146
Views
0
CrossRef citations to date
0
Altmetric
Preliminary Communication

A Sensitive LC–MS/MS Assay to Quantitate Free Payload Aur0101 from ADC PYX-201 in Rat and Monkey Plasma

ORCID Icon, , , , , , , , , , , & show all
Pages 833-843 | Received 27 Mar 2023, Accepted 01 Jun 2023, Published online: 16 Aug 2023

References

  • Wang AJ , GaoY, ShiYY, DaiMY, CaiHB. A review of recent advances on single use of antibody-drug conjugates or combination with tumor immunology therapy for gynecologic cancer. Front. Pharmacol.13, DOI: 10.3389/fphar.2022.1093666 (2022).
  • Abdollahpour-Alitappeh M , LotfiniaM, GharibiTet al. Antibody–drug conjugates (ADCs) for cancer therapy: strategies, challenges, and successes. J. Cell. Physiol.234(5), 5628–5642 (2019).
  • Beck A , GoetschL, DumontetC, CorvaiaN. Strategies and challenges for the next generation of antibody–drug conjugates. Nat. Rev. Drug Discov.16(5), 315–337 (2017).
  • Pandit A . Antibody–drug conjugates in oncology: key considerations and future trends (2022). Premier-research.com/blog-antibody-drug-conjugates
  • Axispharm . Antibody–drug conjugates (ADCs) list approved by FDA (2000–2022) (2022). Axispharm.com/antibody-drug-conjugatesadcs-list-approved-by-fda2000-2022
  • Pazo C , NawazK, WebsterRM. The oncology market for antibody-drug conjugates. Nat. Rev. Drug Discov.20(8), 583–584 (2021).
  • Ritchie M , TchistiakovaL, ScottN. Implications of receptor-mediated endocytosis and intracellular trafficking dynamics in the development of antibody drug conjugates. mAbs5(1), 13–21 (2013).
  • Tarcsa E , GuffroyMR, FalahatpishehH, PhippsC, KalvassJC. Antibody–drug conjugates as targeted therapies: are we there yet? A critical review of the current clinical landscape. Drug Discov. Today Technol.37, 13–22 (2020).
  • Jain N , SmithSW, GhoneS, TomczukB. Current ADC linker chemistry. Pharm. Res.32(11), 3526–3540 (2015).
  • Chen H , LinZ, ArnstKE, MillerDD, LiW. Tubulin inhibitor-based antibody–drug conjugates for cancer therapy. Molecules22(8), 1281 (2017).
  • Sauer S , ErbaPA, PetriniMet al. Expression of the oncofetal ED-B-containing fibronectin isoform in hematologic tumors enables ED-B-targeted 131I-L19SIP radioimmunotherapy in Hodgkin lymphoma patients. Blood113(10), 2265–2274 (2009).
  • Menrad A , MenssenHD. ED-B fibronectin as a target for antibody-based cancer treatments. Expert Opin. Ther. Targets9(3), 491–500 (2005).
  • Khan ZA , CaurteroJ, BarbinYP, ChanBM, UniyalS, ChakrabartiS. ED-B fibronectin in non-small cell lung carcinoma. Exp. Lung Res.31(7), 701–711 (2005).
  • Balza E , SassiF, VenturaEet al. A novel human fibronectin cryptic sequence unmasked by the insertion of the angiogenesis-associated extra type III domain B. Int. J. Cancer125(4), 751–758 (2009).
  • Saw PE , XuX, KangBPet al. Extra-domain B of fibronectin as an alternative target for drug delivery and a cancer diagnostic and prognostic biomarker for malignant glioma. Theranostics11(2), 941–957 (2021).
  • Qiao PL , GargeshaM, LiuYet al. Magnetic resonance molecular imaging of extradomain B fibronectin enables detection of pancreatic ductal adenocarcinoma metastasis. Magn. Reson. Imaging86, 37–45 (2022).
  • Graziani E , SungM, MaDet al. PF-06804103, a site-specific anti-HER2 antibody-drug conjugate for the treatment of HER2-expressing breast, gastric, and lung cancers. Mol. Cancer Ther.19(10), 2068–2078 (2020).
  • Gebleux R , StringhiniM, CasanovaR, SoltermannA, NeriD. Non-internalizing antibody–drug conjugates display potent anti-cancer activity upon proteolytic release of monomethyl auristatin E in the subendothelial extracellular matrix. Int. J. Cancer140(7), 1670–1679 (2017).
