Bristol Myers Squibb (BMS) has entered into a significant agreement to acquire Orbital Therapeutics, a privately held biotechnology company recognized for its groundbreaking work in RNA medicines. This deal marks a strategic move for BMS as it seeks to enhance its portfolio in the field of immunotherapy.
Orbital Therapeutics is at the forefront of developing RNA-based therapies that have the potential to reprogram the immune system directly within the body, a process known as in vivo treatment. This innovative approach provides the precision, control, and flexibility necessary to address the distinct biological characteristics and complexities associated with various diseases.
As part of the acquisition, BMS will gain access to Orbital’s lead candidate, OTX-201, which is currently in the early stages of clinical studies aimed at securing Investigational New Drug (IND) status. OTX-201 features an optimized form of circular RNA that encodes a CD19-targeted chimeric antigen receptor (CAR). This CAR is designed for in vivo expression and is delivered using advanced lipid nanoparticles (LNPs). One of the key advantages of this method is that it allows the patient’s own body to produce CAR T-cells. This has the potential to reduce the treatment burden on patients and improve accessibility compared to traditional ex vivo CAR T-cell therapies, which require cells to be removed from the body, modified in a laboratory, and then reintroduced.
In addition to the OTX-201 candidate, BMS will also acquire Orbital’s proprietary RNA platform. This platform is notable for its integration of both circular and linear RNA engineering, sophisticated LNP delivery mechanisms, and AI-driven design capabilities. Together, these advancements are set to enable the development of durable and programmable RNA therapies that can be tailored to the unique biological needs of a wide array of diseases.
Under the terms of the acquisition agreement, BMS is set to pay $1.5 billion in cash upon closing. However, this transaction is dependent on meeting certain customary closing conditions. Until the requirements are satisfied, BMS and Orbital Therapeutics will continue to operate as separate and independent entities. The final accounting treatment of this acquisition will be determined based on the anticipated closing of the deal.
Advisors: Covington & Burling is serving as legal counsel to Bristol Myers Squibb. Centerview Partners is serving as the exclusive financial advisor to Orbital Therapeutics, and Goodwin Procter is serving as legal counsel.
KEY QUOTES:
“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.”
Robert Plenge, MD, PhD, executive vice president, Chief Research Officer, BMS
“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 optimize in vivo technology in clinical development.”
Lynelle B. Hoch, president, Cell Therapy Organization, BMS
“This agreement with Bristol Myers Squibb, a recognized 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 program, 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.”
Ron Philip, Chief Executive Officer, Orbital Therapeutics
