Preclinical

In Vivo and In Vitro Services to Advance Your Drug Discovery

TD2’s integrated suite of preclinical services provides our clients with data that drives the development of clinical strategy. From the discovery stage to NDA strategy, we offer our clients advanced solutions to move their programs forward.

Our comprehensive service offerings utilized to rapidly move your treatments to the clinic include DMPK/ADME, in vitro and in vivo pharmacology, expert study design and execution. Your in vivo pharmacology studies are run in our AAALAC-accredited rodent facility with the highest regard for animal welfare. All studies are conducted with a commitment to meeting the high-quality standards you expect, and each offering is customizable to meet your unique development needs. With expert drug development insight and strategy and skilled project management, TD2 is your partner for an efficient path to the clinic.

Preclinical

Models and Services

TD2’s service offering is consistently expanding and currently includes:

Non-GLP Safety/Tolerability
Syngeneic Tumor Models
In vitro Pharmacology Assays
Orthotopic Tumor Models
DMPK/ADME services
Adoptive Cell Therapy Models
Tumor Xenograft Models
In vivo Optical Imaging
Humanized Mouse Models
Patient-derived tumor xenograft models (GBM)
Diet-Induced Obesity Tumor Model
Metabolomics and Proteomics Analysis

Tumor Models

Trusted IO Models

At TD2, we are dedicated to providing you with the most comprehensive preclinical immuno-oncology studies possible. Our experienced team offers a broad range of human and murine tumor models that allow for the planning and execution of studies in solid or hematologic malignancies.

Our syngeneic tumor models are fully characterized for gene expression, TIL baseline populations, and response to common immune checkpoint inhibitors (ICI), allowing for rapid, trusted study outcomes. These syngeneic cell lines can also be combined with our wide range of humanized immune checkpoint inhibitor mouse models to evaluate your ICI treatment. When syngeneic mouse systems are not applicable for your drug, we can employ the use of humanized mice either by engrafting with human PBMCs or other effector cells or utilizing sourced CD34+ humanized mice.

TD2’s vast experience in Adoptive Cell Transfer Therapy studies in both solid and hematologic tumors is unmatched in the industry. We have the expertise to provide you with the most accurate and reliable data possible, ensuring the success of your drug development program.

Cell Therapy Models +
Syngeneic Models +
Humanized Immune Checkpoint Inhibitor Mouse Models +

Specialized Animal Models

Regardless of the development question, TD2 has the specialized model you need to move your drug forward. Clients have access to humanized models, induction models, as well as specialty surgical and orthotopic models. Since we specialize in all areas of oncology and work diligently to understand your therapeutic’s mechanism of action and match that with clinical development strategies, we are constantly working to validate new model systems that represent areas of unmet medical need.

We have more than 60 first-presentation and recurrent Primary (PDX) Glioblastoma Models that include:

MOA-Based Filters using selections driven by your drug’s specific mechanism of action and subsequent interrogation
Diverse tissue types including fixed tissue for analysis of novel markers
Assessment of tumor progression as single agents and in combination with standard therapies via orthotopic primary tumor models
Well-established protocols that ensure an extremely high post-surgery survival rate
Data-rich and highly characterized models with standard of care

Specialized Glioblastoma Models +

Our Multiple Myeloma Transgenic Mouse Model is proven to improve multiple myeloma efficacy studies with more than 60 agents from Vk-Myc, a genetically engineered, clinically predictive mouse model from Dr. Leif Bersagel’s lab housed at the Mayo Clinic.

Inflammation is a common factor driving many diseases, including both oncology and fibrosis. Models of fibrosis can be very useful in multiple areas, including understanding drug effects on the tumor microenvironment. Our fibrosis induction liver models include DEN, CCl4, choline-deficient high-fat diet in addition to the bleomycin lung injury model.

In vitro tools to guide your preclinical therapy.

With TD2’s vast set of in vitro preclinical tools, you can explore drug effects on tumor cells, immune cells, and tumor/effector cell potentiation for earlier guidance on efficacy. Utilizing our in-house Tecan D300 digital dispenser, TD2 can ensure precise delivery of test agents giving rapid and confident data sets. When you partner with an oncology CRO like TD2, you will have access to more than 400 proof-of-concept tumor cell lines – all well-characterized – making the transition to in vivo studies seamless.

In our In Vitro Pharmacology Laboratory, we execute assays that can:

Define potency on viability in a panel of cell lines

Identify sensitivity and resistance profiles

Shape in vivo proof of concept study design

Determine combination interaction outcomes with immune effector cells

Assess combination interaction with standard of care agents (Synergy studies)

Determine optimal drug sequencing

Support for your preclinical goals.

With access to our expansive collection of human and murine tumor cell-line based models representing all of the major and many rare histologies, TD2 can assist its clients with expert selection of relevant tumor xenograft or syngeneic models tailored to your development questions in a way that will rapidly drive development of your therapy. Our in vivo efficacy studies are designed to identify, streamline, and optimize development strategies for your oncology therapeutic – including endpoints of tumor growth inhibition, tumor growth delay, imaging endpoints and biomarker analysis – and give you direction on your path to the clinic.

Additional support in in vivo preclinical services includes:

WHigh-tech, multi-modal AMI 1000 optimal imaging designed for powerful bioluminescence, fluorescence and X-ray

Non-GLP toxicology assessments including dose range finding, pharmacokinetic analysis, CBC and blood chemistries, and highly sophisticated histopathology services used to glean early toxicity insights

Accurate data collection and reporting using StudyLog®, our electronic data collection software that enables reliable data collection and faster analysis

Expert project management for efficient study execution and reliable data delivery