Boehringer Ingelheim Expands I&I Portfolio with $357M for Cue

Boehringer Ingelheim has entered into a significant licensing agreement with Cue Biopharma, focusing on the development of CUE-501, a bispecific molecule. This molecule targets autoimmune and inflammatory conditions by selectively depleting B cells. The German pharmaceutical company has committed an initial $12 million to gain rights to this investigational therapy, with potential further investment totaling up to $345 million based on achieving specified research, development, and commercialization milestones. Additionally, Cue Biopharma will receive royalties from the net sales of CUE-501.

CUE-501 is a preclinical compound designed to bind to a specific protein present on B cells. It also activates a particular subset of killer T cells, leading to the selective depletion of B cells. This mechanism aims to provide an advantage over existing cell therapy strategies by avoiding the systemic activation of all T cells, which can lead to unwanted side effects.

As part of this collaboration, Cue Biopharma will use its platform technologies to advance the development of CUE-501. The partnership may expand to include other bispecific molecules targeting B cells for autoimmune diseases. Carine Boustany, who heads Immunology and Respiratory Disease Research at Boehringer Ingelheim, highlighted that this deal represents a strategic extension of their work in autoimmune and inflammatory diseases. It aims to offer patients more effective treatments earlier in their disease progression.

Boehringer Ingelheim's existing portfolio in immunology and inflammatory diseases includes the oral kinase inhibitor Ofev, which is used to treat idiopathic pulmonary fibrosis (IPF). In 2024, Ofev's sales increased by 7%, reaching around $4.26 billion. Despite a decrease of approximately 17% from the prior year, the company’s asthma medication Spiriva also remained a significant contributor, generating over $1.8 billion in sales last year.

In September 2024, Boehringer Ingelheim announced positive results from the Phase III FIBRONEER-IPF study of nerandomilast, another of its drug candidates, which demonstrated significant lung function improvements in IPF patients. The company plans to pursue regulatory approval for nerandomilast in this indication, although no specific timeline has been disclosed.

Beyond its efforts in immunology and inflammation, Boehringer Ingelheim has engaged in multiple strategic collaborations and acquisitions throughout the past year. In January, the company formed partnerships focusing on antibody development, collaborating with Lonza’s Synaffix and Oxford BioTherapeutics in the field of oncology. Furthermore, in July 2024, Boehringer Ingelheim invested $1.3 billion to acquire Nerio Therapeutics, gaining access to small molecule assets capable of modulating the immune system to target cancerous tumors.

This licensing deal with Cue Biopharma reflects Boehringer Ingelheim's ongoing commitment to advancing novel therapies for complex diseases and expanding its influence in the biopharmaceutical landscape. By enhancing its pipeline with innovative treatments like CUE-501, the company aims to address unmet medical needs and improve patient outcomes in autoimmune and inflammatory conditions.