At CD BioSciences, we specialize in accelerating the discovery and preclinical development of innovative therapeutics targeting human herpesviruses (HHVs). Our Pre-clinical Candidate Nomination Package is designed to provide biotech and pharmaceutical clients with a data-driven, regulatory-ready foundation for selecting the most promising candidate(s) for IND-enabling studies. Leveraging deep HHV domain expertise, integrated technology platforms, and a robust network of disease models and assays, we streamline the transition from lead optimization to preclinical nomination—ensuring therapeutic programs are both scientifically validated and strategically aligned for regulatory advancement.
Why Pre-clinical Candidate Nomination Matters in HHV Therapeutics
Human herpesviruses—including HSV-1/2, VZV, CMV, EBV, and KSHV—pose complex therapeutic challenges due to:
- Latency and reactivation cycles that demand novel mechanistic approaches
- Tissue-specific viral reservoirs complicating drug delivery and efficacy testing
- Immune evasion strategies that necessitate multi-modal evaluations
Traditional drug development frameworks often fall short when applied to HHV-related diseases. CD BioSciences addresses this gap by offering virus-specific, mechanism-aware preclinical evaluation strategies that support confident candidate selection.
Our Integrated Solution
Our Pre-clinical Candidate Nomination Package includes a modular yet comprehensive suite of services tailored to HHV drug discovery:
Lead Candidate Evaluation and Down-Selection
- Confirmatory in vitro antiviral efficacy (e.g., plaque reduction, qPCR quantification)
- Cytotoxicity profiling in relevant human and animal cell lines
- Resistance profiling across diverse viral strains and mutants
- Mechanism-of-action (MoA) studies aligned with HHV-specific viral life cycles
Pharmacokinetic (PK) and Pharmacodynamic (PD) Characterization
- In vitro ADME-Tox (e.g., Caco-2 permeability, liver microsomal stability, CYP inhibition)
- PK-PD modeling using HHV-infected animal models (murine, rabbit, or NHP depending on target)
- Assessment of blood-brain barrier (BBB) penetration for neurotropic HHVs
In Vivo Efficacy Validation
- Use of proprietary and customized HHV animal models, including:
- Latency/reactivation models for HSV, VZV, KSHV
- CMV-infected immunocompromised mouse models
- EBV-associated lymphoma xenografts
- Measurement of viral load, immune activation, and tissue tropism
- Comparison with clinical gold-standard antivirals (e.g., acyclovir, valganciclovir)
Preliminary Safety and Toxicology Profiling
- Acute and sub-chronic toxicity studies in rodent models
- Evaluation of off-target effects, especially for nucleoside analogs and epigenetic modulators
- Histopathology, hematology, and serum biomarker analyses
Regulatory-Aligned Data Integration and Reporting
- IND-ready preclinical package including:
- Candidate nomination rationale
- Efficacy and safety summaries
- PK/PD correlations
- Risk assessment documentation
- Delivered in formats compatible with FDA and EMA regulatory expectations
Scientific Strengths & Differentiators
Deep Specialization in HHVs
Unlike general CROs, CD BioSciences is exclusively focused on HHV-related research. Our team includes virologists, pharmacologists, and translational experts who understand the subtle differences across HHV subfamilies and disease contexts.
Proprietary Tools & Assay Systems
- Access to HHV reporter viruses for real-time tracking of replication
- HHV-specific latency and reactivation assay systems
- Genomic and proteomic profiling platforms for candidate mode-of-action validation
Flexibility for Small Molecules, Biologics, and Nucleic Acid Drugs
Whether your therapeutic modality is a small-molecule inhibitor, therapeutic interfering particle (TIP), monoclonal antibody, or gene-editing system, our nomination package adapts to modality-specific evaluation needs.
Cross-Platform Integration
Pre-clinical nomination can be seamlessly integrated with our upstream services:
- Hit-to-Lead Generation
- Solutions for Targeting Latency
- Gene Therapy or Oncolytic Virus Platforms for delivery compatibility studies
Tailored to Support Partner Success
Our nomination package is particularly valuable for:
- Biotech companies preparing for Series B/C fundraising or out-licensing
- Pharma clients seeking HHV-focused preclinical expansion
- Academic spinouts advancing novel mechanisms of action into preclinical stages
Each project is assigned a dedicated scientific liaison and project manager, ensuring transparent communication, milestone-based planning, and customized reporting.
Example Applications
- Nomination of an HSV helicase-primase inhibitor with optimized PK in DRG-targeting formulations
- Selection of a KSHV LANA-targeted epigenetic modulator with demonstrable tumor load reduction in a PEL mouse model
- Evaluation of an siRNA-based CMV therapy, including in vivo biodistribution and target knockdown efficiency
Deliverables
By the end of the engagement, clients receive:
- Final candidate nomination report with supporting scientific evidence
- IND-preparatory documentation ready for pre-IND meeting submission
- Optional consultation sessions with HHV virology and regulatory experts
Partnership Models
We offer flexible engagement models:
- Full package execution with end-to-end service
- Modular service selection to complement in-house capabilities
- Strategic collaboration models for joint development and IP-sharing
To initiate a project discussion or receive a customized quotation, please contact us through our online request form or email info@cd-biosci.com. Our team is ready to assist you in confidently advancing your HHV therapeutic candidate.
References
- Whitley, R. J., & Roizman, B. (2001). Herpes simplex virus infections. The Lancet, 357(9267), 1513–1518.
- Mocarski, E. S., et al. (2013). Cytomegaloviruses. In Fields Virology, 6th ed. Lippincott Williams & Wilkins.
- Dittmer, D. P. (2011). KSHV Latency and Lytic Replication. Current Opinion in Virology, 1(3), 193–198.
- Pellett, P. E., & Roizman, B. (2007). The family Herpesviridae: A brief introduction. In Fields Virology, 5th ed. Lippincott Williams & Wilkins.
- U.S. Food & Drug Administration (FDA). (2020). Preclinical Assessment of Investigational Drugs.