Q32 Bio Inc., a biotech company focused on immune therapies, and Homology Medicines, Inc., have finalized an all-stock merger to advance Q32 Bio’s treatments for autoimmune and inflammatory diseases. The combined entity, operating as Q32 Bio, targets clinical milestones with investments from prominent backers. CEO Jodie Morrison anticipates Phase 2 milestones for their lead candidate by 2024. Homology’s President, Albert Seymour, sees this merger as a strategic move for patient care. The funding will propel the development of bempikibart and ADX-097, offering promising treatments for conditions like atopic dermatitis and ANCA-Associated Vasculitis.
Q32 Bio Inc., a clinical-stage biotechnology company developing biologic therapeutics to restore immune homeostasis, and Homology Medicines, Inc. (Nasdaq: FIXX), today announced they have entered into a definitive merger agreement to combine the companies in an all-stock transaction. The combined company will focus on advancing Q32 Bio’s wholly-owned clinical development candidates for the treatment of autoimmune and inflammatory diseases. Upon completion of the merger, the combined company will operate as Q32 Bio, headquartered in Waltham, Massachusetts, and is expected to trade under the Nasdaq ticker symbol “QTTB”.
In support of the merger agreement, Q32 Bio has agreed to a $42 million private placement with participation from existing and new investors including OrbiMed, Atlas Venture, Abingworth, Bristol Myers Squibb, Acorn Bioventures, Osage University Partners (OUP), CU Healthcare Innovation Fund, Sanofi Ventures, Agent Capital and other undisclosed investors.
“The proposed merger with Homology Medicines and concurrent private placement is expected to provide Q32 Bio with the capital to drive the development of our autoimmune and inflammatory pipeline through multiple clinical milestones,” said Jodie Morrison, Chief Executive Officer of Q32 Bio. “This funding is expected to enable us to deliver two Phase 2 readouts for bempikibart in the second half of 2024, proof-of-concept data for ADX-097, a tissue-targeted inhibitor of complement activation, by year-end 2024, and topline ADX-097 clinical results in the second half of 2025.”
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“Following a comprehensive assessment of our strategic options, management and the Board of Directors believe the merger with Q32 Bio is in the best interest of our shareholders,” said Albert Seymour, President, and Chief Executive Officer of Homology Medicines. “The Q32 Bio management team’s extensive track record, deep biopharmaceutical expertise, and the potential of its clinical development pipeline provide a compelling opportunity to deliver meaningful treatments to patients with critical unmet needs.”
Proceeds from the proposed transactions will be used to advance the clinical development of Q32 Bio’s two wholly owned assets, bempikibart (ADX-914), for which Q32 Bio earlier today announced it regained all rights from Amgen and ADX-097.
Bempikibart, Q32 Bio’s lead program, 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.
ADX-097 is based on a novel platform enabling tissue-targeted regulation of the complement system without long-term systemic blockade, a key differentiator from current complement therapeutics. Q32 Bio recently completed a first-in-human, Phase 1 ascending dose clinical study of ADX-097 in healthy volunteers. Results from the Phase 1 clinical trial demonstrated a favorable tolerability and immunogenicity profile across all single and multiple dose cohorts and weekly subcutaneous dosing met exposures for predicted complete complement inhibition in the tissue with no systemic inhibition. Q32 Bio will be commencing an open-label Phase 2 basket clinical trial, with initial data expected by year-end 2024, and a Phase 2 clinical trial in ANCA-Associated Vasculitis (AAV), with topline results from the AAV and basket trials expected in the second half of 2025.
Source: Biospace