At CD BioSciences, we specialise in serving the research-stage and preclinical sector of human herpesvirus (HHV)-linked therapeutic development. Our oHSV Engineering & Validation Support service is tailored for sponsors and institutions advancing oncolytic herpes simplex virus (oHSV) platforms with an HHV-focus — specifically, we deliver the engineering, design, quality controls and functional validation required for robust pre-clinical candidates. This page outlines how we partner with you to transform your concept into a validated oHSV vector for HHV-relevant malignancies or HHV-associated virus-oncolytic combinations.
Why oncolytic HSV for HHV-related programmes?
While oHSV platforms have made headway in solid tumour oncology, their adaptability and engineering flexibility make them an attractive backbone for HHV-associated malignancies (e.g., those driven by Kaposi's Sarcoma‑associated Herpesvirus (KSHV) / HHV-8, or latent herpesvirus reservoirs). Advantages of HSV-1/2 as vectors include:
- A large ~152 kb double-stranded DNA genome with ample capacity for insertion/deletion of non-essential genes (≈30 kb) and incorporation of immunomodulatory or targeting transgenes.
- Well-understood virology, proven replication machinery, available control drugs for safety management.
- The potential to engineer tumour tropism, immune-stimulatory payload, selective replication in malignant/virus-infected cells, and synergy with immunotherapies.
- Existing clinical precedent of HSV-based oncolytic vectors supporting translational feasibility.
For HHV-driven malignancies (such as primary effusion lymphoma, Kaposi's sarcoma, multicentric Castleman's disease linked to HHV-8) or virus-latency-targeting strategies, the adaptability of the oHSV platform allows us to implement bespoke targeting, payload design and functional validation workflows.
Our Scope of Service
At CD BioSciences, our oHSV Engineering & Validation Support covers the full stack of preclinical design through functional verification — specifically for HHV-related programmes. Key service components include:
1. Vector design & engineering
- Strategic design of the oHSV backbone: gene deletions (e.g., γ34.5, UL39, ICP47) to attenuate neurovirulence / normal cell replication; tropism retargeting for HHV-infected/tumour cells.
- Insertion of payload transgenes or immunomodulators (e.g., cytokines, checkpoint modulators, pro-apoptotic genes) that can complement HHV biology or tumour immune microenvironment.
- Custom promoter/regulatory element selection (tumour/HHV-infected cell-specific) and optimisation of viral replication kinetics to balance safety and potency.
- Support for plasmid/viral BAC constructs, rescue, purification, and pre-GMP small-scale manufacturing of viral seed stocks aimed at pre-clinical studies.
2. In vitro validation & functional profiling
- Infectivity and replication assays in both standard cell lines and HHV-associated tumour models (e.g., KSHV-infected PEL lines, Kaposi's sarcoma derived lines).
- Cytotoxicity/lysis assays, plaque assays, multi-cycle replication kinetics, and comparative analysis versus control vectors.
- Payload expression verification (e.g., transgene mRNA/protein quantification, functional read-outs of cytokine release).
- Selectivity assessments (normal vs tumour cells; HHV+ vs HHV-) to demonstrate preferential oncolytic replication.
- Immune-modulator screening if applicable: e.g., T-cell/NK activation read-outs, cytokine panel profiling, immune checkpoint marker expression.
3. In vivo pre-clinical characterization (non-clinical stage)
- Establishment of appropriate xenograft or syngeneic tumour models — including HHV-associated tumour models when available — for intratumoral or systemic delivery of oHSV.
- Assessment of viral biodistribution, viral shedding, off-target replication, toxicity and tolerability in rodent models.
- Tumour growth inhibition, survival studies, immune cell infiltration and tumour microenvironment profiling (CD8+ T cells, NK cells, myeloid subsets) post-oHSV treatment. Literature notes that insertion of immune-modulatory genes into oHSV enhances CD8+ T cell responses and may improve anti-tumour efficacy.
- Standard virus safety metrics and Good Laboratory Practice (GLP)-compatible assay support (where applicable) to provide robust data packages for pre-clinical candidate nomination.
4. Validation reporting & package for candidate nomination
- A comprehensive identification and validation report summarising vector design rationale, engineering strategy, in vitro and in vivo data, selectivity and safety profiling, with clear next-step recommendations.
