Biological response modifiers: preclinical evaluation and clinical activity

Insights

Biological response modifiers, including interferons and monoclonal antibodies, are emerging as promising tumor-specific therapies. Advances in genetic engineering enable the development of highly pure agents for preclinical and clinical trials, showing early efficacy in cancer treatment.

Area of Science:

  • Immunology
  • Oncology
  • Biotechnology

Background:

  • Biological response modifiers (BRMs) are agents that modulate the host immune response against tumors.
  • These include interferons, lymphokines, tumor antigens, and antibodies, often derived from the human genome.
  • Advances in genetic engineering and monoclonal antibody technology allow for the production of highly purified BRMs.

Purpose of the Study:

  • To discuss the development of biological response modifiers for cancer therapy.
  • To highlight the role of preclinical models in predicting clinical efficacy.
  • To review early clinical results and ongoing Phase II studies of BRMs.

Main Methods:

  • Utilizing genetic engineering and monoclonal antibody technology for BRM production.
  • Employing preclinical models to assess the activity of BRMs.
  • Conducting clinical trials, including Phase II studies, to evaluate efficacy in patients.

Main Results:

  • Highly purified interferons and monoclonal antibodies show potential for tumor-specific therapy.
  • BRMs, alone or conjugated to toxins, are progressing towards clinical application.
  • Early clinical data suggest responses in patients with detectable disease.

Conclusions:

  • Biological response modifiers represent a significant advancement in anticancer strategies.
  • Continued development and testing are crucial for optimizing BRM therapy.
  • The potential for effective, targeted cancer treatment with BRMs is increasingly evident.

Related Concept Videos

Clinical Trials: Overview01:11

Clinical Trials: Overview

Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
Preclinical Development: Overview01:28

Preclinical Development: Overview

Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
Structure-Activity Relationships and Drug Design01:28

Structure-Activity Relationships and Drug Design

Drug design is a dynamic field that involves discovering and developing new medications based on specific biological targets. This process heavily relies on structure-activity relationships (SAR) and quantitative structure-activity relationships (QSAR) to guide the design and optimization of efficient drugs.
SAR studies the intricate relationship between a drug's chemical structure and biological activity. It focuses on understanding how modifications to a drug's structure can influence its...
Drug Products: Biologics, Biosimilars and Interchangeables01:28

Drug Products: Biologics, Biosimilars and Interchangeables

Biologics, derived from living sources such as humans, animals, or microorganisms, represent a significant category of pharmaceuticals. These complex molecules, developed through advanced biotechnological methods or purified from natural sources, include essential medical treatments like insulin and growth hormones. The complexity of biologics arises from their large molecular structures and the intricate processes required for their production, making them distinct from conventional...
Pharmacodynamic Responses: Different Types01:03

Pharmacodynamic Responses: Different Types

Pharmacodynamics is the scientific study of a drug's biochemical or physiological influence on the body. It categorizes responses into continuous, discrete (or categorical), and time-to-event outcomes. Continuous responses yield numerical values within a certain range, such as blood pressure readings and blood glucose levels, gauging the efficacy of antihypertensive and antidiabetic drugs. Discrete responses can be binary, indicating whether a drug has an effect or not, or ordinal, exemplifying...
Pharmacodynamic Models: Direct Effect Model and Indirect Response Model01:29

Pharmacodynamic Models: Direct Effect Model and Indirect Response Model

Pharmacodynamic models are essential tools in understanding the relationship between drug concentrations and their effects on biological systems. By characterizing the dynamics of drug action, these models guide dose selection, optimize therapeutic efficacy, and inform the development of new drugs. Two major classes of pharmacodynamic models include direct effect and indirect response models.Direct Effect ModelsDirect effect models describe the immediate relationship between drug concentration...