Recent Publications

Tumor-targeted interleukin-12 synergizes with entinostat to overcome PD-1/PD-L1 blockade-resistant tumors harboring MHC-I and APM deficiencies.
Minnar CM, Chariou PL, Horn LA, Hicks KC, Palena C, Schlom J, Gameiro SR.
J Immunother Cancer. 2022;10(6):e004561.

Immune correlates of clinical parameters in patients with HPV-associated malignancies treated with bintrafusp alfa.
Tsai Y-T, Strauss J, Toney NJ, Jochems C, Gulley JL, Schlom J, Donahue RN.
J Immunother Cancer. 2022;10(4):e004601. doi: 10.1136/jitc-2022-004601.

Cure of syngeneic carcinomas with targeted IL-12 through obligate reprogramming of lymphoid and myeloid immunity.
Hong Y, Robbins Y, Yang X, Mydlarz WK, Sowers A, Mitchell JB, Gulley JL, Schlom J, Gameiro SR, Sievers C, Allen CT.
JCI Insight. 2022;2(5):e157448. doi: 10.1172/jci.insight.157448.

Preclinical and clinical studies of bintrafusp alfa, a novel bifunctional anti-PDL1/TGFβRII agent: current status. 
Gameiro SR, Strauss J, Gulley JL, Schlom J.
J Exp Biol Med. 2022;Apr 27:15353702221089910. Online ahead of print.

A randomized phase II trial of mFOLFOX6 + bevacizumab alone or with AdCEA vaccine + avelumab immunotherapy for untreated metastatic colorectal cancer.
Redman JM, Tsai Y-T, Weinberg BA, Donahue RN, Gandhy S, Gatti-Mays ME, Abdul Sater H, Bilusic M, Cordes LM, Steinberg SM, Marte JL, Jochems C, Kim SS, Marshall JL, McMahon S, Redmond E, Schlom J, Gulley JL, Strauss J.
The Oncologist. 2022;27(3):198-209.

Post-transplantation cyclophosphamide uniquely restrains alloreactive CD4 + T-cell proliferation and differentiation after murine MHC-haploidentical hematopoietic cell transplantation.
Hadjis AD, Nunes NS, Khan M, Fletcher RE, de Paula Pohl A , Venzon DJ , Eckhaus MA,  Kanakry CG.
Front Immunol. 2022;13:796349.

HLA-A*03 and response to immune checkpoint blockade in cancer: an epidemiological biomarker study.
Naranbhai V, Viard M, Dean M, Groha S, Braun DA, Labaki C, Shukla SA, Yuki Y, Shah P, Chin K, Wind-Rotolo M, Mu XJ, Robbins PB, Gusev A, Choueiri TK, Gulley JL, Carrington. 
Lancet Oncol. (Jan) 2022;23(1):172-184.

Dual PD-L1 and TGF-β blockade in patients with recurrent respiratory papillomatosis.
Robbins Y, Freidman J, Clavijo PE, Sievers C, Bai K, Donahue RN, Schlom J, Sinkoe A, Hinrichs CS, Allen C, Abdul Sater H, Gulley JL, Norberg S.
J Immunother Cancer. 2021;9(8):e003113. 

TCR-engineered T cells targeting E7 for patients with metastatic HPV-associated epithelial cancers.
Nagarsheth NB, Norberg SM, Sinkoe AL, Adhikary S, Meyer TJ, Lack JB, Warner AC, Schweitzer C, Doran SL, Korrapati S, Stevanović S, Trimble CL, Kanakry JA, Bagheri  MH, Ferraro E, Astrow SH , Bot A, Faquin WC, Stroncek D, Gkitsas N , Highfill S, Hinrichs  CS.
Nat Med.  2021;27(3):419-425. 

Tumour-targeted interleukin-12 and entinostat combination therapy improves cancer survival by reprogramming the tumour immune cell landscape. 
Hicks KC, Chariou P, Ozawa Y, Minnar C, Knudson KM, Meyer T, Bian J, Cam M, Schlom J., Gameiro SR. 
Nat Commun. 2021;12(1):5151.

Phase 1 open-label trial of intravenous administration of MVA-BN-brachyury vaccine in patients with advanced cancer. 
DeMaria PJ, Lee-Wisdom K, Donahue RN, Madan RA, Karzai F, Schwab A, Palena C, Jochems C, Floudas CS, Strauss J, Marté JL, Redman JM, Dombi E, Widemann B, Korchin B, Adams T, Pico-Navarro C, Heery CR, Schlom J, Gulley JL, Bilusic M.
J ImmunoTher Cancer. 2021;9(9):e003238.

Exploiting off-target effects of estrogen deprivation to sensitize estrogen receptor negative breast cancer to immune killing.
Wolfson B, Padget MR, Schlom J, Hodge JW.
 ImmunoTher Cancer. 2021;9(7):e002258.

