Bristol Myers Squibb (BMS) has agreed to acquire CAR-T specialist Orbital Therapeutics for $1.5bn, adding several RNA-based therapies to the drugmaker’s portfolio.
BMS will pay the full amount in cash to buy privately held Orbital, a biotech that is developing in vivo immunotherapies that reprogram T cells to identify and attack
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Orbital does not have any programmes in clinical trials currently, though its lead product OTX-201 is in investigational new drug (IND)-enabling studies. OTX-201, which comprises a circular RNA encoding a CD19-targeted CAR for in vivo expression, is delivered via targeted lipid nanoparticles (LNPs). Clinical evaluation of the drug is expected in the first half of 2026.
Orbital states that the asset is being developed for “B-cell driven autoimmune diseases”. B-cell driven autoimmune diseases span more than 40 disease indications across multiple therapeutic areas, including rheumatology, neurology, and dermatology.
“In vivo CAR T represents a novel treatment approach that could redefine how we treat autoimmune diseases,” said BMS’ chief research officer, Robert Plenge.
“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,” Plenge added.
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By GlobalDataPlatforms that employ the in vivo approach, in which the patient’s own body serves as the manufacturer of CAR T-cells, are gaining traction over ex vivo peers. In vivo CAR T-cell therapies are preferred for organs that cannot be readily accessed and have the benefits of reducing both costs and manufacturing complexity. Analysts at GlobalData, for example, forecast the class could displace ex-vivo in the future, despite safety concerns.
Also, as part of the acquisition, BMS will acquire Orbital’s proprietary RNA platform. As per Orbital, the platform provides the framework to develop anti-cancer therapies, RNA vaccines, and protein therapeutics.
BMS’ Cell Therapy Organisation president Lynelle Hoch said: “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.”
BMS already has two US Food and Drug Administration (FDA)-approved ex vivo CAR T therapies – Breyanzi (lisocabtagene maraleucel) for certain B-cell lymphomas and Abecma (idecabtagene vicleucel) for multiple myeloma treatment.
BMS’ buyout of Orbital comes at an uncertain time in the cell and gene therapy sector. Japanese big pharma Takeda pulled the plug on its cell therapy programmes, instead deciding to focus on antibody-drug conjugates (ADCs), biologics and small molecules.
Vor Bio meanwhile pivoted to the lucrative autoimmune sector, calling it a day on its advanced therapy pipeline.
However, CAR-T has been a beacon of light in the sector. AbbVie and AstraZeneca have both outlaid significant funds on the modality, acquiring Capstan Therapeutics and EsoBiotec for $2.1bn and up to $1bn in March and July 2025, respectively.
Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.
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