Q32 Biologics, based in Cambridge, Mass., announced the official launch of the company, with plans to enter the clinic this year with its lead candidate, ADX-914, and a portfolio of biologics targeting the body’s innate and adaptive immune systems. Q32 Bio was seeded and incubated by Atlas Venture with foundational science from renowned researchers in immunology Michael Holers, M.D. and Joshua Thurman, M.D., both from the University of Colorado, and Steven Tomlinson, Ph.D. from the Medical University of South Carolina. Dr. Holers serves as chairman of the Scientific Advisory Board, which is comprised of distinguished global experts in autoimmune and inflammatory disease. The subsequent $46 million Series A financing included Atlas Venture, OrbiMed Advisors, Abingworth, Sanofi Ventures, University of Colorado and Children’s Hospital Colorado Center for Innovation.
Q32 Bio’s most advanced program is ADX-914, is a fully human anti-IL-7R antibody licensed from Bristol Myers Squibb that re-regulates adaptive immune function. Inhibition of IL-7R signaling has the potential to durably and safely restore healthy immune regulation in numerous autoimmune and inflammatory diseases. Due to the potential impact of COVID-19 on clinical operations, Q32 Bio awaiting confirmation that trial sites can operate and enroll patients safely. Once that is received a Phase 1 trial is planned to start in late 2020.
Q32 Bio is developing ADX-914 (formerly known as BMS-986265) as part of an exclusive worldwide licensing agreement with Bristol Myers Squibb. Under the terms of the agreement, Bristol Myers Squibb received an upfront payment and became a minority shareholder of Q32 Bio. Bristol Myers Squibb has the potential to earn additional milestone payments subject to the achievement of certain development, regulatory and sales-based milestones, as well as tiered annual net sales royalties. Q32 Bio is solely responsible for all future development and commercialization costs of ADX-914.
Q32 Bio’s lead program in innate immunity, ADX-097, is based on a proprietary platform providing tissue-targeted regulation of the complement system. In a wide range of autoimmune and inflammatory diseases the complement system becomes hyperactivated, causing the immune system to attack and damage otherwise healthy tissue. Q32 Bio has initiated IND-enabling activities for ADX-097 and first-in-human dosing is planned for 2H 2021.
“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, MD, Partner, 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.”