Identification and validation of expressed HLA-binding breast cancer neoepitopes for potential use in individualized cancer therapy.
Reimann H, Nguyen A, Sanborn JZ, Vaske CJ, Benz SC, Niazi K, Rabizadeh S, Spilman P, Mackensen A, Ruebner M, Hein A, Beckmann MW, van der Meijden ED, Bausenwein J, Kretschmann S, Griffioen M, Schlom J, Gulley JL, Lee KL, Hamilton D, Soon-Shiong P, Fasching PA, Kremer AN. J ImmunoTher Cancer. 2021;9(6):e002605.

Analysis of the tumor microenvironment and anti-tumor efficacy of subcutaneous vs systemic delivery of the bifunctional agent bintrafusp alfa.
Ozawa Y, Hicks KC, Minnar CM, Knudson KM, Schlom J, Gameiro SR.
OncoImmunology. 2021;10(1):e1915561.

NHS-IL12, a tumor-targeting immunocytokine [review].
Greiner JW, Morillon II YM, Schlom
Immunotargets Ther. 2021;10:155-169.

Phase 1 study of a multi-targeted recombinant Ad5 PSA/MUC-1/brachyury-based immunotherapy vaccine in patients with metastatic castration-resistant prostate cancer (mCRPC). 
Bilusic M, McMahon S, Madan RA, Karzai F, Tsai Y-T, Donahue RN, Palena C, Jochems C, Marté JL, Strauss J, Redman JM, Abdul Sater H, Floudas C, Rabizadeh S, Soon-Shiong P, Schlom J, Gulley JL.
 ImmunoTher Cancer. 2021;9(3):e002374.

Vaccine increases the diversity and activation of intratumoral T cells in the context of combination immunotherapy.
Horn LA, Fousek K, Hamilton DH, Hodge JW, Zebala JA, Maeda DY, Schlom J, Palena C.
Cancers [special issue: Cancer Immunology]. 2021;13:968.

Immunology of Lynch syndrome.
Pastor DM and Schlom J.
Curr Oncol Rep. 2021;23(8):96.

Characterization of a recombinant gorilla-adenovirus HPV therapeutic vaccine (PRGN-2009).
Pellom ST, Smalley Rumfield C, Morillon II YM, Roller N, Poppe LK, Brough DE, Sabzevari H, Schlom J, Jochems C.
CI Insight. 2021;6(7):141912.

Interrogation of the cellular immunome of cancer patients with regard to the COVID-19 pandemic.
Donahue RN, Marté JL, Goswami M, Toney NJ, Tsai Y-T, Gulley JL, Schlom J.
J Immunother Cancer. 2021;9:e002087.

The importance of cellular immunity in the development of vaccines and therapeutics for COVID-19 (Perspective).
Schlom J and Donahue RN.
J Infect Dis. 2020;222(9):1435-1438.

Bintrafusp alfa, a bifunctional fusion protein targeting TGF-β and PD-L1, in patients with human papillomavirus-associated malignancies.
Strauss J, Gatti-Mays ME, Cho BC, Hill A, Salas S, McClay E, Redman JM, Sater HA, Donahue RN, Jochems C, Lamping E, Burmeister A, Marté JL, Cordes LM, Bilusic M, Karzai F, Ojalvo LS, Jehl G, Rolfe PA, Hinrichs CS, Madan RA, Schlom J, Gulley JL.
J Immunother Cancer. 2020;8(2):e001395.

Immunomodulation to enhance the efficacy of an HPV therapeutic vaccine.
Smalley Rumfield C, Pellom ST, Morillon II YM, Schlom J, Jochems C.
J Immunother Cancer. 2020;8(1):e000612.

The development of next-generation PBMC humanized mice for preclinical investigation of cancer immunotherapeutic agents. [review].
Morillon II YM, Sabzevari A, Schlom J, Greiner JW.
Anticancer Res. 2020;40: 5329-5341.

Functional and mechanistic advantage of the use of a bifunctional anti-PD-L1/IL-15 superagonist.
Knudson KM, Hicks KC, Ozawa Y, Schlom J, Gameiro SR.
J Immunother Cancer. 2020;8(1):e000493. 

Neoadjuvant PROSTVAC prior to radical prostatectomy enhances T-cell infiltration into the tumor immune microenvironment in men with prostate cancer.
Abdul Sater H, Marté JL, Donahue RN, Walter-Rodriguez B, Heery CR, Steinberg SM, Cordes LM, Chun G, Karzai F, Bilusic M, Harmon SA, Turkbey IB, Choyke PL, Schlom J, Dahut WL, Madan RA, Pinto PA, Gulley JL.
J Immunother Cancer. 2020;8(1):e000655. 

