NEO-STIM advances personalized neoantigen-specific adoptive T cell therapy

D Divya Lenkala J Jessica Kohler B Brian McCarthy M Michael Nelson N Noor A. M. Bakker R Renate de Boer E Emily K. Jackson J Joong Hyuk F. Sheen S Susan Hannes E Ekaterina Esaulova K Kai Stewart C Claudia Gottstein J John Attanasio F Flavian D. Brown S Sebastian Hymson S Shirisha Meda M Maaike van Zon S Saskia Scheij R Rhianne Voogd B Brenda Raud Z Ziyan Xu (Department of Molecular Genetics and Microbiology, Duke University Medical Center) J Jessica S. W. Borgers M Maartje W. Rohaan K Kristen N. Balogh A Asaf Poran M Michael Rooney J Jesse Z. Dong J John R. Srouji V Vikram R. Juneja C Christina M. Arieta C Cynthia M. Nijenhuis B Bastiaan Nuijen M Mark DeMario K Kelledy Manson T Ton N. M. Schumacher R Richard B. Gaynor J John B. Haanen J Joost H. van den Berg M Marit M. van Buuren

Abstract

Abstract 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.

Article Details

Volume / Issue Vol. 17, Issue 1
Published February 05, 2026
ISSN 2041-1723
Publisher Nature Portfolio

Journal Info

Nature Communications

Nature Portfolio

ISSN: 2041-1723 Open Access Life Sciences

Authors (39)

D

Divya Lenkala

J

Jessica Kohler

B

Brian McCarthy

M

Michael Nelson

N

Noor A. M. Bakker

R

Renate de Boer

E

Emily K. Jackson

J

Joong Hyuk F. Sheen

S

Susan Hannes

E

Ekaterina Esaulova

K

Kai Stewart

C

Claudia Gottstein

J

John Attanasio

F

Flavian D. Brown

S

Sebastian Hymson

S

Shirisha Meda

M

Maaike van Zon

S

Saskia Scheij

R

Rhianne Voogd

B

Brenda Raud

Z

Ziyan Xu

Department of Molecular Genetics and Microbiology, Duke University Medical Center

J

Jessica S. W. Borgers

M

Maartje W. Rohaan

K

Kristen N. Balogh

A

Asaf Poran

M

Michael Rooney

J

Jesse Z. Dong

J

John R. Srouji

V

Vikram R. Juneja

C

Christina M. Arieta

C

Cynthia M. Nijenhuis

B

Bastiaan Nuijen

M

Mark DeMario

K

Kelledy Manson

T

Ton N. M. Schumacher

R

Richard B. Gaynor

J

John B. Haanen

J

Joost H. van den Berg

M

Marit M. van Buuren