NEO-STIM advances personalized neoantigen-specific adoptive T cell therapy
- Divya Lenkala
- Jessica Kohler
- Brian McCarthy
- Michael Nelson
- Noor A. M. Bakker
- Renate de Boer
- Emily K. Jackson
- Joong Hyuk F. Sheen
- Susan Hannes
- Ekaterina Esaulova
- Kai Stewart
- Claudia Gottstein
- John Attanasio
- Flavian D. Brown
- Sebastian Hymson
- Shirisha Meda
- Maaike van Zon
- Saskia Scheij
- Rhianne Voogd
- Brenda Raud
- Ziyan Xu
- Jessica S. W. Borgers
- Maartje W. Rohaan
- Kristen N. Balogh
- Asaf Poran
- Michael Rooney
- Jesse Z. Dong
- John R. Srouji
- Vikram R. Juneja
- Christina M. Arieta
- Cynthia M. Nijenhuis
- Bastiaan Nuijen
- Mark DeMario
- Kelledy Manson
- Ton N. M. Schumacher
- Richard B. Gaynor
- John B. Haanen
- Joost H. van den Berg
- Marit M. van Buuren
2026-02-05
Neoantigen-based adoptive T cell therapies (ACTs) represent a promising avenue in cancer immunotherapy due to their exquisite tumor specificity. The first cell-based immunotherapy for a solid tumor, comprising tumor-infiltrating lymphocytes, recently received FDA approval. Building on this, we designed a distinct ACT approach, where T cell responses against personalized neoantigens are systematically generated from autologous peripheral blood. Here we report the establishment of NEO-STIM, an ex vivo induction process to prime and expand pre-existing memory and de novo CD8 + and CD4 + T cell responses, thereby highlighting critical parameters for generating potent neoantigen-specific T cell responses. The drug products comprise mutant-reactive, polyfunctional, and cytotoxic CD8 + and CD4 + T cells, able to recognize autologous tumor material. Following infusion, T cell responses are detected in tumor and blood of a patient, and display activated/exhausted and cytotoxic phenotypes. A first-in-human clinical trial (NCT04625205) recently further validated proof-of-concept, supporting continued development of this ACT approach.