- Data-ready deliverables formatted for integration into downstream IND-enabling or academic publication pipelines (even if CD BioSciences does not support clinical stage); we ensure high-quality documentation aligned with regulatory expectations (e.g., trackable design changes, CoA-style viral seed certificates, replication/titer data).
- Advisory consultation on next-stage development: translation risk assessment, combination therapy considerations, manufacturing scale-up strategy (pre-GMP to GMP bridging, as needed) and alignment with HHV programme-specific challenges (latency, viral vector interactions with HHV-infected compartments).
Why choose CD BioSciences for your HHV-focused oHSV programme?
- Deep HHV domain expertise: Our company's core focus is human herpesviruses (HHV)—including herpesviridae latency/reactivation biology, HHV-associated malignancies and virology services. This domain specialisation ensures that when we engineer an oHSV platform for an HHV-linked programme, we are sensitive to unique virus/host interactions, latency reservoirs, immune evasion strategies and potential cross-virus considerations.
- Preclinical-stage focused: We align with clients who are in the research or preclinical phase (not providing clinical/manufacturing GMP stage). That means our workflows, timelines, pricing and deliverables are optimised for non-clinical, discovery and early translational use—ideal for new drug development companies, biotech, academic spin-outs and HHV research consortia.
- Integration of virology, vectorology and immuno-profiling services: In addition to vector engineering, we bring in expertise around viral replication kinetics, cytotoxicity assays, immune profiling and vector safety/shed studies. Many service providers specialise in one area; we offer a unified solution tailored for HHV-oncolytic virus programmes.
- Regulatory-conscious documentation: Recognising your underlying interest in compliance and high standards (e.g., CoAs, endotoxin limits, traceability), we deliver documentation and data packages designed for robust internal decision-making, potential publication and due diligence by pharma/academic partners.
- Customise & adapt: Because HHV programmes vary widely (latent viral reservoirs, virus-associated tumour types, immune infiltration differences, need for combination immunotherapy), we emphasise a collaborative project plan: custom vector design, tailored assay workflow, flexible model selection and milestone gating that matches your R&D timeline and budget.
Typical Project Outline
Below is a representative workflow for an oHSV Engineering & Validation project with CD BioSciences (timelines indicative; final plan quoted per project).
1. Discovery & Design Phase (Weeks 0-4)
- Kick-off meeting: biology briefing, tumour/HHV model selection, vector‐backbone decision, payload/regulatory element set.
- Vector design dossier: gene deletion list, promoter selection, payload specification, expected replication/selectivity profile.
- Construction of plasmid/BAC and rescue strategy.
2. Engineering Phase (Weeks 5-10)
- Transfection/rescue of engineered oHSV; plaque purification; viral seed stock generation.
- Titering, short term quality control (sterility, mycoplasma, endotoxin, identity by PCR/sequencing).
3. In Vitro Validation (Weeks 11-20)
- Infectivity & replication kinetics in tumour/HHV models and control cells.
- Cytotoxicity assays, payload expression quantification, selectivity index calculation.
- Optional immune-cell coculture read-outs (e.g., NK, CD8+ T cell activation) if payload is immuno-modulatory.
4. In Vivo Proof-of-Concept (Weeks 21-36)
- Rodent tumour model set-up (including HHV-tumour models if required).
- Dosing study: intratumoral/systemic administration of oHSV, monitoring tumour growth, survival, viral biodistribution, shed/replication in off-target tissues.
- Immune profiling of tumour microenvironment post-treatment (flow cytometry, IHC for CD8, NK, myeloid markers).
- Safety endpoints: weight change, behaviour, histopathology of major organs, viral detection in non-tumour tissues.
5. Reporting & Candidate Nomination Package (Weeks 37-40)
- Deliver final report with design summary, in vitro/in vivo data, selectivity/safety table, next-step recommendations (e.g., combination with checkpoint inhibitors, dosing optimisation, GMP-seed considerations).
- Provide data-ready plots, raw data spreadsheets, vector construct maps, sequence data, QC summaries.
Key Considerations & Best Practices for HHV-Relevant oHSV Programmes
- Tropism and selectivity for HHV-infected or HHV-associated tumour cells: When targeting HHV-linked malignancies (e.g., KSHV/HHV-8), consider engineering the oHSV to exploit virus-associated promoters or virus-infected cell markers rather than generic tumour tropism.
