Growing body of evidence about IRX‑2

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Clinical Data

Tumor infiltrating lymphocytes after neoadjuvant IRX-2 immunotherapy in oral squamous cell carcinoma: Interim findings from the INSPIRE trial

Gregory T. Wolf, Siyu Liu, Emily Bellile, Maureen Sartor, Laura Rozek, Dafydd Thomas, Ariane Nguyen, Katie Zarins, Jonathan B. McHugh

Multispectral immunofluorescence (mIF) to detect dynamic changes in PD-L1 expression, immune cell (IC)
infiltration, and tumor-IC interactions in primary breast cancer (BC) immuno-oncology (I-O) clinical trials

Katherine Sanchez MD, Isaac Kim MD, Shuching Chang PhD, Maritza Martel MD, Yaping Wu MD, Brady Bernard PhD,
Zhaoyu Sun PhD, Joanna Pucilowska PhD, William Redmond PhD, Walter Urba PhD, MD and David Page MD

A phase Ib study of pre-operative, locoregional IRX-2 cytokine immunotherapy to prime immune responses in patients with early stage breast cancer.

David B. Page, Joanna Pucilowska, Katherine G. Sanchez, Alison K Conlin, Anupama K Acheson, Kelly S. Perlewitz, James H. Imatani, Shaghayegh Aliabadi-Wahle, Nicole Moxon, Staci L. Mellinger, Amanda Y. Seino, Martiza Martel, Yaping Wu, Zhaoyu Sun, William L Redmond, Valerie K. Conrad, Venkatesh Rajamanickam, Dottie Waddell, Deborah Laxague, Monil Shah, Shu-Ching Chang and Walter J. Urba

IRX-2 natural cytokine biologic for immunotherapy in patients with head and neck cancers

Gregory T Wolf, Jeffrey S Moyer, Michael J Kaplan, Jason G Newman, James E Egan, Neil L Berinstein, Theresa L Whiteside, et al., OncoTargets and Therapy, 2018:11 3731–3746

Increased immune infiltration and chemokine receptor expression in head and neck epithelial tumors after neoadjuvant immunotherapy with the IRX-2 regimen

Neil L. Berinstein, Michael McNamara, Ariane Nguyen, James Egan & Gregory T. Wolf, et al. , OncoImmunology, DOI: 10.1080/2162402X.2017.1423173

A phase 1 safety study of an IRX-2 regimen in patients with squamous cell carcinoma of the head and neck.

Freeman SM, Barrera Franco JL, Kenady DE, et al. Am J Clin Oncol. 2011;34(2):173-178.

Novel neoadjuvant immunotherapy regimen safety and survival in head and neck squamous cell cancer.

Wolf GT, Fee WE Jr, Dolan RW, et al. Head Neck. 2011;33(12):1666-1674.

A short course of neoadjuvant IRX-2 induces changes in peripheral blood lymphocyte subsets of patients with head and neck squamous cell carcinoma.

Whiteside TL, Butterfield LH, Naylor PH, et al. Cancer Immunol Immunother. 2012;61(6):783-738.

Increased lymphocyte infiltration in patients with head and neck cancer treated with the IRX-2 immunotherapy regimen.

Berinstein NL, Wolf GT, Naylor PH, et al. Cancer Immunol Immunother. 2012;61(6):771-782.

Preclinical Data

IRX-2, a novel immunotherapeutic, protects human T cells from tumor-induced cell death.

Czystowska M, Han J, Szczepanski MJ, et al. Cell Death Differ. 2009;16(5):708-718.

Mechanisms of T-cell protection from death by IRX-2: a new immunotherapeutic.

Czystowska M, Szczepanski MJ, Szajnik M, et al. Cancer Immunol Immunother. 2011;60(4):495-506.

IRX-2, a novel in vivo immunotherapeutic, induces maturation and activation of human dendritic cells in vitro.

Egan JE, Quadrini KJ, Santiago-Schwarz F, Hadden JW, Brandwein HJ, Signorelli KL. J Immunother. 2007;30(6):624-633.

IRX-2, a novel immunotherapeutic, enhances functions of human dendritic cells.

Schilling B, Harasymczuk M, Schuler P, Egan J, Ferrone S, Whiteside TL. PLoS One. 2013;8(2):e47234.

IRX-2, a novel biologic, favors the expansion of T effector over T regulatory cells in a human tumor microenvironment model.

Schilling B, Harasymczuk M, Schuler P, Egan JE, Whiteside TL. J Mol Med (Berl). 2012;90(2):139-147.

IRX-2, a novel immunotherapeutic, enhances and protects NK-cell functions in cancer patients.

Schilling B, Halstead ES, Schuler P, Harasymczuk M, Egan JE, Whiteside TL. Cancer Immunol Immunother. 2012;61(9):1395-1405.

IRX-2 increases the T cell-specific immune response to protein/peptide vaccines.

Naylor PH, Hernandez KE, Nixon AE, et al. Vaccine. 2010;28(43):7054-7062.

Peptide based vaccine approaches for cancer—a novel approach using a WT-1 synthetic long peptide and the IRX-2 immunomodulatory regimen.

Naylor PH, Egan JE, Berinstein NL. Cancers (Basel). 2011;3(4):3991-4009.


Prognostic Value of Tumor-Infiltrating Lymphocytes in Head and Neck Squamous Cell Carcinoma

Spector ME, Bellile E, Amlani L, et al. JAMA Otolaryngol Head Neck Surg. Published online September 05, 2019. doi:10.1001/jamaoto.2019.2427