Cooperative immune-mediated mechanisms of the HDAC inhibitor entinostat, an IL15 superagonist, and a cancer vaccine effectively synergize as a novel cancer therapy.
Hicks KC, Knudson KM, Lee KL, Hamilton DH, Hodge JW, Figg WD, Ordentlich P, Jones FR, Rabizadeh S, Soon-Shiong P, Schlom J, Gameiro SR.
Clin Cancer Res. 2020;26(3):704-716. 

A phase I trial using a multitargeted recombinant adenovirus 5 (CEA/MUC1/Brachyury)-based immunotherapy vaccine regimen in patients with advanced cancer.
Gatti-Mays ME, Redman JM, Donahue RN, Palena C, Madan RA, Karzai F, Bilusic M, Sater HA, Marté JL, Cordes LM, McMahon S, Steinberg SM, Orpia A, Burmeister A, Schlom J, Gulley JL, Strauss J.
Oncologist. 2020;25(6):479-e899. 

Efficient tumor clearance and diversified immunity through neoepitope vaccines and combinatorial immunotherapy.
Lee KL, Benz SC, Hicks KC, Nguyen A, Gameiro SR, Palena C, Sanborn JZ, Su Z, Ordentlich P, Rohlin L, Lee JH, Rabizadeh S, Soon-Shiong P, Niazi K, Schlom J, Hamilton DH.
Cancer Immunol Res. 2019;7(8):1359-1370. 

Temporal changes within the (bladder) tumor microenvironment that accompany the therapeutic effects of the immunocytokine NHS-IL12. 
Morillon YM II, Su Z, Schlom J, Greiner JW.
J Immunother Cancer. 2019;7(1):150.

A phase I dose-escalation trial of BN-CV301, a recombinant poxviral vaccine targeting MUC1 and CEA with costimulatory molecules. 
Gatti-Mays ME, Strauss J, Donahue RN, Palena C, Del Rivero J, Redman JM, Madan RA, Marté JL, Cordes LM, Lamping E, Orpia A, Burmeister A, Wagner E, Pico Navarro C, Heery CR, Schlom J, Gulley JL.
Clin Cancer Res. 2019;25(16):4933-4944. 

The multi-functionality of N-809, a novel fusion protein encompassing anti-PD-L1 and the IL-15 superagonist fusion complex.
Jochems C, Tritsch SR, Knudson KM, Gameiro SR, Smalley Rumfield C, Pellom ST, Morillon YM, Newman R, Marcus W, Szeto C, Rabizadeh S, Wong HC, Soon-Shiong P, Schlom J.
Oncoimmunology. 2018;8(2):e1532764. 

Vaccines as an integral component of cancer immunotherapy. [Viewpoint]
Schlom J, Gulley JL.
 JAMA. 2018;320(21):2195-2196.

Epigenetic priming of both tumor and NK cells augments antibody-dependent cellular cytotoxicity elicited by the anti-PD-L1 antibody avelumab against multiple carcinoma cell types.
Hicks KC, Fantini M, Donahue RN, Schwab A, Knudson KM, Tritsch SR, Jochems C, Clavijo PE, Allen CT, Hodge JW, Tsang KY, Schlom J, Gameiro SR.
Oncoimmunology. 2018;7(11):e1466018. 

First-in-human phase I trial of a tumor-targeted cytokine (NHS-IL12) in subjects with metastatic solid tumors.
Strauss J, Heery CR, Kim JW, Jochems C, Donahue RN, Montgomery AS, McMahon S, Lamping E, Marté JL, Madan RA, Bilusic M, Silver MR, Bertotti E, Schlom J, Gulley JL.
Clin Cancer Res. 2019;25(1):99-109.

M7824, a novel bifunctional anti-PD-L1/TGFβ Trap fusion protein, promotes anti-tumor efficacy as monotherapy and in combination with vaccine.
Knudson KM, Hicks KC, Luo X, Chen JQ, Schlom J, Gameiro SR.
Oncoimmunology. 2018 Feb 14;7(5):e1426519.

Phase I trial of M7824 (MSB0011359C), a bifunctional fusion protein targeting PD-L1 and TGFβ, in advanced solid tumors.
Strauss J, Heery CR, Schlom J, Madan RA, Cao L, Kang Z, Lamping E, Marté JL, Donahue RN, Grenga I, Cordes L, Christensen O, Mahnke L, Helwig C, Gulley JL.
Clin Cancer Res. 2018 Mar 15;24(6):1287-1295. 

Anti-PD-L1/TGFβR2 (M7824) fusion protein induces immunogenic modulation of human urothelial carcinoma cell lines, rendering them more susceptible to immune-mediated recognition and lysis.
Grenga I, Donahue RN, Gargulak ML, Lepone LM, Roselli M, Bilusic M, Schlom J.
Urol Oncol. 2018 Mar;36(3):93.e1-93.e11.