Bristol Myers Squibb Co has stepped up its commitment to cell therapies with plans to spend $1.5 billion to acquire a Cambridge, Massachusetts biotech which is developing a medicine to reprogramme the immune system and treat autoimmune diseases. Orbital’s lead product, OTX-201, is an in vivo chimeric antigen receptor (CAR) T cell therapy that is being developed using ribonucleic acid (RNA) technology. The preclinical product consists of a circular RNA that encodes a CAR which targets cells expressing CD19, a B cell specific antigen. The RNA molecule is delivered to the body using lipid nanoparticles. Once delivered, the body manufactures CAR T cells internally in order to induce the immune system to reset in cases of an autoimmune disease.
On 22 July, Orbital presented preclinical data for OTX-201 which showed that it achieved the full depletion of B cells in blood, spleen and lymph nodes in an autoimmune setting. While B cells defend the body against pathogens they can also malfunction and contribute to the production of auto-antibodies.
Orbital, soon to be part of BMS, said it planned to start clinical development of OTX-201 in the first half of 2026. In a statement, Robert Plenge, BMS’s chief research officer, said that in vivo CAR T therapies “could redefine how we treat autoimmune diseases.” The in vivo cell therapy is a relatively new approach, following on from ex vivo CAR T cell therapies that were first approved by the US Food and Drug Administration in 2017. The first ex vivo treatment was Kymriah (tisagenlecleucel) for acute lymphoblastic leukaemia and produced by Novartis. Three more ex vivo therapies were then approved in a second wave. One of these was Breyanzi (lisocabtagene maraleucel) from BMS which was authorised in 2021 for refractory large B-cell lymphoma. A month later, BMS had a second ex vivo product approved for multiple myeloma. This was Abecma (idecabtagene vicleucel). In 2024 Breyanzi generated sales of $747 million and Abecma, $406 million.
Copyright 2025 Evernow Publishing Ltd