Immuno-Oncology Services

Immuno-oncology therapeutics act on the immune system rather than directly on the tumor, and that single fact governs every decision in preclinical study design. An agent that depends on human T cells cannot be evaluated in a host that has none. An agent acting through myeloid cells cannot be evaluated where the myeloid compartment is absent or murine. Model selection is therefore a scientific decision rather than a logistical one, and choosing wrongly produces data that cannot be interpreted no matter how well the study was executed.

Altogen Labs designs and executes immuno-oncology studies across humanized, syngeneic, and patient-derived platforms, with immune monitoring and tumor endpoints measured within a single protocol. The service covers immune checkpoint inhibitors, bispecific antibodies and other CD3-targeting biologics, CAR-T cell therapy, CAR-NK cell therapy, NK cell therapy, gamma delta T-cell therapy, cytokine and immune agonist programs, and combination regimens pairing an immunotherapy with a cytotoxic, targeted, or radiation modality.

Altogen Labs has supported immuno-oncology programs for pharmaceutical and biotechnology clients worldwide, from early mechanism work through IND-enabling packages, and company scientists have contributed to the peer-reviewed literature on preclinical model selection and standardization in oncology drug development.

Model platforms

Humanized mouse models reconstitute an immunodeficient host with human immune components so a human tumor can be studied in the presence of human effector cells. Altogen Labs supports peripheral blood mononuclear cell reconstitution for short studies where rapid T-cell engraftment is the priority, CD34-positive hematopoietic stem cell reconstitution for longer studies requiring multilineage human immunity, an artificial thymic organoid supported BLT-equivalent platform built on commercially obtained cord blood derived CD34-positive cells, and an iPSC-derived humanized platform.

Syngeneic models place murine tumor lines in matched immunocompetent hosts. Because the immune system is intact and murine throughout, these models answer mechanistic questions about immune-mediated tumor control that humanized systems cannot, and they remain the standard platform for checkpoint inhibitor benchmarking where a murine surrogate antibody exists. The trade-off is that the biology is murine, so target expression, epitope, and cross-reactivity must be confirmed for the species.

Humanized PDX models combine donor tumor heterogeneity with a human immune compartment and are the appropriate platform where inter-patient variability in immunotherapy response is itself the object of study.

For study design support or a costed protocol, request a quote.

Immune monitoring

An immuno-oncology study reporting only tumor volume has discarded most of its information. Altogen Labs measures the immune response alongside the tumor response in the same animals, so efficacy can be attributed to a mechanism rather than merely observed.

Flow cytometric profiling quantifies reconstitution and characterizes peripheral and intratumoral populations, including T-cell subsets, activation and exhaustion markers, NK cells, B cells, and myeloid populations. Cytokine quantification by ELISA and multiplex methods tracks systemic and intratumoral release, which is central to interpreting both efficacy and the cytokine-driven toxicities characteristic of T-cell engaging agents. Immunohistochemistry resolves the spatial question flow cytometry cannot: whether effector cells entered the tumor, where they sit relative to the margin, and at what density.

Where a cell therapy is under evaluation, persistence and trafficking of the transferred product are followed across the study, since durability of response frequently correlates with persistence rather than peak expansion.

Applied examples

Checkpoint inhibitor evaluation. CD34-positive humanized mice bearing subcutaneous solid tumors are randomized to vehicle or anti-PD-1 therapy. Tumor volume and survival are followed to endpoint, with CD8-positive infiltration quantified by immunohistochemistry and interferon gamma measured in tumor and plasma, so that a reduction in tumor growth can be linked to increased effector infiltration rather than reported alone.

Bispecific antibody dose selection. A CD3-engaging bispecific is administered across a dose range in a humanized model, with tumor response and cytokine release measured in parallel. The objective is therapeutic index rather than maximum efficacy: identifying the dose at which tumor control is achieved without the cytokine elevation that would limit clinical use.

CAR-T persistence. A systemic leukemia model is established in an immunodeficient host and treated with CAR-T cells at escalating doses. Tumor burden is followed by imaging, and circulating CAR-T cells are quantified across the study to distinguish transient clearance from durable engraftment of the product.

Design considerations that determine interpretability

Three questions decide whether an immuno-oncology study yields usable data. Species cross-reactivity comes first, since several checkpoint antibodies bind human but not murine target, and a human-specific antibody given to a model without human target expression shows no effect for reasons unrelated to its clinical potential. The study window comes second, because models reconstituted with peripheral blood cells develop graft-versus-host disease within weeks, placing a hard limit on duration that must be accommodated at design stage rather than discovered mid-study. Donor variability comes third and is a genuine variance component in humanized work, managed through donor selection, stratified randomization, and adequate cohort sizing.

Altogen Labs settles these at protocol stage. Model selection, host background, reconstitution criteria, eligibility thresholds, treatment window, and the immune monitoring panel are specified before any animal enters study, and reconstitution is verified by flow cytometry before randomization to treatment.

Scope, oversight, and human material

All procedures are conducted under active IACUC protocols in an IACUC-regulated facility, and GLP standards are applied where a study is formally designated as GLP. Human cells used in humanized platforms are commercially obtained from suppliers maintaining donor eligibility documentation; no fetal tissue or other primary human tissue is used or offered by Altogen Labs. Study protocols specify reconstitution thresholds, randomization criteria, treatment schedule, immune monitoring panel, humane endpoints, and the statistical analysis plan before initiation, and data are reported in a format suitable for inclusion in regulatory submissions.

Send study details to discuss model selection and protocol design, or request a quote.