Eli Lilly and Company has entered into a definitive agreement to acquire Orna Therapeutics, a biotechnology company focused on engineering immune cells directly within the body, in a move aimed at expanding its capabilities in next-generation cell and genetic medicines.
The acquisition is expected to strengthen Lilly’s immunology pipeline by integrating Orna’s proprietary platform based on engineered circular RNA combined with novel lipid nanoparticle delivery systems. This technology is designed to enable patients’ own cells to generate therapeutic immune responses in vivo, potentially overcoming the complexity and logistical challenges associated with conventional ex vivo cell therapies.
Orna’s lead asset, ORN-252, is a clinical trial-ready in vivo chimeric antigen receptor T-cell (CAR-T) therapy targeting CD19. The program is being developed for the treatment of B cell-driven autoimmune diseases and represents a new approach to applying CAR-T therapies beyond oncology. Preclinical studies conducted to date indicate that Orna’s circular RNA platform may support more durable expression of therapeutic proteins compared with traditional RNA-based or cell therapy technologies, potentially enabling treatments not achievable with existing modalities.
The transaction reflects growing industry interest in in vivo cell therapy strategies, which aim to simplify manufacturing, reduce costs, and broaden patient access by eliminating the need for personalised cell extraction and reinfusion processes.
Under the terms of the agreement, Lilly will acquire Orna Therapeutics, with Orna shareholders eligible to receive up to $2.4 billion in cash. The consideration includes an upfront payment as well as additional payments contingent on the achievement of specified clinical development milestones.
Following the completion of the transaction, Lilly will determine the appropriate accounting treatment in accordance with Generally Accepted Accounting Principles. The acquisition will subsequently be incorporated into the company’s financial statements and forward guidance.
Paul, Weiss, Rifkind, Wharton & Garrison LLP is serving as legal counsel to Lilly, while Lazard is acting as financial advisor to Orna Therapeutics. Goodwin Procter LLP is providing legal counsel to Orna.
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