Acrivon Therapeutics AB
Precision oncology across two continents
A Swedish-American company processing terabytes of proteomic data, pursuing FDA approval for its OncoSignature companion diagnostic
- Precision Oncology
- Lund, Sweden / Watertown, Massachusetts
- January 2026
A4BEE prepared this analysis from publicly available sources. It reflects our own reading of Acrivon Therapeutics AB's published strategy and is not endorsed by, or produced in cooperation with, Acrivon Therapeutics AB. Company website
Strategic priorities
Acrivon Therapeutics is a precision oncology company headquartered in Lund, Sweden with clinical operations in Watertown, Massachusetts. The company's AP3 discovery engine generates terabytes of high-resolution phosphoproteomic data per campaign — mapping the activity of thousands of protein phosphorylation sites to characterise drug mechanisms and identify patient subgroups most likely to respond to ACR-368, the company's lead asset. The OncoSignature companion diagnostic — developed on the Akoya PhenoImager HT platform — stratifies patients for ACR-368 trials and is being prepared for FDA Pre-Market Approval, creating a direct link between the proteomic data platform and the clinical registration strategy.
The structural challenge is the trans-Atlantic bifurcation: the AP3 discovery engine is in Lund while clinical operations run from Watertown. Terabytes of phosphoproteomic spectra must be accessible to clinical teams for real-time trial design and patient stratification decisions. Separately, the companion diagnostic turnaround time is critical — if the OncoSignature test takes more than seven to ten days, metastatic cancer patients may deteriorate or enrol in competing trials before results return.
The KaiSR generative AI model requires clean, structured datasets for effective training — the phosphoproteomic data from mass spectrometers must be processed, linked to clinical outcomes, and fed into the model retraining pipeline automatically. The legacy ACR-368 manufacturing process — originally developed by Eli Lilly — introduces a third challenge: the CDMO supply chain is opaque, with real-time production visibility limited to retrospective Certificates of Analysis.
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01
AP3 Platform Expansion
Scaling the Acrivon Predictive Precision Proteomics platform to generate terabytes of high-resolution phosphoproteomic data for drug mechanism elucidation and patient selection biomarker discovery across oncology indications.
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02
Clinical Development Velocity
Accelerating registrational Phase 2b trials for ACR-368 across ovarian, endometrial, and urothelial cancers using Master Protocol design for efficient patient routing and rapid enrolment.
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03
Companion Diagnostic Commercialization
Pursuing FDA Pre-Market Approval for the OncoSignature test developed on Akoya PhenoImager HT — converting the companion diagnostic from a clinical tool into a regulatory-grade commercial product.
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04
Generative AI Integration
Deploying the KaiSR ensemble model as a generative AI tool to assess drug effects on intracellular protein signalling networks and accelerate drug discovery iterations across the AP3 platform.
Challenges we see
- Digital Integration
Phosphoproteomic data gravity limiting trans-Atlantic collaboration
The AP3 platform in Lund generates terabytes of high-resolution phosphoproteomic spectra per campaign. Moving this data internationally for analysis by the Watertown clinical team is slow, expensive, and technically constrained by file sizes and bandwidth. The result is that the discovery engine and the clinical team operate with a latency between them that slows every decision that depends on linking new data to ongoing trials.
When discovery data cannot reach clinical teams in real time, patient stratification decisions are based on stale data rather than the latest phosphoproteomic characterisation — the personalised medicine promise of the AP3 platform is undermined by the infrastructure gap between Lund and Watertown.
- Operations Manufacturing
OncoSignature tissue logistics creating diagnostic turnaround delays
The OncoSignature companion diagnostic requires physical tissue samples to be shipped from distributed clinical sites to central laboratories for processing on Akoya PhenoImager instruments. With only 30 to 40 percent of screened patients being OncoSignature Positive, the screening programme generates significant sample logistics. Each day of turnaround time is a day the patient remains on an unsuitable therapy or is lost to competing trials.
