Q32 Bio Launches to Develop Next-Gen Therapies for Severe Autoimmune and Inflammatory Diseases

Rare Daily Staff

Q32 Bio, a biotechnology company developing biologics to restore healthy immune regulation, launched with a $46 million in a series A financing.

Atlas Venture led the financing, which included investment from OrbiMed Advisors, Abingworth, Sanofi Ventures, University of Colorado, and Children’s Hospital Colorado Center.

The company has a pipeline of biologics targeting the body’s innate and adaptive immune systems. This includes a monoclonal antibody antagonist of the interleukin-7 receptor (IL-7R), and a complement therapeutics platform that has generated fusion proteins that down-regulate complement activity specifically in disease-affected tissues.

Q32 Bio’s most advanced program, ADX-914, is a fully human anti-IL-7R antibody licensed from Bristol Myers Squibb that re-regulates adaptive immune function. The cytokine IL-7 has demonstrated the ability to drive several T-cell mediated pathological processes. It stimulates T-effector and T-memory cells, lowering the threshold-response to disease related antigens; inhibits the immunosuppressive function of T-regulatory cells; and promotes pathogenic autoantibody production. Inhibition of IL-7R signaling has the potential to durably and safely restore healthy immune regulation in numerous autoimmune and inflammatory diseases.

Q32 Bio is advancing plans for the first-in-human trial of ADX-914 while continuing to monitor the potential impact of COVID-19 on clinical operations. Pending confirmation that trial sites are able to operate and enroll patients safely, a biomarker-guided ADX-914 phase 1 trial is planned to start in late 2020.

Q32 Bio’s lead program in innate immunity, ADX-097, is based on a platform providing tissue-targeted regulation of the complement system. Complement is an integral component of the innate immune system that provides a first line of defense for clearing pathogens and removing damaged cells. In a wide range of autoimmune and inflammatory diseases the complement system becomes hyper-activated, causing the immune system to attack and damage otherwise healthy tissue.

Q32 Bio’s proprietary platform has yielded a pipeline of novel protein therapeutics that provide potent inhibition of complement in diseased tissues without long-term systemic blockade – a key differentiator versus current complement therapeutics. Q32 Bio has initiated IND-enabling activities for ADX-097 and first-in-human dosing is planned for the second half of 2021.

Q32 Bio CEO Michael Broxson has more than 20 years of industry experience, first at Takeda Pharmaceuticals, and then at Goldfinch Bio, where he was chief business and operating officer. Co-founder Shelia Violette is the biotech’s chief scientific officer and president of research. Violette joined Q32 Bio from Atlas Venture, where she was an entrepreneur in residence and initially co-led the formation of Q32 Bio. Previously she served in leadership roles Biogen and Stromedix.

Q32 Bio was seeded and incubated by Atlas Venture with foundational science from Immunology researchers Michael Holers, and Joshua Thurman, both from the University of Colorado, and Steven Tomlinson, from the Medical University of South Carolina. Holers serves as chairman of the Scientific Advisory Board.

“Given their broad roles in mediating immunity, the complement system and IL-7 signaling pathways are high potential arenas for drug development,” said Dave Grayzel, partner at Atlas Venture and chairman of the Q32 Bio board of directors. “With a best-in-class IL-7R antibody and fusion proteins designed to target the complement system at sites of activation in a unique and differentiated manner, Q32 Bio is well positioned to make a meaningful impact for patients with serious inflammatory and autoimmune diseases.”

Photo: Michael Broxson, CEO of Q32 Bio