functional and predictive assays for biotherapeutics ...€¦ · 1hansel tt, et. al. nature reviews...

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Thrombocytopenia Neutropenia Our predictive assays help you assess Functional and Predictive Assays Cytokine release syndrome Cytokine storm Primary cell binding Primary cell activation Targeted killing Cell signaling Efficacy and Toxicity for Biotherapeutics Development

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Page 1: Functional and Predictive Assays for Biotherapeutics ...€¦ · 1Hansel TT, et. al. Nature Reviews Drug Discovery 9, 325 (2010) Extensive biotherapeutic experience About Us Functional

Thrombocytopenia

Neutropenia

Our predictive assays help you assess

Functional and Predictive Assays

Cytokine release syndrome

Cytokine storm

Primarycell binding

Primary cellactivation

Targeted killing

Cell signaling

E�cacy and Toxicity

for Biotherapeutics Development

Page 2: Functional and Predictive Assays for Biotherapeutics ...€¦ · 1Hansel TT, et. al. Nature Reviews Drug Discovery 9, 325 (2010) Extensive biotherapeutic experience About Us Functional

1Hansel TT, et. al. Nature Reviews Drug Discovery 9, 325 (2010)

Extensive biotherapeutic experience

About Us

Functional and Predictive Assays for Biotherapeutics Development

Many biotherapeutic developers use the services of ReachBio Research Labs as an important part of their biologic

development programs.

Take advantage of our experience, �exibility and research depth to tailor assays to suit your needs.

Our experience supporting biotherapeutic development includes assays to evaluate primary cell functionality and toxicity of

monoclonal antibodies, bi-speci�c antibodies, antibody-drug conjugates, nanobodies and other biologics.

We have extensive experience measuring the ability of biotherapeutics to bind to cells and trigger complement-dependent

cytotoxicity, antibody-dependent cytotoxicity and T cell-mediated cytotoxicity.

Frequently observed side e�ects of biotherapeutics include thrombocytopenia, neutropenia and severe anemia.1

We have proven and predictive primary cell-based assays to address each of these issues.

Ranking toxicity of lead biotherapeutics to predict clinical thrombocytopenia, neutropenia and severe anemia

Evaluating bi-speci�c immunotherapies for the ability to recruit immune cells to kill cancer cells

Assessing biotherapeutics’ e�ects on cancer stem cells

Customizing cell biology assays to �t client needs

Helping support INDs and Phase 1 clinical trials

Primary cell biology experts

© ReachBio LLC. All rights reserved.

• Primary blood and bone marrow cell culture from multiple species

• Primary blood cancer stem cell culture from multiple donors

• Immunotherapy evaluation using primary immune cells and cancer cells

• Cell bank production of expanded primary cells

• Blood progenitor (normal and cancer) cell culture

• Flow cytometry (up to 16 color)

• Coming soon: CyTOF Mass Cytometry!

• Small animal and NHP dosing models (performed with collaborators)

• Luminex® and intracellular cytokine analysis

• Coming soon: Genomic analysis!

Page 3: Functional and Predictive Assays for Biotherapeutics ...€¦ · 1Hansel TT, et. al. Nature Reviews Drug Discovery 9, 325 (2010) Extensive biotherapeutic experience About Us Functional

Evaluate and rank your biotherapeutic candidates for their risk of clinical thrombocytopenia, neutropenia or severe anemia

• Applicable for evaluation of both biologics and small molecules

• Predictive of clinical thrombocytopenia, neutropenia or severe anemia

• Evaluate molecules alone or in combination with standard-of-care drugs

• Customized to your program’s needs

Blood and bone marrow toxicity assays

Evaluate and rank the e�ectiveness of your biotherapeutic candidates at inhibiting cancer stem- and progenitor - cell expansion

Cancer stem cell assays

• Applicable to both biologics and small molecules

• Measure functional inhibition of cancer progenitor cell expansion

• Customized to your program’s needs

• Evaluate therapies that target cell surface receptors (e.g. CD24) and stem cell-associated signaling pathways (e.g. Wnt/Hedgedhog)

Correlation of in vitro CFC IC50 values with clinical neutropenia

AML Blast-Derived Colony MM-Derived Colony Normal CFU-GM-Derived Colony

Page 4: Functional and Predictive Assays for Biotherapeutics ...€¦ · 1Hansel TT, et. al. Nature Reviews Drug Discovery 9, 325 (2010) Extensive biotherapeutic experience About Us Functional

123 NW 36th Street, Suite 235, Seattle, WA 98107, USA • NA Toll-Free 1 877 838 CELL (2355) T 1 206 420 0300 • F 1 206 420 0301 • [email protected] • www.reachbio.com

Contact Us

Evaluate and rank the ability of your candidates to recruit T cells and NK cells to kill cancer cells

Cancer immunotherapy assays

• Compatible with bi-speci�c antibodies and other immune cell recruiters

• Measure primary immune cell killing of target cells

• Flow cytometry based readout with additional intracellular analysis, if desired

• Customized to your program’s needs

Functional and Predictive Assays for Biotherapeutics Development

Cytokine storm and cytokine release syndrome (CRS)

• Human cells are more relevant at predicting risk of cytokine storms or CRS than are in vivo primate models due to nuanced immunological differences between the species

• Human primary cell-based assays with pro-inflammatory cytokine quantification using the Luminex® platform

• Uses the soluble, not plastic-immobilized form of the biologic

• Helps to understand the risk of non-specific immune cell activation prior to NHP studies

Evaluate and rank the potential risk of your candidates to induce cytokine release or cytokine storms with our in vitro assays

ReachBio LLC. All rights reserved.®©

Luminex is a registered trade mark of Luminex Corporation

Therap.Ab(pg/mL)

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