When the companion diagnostic turnaround exceeds the clinical team's tolerance, clinicians default to enrolling patients on the basis of their own assessment rather than waiting for OncoSignature results — reducing the precision medicine benefit of the diagnostic and undermining the patient selection strategy.
- Compliance Regulatory
FDA PMA documentation burden for novel companion diagnostic
The FDA Pre-Market Approval pathway for OncoSignature is the most stringent regulatory route for a diagnostic device. It requires complete, immutable audit trails of every manufacturing step, software version, image file format, and data transfer protocol. A variation in any of these parameters without proper documentation can trigger regulatory rejection and delay commercial launch by years.
When the software development and manufacturing processes are not documented with regulatory-grade traceability, every software update and every equipment change requires a retroactive documentation effort that creates timeline risk and cost for the PMA submission.
- Operations Manufacturing
CDMO manufacturing opacity for legacy ACR-368 process
ACR-368 was originally developed by Eli Lilly and the manufacturing processes were established in the mid-2000s. Technical transfer to modern CDMO partners has likely introduced process documentation gaps. Acrivon has limited real-time visibility into production status, yield metrics, and quality deviations — the supply chain is a Black Box where batch-level information only arrives retrospectively through Certificates of Analysis.
When a quality deviation occurs at a CDMO site and Acrivon learns about it through the Certificate of Analysis rather than through real-time monitoring, the corrective action applies to future batches but cannot recover the failed batch or prevent the patient impact that occurred while the deviation was undiscovered.
- Digital Integration
Multi-modal data silos between mass spectrometry and imaging platforms
Acrivon generates two distinct massive data types: phosphoproteomic spectra from mass spectrometry in Lund and spatial imaging data from the OncoSignature immunofluorescence assays via the Akoya ecosystem. These data types reside in separate vendor ecosystems — Mass Spec data in proprietary vendor formats in Sweden, imaging data in the Akoya platform — preventing unified analysis that would refine the KaiSR predictive model.
When phosphoproteomic and imaging data cannot be analysed together, the KaiSR model is trained on each data type separately rather than on their joint predictive signal — limiting the model's ability to identify the multi-modal patterns that are most predictive of patient response.
Opportunities, by urgency and business impact
Each bubble is one opportunity, numbered to match the list below. Further right means it bites sooner; higher means a bigger effect on the business. A bigger bubble means a bigger implementation effort.
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Global cloud proteomics data lake for trans-Atlantic data access
The AP3 platform in Lund generates terabytes of phosphoproteomic spectra per campaign. Moving this data internationally is constrained by file sizes and bandwidth, limiting the Watertown clinical team's ability to use the latest discovery data in real-time patient stratification decisions.
Deploy a cloud-native Global Proteomics Fabric using Data Lakehouse architecture with automated ingestion from mass spectrometers, enabling Watertown scientists to access processed phosphoproteomic heatmaps within minutes of experiment completion — eliminating the trans-Atlantic data gravity bottleneck.
- AP3 platform data generation rate and Lund-Watertown data flow analysis
- Current mass spectrometer data export and transfer methodology
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Digital pathology hub-and-spoke network for companion diagnostic turnaround
Physical tissue logistics — shipping biopsies to central labs for PhenoImager processing — creates a seven to ten day turnaround that threatens ACR-368 recruitment velocity as metastatic patients may deteriorate or enrol in competing trials.
Implement a Hub-and-Spoke digital pathology network with regional PhenoImager instruments uploading to Acrivon's cloud via Akoya Proxima platform, enabling instant algorithmic OncoSignature scoring that reduces turnaround time by eliminating physical sample transit.
- OncoSignature turnaround time analysis and clinical site geography
- Akoya Proxima platform integration capabilities
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MLOps pipeline for KaiSR generative proteomics model
The KaiSR generative AI model requires clean, structured datasets for effective training. When phosphoproteomic data is stored in proprietary vendor formats or scattered across disconnected servers, model learning rate is throttled — the model's clinical utility degrades because it is not retrained on the latest outcome data.
