Proven Intelligence Accelerating Next-Generation Therapies.

Executive Summary

The framework for dose-range finding (DRF) and maximum tolerated dose (MTD) studies for novel oncolytic virus platforms is designed to define a therapeutic window that informs subsequent IND-enabling toxicology programs. Our approach integrates a data-driven preclinical strategy with GxP-compliant execution in our >100,000 sq ft facility, structured to move candidates toward IND within an 18-24 month timeline. While the Franklin Biolabs brand launched in 2024, our scientific leadership has maintained a 100% successful IND rate for programs under our management since 2019.

Defining a Data-Driven Preclinical Strategy

A standardized preclinical testing template does not exist for oncolytic virus platforms. Each construct possesses a unique replication profile, immunogenic signature, and mechanism of action that requires a tailored evaluation. Our process begins with designing a study that can accurately define the dose-response relationship and identify potential liabilities before committing to resource-intensive, GxP-compliant toxicology programs.

Selecting an appropriate in vivo system directly impacts the clinical relevance of the data. Observed differences in vector transduction efficiency between preclinical models and human tissues (PMID: 17028800) underscore the need for careful model selection to generate clinically translatable data. By characterizing the vector’s activity in a competent biological system, we provide high-fidelity in vivo intelligence for complex modalities.

Study Design and Execution

A typical DRF study for an oncolytic virus involves several dose cohorts, including a vehicle control, to assess the full spectrum of biological response.

• Dose Escalation: A systematic dose-escalation scheme is employed to observe the onset of any adverse clinical signs.

• Clinical Monitoring: Animals are monitored daily for changes in health status, behavior, and body weight.

• Tumor Burden Analysis: Tumor growth is measured regularly to assess anti-neoplastic activity across dose levels.

• Terminal Analysis: At the conclusion of the study, blood is collected for clinical pathology, and a comprehensive set of tissues is collected for histological examination to identify any target organ toxicity.

This structured approach ensures the MTD is supported by a robust dataset of clinical and anatomical pathology findings. The ability of a vector to produce a meaningful biological effect and improve outcomes in preclinical models (PMID: 17180118) is the core principle guiding the progression of a candidate from these early assessments to formal IND-enabling studies.

Learn more about the infrastructure required for next-generation therapeutics in the full video: .

Animal Welfare and Regulatory Compliance

All in vivo procedures are conducted in compliance with GxP principles where required and with strict adherence to animal welfare regulations. Our commitment to the highest standards of animal care is reflected in our operational protocols, enhanced housing conditions, and enrichment programs. Our animal welfare strategy is built upon the 3Rs Principle:

• Replacement: Using non-animal methods where scientifically valid.

• Reduction: Minimizing the number of animals used per study.

• Refinement: Modifying procedures to minimize potential distress.

This page is a specific service offering. For more general information, please see our parent hub page on Preclinical | Translational Services.