Quantification of antibody-drug conjugate PYX-201 in rat and monkey plasma via ELISA and its application in preclinical studies

被引：7

作者：

Yin, Feng ^{[1
]}

DeCiantis, Chris ^{[2
]}

Pinkas, Jan ^{[1
]}

Das, Biplab ^{[1
]}

Wang, Frank ^{[1
]}

Zheng, Nancy ^{[3
]}

Hahn, David ^{[3
]}

Amrite, Aniruddha ^{[1
]}

Adhikari, Diana ^{[1
]}

Kane, Cheikh ^{[2
]}

Sikora, Jack ^{[1
]}

Pittman, Justin ^{[2
]}

Wates, Rebecca ^{[2
]}

Shaheen, Elizabeth ^{[1
]}

Harriman, Shawn ^{[1
]}

机构：

[1] Pyxis Oncol Inc, 150 Cambridgepk Dr, Cambridge, MA 02140 USA

[2] KCAS Bioanalyt & Biomarker Serv, 10830 South Clay Blair Blvd, Olathe, KS 66061 USA

[3] Amador Biosci Inc, 4695 Chabot Dr, Pleasanton, CA 94588 USA

来源：

BIOANALYSIS | 2023年 / 15卷 / 01期

关键词：

ADC; Aur0101; ELISA; extra domain B fibronectin; oncology; preclinical; PYX-201; toxicokinetic; validation; vc0101; ED-B FIBRONECTIN; EXTRA-DOMAIN B; TARGET; BIOANALYSIS; EXPRESSION; TUMORS;

D O I：

10.4155/bio-2022-0233

中图分类号：

Q5 [生物化学];

学科分类号：

071010 ; 081704 ;

摘要：

Aim: PYX-201 is a novel antibody-drug conjugate targeting the extra domain B splice variant of fibronectin in the tumor microenvironment. Accurate quantification of PYX-201 is critical for PYX-201 pharmacokinetics profiling in preclinical studies. Materials & methods: ELISA was performed using reference standard PYX-201, mouse monoclonal anti-monomethyl auristatin E antibody, mouse IgG1, mouse monoclonal anti-human IgG horseradish peroxidase and donkey anti-human IgG horseradish peroxidase. Results: This assay was validated at 50.0-10,000 ng/ml in rat dipotassium EDTA plasma and 250-10,000 ng/ml in monkey dipotassium EDTA plasma. Conclusion: This is the first time for a PYX-201 bioanalytical assay in any matrix to be reported.

引用

页码：43 / 52

页数：10

共 22 条

[1]

[Anonymous], 2018, Guidance for Industry: Bioanalytical Method Validation, DOI DOI 10.1164/RCCM.201301-0153OC

[2]

[Anonymous], 2019, ICH guideline M10 on bioanalytical method validation

[3] A novel human fibronectin cryptic sequence unmasked by the insertion of the angiogenesis-associated extra type III domain B [J].

Balza, Enrica ;

Sassi, Francesca ;

Ventura, Elisa ;

Parodi, Arianna ;

Fossati, Sara ;

Blalock, William ;

Carnemolla, Barbara ;

Castellani, Patrizia ;

Zardi, Luciano ;

Borsi, Laura .

INTERNATIONAL JOURNAL OF CANCER, 2009, 125 (04) :751-758

[4] Multiplex LC-MS/MS Assays for Clinical Bioanalysis of MEDI4276, an Antibody-Drug Conjugate of Tubulysin Analogue Attached via Cleavable Linker to a Biparatopic Humanized Antibody against HER-2 [J].

Faria, Morse ;

Peay, Marlking ;

Lam, Brandon ;

Ma, Eric ;

Yuan, Moucun ;

Waldron, Michael ;

Mylott, William R., Jr. ;

Liang, Meina ;

Rosenbaum, Anton I. .

ANTIBODIES, 2019, 8 (01)

[5]

Gorovits B, 2013, BIOANALYSIS, V5, P997, DOI [10.4155/BIO.13.38, 10.4155/bio.13.38]

[6] Anti-Extra Domain B Splice Variant of Fibronectin Antibody-Drug Conjugate Eliminates Tumors with Enhanced Efficacy When Combined with Checkpoint Blockade [J].

Hooper, Andrea T. ;

Marquette, Kimberly ;

Chang, Chao -Pei Betty ;

Golas, Jonathon ;

Jain, Sadhana ;

Lam, My-Hanh ;

Guffroy, Magali ;

Leal, Mauricio ;

Falahatpisheh, Hadi ;

Mathur, Divya ;

Chen, Ting ;

Kelleher, Kerry ;

Khandke, Kiran ;

Muszynska, Elwira ;

Loganzo, Frank ;

Rosfjord, Edward ;

Lucas, Judy ;

Kan, Zhengyan ;

Subramanyam, Chakrapani ;

O'Donnell, Christopher ;

Neri, Dario ;

Gerber, Hans-Peter ;

May, Chad ;

Sapra, Puja .

MOLECULAR CANCER THERAPEUTICS, 2022, 21 (09) :1462-1472

[7] ED-B fibronectin in non-small cell lung carcinoma [J].

Khan, ZA ;

Caurtero, J ;

Barbin, YP ;

Chan, BM ;

Uniyal, S ;

Chakrabarti, S .

EXPERIMENTAL LUNG RESEARCH, 2005, 31 (07) :701-711

[8] Evaluation of EDB Fibronectin in Plasma, Patient-Derived Xenograft Formalin-Fixed Paraffin-Embedded and Fresh Frozen Tumor Tissues Using Immunoaffinity LC-MS/MS [J].

Li, Fengping ;

Hooper, Andrea T. ;

Golas, Jonathon ;

Chang, Chao-Pei Betty ;

Neubert, Hendrik ;

King, Lindsay .

JOURNAL OF PROTEOME RESEARCH, 2022, 21 (10) :2331-2340

[9] 抗体偶联药物研发中的生物分析 [J].

李秀立 ;

陈笑艳 ;

钟大放 .

药学学报, 2016, (04) :517-528

[10] Expression of fibronectin isoforms in human breast tissue:: Production of extra domain A+ extra domain B+ by cancer cells and extra domain A+ by stromal cells [J].

Matsumoto, E ;

Yoshida, T ;

Kawarada, Y ;

Sakakura, T .

JAPANESE JOURNAL OF CANCER RESEARCH, 1999, 90 (03) :320-325

← 1 2 3 →