Spero snaps up Innovent immunology drug in strategic pivot
Spero president and CEO Esther Rajavelu.
Spero Therapeutics has licensed rights to an anti-CD40L antibody developed by China's Innovent Biologics, planning to develop it for IgG4-related disease (IgG4-RD), a chronic, immune-mediated inflammatory disorder that causes tumour-like masses in organs.
Cambridge, Massachusetts-based Spero has pledged up to $1.1 billion in upfront and milestone payments for ex-Greater China rights to the drug, developed by Innovent as IBI355, and said it plans to start a phase 2 trial in IgG4-RD next year.
The company has also announced a $105 million financing that will be used to fund the development of IBI355, which it has renamed SP001. The financing comes from Healthcare Royalty, which has bought Spero's royalty and milestone payment stream for recently approved antibiotic Utebzi (tebipenem pivoxil), which is licensed to GSK.
The cash injection will give Spero operating money into the second half of 2029, enough time to explore SP001's potential in a range of immune-mediated diseases.
IgG4-RD is fairly rare, with 20,000 cases in the US, and is primarily seen in people – most often men – who are middle-aged or older. It has limited treatment options, although last year Amgen's anti-CD19 antibody Uplizna (inebilizumab) became the first FDA-approved treatment. It is very hard to diagnose as its scattergun impact on organs can mimic other diseases.
Innovent is focusing initially on developing IBI355 for Sjögren's disease (SjD), a chronic autoimmune disorder that causes dryness in mucosal surfaces like the eyes and mouth, as well as organ damage and an increased risk of life-threatening cancers, and said it plans to start a phase 2 trial in this indication early next year.
The deal marks a pivot in strategic direction for Spero, away from infectious disease therapies and towards the immunology and inflammation (I&I) category, said chief executive Esther Rajavelu.
"This in-licensing transaction establishes the foundation of our new pipeline and positions Spero to pursue potentially transformative therapies for patients living with chronic, debilitating conditions," she added.
"We view CD40L as a clinically validated pathway with broad applicability across several immune-mediated diseases."
CD40L is an immune signal protein that sits upstream of multiple immune pathways and has become a popular target for I&I therapy developers. The candidate arguably furthest along in development at the moment is Sanofi's frexalimab, in phase 3 trials for multiple sclerosis and kidney transplant rejection and phase 2 for type 1 diabetes and Graves' disease.
Others include UCB and Biogen's dapirolizumab pegol in phase 3 for systemic lupus erythematosus (SLE), as well as Eledon Pharma's tegoprubart and Tonix Pharma's TNX-1500 in early- to mid-stage human testing for transplant rejection.
