Pharma's Next-Gen Antibodies: Multi-Targeting Approach Gains Traction in Oncology and Autoimmune Diseases

The pharmaceutical industry is witnessing a surge in the development and testing of multifunctional antibodies, with a particular focus on bispecific and higher-order multispecific antibodies (msAbs). These advanced therapeutics, capable of targeting two or more sites simultaneously, are attracting significant investment and showing promise in both oncology and autoimmune diseases.

Rising Interest in Multispecific Antibodies

Since the FDA's approval of Amgen's Blincyto in 2014, the first bispecific therapy to hit the market, more than a dozen similar drugs have followed. The pipeline now boasts nearly 250 msAb candidates in clinical trials, with 24 in late-stage registrational studies, according to a recent report from Back Bay Life Science Advisors.

The growing interest in msAbs is driven by their potential for improved efficacy, safety profiles, and pharmacokinetics. Two msAbs have already achieved blockbuster status: Genentech's Hemlibra for hemophilia and Vabysmo for eye diseases. Industry experts predict more will reach this billion-dollar threshold in the coming years.

Expanding Beyond Oncology

While the majority of approved msAbs target cancer, there's a notable shift in the pipeline towards autoimmune diseases. This expansion is partly inspired by encouraging results seen with cell therapies in these indications.

Peter Bak, a managing director at Back Bay and co-author of the report, highlighted lupus as an area of particular interest. "Lupus is an area where there's been some interesting data generated by a couple academic groups, and now a lot of companies are rethinking their strategy," Bak noted.

Several companies are exploring msAbs for autoimmune conditions:

• Roche's Lunsumio, already approved for lymphoma, recently completed an early-stage trial in lupus.
• Amgen is testing Blincyto in phase 2 trials for lupus with nephritis and refractory rheumatoid arthritis.
• Cullinan Therapeutics' CLN-978 is in phase 1 trials for lupus and rheumatoid arthritis, with initial data expected in early 2026.
• MoonLake Immunotherapeutics is developing a bispecific antibody targeting two forms of IL-17, with phase 3 results for hidradenitis suppurativa expected imminently.

Investment and Market Potential

The potential of msAbs has attracted substantial investment. In the first half of 2025, immunology and inflammation-focused msAb companies raised $269 million more than their oncology counterparts. Dealmaking in the msAb space has accelerated, with transaction volumes comparable to those involving antibody-drug conjugates over the past five years.

Industry analysts project that at least seven msAb drugs in oncology are on track to become blockbusters by 2030. However, the market potential extends beyond cancer, with some experts suggesting that msAbs could be used as first-line biologics in areas of high unmet need, such as systemic lupus erythematosus.

As the field evolves, companies are exploring msAbs in neurology, neurodegenerative diseases, and solid tumors. However, challenges remain, including manufacturing complexities and the need to demonstrate superiority over emerging treatment modalities such as radiopharmaceuticals, protein degraders, and cell therapies.

With 14 FDA-approved msAbs as of August 2025 and a robust pipeline, the pharmaceutical industry is poised for continued innovation in this space. As Bak concludes, "In hematology/oncology, it's already a commercial market. In areas such as autoimmune conditions, it's very much a race to market right now."