Build an MLOps pipeline that automatically triggers KaiSR model retraining whenever new clinical outcome data is linked to patient proteomic profiles, with HPC clusters on demand for burst compute during intensive training sessions — accelerating the model velocity cycle from months to weeks.
- KaiSR current model training cycle and data bottleneck analysis
- HPC compute infrastructure requirements for proteomics ML workloads
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CMC digital twin and CDMO supply chain control tower
ACR-368 manufacturing at third-party CDMO sites leaves Acrivon with no real-time visibility into production status, yield, or quality deviations — batch-level information only arrives retrospectively through Certificates of Analysis, limiting the ability to intervene before a quality issue affects clinical supply.
Implement a CMC Digital Twin with continuous sensor data streams from CDMO partners, creating a Supply Chain Control Tower that enables real-time Continuous Process Verification and predictive batch failure detection — shifting from retrospective CoA review to proactive supply chain management.
- CDMO partner assessment and current data sharing arrangements
- CMC regulatory requirements for clinical supply visibility
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Unified scientific data fabric across mass spec and imaging platforms
Phosphoproteomic spectra and spatial imaging data reside in separate vendor ecosystems — Mass Spec data in proprietary formats in Lund, imaging data in Akoya — preventing the unified analysis that would accelerate KaiSR model refinement and patient stratification accuracy.
Deploy a unified Scientific Data Management System with IoT connectors to mass spectrometers, API integration with Akoya imaging platforms, and ELN synchronisation to create a Common Operating Picture across Lund and Watertown — enabling multi-modal analysis that each data source alone cannot support.
- Current data architecture for Lund and Watertown operations
- Akoya Proxima API integration feasibility for imaging data
What we'd propose
- Enterprise AI
Global Cloud Proteomics Data Lakehouse
We deploy a cloud-native Data Lakehouse architecture spanning Lund and Watertown that eliminates the trans-Atlantic data gravity bottleneck — automated data ingestion from mass spectrometers, standardised phosphoproteomic data formats, and controlled access for Watertown scientists to process and view results within minutes of experiment completion in Sweden.
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Automated mass spectrometer data ingestion pipeline
Build an automated data ingestion pipeline from Lund's mass spectrometry instruments to the cloud data lakehouse — handling the large raw files, running the standard proteomics processing workflow automatically, and making processed results available to Watertown scientists through a secured browser interface without manual file transfer steps.
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Cross-Atlantic data access governance
Implement data access governance that satisfies both Swedish and US data protection requirements — ensuring that patient-level proteomics data from clinical trials is accessible for analysis without violating jurisdictional data residency requirements.
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Real-time phosphoproteomic heatmap visualisation
Deploy a cloud-native visualisation layer that renders phosphoproteomic heatmaps and pathway activation scores in real time for Watertown scientists — the same views that Lund researchers see, accessible from the clinical team's workflow without installing specialised software.
- Clinical decisions — patient stratification, trial inclusion/exclusion — are based on the latest phosphoproteomic characterisation rather than data that is days or weeks old because it had to be manually transferred.
- The data lakehouse becomes the single source of truth for AP3 data, enabling Lund and Watertown to collaborate on the same dataset without the version control and file transfer overhead that currently creates confusion about which team has which version of which dataset.
- The infrastructure investment is reusable — when Acrivon expands to additional therapeutic areas or imaging modalities, the data lakehouse ingestion framework provides the foundation without starting from scratch.
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- Digital Lab
Digital Pathology Hub-and-Spoke Network for OncoSignature
We design and implement a Hub-and-Spoke digital pathology infrastructure integrating regional PhenoImager instruments with centralised OncoSignature scoring algorithms — enabling algorithmic diagnostic scoring at distributed imaging sites with results available to the clinical team within hours of tissue preparation rather than days of physical sample transit.
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Regional PhenoImager instrument connectivity
Deploy Akoya Proxima integration at regional imaging sites — connecting each PhenoImager to Acrivon's cloud scoring engine so that slide images are uploaded digitally as soon as staining is complete, eliminating the physical sample logistics that currently determine turnaround time.
