Biotherapeutics Expansion in Immunology and Autoimmunity

Biotherapeutics Expansion in Inflammatory and Immunology Therapies: How is Preclinical Testing Adapting?

The 2010s were marked by a major expansion in biotherapeutics development, as Keytruda, Opdivo, and a host of other immuno-oncology (I/O) drugs reshaped the oncology market across multiple indications. These PD-1 immunotherapies set a high bar, both clinically and commercially, that many biopharma companies have spent the past decade trying to match

Unfortunately, many of those efforts have struggled to reproduce similar outcomes, and the broader pipeline has become saturated with attempts to improve upon or combine checkpoint inhibitors. More recently, emerging and large biopharma companies have reoriented their pipelines towards indications in the inflammation and immunology (I&I) therapeutic space, where antibody therapeutics can modulate immune pathways with greater mechanistic precision. Just look at Sanofi’s recent $1.7B deal with Dren Bio to develop autoimmune drugs, building off their pre-existing partnership around the acquisition of a bispecific antibody, DR-0201, that directs B-cell depletion.

I&I Therapeutic Opportunities

Inflammation and immunology diseases encompass a range of chronic conditions, including rheumatoid arthritis, multiple sclerosis, type 1 diabetes, and others, characterized by aberrant immune activity that traditional broad immunosuppressants only partially control. Antibody-based immunotherapies offer the potential for more targeted intervention by selectively modulating immune cell activity and signaling pathways.

Approved and emerging antibody therapies in I&I commonly target cytokines (e.g., TNF-α, IL-1, IL-6), immune cell surface markers (e.g., CD20 on B cells, CD40 on T cells), or intracellular signaling pathways such as JAK and TYK kinases. Despite a growing number of approved biologics, innovation in this space remains active. Ziltivekimab, for example, is an anti-IL-6 monoclonal antibody under development for cardiovascular disease in patients with chronic kidney disease, highlighting the continued expansion of immune-targeted antibodies beyond traditional autoimmune indications.

The Needs of Preclinical I&I Programs

Preclinical research for I&I biologics requires a different assay strategy than that used in oncology-focused cytotoxicity screens. Rather than prioritizing tumor cell killing, I&I programs require functional and phenotypic assays that characterize immune modulation, including T-cell activation, cytokine up- and down-regulation, and immune cell phenotyping.

Assays that assess activation thresholds, cytokine secretion, and T-cell dynamics are critical for understanding the MoA, informing translational strategy, and evaluating safety. These functional immunology assays are foundational tools for de-risking I&I antibody programs before entering the clinic.

Flexible Antibody Characterization with Eurofins Discovery

Eurofins Discovery supports I&I antibody development with a comprehensive portfolio of immunology services designed to deliver mechanistic insight and translational relevance, including:

T-cell activation assays to evaluate antigen-specific responses
Flow cytometry assays for immune cell phenotyping and cytokine production
Cytotoxicity and cell-based assays to assess ADCC, CDC, and/or ADCP
Co-culture systems with multiplexed readouts that capture complex immune interactions
Cytokine regulation panels to quantify changes in inflammatory signaling pathways

Most antibody programs are not “plug-and-play.” Eurofins Discovery differentiates itself through customized assay design tailored to each program’s mechanism, target, and format. Our teams work collaboratively with clients to define, develop, and validate assays that align with scientific objectives, regulatory expectations, and translational goals.

As antibody development continues to evolve beyond I/O into the complexity of immune modulation and chronic autoimmune diseases, flexibility in assay design and execution will be key drivers of success.

Biotherapeutics Expansion in Immunology and Autoimmunity

I&I Therapeutic Opportunities

The Needs of Preclinical I&I Programs

Flexible Antibody Characterization with Eurofins Discovery

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