Select Publications

Lebrec, H., Bui, J., Clingan, J., Do, J., Dubovsky, J., Dragone, L., Gibiansky, E., Lam, W.Y., Matsuda, K., Mihalcik, L., Ramsdell, F., van der Vuurst de Vries, A.R., Xiao, Y., Bluestone, J.A. Second generation CD2-targeting LFA-3 fusion protein SBT115301 to restore immune homeostasis in autoimmune disease. iScience, Volume 28, Issue 5, 112447 (2025). DOI: 10.1016/j.isci.2025.112447.

Bluestone, J.A., Burnett, B.K., Crute, C.E., Fellows, M.D., Levings, M., Lebrec, H., Peireira Mouriès, L., Rice, J., Rohan, P., Roncarolo, M.G., Rotrosen, D. Regulatory T cell therapies to treat autoimmune diseases and transplant rejection. Nat Immunol 26, 819–824 (2025). https://doi.org/10.1038/s41590-025-02154-2.

Tod Harper, Amy Sharma, Sarav Kaliyaperumal, Flordeliza Fajardo, Katie Hsu, Lily Liu, Rhian Davies, Yu-Ling Wei, Jinghui Zhan, Juan Estrada, Majk Kvesic, Lisa Nahrwold, Wibke Deisting, Marc Panzer, Keegan Cooke, Hervé Lebrec, Olivier Nolan-Stevaux, Characterization of an Anti-CD70 Half-Life Extended Bispecific T-Cell Engager (HLE-BiTE) and Associated On-Target Toxicity in Cynomolgus Monkeys, Toxicological Sciences, Volume 189, Issue 1, (2022), Pages 32–50. https://doi.org/10.1093/toxsci/kfac052

Lebrec H, Maier C, Maki K, Ponce R, Shenton J, Green S. Nonclinical Safety Assessment of Engineered T cell Therapies. Regulatory Toxicology and Pharmacology. 127 (2021): 105064. https://doi.org/10.1016/j.yrtph.2021.105064.

Mihalcik L, Chow V, Ramchandani M, Hinkle B, McBride H, Lebrec H. Use of nonclinical toxicity studies to support biosimilar antibody development. Regulatory Toxicology and Pharmacology 122 (2021): 104912. https://doi.org/10.1016/j.yrtph.2021.104912

Karbowski C, Goldstein R, Frank B, Kim K, Li CM, Homann O, Hensley K, Brooks B, Wang X, Yan Q, Hernandez R, Adams G, Boyle M, Arvedson T, and Lebrec H. Nonclinical Safety Assessment of AMG 553, an Investigational Chimeric Antigen Receptor (CAR) T-cell Therapy for the Treatment of Acute Myeloid Leukemia. Toxicology Sciences. 177(1): 94-107. (2020). https://doi.org/10.1093/toxsci/kfaa098

Kamperschroer C, Shenton J, Lebrec H, Leighton JK, Moore PA & Thomas O. Summary of a workshop on preclinical and translational safety assessment of CD3 bispecifics. Journal of immunotoxicology, 17:1:67–85. (2020). https://doi.org/10.1080/1547691x.2020.1729902

Lebrec H, Brennan FR, Haggerty H, Herzyk D, Kamperschroer C, Maier CC, Ponce R, Preston BD, Weinstock D, Mellon RD. HESI/FDA workshop on immunomodulators and cancer risk assessment: Building blocks for a weight-of-evidence approach. Regulatory Toxicology and Pharmacology 75:72-80. (2016). https://doi.org/10.1016/j.yrtph.2015.12.018

Lebrec H, Ponce R, Preston BD, Iles J, Born TL, Hooper M. Tumor necrosis factor, tumor necrosis factor inhibition, and cancer risk. Current Medical Research and Opinion. 31(3):557-574. (2015). https://doi.org/10.1185/03007995.2015.1011778

Lebrec, H., Molinier, B., Boverhof, D., Collinge, M., Freebern, W., Henson, K., Mytych, D., Ochs, H.D., Wange, R., Yang, Y., Zhou, L., Arrington, J., Christin-Piché, M.S., Shenton., J. The T-cell-dependent antobody response assay in nonclinical studies of pharmaceuticals and chemicals: Study design, data analysis, interpretation. Regulatory Toxicology and Pharmacology. 69:7-21. (2014). https://doi.org/10.1016/j.yrtph.2014.02.008

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