Development and validation of an ELISA method for quantification of the anti-HER3 antibody HMBD-001 in human serum

被引：3
|
作者：
Idowu, Oladipo S. [1 ]
Craigen, Jenny L. [2 ]
Veal, Gareth J. [1 ]
Jamieson, David [1 ]
机构：
[1] Newcastle Univ, Newcastle Univ Ctr Canc, Newcastle Upon Tyne NE2 4HH, England
[2] Canc Res UK Ctr Drug Dev, London E20 1JQ, England
来源：
BIOANALYSIS | 2022年 / 14卷 / 18期
关键词：
assay validation; cancer; ELISA; HER3; pharmacokinetics; RECEPTOR HETERODIMERIZATION; ERBB3; EXPRESSION; GROWTH; CANCER; HER3;
D O I：
10.4155/bio-2022-0141
中图分类号：
Q5 [生物化学];
学科分类号：
071010 ; 081704 ;
摘要：
Background: HMBD-001 is an IgG1 humanized monoclonal antibody specifically targeting HER3, a receptor highly expressed on cancer cells in certain tumors. A bioanalytical method was required to quantify HMBD-001 in human serum, with high selectivity and without interference from HER3. Methods and results: A bridging ELISA using an anti-idiotypic monoclonal capture and detection was developed and validated for quantitative measurement of HMBD-001 in human serum. The assay is sensitive, with a lower limit of quantification of 250 ng/ml, has a broad dynamic range of 250-7000 ng/ml HMBD-001, and exhibits excellent precision and overall accuracy. Conclusion: We have developed and validated a sensitive and selective method for measuring HMBD-001 in human serum. This assay is now being used in a clinical trial setting.
引用
收藏
页码：1241 / 1249
页数：9
相关论文
共 50 条
  • [1] Combining Anti-HER3 Antibody, HMBD-001, with EGFR Inhibition and Chemotherapy may Improve Treatment Outcomes in SqNSCLC
    Toy, W.
    Thakkar, D.
    Luu, K.
    Bui, N. L. C.
    Chau, K. F.
    Lai, J.
    Ray, D.
    Wu, S.
    Poi, M.
    Gandhi, N. A.
    Mas, A.
    Paszkiewicz, K.
    Ingram, P.
    Boyd-Kirkup, J.
    JOURNAL OF THORACIC ONCOLOGY, 2023, 18 (11) : S208 - S209
  • [2] Trial in Progress: A Phase Ib Study of HMBD-001, An Anti-HER3 Antibody, in Advanced Squamous NonSmall Cell Lung Cancer
    Pavlakis, N.
    Kichenadasse, G.
    Richardson, G.
    Bowyer, S.
    Andelkovic, V.
    Ganju, V.
    Tan, A.
    Samol, J.
    Thomas, D.
    Fernandez, A. Mas
    Paszkiewicz, K.
    Ingram, P.
    Boyd-Kirkup, J.
    Kwek, K. Y.
    JOURNAL OF THORACIC ONCOLOGY, 2024, 19 (10) : S350 - S350
  • [3] A CRUK phase I/IIA, first in human dose-escalation and expansion trial of HMBD-001 (an anti-HER3 antibody) in patients with advanced HER3 positive solid tumours
    de Bono, J. S.
    Lord, S.
    Yap, C.
    Miranda, S.
    Veal, G. J.
    Chandran, K.
    Paschalis, A.
    Peron, C.
    Rekowski, J.
    Gurel, B.
    Paisley, D.
    McGuigan, L.
    Ingram, P. J.
    Kwek, K. Y.
    Halbert, G.
    Westwood, N. B.
    Griffin, A. E.
    Kostaras, L.
    Boyd-Kirkup, J. D.
    Walter, H. S.
    ANNALS OF ONCOLOGY, 2023, 34 : S479 - S480
  • [4] Anti-HER3 antibody, HMBD-001, in combination with an EGFR inhibitor effectively inhibits tumor growth in biomarker-selected pre-clinical models of squamous cell carcinomas
    Toy, Weiyi
    Thakkar, Dipti
    Luu, Khang
    Chi, Bui Ngoc Linh
    Lai, Jason
    Ray, Debleena
    Gandhi, Namita
    Mas, Alejandro
    Paszkiewicz, Konrad
    Ingram, Piers
    Boyd-Kirkup, Jerome
    CANCER RESEARCH, 2023, 83 (07)
  • [5] Pharmacokinetics of HMBD-001, a human monoclonal antibody targeting HER3, a CRUK first-in-human phase I trial in patients with advanced solid tumours
    Idowu, O.
    Craigen, J.
    Svetlik, S.
    Veal, J.
    Jamieson, D.
    ANNALS OF ONCOLOGY, 2023, 34 : S480 - S480
  • [6] A CRUK phase I/IIA, first in human dose-escalation and expansion trial of HMBD-001 (an anti-HER-3 antibody) in patients with advanced HER3-positive solid tumours
    de Bono, J. S.
    Lord, S.
    Yap, C.
    Rowinsky, E. K.
    Gandhi, N. A.
    Thakkar, D.
    Ingram, P. J.
    Padmanabhan, N.
    Chandran, K.
    Paschalis, A.
    McGuigan, L.
    Neal, P.
    Paisley, D.
    Walter, H. S.
    Kelly, F.
    Craigan, J.
    Westwood, N. B.
    Halbert, G.
    Boyd-Kirkup, J. D.
    Halford, S. E. R.
    ANNALS OF ONCOLOGY, 2022, 33 (07) : S767 - S767
  • [7] An anti-HER3 antibody, HMBD-001, that uniquely binds to and blocks the HER3 heterodimerization interface, shows superior tumor growth inhibition in biomarker-defined preclinical cancer models including NRG1-fusion driven cancers
    Thakkar, Dipti
    Paliwal, Shalini
    Kar, Shreya
    Gandhi, Namita
    Paszkiewicz, Konrad
    Ingram, Piers
    Boyd-Kirkup, Jerome
    MOLECULAR CANCER THERAPEUTICS, 2021, 20 (12)
  • [8] A phase Ib study of HMBD-001, a monoclonal antibody targeting HER3, with or without chemotherapy in patients with genetic aberrations in HER3 signaling
    Pavlakis, N.
    Millward, M.
    Richardson, G.
    Andelkovic, V.
    Kichenadasse, G.
    Thomas, D. M.
    Fernandez, A. Mas
    Thakkar, D.
    Arbabzade, T.
    Goey, C. H.
    Seet, Q.
    Toy, W.
    Paszkiewicz, K.
    Ingram, P. J.
    Boyd-Kirkup, J. D.
    Kwek, K. Y.
    ANNALS OF ONCOLOGY, 2023, 34 : S1501 - S1501
  • [9] HMBD001-10D1, a novel humanized anti-HER3 antibody with a unique mechanism of action, demonstrates superior tumor inhibition in multiple tumor models compared to other EGFR family therapies
    Thakkar, D.
    Taguiam, M.
    Sancenon, V.
    Guan, S.
    Paszkiewicz, K.
    Ingram, P.
    Boyd-Kirkup, J.
    EUROPEAN JOURNAL OF CANCER, 2018, 103 : E36 - E37
  • [10] Development and validation of sensitive ELISA method for quantification of filgrastim (RHG-CSF) in human serum: Application to a pharmacokinetic study
    Agarwal, N.
    Jain, S.
    Behl, V
    Varshney, B.
    Paliwal, J. K.
    INDIAN JOURNAL OF PHARMACOLOGY, 2008, 40 : 95 - 95
12345