Dr Wyatt McDonnell, Infinimmune CEO, Highlights Why Human-Derived Antibody Platforms Align with FDA's Non-Animal Model Framework

Wyatt McDonnell, PhD, chief executive officer (CEO) and co-founder of Infinimmune, spoke further with BioPharm International® in conjunction with his presentation in the session, “Beyond Animal Testing: How Organoids and Human-Based Models Are Transforming Drug Discovery,” at the 2026 BIO International Convention (BIO 2026). Dr McDonnell highlights recent FDA guidance documents^1–2 and their implications for companies developing human-derived monoclonal antibodies (mAbs).

Dr McDonnell identifies 2 guidances that are particularly significant for Infinimune. In December 2025, FDA's Center for Drug Evaluation and Research (CDER) released draft guidance specifically addressing streamlined non-clinical safety studies for mAbs,¹ including weight-of-evidence approaches that could reduce or eliminate long-term primate toxicology studies. In March 2026, CDER released broader new approach methodologies (NAMs) guidance² formalizing the use of computational models, in vitro human-based systems, and other non-animal methods as primary evidence in safety packages.

How does FDA's NAMs guidance change the non-clinical safety strategy for mAb developers?

Dr McDonnell explains that Infinimune's platform already generates the type of human-relevant evidence these guidances encourage. The company discovers antibodies directly from human B cells and uses an artificial intelligence (AI) model trained entirely on human antibody data to predict drug-like properties computationally. He notes that this approach eliminates the species-translation step that introduces failure risk in conventional development paths, in which molecules discovered in animals must be humanized and re-tested, and then developers must hope that the molecules translate clinically.

"Every species transition is a chance for something to break or to select for a false negative, and every re-engineering cycle costs both time and money," Dr McDonnell states.

He further notes that animal studies have not been eliminated entirely, for instance, Infinimune continues to run good laboratory practice (GLP) toxicology programs, but the guidance shifts how much animal-derived data is required in an investigational new drug package. He explains that the efficiency of starting from human biology has allowed the company to advance clinical-stage drug candidates with approximately 10 employees and a fraction of the capital a traditional program would require.

Watch additional interviews with Dr McDonnell at BIO 2026 by clicking here for segment 1 and here for segment 2. Click here for more conference coverage.

BIO 2026 occurred June 22–25 in San Diego.

About the speaker

Wyatt McDonnell, PhD, CEO and Co-Founder, Infinimnune

Dr McDonnell also serves as chairman of Infinimmune, a biotechnology company pioneering antibody discovery and design by leveraging natural human immunity to develop safer and more effective therapeutics for complex diseases. Under his leadership, Infinimmune has established strategic collaborations with Merck, Immunome, and GRID Therapeutics to advance the discovery and development of novel antibody therapeutics. Previously, Dr McDonnell helped develop 10x Genomics’ first therapeutic antibodies and core immunology intellectual property behind three commercial products. He has co-authored 31 peer-reviewed publications, including in Nature, Cell, and Nature Medicine, and is an inventor on 19 published patents. Dr McDonnell earned a PhD and Master of Science from Vanderbilt University School of Medicine.

References

1. FDA. FDA Releases Draft Guidance on Reducing Testing on Non-Human Primates for Monoclonal Antibodies. Published December 2, 2025. Accessed June 29, 2026. https://www.fda.gov/news-events/press-announcements/fda-releases-draft-guidance-reducing-testing-non-human-primates-monoclonal-antibodies
2. FDA. FDA Releases Draft Guidance on Alternatives to Animal Testing in Drug Development. Published March 18, 2026. Accessed June 29, 2026. https://www.fda.gov/news-events/press-announcements/fda-releases-draft-guidance-alternatives-animal-testing-drug-development