Jodie Morrison, Chief Executive Officer of Q32 Bio. “Through its blockade of IL-7 and TSLP, we believe bempikibart has the potential to bring a differentiated, disease-modifying alternative to the treatment of high unmet need autoimmune and inflammatory diseases. We are committed to advancing bempikibart expeditiously through both the AD and AA Phase 2 clinical trials and look forward to unblinding the ongoing clinical trials and releasing topline data in the second half of next year.”  

Under the terms of the re-acquisition agreement with Amgen, Q32 Bio retains the initial consideration and all development funding received. Q32 Bio will pay Amgen a milestone upon the first regulatory approval and subsequent downstream commercial milestones based on annual net sales thresholds.

About Q32 Bio

Q32 Bio is a clinical stage biotechnology company developing biologic therapeutics targeting potent regulators of the innate and adaptive immune systems to re-balance immunity in 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 wholly owned bempikibart (ADX-914) is a fully human anti-IL-7Rα antibody that re-regulates adaptive immune function and is being developed for the treatment of autoimmune diseases, including Phase 2 trials in atopic dermatitis and alopecia areata. 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 program for innate immunity, ADX-097, is based on a novel platform enabling tissue-targeted regulation of the complement system without long-term systemic blockade – a key differentiator versus current complement therapeutics. Q32 Bio has recently completed a first-in-human, Phase 1 clinical study of ADX-097 in healthy volunteers.

For more information, visit www.Q32bio.com.