Cambridge, Mass. – October 18, 2021 – Q32 Bio, a clinical stage biotechnology company developing biologic therapeutics to restore immune homeostasis, today announced that it will present preclinical data supporting the Company’s lead program for innate immunity, ADX-097, during an oral presentation at the American Society of Nephrology (ASN) Kidney Week 2021, taking place virtually from November 4 to 7, 2021. Abstracts are available at www.asn-online.org/education/kidneyweek/2021/program-abstract.aspx?controlId=3609511. ADX-097 is a first-in-class fusion protein that Q32 Bio is developing to restore innate immune balance via targeted regulation of the complement cascade directly in diseased tissue without long-term systemic blockade.
“We are developing ADX-097, a first-in-class, next generation complement inhibitor that has been designed to specifically target diseased tissue where the complement system is overactive. This approach has the potential to provide potent and durable efficacy with decreased risk of infection as compared to systemic complement inhibitors,” said Shelia Violette, Ph.D., Co-Founder, Chief Scientific Officer and President of Research of Q32 Bio. “We are advancing ADX-097 as a potential therapy with a favorable route of administration and a dosing regimen that reduces treatment burden for patients, and we believe ADX-097 has the potential to treat multiple complement-mediated diseases of high unmet need. We look forward to presenting data from the program at ASN Kidney Week 2021.”
Summary: ADX-097, a humanized anti-C3d monoclonal antibody linked to two moieties of the first five consensus repeats of the complement negative regulatory protein human factor H (fH1-5), binds to high-density glomerular C3d across a range of renal disease models. Preclinical studies demonstrate potent, durable, and efficacious complement blockade in kidney while avoiding systemic complement inhibition.
ADX-097 is a first-in-class fusion protein that Q32 Bio is developing to restore innate immune balance by potent and targeted regulation of complement directly in diseased tissues without long-term systemic blockade. In preclinical studies, ADX-097 has proven in vivo biodistribution to affected tissues/organs, durable tissue pharmacokinetics (PK)/pharmacodynamics (PD), robust in vivo efficacy, and attractive drug properties. Q32 Bio plans to initiate first-in-human trials for ADX-097 in the first half of 2022.
About Q32 Bio
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. 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 has completed dosing in a Phase 1 trial of ADX-914 in healthy volunteers and plans to initiate Phase 2 studies in in the first half of 2022.
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 plans to initiate first-in-human trials for ADX-097 in the first half of 2022.
For more information, please visit www.Q32bio.com.
Investors: Brendan Burns
Media: Sarah Sutton