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From Hypothesis to Approval

The Scientific Evidence Behind Our Platform

We don't just claim to de-risk antibody development. We have proven it in the clinic. See the data that supported the successful advancement of two of BioArctic's antibody drug development projects into clinical trials.

Co-Authoring the Path to Clinical Success

The Exidavnemab Breakthrough

BioArctic engaged Offspring Biosciences to apply a rigorous translational validation strategy to their anti-alpha-synuclein program (Exidavnemab). Using our Tissue Insights™ platform, we mapped the antibody's binding profile directly in human Parkinson’s disease (PD) tissue.

The Challenge: To screen and select lead antibodies exhibiting the highest selectivity for pathological alpha-synuclein aggregates, distinguishing them from the physiological protein found in healthy synapses.

   

The Solution: Offspring Biosciences supported the identification of Exidavnemab as the lead candidate. We demonstrated specific target engagement in the complex environment of human post-mortem PD and MSA brain samples, utilizing high-resolution IHC and isPLA.

    

The Result: Based partly on our translational data, BioArctic advanced Exidavnemab into clinical testing (currently in Phase 2a).

    

The Impact: Another major antibody candidate successfully de-risked for clinical development using our platform.

The Science Behind the Success: Targeting Alpha-Synuclein

    

Why Competitors Failed: Previous antibodies targeting alpha-synuclein have struggled in the clinic, often because they bind indiscriminately to monomers. Exidavnemab was designed to target toxic aggregates specifically.

    

The Data: BioArctic achieved a massive >100,000-fold selectivity of their antibody to aggregated forms over monomers and native alpha-synuclein. Our tissue-based validation confirmed this selectivity in the patient context.

The Foundation of Success: Developing an effective treatment for Alzheimer’s

Our partnership with BioArctic is built on a decade of rigorous translational validation. This collaboration was instrumental in the development, and ultimately market launch, of a novel disease-modifying antibody for Alzheimer’s Disease.

How We Supported the Development:

  • Lead Characterization: Screening antibody candidates to identify the clone with the optimal binding profile in human tissue.

  • Target Engagement: Demonstrating ex vivo target engagement in animal models.

  • Safety Profiling: Characterizing binding to cerebral vasculature (CAA) to assess safety risks early.

  • Clinical Strategy: Supporting patient stratification definitions and evaluating potential secondary indications.

Dual immunofluorescence staining of Amyloid-beta and Phospho-Tau in human Alzheimer's brain tissue.

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Moa Fransson
CEO, Genagon Therapeutics AB

 

In close dialogue, Offspring delivered a relevant assay design for a previously uncharacterized protein. Their exceptional analysis  of cell-based markers on quality-controlled tissue samples aided us in determining the biological relevance of our target - a most important piece in our pre-clinical program.  

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We have worked with Offspring for several years and have always been impressed by the quality in their deliveries.  Also the engagement they show in our projects and what we want to achieve as a company.  We can highly recommend them to anyone looking for a first class CRO.

Johanna Fälting
Chief R&D Officer, Head of Research & Development at BioArctic AB

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Jonas Ekblom
CEO at Promore Pharma AB

 

We collaborated with Offspring on a large-scope Phase II clinical trial project. Their sense of urgency and rapid protocol adaptations were impressive, resulting in the on-time delivery of a complex operation. Their flexibility and effective management ensured a seamless collaboration. We wholeheartedly recommend Offspring as a service partner.

 

In close dialogue, Offspring delivered a relevant assay design for a previously uncharacterized protein. Their exceptional characterization of cell-based markers on quality-controlled tissue samples aided us in determining the biological relevance of our target—a most important piece in our pre-clinical program

See What We Can Do For Your Candidate

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