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Cloud OncoSignature algorithmic scoring engine
Deploy the OncoSignature scoring algorithm in a cloud-hosted environment that receives digitised slide images from regional instruments and returns AI-scored results to the clinical team — with the algorithm version and confidence score recorded for each result as part of the FDA PMA audit trail.
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Turnaround time monitoring dashboard
Build a clinical operations dashboard that tracks each patient sample from collection at the clinical site through tissue preparation, imaging, and algorithmic scoring — surfacing bottlenecks in the logistics chain that are causing turnaround delays and enabling proactive intervention before a patient is lost to a competing trial.
- Turnaround time drops from seven to ten days to within 24 to 48 hours of slide preparation — the clinical team receives OncoSignature results before the patient's condition has deteriorated or before competing trial enrolment windows have closed.
- The digital pathology network generates the imaging volume data required to continuously improve the OncoSignature algorithm — every additional case increases the model's accuracy and the evidence base for the FDA PMA submission.
- Regional PhenoImager placement expands the geographic footprint of clinical trial sites — patients who live far from the central laboratory can participate in ACR-368 trials, increasing enrolment velocity.
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- Enterprise AI
MLOps Pipeline for KaiSR Generative Proteomics Model
We build an automated machine learning operations infrastructure for the KaiSR model — automated data labelling pipelines from clinical outcomes, HPC compute orchestration for burst model retraining, and model version management with regulatory-grade audit trails that satisfy FDA expectations for AI/ML-based medical device software.
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Clinical outcome data integration pipeline
Build a data pipeline that automatically links clinical outcome data — patient response, progression-free survival, adverse events — to the phosphoproteomic profiles from the same patients, creating the labelled training dataset that triggers KaiSR model retraining with the latest clinical evidence.
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HPC-on-demand compute for model training
Configure cloud-based HPC clusters that spin up on demand when a model retraining cycle is triggered — providing the compute capacity for intensive training sessions without requiring Acrivon to maintain permanent HPC infrastructure that would sit idle between training cycles.
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ML model governance and audit trail
Implement a model governance layer that tracks every version of the KaiSR model — training data, hyperparameters, performance metrics, and deployment status — creating the documentation that FDA reviewers expect for AI/ML-based software as a medical device and enabling rollback to any previous version if a new release underperforms.
- The model learning cycle accelerates from months to weeks — every new clinical outcome contributes to model improvement within days rather than being added to a backlog of manual retraining requests.
- The HPC-on-demand approach eliminates the capital cost of permanent HPC infrastructure while providing burst compute when needed — the model training cost scales with training frequency rather than with maximum theoretical compute demand.
- The model governance framework satisfies FDA expectations for AI/ML device software — the PMA submission includes the model version management documentation that regulators increasingly require for algorithmic diagnostics.
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- Digital CDMO
CMC Digital Twin and CDMO Supply Chain Control Tower
We implement a real-time manufacturing visibility platform connecting ACR-368 CDMO partners to a centralised CMC Digital Twin — enabling Continuous Process Verification, predictive batch failure detection, and proactive supply chain management for the clinical trial material that ACR-368 trials depend on.
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CDMO sensor data integration and normalisation
Deploy OPC UA or equivalent data connectors to the CDMO manufacturing sites, normalising production data — temperature profiles, pH curves, yield metrics, deviation logs — into a common data model that the CMC Digital Twin can ingest and analyse regardless of which CDMO or which SCADA system is used at each site.
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Continuous Process Verification dashboard
Build a Continuous Process Verification dashboard that presents each active manufacturing batch with its real-time sensor profile against the validated process recipe — flagging any parameter that approaches an out-of-specification boundary before the batch is complete and must be dispositioned as failed.
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Predictive batch outcome model
Train a predictive model on historical batch data that takes the real-time sensor profile from an in-progress batch and predicts the probability of meeting final quality specifications — enabling the manufacturing team to make go/no-go decisions on a batch before the quality outcome is measured rather than after.
- The supply chain for ACR-368 clinical trial material is no longer a Black Box — real-time visibility into CDMO manufacturing means that a developing deviation is identified and addressed while the batch is still in progress rather than after it has already failed.
