Eli Lilly and Company has entered into a definitive agreement to acquire Orna Therapeutics, a biotechnology company specialising in in vivo immune cell engineering, as the pharmaceutical group looks to accelerate the development of next-generation cell therapies for autoimmune diseases.
Under the terms of the deal, Orna shareholders could receive up to $2.4bn in cash, including an upfront payment and additional milestone-based payments linked to clinical development progress.
The transaction is expected to support Lilly’s long-term strategy in genetic medicine and advanced cell therapy platforms.
Orna is developing a novel class of therapeutics based on engineered circular RNA combined with proprietary lipid nanoparticle (LNP) delivery systems.
Unlike conventional ex vivo CAR-T approaches, Orna’s technology is designed to enable patients’ bodies to generate therapeutic immune cells in vivo, potentially reducing manufacturing complexity, costs and logistical barriers associated with personalised cell therapies.
The company’s lead asset, ORN-252, is a clinical trial-ready, CD19-targeting in vivo CAR-T candidate intended to treat B-cell-driven autoimmune diseases.
Preclinical data suggest Orna’s circular RNA platform may enable more durable expression of therapeutic proteins compared with existing linear RNA technologies, potentially expanding the scope of diseases addressable through RNA-based and cell therapy modalities.
Lilly said the acquisition aligns with growing evidence that autologous CAR-T therapies can deliver meaningful clinical benefit in autoimmune indications, while acknowledging that current ex vivo manufacturing models present significant scalability and access challenges.
Francisco Ramírez-Valle, Senior Vice President and Head of Immunology Research and Early Clinical Development at Lilly, said: "Early autologous CAR-T studies have shown the promise of cell therapy for patients with autoimmune diseases, but the complexity, cost and logistics of ex vivo approaches make it challenging to deliver these breakthroughs to the broader population."
He added that the integration of Orna’s platform could enable "an entirely new class of genetic medicines and cell therapies" for patients with limited treatment options.
From a manufacturing perspective, the move reflects increasing industry interest in in vivo approaches that could streamline supply chains, reduce reliance on patient-specific manufacturing and support more scalable production models for advanced therapies.
Joe Bolen, CEO of Orna Therapeutics, said the partnership with Lilly would help realise the full potential of the company’s circular RNA and LNP technologies across a broad range of autoimmune indications.
Lilly will determine the accounting treatment of the transaction in accordance with Generally Accepted Accounting Principles (GAAP) following completion, with the acquisition subsequently reflected in its financial results and guidance.