- Latency vs active replication context: HHV programmes often involve latent viral reservoirs; ensure that your model selection (cell lines, in vivo models) appropriately reflects latent vs lytic state, and the oHSV is designed to function in that context.
- Payload design aligned with HHV immune evasion mechanisms: HHVs encode multiple immune-evasion proteins; your oHSV payload strategy may need to counteract or bypass HHV-mediated immunosuppression (for example, by encoding immune-stimulatory cytokines, checkpoint modulators or genes that exploit HHV-infected cell vulnerabilities).
- Safety, biosafety and viral shedding concerns: Although oHSV is well-characterised, when engineering for HHV-associated indications you must address potential recombination, cross-infection, latent reactivation risk and viral shedding in non-tumour tissue. Robust biodistribution and shedding studies are vital.
- Combination therapy readiness: Modern oHSV programmes increasingly integrate with immune-checkpoint inhibitors, adoptive cell therapies or therapeutic vaccines. Designing your vector with combination-therapy compatibility in mind (transgene payloads, immune-modular features) improves translational readiness.
- Manufacturing & regulatory foresight: Even though your focus is preclinical, it is prudent to document vector construction, seed stock provenance, potency assays, sterility/mycoplasma testing, endotoxin levels and storage stability now—this will pay dividends if you advance to IND-enabling activities.
FAQs
Q1: At which stage can CD BioSciences engage in my oHSV project?
A1: We support from discovery/design through to preclinical (in vivo) validation and candidate nomination stages. We do not provide GMP manufacturing, first-in-human clinical execution or commercialization services. If you require clinical-stage support, we can recommend partner labs.
Q2: Can you use my proprietary tumour model or HHV-infected cell line?
A2: Yes. We welcome use of client-provided cell lines, animal models or viral constructs under suitable material transfer agreement (MTA). We will integrate these materials into our workflow and ensure confidentiality and IP protection.
Q3: What regulatory documentation will I receive?
A3: You will receive detailed reports including vector maps, sequencing verification, QC data (sterility, mycoplasma, titer, identity), in vitro/in vivo assay results, biodistribution/shedding data (if included) and full raw data sets. While not GMP certified, these reports are structured to support downstream IND/CTA-enabling documentation.
Q4: How long does a typical project take and what are cost drivers?
A4: A typical full engineering & validation project (in vitro + in vivo) spans approximately 8–10 months. Time and cost drivers include: complexity of vector engineering (multiple payloads or retargeting modifications), length of in vivo study, number of models tested, immune profiling depth and level of GLP-compliance required.
Q5: How do you address biohazard safety concerns with oHSV?
A5: We operate under BSL-2+/BSL-2(+) conditions, with appropriate viral vector risk assessments, staff training, viral containment logistics and shedding monitoring protocols. We also counsel clients on biosafety, regulatory permits (e.g., NIH Guidelines, local biosafety committees) and provide guidance on vector risk classification.
Why work with us right now?
HHV-driven disease areas are emerging and under-served in oncolytic virotherapy. By leveraging an oHSV engineering strategy aligned to HHV biology, you position your programme for differentiation and translational potential. At CD BioSciences we integrate deep HHV knowledge, rigorous virology and vector engineering services, and flexible pre-clinical workflows to help you progress from concept to validated candidate. Our service offering is ideal for biotech companies, academic teams or research consortia developing HHV-linked therapeutic strategies at the pre-clinical stage.
References
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- Hu Z et al. "Improved antitumor effectiveness of oncolytic HSV-1 viruses engineered with IL-15/IL-15Rα complex combined with oncolytic HSV-1-aPD1 targets colon cancer." Sci Rep. 2024;14:23671.
- Ghorab BEA, Liu T, Ying M, Wang P, Qin M, Xing J, Wang H & Xu F. "Advances in the Drug Development and Quality Evaluation Principles of Oncolytic Herpes Simplex Virus." Viruses. 2025;17(4):581.
- Maldonado AR, Klanke C, Jegga AG, et al. "Molecular engineering and validation of an oncolytic herpes simplex virus type 1 transcriptionally targeted to midkine-positive tumors." J Gene Med. 2010;12(7):613-23.
- Zou Y et al. "Engineering HSV-1 for oncolytic therapy." ScienceDirect. 2025.