Safety, Efficacy and Biomarker Analysis of Toripalimab in Patients with Previously Treated Advanced Urothelial Carcinoma: Results from a Multicenter Phase II Trial POLARIS-03

Sheng X, Chen H, Hu B, Yao X, Liu Z, Yao X, Guo H, Hu Y, Ji Z, Luo H, Shi B, Liu J, Wu J, Zhou F, He Z, Fan J, Wang W, Feng H, Yao S, Keegan P, Huang Y, Guo

J.Clin Cancer Res. 2021 Nov 5:clincanres.2210.2021. doi: 10.1158/1078-0432.CCR-21-2210. Online ahead of print.

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Toripalimab or placebo plus chemotherapy as first-line treatment in advanced nasopharyngeal carcinoma: a multicenter randomized phase 3 trial.

Mai, H.-Q., Yao S, Xu RH et al.

Nature Medicine 27, 1536–1543 (2021).

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Toripalimab plus chemotherapy as second-line treatment in previously EGFR-TKIs treated patients with EGFR-mutant advanced NSCLC: a multi-center phase II trial

Jiang T, Wang P, Zhang J, Zhao Y, Zhou J, Fan Y, Shu Y, Liu X, Zhang H, He J, Gao G, Mu X, G, Bao Z, Xu Y, Guo R, Wang H, Deng L, Ma L, Zhang Y, Feng H, Yao S, Wu J, Chen L, Zhou C, and Ren S.

Signal Transduct Target Ther 6, 355 (2021).

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Efficacy, Safety, and Correlative Biomarkers of Toripalimab in Previously Treated Recurrent or Metastatic Nasopharyngeal Carcinoma: A Phase II Clinical Trial (POLARIS-02)

Wang F, Wei X, Feng J, Li Q, Xu N, Hu X, Liao W, Jiang Y, Lin X, Zhang Q, Yuan X, Huang H, Chen Y, Dai G, Shi J, Shen L, Yang S, Shu Y, Liu Y, Wang W, Wu H, Feng H, Yao S, Xu R.

J Clin Oncol. 2021 Mar 1;39(7):704-712.

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Tolerability, Safety, Pharmacokinetics, and Immunogenicity of a Novel SARS-CoV-2 Neutralizing Antibody, Etesevimab, in Chinese Healthy Adults: a Randomized, Double-Blind, Placebo-Controlled, First-in-Human Phase 1 Study.

Wu X, Li N, Wang G, Liu W, Yu J, Cao G, Wang J, Chen Y, Ma J, Wu J, Yang H, Mao X, He J, Yu Y, Qiu C, Li N, Yao S, Feng H, Yan J, Zhang W, Zhang J

Antimicrob Agents Chemother. 2021 Jul 16;65(8):e0035021.

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Efficacy and Biomarker Analysis of Toripalimab in previously treated advanced melanoma: results of the POLARIS-01 multicenter phase II trial

Tang B, Chi Z, Chen YB, Liu X, Wu D, Chen J, Song X, Wang W, Dong L, Song H, Wu H, Feng H, Yao S, Qin SK, Zhang X, Guo J

Clin Cancer Res. 2020 Sep 15;26(18):5048.

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Identification of a hotspot on PD-L1 for pH-dependent binding by monoclonal antibodies for tumor therapy

Liu H, Bi X, Zhou Y, Shi R, Yao S, Qi J, Feng H, Feng M, Yan J, Tan S

Signal Transduct Target Ther 2020; 5(1): 158.

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A phase I study of toripalimab, an anti-PD-1 antibody, in patients with refractory malignant solid tumors.

Wei XL, Ren C, Wang FH, Zhang Y, Zhao HY, Zou BY, Wang ZQ, Qiu MZ, Zhang DS, Luo HY, Wang F, Yao S, Xu RH.

Cancer Commun (Lond). 2020 Aug;40(8):345-354

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A human neutralizing antibody targets the receptor-binding site of SARS-CoV-2

Shi R, Shan C, Duan X, Chen Z, Liu P, Song J, Song T, Bi X, Han C, Wu L, Gao G, Hu X, Zhang Y, Tong Z, Huang W, Liu WJ, Wu G, Zhang B, Wang L, Qi J, Feng H, Wang FS, Wang Q, Gao GF, Yuan Z, Yan J. Nature. 2020 Aug;584(7819):120-124. doi: 10.1038/s41586-020-2381-y. Epub 2020 May 26.
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Safety and clinical efficacy of toripalimab, a PD-1 mAb, in patients with advanced or recurrent malignancies in a phase I study.

Yang J, Dong L, Yang S, Han X, Han Y, Jiang S, Yao J, Zhang Z, Zhang S, Liu P, Qin Y, Wu H, Feng H, Yao S, Sun Y, Song H, Shi Y.

Eur J Cancer. 2020 May;130:182-192. doi: 10.1016/j.ejca.2020.01.028. Epub 2020 Mar 27.

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Efficacy, Safety, and Biomarkers of Toripalimab in Patients with Recurrent or Metastatic Neuroendocrine Neoplasms: A Multiple-Center Phase Ib Trialipalimab, a PD1 antibody in phase Ib/II clinical trial NCT02915432

Lu M, Zhang P, Zhang Y, Li Z, Gong J, Li J, Li J, Li Y, Zhang X, Lu Z, Wang X, Zhou J, Peng Z, Wang W, Feng H, Wu H, Yao S, Shen L.