  • Hooper AT , MarquetteK, ChangC-PBet al. Anti-extra domain B splice variant of fibronectin antibody–drug conjugate eliminates tumors with enhanced efficacy when combined with checkpoint blockade. Mol. Cancer Ther.21(9), 1462–1472 (2022).
  • Damelin M , BankovichA, BernsteinJet al. A PTK7-targeted antibody–drug conjugate reduces tumor-initiating cells and induces sustained tumor regressions. Sci. Transl. Med.9(372), DOI: 10.1126/scitranslmed.aag2611 (2017).
  • Maderna A , DoroskiM, SubramanyamCet al. Discovery of cytotoxic dolastatin 10 analogues with N-terminal modifications. J. Med. Chem.57(24), 10527–10543 (2014).
  • Rosen LS , WesolowskiR, BaffaRet al. A phase I, dose–escalation study of PF-06650808, an anti-Notch3 antibody–drug conjugate, in patients with breast cancer and other advanced solid tumors. Invest. New Drug.38(1), 120–130 (2020).
  • Meric-Bernstam F , CalvoE, MorenoVet al. A phase I dose escalation study evaluating the safety and tolerability of a novel anti-HER2 antibody-drug conjugate (PF-06804103) in patients with HER2-positive solid tumors. J. Clin. Oncol.38(Suppl. 15), 1039 (2020).
  • Maitland ML , SachdevJC, SharmaMRet al. First-in-human study of PF-06647020 (cofetuzumab pelidotin), an antibody–drug conjugate targeting protein tyrosine kinase 7, in advanced solid tumors. Clin. Cancer Res.27(16), 4511–4520 (2021).
  • King GT , EatonKD, BeagleBRet al. A phase 1, dose–escalation study of PF-06664178, an anti-Trop 2/Aur0101 antibody–drug conjugate in patients with advanced or metastatic solid tumors. Invest. New Drug.36(5), 836–847 (2018).
  • Dong L , LiC, LocusonC, ChenS, GianMG. A two-step immunocapture LC/MS/MS assay for plasma stability and payload migration assessment of cysteine-maleimide-based antibody drug conjugates. Anal. Chem.90(10), 5989–5994 (2018).
  • Park MH , LeeBI, ByeonJJet al. Pharmacokinetic and metabolism studies of monomethyl auristatin F via liquid chromatography-quadrupole-time-of-flight mass spectrometry. Molecules24(15), 2754 (2019).
  • Yin F , KellerJ, KrausD, MangusH, LiF, LiuG. A double surrogate approach for the quantitation of 2-hydroxyglutarate – an oncometabolite in human brain tumors via LC–MS/MS. J. Pharm. Biomed. Anal.179, DOI: 10.1016/j.jpba.2019.112916 (2020).
  • Yin F , LingY, KellerJet al. Quantitation of 2-hydroxyglutarate in human plasma via LC–MS/MS using a surrogate analyte approach. Bioanalysis12(16), 1149–1159 (2020).
  • Lee BI , ParkMH, ChoiJet al. Liquid chromatography-high resolution mass spectrometric method for the quantitation of monomethyl auristatin E (MMAE) and its preclinical pharmacokinetics. Biomed. Chromatogr.34(8), e4855 (2020).
  • Yin F , LingY, MartinJet al. Quantitation of uridine and L-dihydroorotic acid in human plasma by LC–MS/MS using a surrogate matrix approach. J. Pharm. Biomed. Anal.192, DOI: 10.1016/j.jpba.2020.113669 (2021).
  • Yin F , YuS, NarayanaswamyR, MangusH, McCourtE, LiuG. Quantitation of ivosidenib in human plasma via LC–MS/MS and its application in clinical trials. Bioanalysis13(11), 875–889 (2021).
  • Yin F , DeCiantisC, PinkasJet al. Quantitation of an ADC drug PYX-201 in rat and monkey plasma via ELISA and its application in preclinical studies. Bioanalysis15(1), 43–52 (2023).
  • US FDA . Guidance for industry, bioanalytical method validation (2018). https://www.fda.gov/files/drugs/published/Bioanalytical-Method-Validation-Guidance-for-Industry.pdf
  • USDepartment of Health and Human Services FDA, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER) . Guidance for Industry, M10 bioanalytical method validation and study sample analysis (2022). https://www.fda.gov/media/162903/download

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.