Development of Biomarkers and Antineoplastic Drugs in Solid Tumors

A special issue of Cancers (ISSN 2072-6694). This special issue belongs to the section "Cancer Drug Development".

Deadline for manuscript submissions: 31 July 2025 | Viewed by 451

Special Issue Editors


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Guest Editor
Istituto Dermopatico dell’Immacolata, IDI-IRCCS, Rome, Italy
Interests: melanoma; biomarkers; drugs; immunotherapy; digital

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Guest Editor Assistant
Istituto Dermopatico dell’Immacolata, IDI-IRCCS, Rome, Italy
Interests: melanoma; immunotherapy; target therapy; biomarkers; drugs

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Guest Editor Assistant
Policlinico Umbero I, Rome, Italy
Interests: genitourinary cancers; precision medicine; biomarkers

Special Issue Information

Dear Colleagues,

In recent decades, biomarkers’ discovery in oncology has run parallel to the development of novel antineoplastic agents.

Drug regulatory agencies have approved new compounds, combinations, or extensions of indications for already approved drugs. Clinicians have not abandoned chemotherapy but rather rejuvenated it by combining it with other agents (i.e., immunotherapy) or conjugating cytotoxic drugs to a monoclonal antibody. Immune checkpoint inhibitors, antibody–drug conjugates, and targeted agents have improved the survival outcomes of many patients suffering from different cancer types and modified toxicity profiles. Tumor-infiltrating lymphocyte cell therapy (TIL) and autologous vaccine therapy represent two pioneering examples of highly personalized treatments with unique properties for every patient.

Besides drug development, biomarkers play a crucial role in tumor diagnosis, predicting response to therapies, mechanisms of resistance, and prognosis. Tissues, fluid, and fecal samples represent the sources for biomarker identification. Gene signatures and cell-free DNA are routinely used in oncology practice to support clinicians in medical choices. Novel biomarkers (digital biomarkers, microbiome profiles, etc.) are currently under evaluation.

Dr. Rosa Falcone
Guest Editor

Dr. Sofia Verkhovskaia
Dr. Michela Roberto
Guest Editor Assistants

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Keywords

  • solid tumors
  • drugs
  • biomarkers
  • immunotherapy
  • targeted therapy
  • artificial intelligence

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Published Papers (1 paper)

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Research

18 pages, 7251 KiB  
Article
Assessment of the Effects of Single-Domain Anti-Idiotypic Distribution Enhancers on the Disposition of Trastuzumab and on the Efficacy of a PE24-Trastuzumab Immunotoxin
by Ping Chen, Yu Zhang, Brandon M. Bordeau and Joseph P. Balthasar
Cancers 2025, 17(9), 1468; https://doi.org/10.3390/cancers17091468 - 27 Apr 2025
Viewed by 262
Abstract
Background/Objectives: Antibody-based therapies often exhibit limited distribution within solid tumors due to the “binding-site barrier” (BSB). Our group has developed and validated the use of anti-idiotypic distribution enhancers (AIDEs), which transiently block antibody binding, improving intra-tumoral distribution and efficacy. This study evaluated 1HE [...] Read more.
Background/Objectives: Antibody-based therapies often exhibit limited distribution within solid tumors due to the “binding-site barrier” (BSB). Our group has developed and validated the use of anti-idiotypic distribution enhancers (AIDEs), which transiently block antibody binding, improving intra-tumoral distribution and efficacy. This study evaluated 1HE and LG1, model anti-trastuzumab AIDEs, in combination with trastuzumab–PE24, a highly potent immunotoxin. Methods: The effects of 1HE on the whole-body disposition of radiolabeled trastuzumab were assessed in NCI-N87 tumor-bearing mice. Mechanistic pharmacokinetic/pharmacodynamic (PK/PD) modeling was employed to explore how AIDE binding kinetics influence antibody intra-tumoral distribution and immunotoxin potency. Trastuzumab–PE24 was developed by site-specific conjugation, enabled by self-splicing split intein, with cytotoxicity tested on various cell lines in vitro. The impact of 1HE and LG1 coadministration on trastuzumab–PE24 efficacy was evaluated in NCI-N87 xenograft-bearing mice. Results: 1HE coadministration decreased trastuzumab tumor maximum concentration, reducing tumor terminal slope by 8% and overall tumor exposure by 2.6%, without negatively affecting selectivity. Modeling predicted the optimal AIDE dissociation rate constant for trastuzumab–PE24 to be between 0.015 and 0.3 h−1. The coadministration of trastuzumab–PE24 with 1HE and LG1 improved anti-tumor efficacy and extended median survival to 60 days (p = 0.0002). Conclusions: AIDE coadministration led to minimal negative impacts on overall tumor exposure, consistent with model simulations. AIDE coadministration improved the efficacy of trastuzumab–PE24 in NCI-N87 xenografts. Modeling further predicted that repeated AIDE administration with trastuzumab–PE24 could induce complete tumor regression. These findings highlight the advantages of the AIDE strategy, particularly when coadministered with highly potent immunotoxins. Full article
(This article belongs to the Special Issue Development of Biomarkers and Antineoplastic Drugs in Solid Tumors)
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