Bristol Myers Squibb has entered into a definitive agreement to acquire Orbital Therapeutics. Orbital’s technology aims to reprogramme the immune system in vivo, enabling highly precise and adaptable therapies that target the underlying biology and complexities of individual diseases.

“In vivo CAR-T represents a novel treatment approach that could redefine how we treat autoimmune diseases. This acquisition enhances our robust cell therapy research platform and provides an opportunity to advance a potential best-in-class therapy designed to deplete autoreactive B cells and reset the immune system. We are excited by the promise this holds for patients with autoimmune diseases who are waiting for better options,” said Robert Plenge, MD, PhD, Executive Vice President, Chief Research Officer, BMS.

The acquisition includes Orbital’s RNA immunotherapy pre-clinical candidate currently in IND-enabling studies, OTX-201, which comprises an optimised circular RNA encoding a CD19-targeted CAR for in-vivo expression delivered via targeted Lipid NanoParticles (LNPs). This in-vivo approach, in which the patient’s own body serves as the manufacturer of CAR T-cells, has the potential to offer a reduced treatment burden and improved accessibility compared to ex-vivo CAR T-cell therapies. Additionally, BMS will acquire Orbital’s proprietary RNA platform, which integrates circular and linear RNA engineering, advanced LNP delivery and AI-driven design to enable durable, programmable RNA therapies tailored to the distinct biology of a broad spectrum of diseases.

“With the acquisition of Orbital Therapeutics and its next-generation RNA platform, we have an incredible opportunity to make CAR T-cell therapy more efficient and accessible to more patients. As a leader in cell therapy, we are uniquely positioned to evaluate multiple different platform approaches to induce immune reset in autoimmune diseases and continue to optimise in-vivo technology in clinical development,” said Lynelle B Hoch, President, Cell Therapy Organisation, BMS.

Under the terms of the agreement, BMS will pay USD 1.5 billion in cash at closing to acquire Orbital, which is subject to the satisfaction of customary closing conditions, including expiration of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, and until then, BMS and Orbital will continue to operate as separate and independent companies. The accounting treatment as a business combination or asset acquisition will be determined upon the expected close of the transaction.

 “This agreement with Bristol Myers Squibb, a recognised leader in global medicine, marks a transformational moment for Orbital and the advancement of RNA medicine. Since inception, Orbital has made significant strides developing a differentiated RNA platform designed to enable a new generation of RNA medicines that reach more tissues, address more diseases, and benefit more patients. The promising early data from our lead programme, OTX-201, underscore the strength of this approach and the potential of our integrated RNA technologies. Together, we aim to deliver RNA medicines that provide patients with treatments that are simpler, safer and more accessible compared to today’s complex therapies,” said Ron Philip, Chief Executive Officer, Orbital Therapeutics.