Clin Cancer Res. 2020 May 15;26(10):2337-2345. doi: 10.1158/1078-0432.CCR-19-4000. Epub 2020 Feb 21.

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Axitinib in Combination With Toripalimab, a Humanized Immunoglobulin G4 Monoclonal Antibody Against Programmed Cell Death-1, in Patients With Metastatic Mucosal Melanoma

Sheng X, Yan X, Chi Z, Si L, Cui C, Tang B, Li S, Mao L, Lian B, Wang X, Bai X, Zhou L, Kong Y, Dai J, Wang K, Tang X, Zhou H, Wu H, Feng H, Yao S, Flaherty KT, Guo J.

2019 Aug 12:JCO1900210. doi: 10.1200/JCO.19.00210.

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Safety, efficacy and tumor mutational burden as a biomarker of overall survival benefit in chemo-refractory gastric cancer treated with toripalimab, a PD1 antibody in phase Ib/II clinical trial NCT02915432

Wang F, Wei XL, Wang FH, Xu N, Shen L, Dai GH, Yuan XL, Chen Y, Yang SJ, Shi JH, Hu XC, Lin XY, Zhang QY, Feng JF, Ba Y, Liu YP, Li W, Shu YQ, Jiang Y, Li Q, Wang JW, Wu H, Feng H, Yao S, Xu RH.

Ann Oncol. 2019 Jun 24. pii: mdz197. doi: 10.1093/annonc/mdz197.

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Development of 99mTc-conjugated JS001 antibody for in vivo mapping of PD-1 distribution in murine.

Guo X, Zhu H, Liu T, Xu X, Kong Y, Yao S, Sheng X, Yang Z.

Bioorg Med Chem Lett. 2019 Jun 17. pii: S0960-894X(19)30399-3. doi: 10.1016/j.bmcl.2019.06.019

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Glycosylation-independent binding of monoclonal antibody toripalimab to FG loop of PD-1 for tumor immune checkpoint therapy

Liu H, Guo L, Zhang J, Zhou Y, Zhou J, Yao J, Wu H, Yao S, Chen B, Chai Y, Qi J, Gao GF, Tan S, Feng H, Yan J.

2019 May/Jun;11(4):681-690. doi: 10.1080/19420862.2019.1596513. Epub 2019 Apr 19.

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Safety and clinical activity with an anti-PD-1 antibody JS001 in advanced melanoma or urologic cancer patients

Tang B, Yan X, Sheng X, Si L, Cui C, Kong Y, Mao L, Lian B, Bai X, Wang X, Li S, Zhou L, Yu J, Dai J, Wang K, Hu J, Dong L, Song H, Wu H, Feng H, Yao S, Chi Z, Guo J

J Hematol Oncol. 2019 Jan 14;12(1):7. doi: 10.1186/s13045-018-0693-2

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Ferritin nanoparticle-based SpyTag/SpyCatcher-enabled click vaccine for tumor immunotherapy

Wenjun Wang 1, Zhida Liu 2, Xiaoxiao Zhou 1, Zhenqian Guo 3, Jing Zhang 4, Ping Zhu 3, Sheng Yao 4, Mingzhao Zhu 5

Nanomedicine. 2019 Feb;16:69-78. doi: 10.1016/j.nano.2018.11.009. Epub 2018 Dec 8.

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Human Semaphorin-4A drives Th2 responses by binding to receptor ILT-4

Ning Lu 1 2, Ying Li 3, Zhiqiang Zhang 4 5, Junji Xing 5, Ying Sun 6 7, Sheng Yao 8 9, Lieping Chen 8

Nat Commun. 2018 Feb 21;9(1):742. doi: 10.1038/s41467-018-03128-9.

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Identification of CD112R as a novel checkpoint for human T cells

Yuwen Zhu 1, Alessandro Paniccia 2, Alexander C Schulick 2, Wei Chen 3, Michelle R Koenig 2, Joshua T Byers 2, Sheng Yao 4, Shaun Bevers 5, Barish H Edil 1

J Exp Med. 2016 Feb 8;213(2):167-76. doi: 10.1084/jem.20150785. Epub 2016 Jan 11.

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Preclinical evaluation of the efficacy, pharmacokinetics and immunogenicity of JS-001, a programmed cell death protein-1 (PD-1) monoclonal antibody

Jie Fu 1, Fang Wang 1, Li-Hou Dong 1, Jing Zhang 2, Cheng-Lian Deng 2, Xue-Li Wang 2, Xin-Yao Xie 2, Jing Zhang 3, Ruo-Xian Deng 4, Li-Bo Zhang 3, Hai Wu 3, Hui Feng 3, Bo Chen 3, Hai-Feng Song 1

Acta Pharmacol Sin. 2017 May;38(5):710-718. doi: 10.1038/aps.2016.161. Epub 2017 Mar 20.

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PD-1 as an immune modulatory receptor

Sheng Yao 1, Lieping Chen

Cancer J. Jul-Aug 2014;20(4):262-4. doi: 10.1097/PPO.0000000000000060.

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