August 16, 2023

InSysBio announces its participation in the 14^th Annual World Bispecific Summit which is to be held on October 2-4, 2023 at Boston Park Plaza, Boston, MA. Oleg Demin Jr, Scientific Director, QSP modeling in Oncology & Immuno-Oncology, InSysBio will give a talk in frames of Preclinical & Clinical Track - Optimizing Translation into the Clinic to Maximize Bispecific Therapeutic Indexes.

Tuesday, October 3, 12:30 pm

• "Mechanistic Translational PK/RO Modeling vs MABEL to Predict First-in-Human Dose for Bispecific & Multispecific Antibodies"

Oleg Demin Jr will cover the following points:

• Minimal Anticipated Biological Effect Level (MABEL) approach is recommended to select clinical starting dose for mAbs and multispecific biotherapeutics.  
• For many immune-activating antibodies first-in-human (FIH) doses identified by MABEL were low and required many dose escalation steps exposing patients to sub-therapeutic doses.  
• Mechanistic translational PK/RO modeling predicts FIH dose for multispecific antibodies taking into account specific features of the candidate (affinity, avidity, targets), its concentration in tumor, and mechanism of action (trimers and other complexes in immunological synapse responsible for effect, bell-shaped dose dependence, etc.): a case of HPN536, a T-cell engager targeting mesothelin.

About InSysBio

InSysBio is a group of Quantitative Systems Pharmacology (QSP) companies located in Edinburgh, UK (INSYSBIO UK LIMITED), Limassol, Cyprus (INSYSBIO CY Ltd) and Moscow, Russia (INSYSBIO LLC). InSysBio was founded in 2004 and has an extensive track record of helping pharmaceutical companies to make right decisions on the critical stages of drug research and development by application of QSP modeling. InSysBio’s innovative QSP approach has already become a part of the drug development process implemented by our strategic partners: there are more than 100 completed projects in collaboration with leaders of pharmaceutical industry. For more information about InSysBio, its solutions and services, visit www.insysbio.com

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