Q32 Bio, a clinical-stage biotech developing treatments for autoimmune and inflammatory diseases, announced it has entered into a definitive agreement to merge with Homology Medicines in an all-stock deal. The combined company will operate under the Q32 Bio name and focus on progressing Q32’s pipeline of novel immunomodulators.
Q32 is developing bempikibart (ADX-914), an anti-IL-7Rα antibody, as well as ADX-097, a tissue-targeted complement inhibitor. The merger will provide Q32 with access to public markets and additional capital to support the advancement of these programs through upcoming milestones.
Under the terms of the agreement, Homology Medicines shareholders will receive 25% ownership in the combined company, with Q32 shareholders owning 75%. The Board of Directors will consist of seven members from Q32 Bio and two from Homology Medicines. The companies expect the transaction to close in Q1 2024.
Regaining Worldwide Rights to Lead Candidate Bempikibart
Concurrent with the merger announcement, Q32 revealed that it has re-acquired full worldwide rights to bempikibart from Amgen. Q32 originally licensed bempikibart from Amgen in 2021 after the pharma giant took it through Phase 1 trials.
Bempikibart blocks signaling mediated by IL-7 and TSLP to modulate T cell-driven inflammation. It is currently being evaluated in two Phase 2 studies in atopic dermatitis and alopecia areata, with topline results expected in the second half of 2024.
Regaining full rights to bempikibart provides Q32 with greater control over the program’s development and commercial potential. The merger and additional funding will support pivotal studies to bring bempikibart to market.
Advancing Complement Inhibitor ADX-097 into the Clinic
In addition to bempikibart, Q32 is developing ADX-097 as an innovative approach to inhibiting complement activation for autoimmune and inflammatory disorders. Excessive complement activation is implicated in diseases like ANCA-associated vasculitis, IgA nephropathy, and NMOSD.
Unlike current complement drugs that cause systemic inhibition, ADX-097 is engineered to potently inhibit complement only in targeted tissues. This allows greater on-target activity with potentially improved safety.
Q32 recently completed a Phase 1 trial of ADX-097, demonstrating a favorable tolerability and immunogenicity profile. The company will now advance ADX-097 into Phase 2 testing, with initial proof-of-concept data expected by end of 2024 and topline results from two trials in 2H 2025.
Strengthening Financial Position to Reach Critical Milestones
To support its pipeline advancement, Q32 has secured a $42 million private placement in conjunction with the proposed merger. New and existing investors participated, including OrbiMed, Bristol Myers Squibb, Sanofi Ventures and others.
This additional capital will fund operations through several key milestones:
- Phase 2 data for bempikibart in atopic dermatitis and alopecia areata in 2H 2024
- Initial Phase 2 proof-of-concept data for ADX-097 by end of 2024
- Topline Phase 2 results for ADX-097 in 2H 2025
The combined company is expected to have approximately $115 million in cash at closing, providing runway into mid-2026. This strengthened financial position will enable Q32 to reach meaningful catalysts for its lead programs.
Experienced Leadership to Drive Clinical Development
The combined immunology-focused company will be led by the Q32 Bio executive team, including:
- Jodie Morrison, CEO
- Shelia Violette, PhD, Founder and CSO
- Jason Campagna, MD, PhD, CMO
- Saul Fink, PhD, CTO
- Maria Marzilli, MPH, EVP of Corporate Strategy & Operations
- David Appugliese, JD, SVP, Head of People
Q32’s management has extensive experience leading R&D, corporate strategy, and operations at companies like Editas Medicine, Bioverativ, and Ironwood Pharmaceuticals.
Ms. Morrison commented, “The proposed merger with Homology Medicines and concurrent private placement is expected to provide Q32 Bio with the capital to drive development of our autoimmune and inflammatory pipeline through multiple clinical milestones. We look forward to delivering Phase 2 data for bempikibart and ADX-097 that could support the advancement of these programs toward commercialization.”
The transaction will provide Q32 Bio with the financial capacity and public listing to further advance its pipeline of novel immunology therapies for patients with autoimmune and inflammatory diseases. Shareholders of both companies will have the opportunity to realize future value if the combined pipeline progresses as planned.