Craig J. Thalhauser
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View article: Advancing cancer drug development with mechanistic mathematical modeling: bridging the gap between theory and practice
Advancing cancer drug development with mechanistic mathematical modeling: bridging the gap between theory and practice Open
View article: Dose Selection for <scp>DuoBody</scp>®‐<scp>CD40x4</scp>‐<scp>1BB</scp> (<scp>GEN1042</scp>/<scp>BNT312</scp>) Using a <scp>mPBPK</scp>/<scp>RO</scp> Model Leveraging Preclinical and Clinical Data
Dose Selection for <span>DuoBody</span>®‐<span>CD40x4</span>‐<span>1BB</span> (<span>GEN1042</span>/<span>BNT312</span>) Using a <span>mPBPK</span>/<span>RO</span> Model Leveraging Preclinical and Clinical Data Open
Optimizing target engagement for bispecific antibodies (bsAbs) is challenging, as bsAbs bind to two different targets in vivo to form a trimolecular complex (trimer), and likely display a bell‐shaped concentration–response curve. bsAbs tri…
View article: Acasunlimab, an Fc-inert PD-L1×4-1BB bispecific antibody, combined with PD-1 blockade potentiates antitumor immunity via complementary immune modulatory effects
Acasunlimab, an Fc-inert PD-L1×4-1BB bispecific antibody, combined with PD-1 blockade potentiates antitumor immunity via complementary immune modulatory effects Open
Background Next-generation cancer immunotherapies aim to improve patient outcomes by combining inhibitory signal blockade with targeted T-cell costimulation in tumor and lymphoid tissues. Acasunlimab (DuoBody-PD-L1×4-1BB) is an investigati…
View article: 719 Acasunlimab combined with PD-1 blockade elicits complementary immune-modulatory effects and enhances anti-tumor activity in preclinical models
719 Acasunlimab combined with PD-1 blockade elicits complementary immune-modulatory effects and enhances anti-tumor activity in preclinical models Open
View article: Advancing cancer drug development with mechanistic mathematical modeling: bridging the gap between theory and practice
Advancing cancer drug development with mechanistic mathematical modeling: bridging the gap between theory and practice Open
View article: Application of identifiability analysis to obtain reliable parameters of the QSP model describing mechanism of action GEN1042 (BNT312) and acasunlimab
Application of identifiability analysis to obtain reliable parameters of the QSP model describing mechanism of action GEN1042 (BNT312) and acasunlimab Open
View article: Towards A QSP Platform To Support Drug Development In Hematological Cancers
Towards A QSP Platform To Support Drug Development In Hematological Cancers Open
View article: Development of QSP model of non-small cell lung cancer and its application to support optimal dose selection for acasunlimab, a bispecific antibody targeting 4-1BB and PD-L1
Development of QSP model of non-small cell lung cancer and its application to support optimal dose selection for acasunlimab, a bispecific antibody targeting 4-1BB and PD-L1 Open
View article: Leveraging quantitative systems pharmacology (QSP) modeling to understand effects of corticosteroids on immune cells and cytokine release following administration of SC Epcoritamab
Leveraging quantitative systems pharmacology (QSP) modeling to understand effects of corticosteroids on immune cells and cytokine release following administration of SC Epcoritamab Open
View article: 1280 Modeling of direct (EGFR- based) and ADCC cytotoxic effect of Cetuximab on the basis of literature available <i>in vitro</i> data
1280 Modeling of direct (EGFR- based) and ADCC cytotoxic effect of Cetuximab on the basis of literature available <i>in vitro</i> data Open
Background Cetuximab is a recombinant human/mouse chimeric epidermal growth factor receptor (EGFR) monoclonal antibody. Cetuximab mechanisms of action is based on disruption of EGFR signaling pathways as dominant mechanism and ADCC …
View article: 874 A quantitative systems pharmacology model of head and neck squamous cell carcinoma: a tool for evaluating treatment outcomes for combination therapies
874 A quantitative systems pharmacology model of head and neck squamous cell carcinoma: a tool for evaluating treatment outcomes for combination therapies Open
Background Head and neck squamous cell carcinoma (HNSCC) is one of the most frequent cancers worldwide. Different approaches are applied to treat the cancer. Recently, several therapies were approved for treatment of head and neck cancers,…
View article: Assessing the performance of QSP models: biology as the driver for validation
Assessing the performance of QSP models: biology as the driver for validation Open
View article: 786 Dose selection for DuoBody®-PD-L1×4-1BB (GEN1046) using a semimechanistic pharmacokinetics/pharmacodynamics model that leverages preclinical and clinical data
786 Dose selection for DuoBody®-PD-L1×4-1BB (GEN1046) using a semimechanistic pharmacokinetics/pharmacodynamics model that leverages preclinical and clinical data Open
Background DuoBody-PD-L1×4-1BB (GEN1046) is a class-defining bispecific antibody, designed to elicit an anti-tumor immune response by simultaneous and complementary blockade of PD-L1 on tumor cells and conditional stimulation of 4-1BB on T…
View article: Immunogenicity in Clinical Practice and Drug Development: When is it Significant?
Immunogenicity in Clinical Practice and Drug Development: When is it Significant? Open
Managing immunogenicity in clinical practice and during drug development was a recent topic at the ASCPT 2019 annual meeting. This commentary expands on the discussion to facilitate a broader engagement across the community. The intent is …
View article: A Quantitative Systems Pharmacology Consortium Approach to Managing Immunogenicity of Therapeutic Proteins
A Quantitative Systems Pharmacology Consortium Approach to Managing Immunogenicity of Therapeutic Proteins Open
Immunogenicity is a major challenge in drug development and patient care. Currently, most efforts are dedicated to the elimination of the unwanted immune responses through T-cell epitope prediction and protein engineering. However, because…
View article: Evaluating a Multiscale Mechanistic Model of the Immune System to Predict Human Immunogenicity for a Biotherapeutic in Phase 1
Evaluating a Multiscale Mechanistic Model of the Immune System to Predict Human Immunogenicity for a Biotherapeutic in Phase 1 Open
View article: A Flexible Approach for Context‐Dependent Assessment of <scp>Quantitative Systems Pharmacology</scp> Models
A Flexible Approach for Context‐Dependent Assessment of <span>Quantitative Systems Pharmacology</span> Models Open
Systems pharmacology models are having an increasing impact on pharmaceutical research and development from preclinical through postapproval phases, including use in regulatory interactions. Given the wide diversity among the models and th…
View article: A Survey of Software Tool Utilization and Capabilities for Quantitative Systems Pharmacology: What We Have and What We Need
A Survey of Software Tool Utilization and Capabilities for Quantitative Systems Pharmacology: What We Have and What We Need Open
Quantitative systems pharmacology (QSP) is a rapidly emerging discipline with application across a spectrum of challenges facing the pharmaceutical industry, including mechanistically informed prioritization of target pathways and combinat…
View article: QSP Toolbox: Computational Implementation of Integrated Workflow Components for Deploying Multi-Scale Mechanistic Models
QSP Toolbox: Computational Implementation of Integrated Workflow Components for Deploying Multi-Scale Mechanistic Models Open
Quantitative systems pharmacology (QSP) modeling has become increasingly important in pharmaceutical research and development, and is a powerful tool to gain mechanistic insights into the complex dynamics of biological systems in response …