- Predictive batch outcome modelling reduces the number of failed batches that Acrivon discovers only through the Certificate of Analysis — each prevented failed batch avoids the patient impact of a supply disruption and the cost of replacing clinical trial material.
- The CDMO relationship is transformed from a passive reporting model to an active partnership — the Control Tower data enables Acrivon to have informed conversations with CDMO partners about process optimisation rather than accepting whatever the CoA reports.
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- Digital Lab
Unified Scientific Data Fabric Across Lund and Watertown
We deploy an enterprise scientific data management platform that integrates phosphoproteomic spectra, spatial imaging data, and clinical metadata into a single searchable source of truth — connecting the Lund discovery engine and the Watertown clinical operation through a unified data architecture that enables multi-modal analysis, ELN synchronisation, and the Common Operating Picture that the trans-Atlantic structure currently prevents.
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Multi-modal data ontology and harmonisation layer
Build a data ontology that harmonises phosphoproteomic spectra and spatial imaging data into a common patient-centric data model — enabling queries that span both data types for the same patient without requiring manual cross-referencing between separate systems.
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Mass spec instrument IoT connectors
Deploy IoT data connectors for the Lund mass spectrometry instruments that automatically capture raw spectra, run the standard processing pipelines, and store processed results in the harmonised data model — eliminating the manual export and import steps that currently create data versioning problems.
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ELN synchronisation with clinical trial管理系统
Implement bi-directional synchronisation between the Lund ELN and the Watertown clinical trial management system — ensuring that any protocol amendment or data clarification is reflected in both sites' record-keeping systems without manual re-entry.
- The KaiSR model trains on multi-modal data — phosphoproteomic and imaging signals combined — rather than on each data type in isolation, which improves the model's predictive accuracy for patient response to ACR-368.
- Cross-site collaboration shifts from email and file sharing to structured data queries — scientists in Lund and Watertown work from the same data platform rather than from different versions of the same dataset.
- The unified data fabric provides the foundation for any future expansion — whether into new therapeutic areas, new imaging modalities, or new partnership arrangements — without requiring a new data architecture.
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Digital maturity: today and target
Scored out of 100 across six dimensions. The target is what Acrivon Therapeutics AB's own published ambition implies — not a perfect score.
- Data Infrastructure 45 → 85
- Phosphoproteomic spectra and spatial imaging data reside in separate vendor ecosystems — Mass Spec data in proprietary formats in Lund, imaging data in Akoya — without a unified data architecture connecting the Lund discovery engine to the Watertown clinical team. The trans-Atlantic data flow is constrained by manual file transfer steps and bandwidth limitations.
- Process Automation 40 → 80
- OncoSignature tissue logistics require manual handling at every step — collection, shipping, staining, imaging, scoring — with no automation beyond the PhenoImager instrument itself. The MLOps pipeline for KaiSR model retraining has not been built. CDMO manufacturing data is received retrospectively by email and CoA upload.
- AI/ML Capabilities 55 → 90
- The KaiSR model exists but the MLOps pipeline for continuous retraining on new clinical outcome data has not been implemented. Model training is triggered manually, and the model governance framework required for FDA AI/ML device standards has not been built.
- Supply Chain Visibility 30 → 75
- CDMO manufacturing is a Black Box — Acrivon receives retrospective Certificates of Analysis but has no real-time visibility into production status, yield, or in-process quality metrics. The Supply Chain Control Tower required for proactive CMC management has not been built.
- Regulatory Readiness 50 → 90
- The FDA PMA submission for OncoSignature requires complete audit trails of every software version, image file format, and data transfer step. The current digital pathology workflow does not include the documentation controls and version tracking that a PMA submission requires. The model governance framework for the AI/ML diagnostic is not yet aligned with FDA guidance.
- Cross-Site Collaboration 35 → 80
- Lund and Watertown operate as semi-independent sites with data shared primarily through email and file transfers. The unified Scientific Data Management System and ELN synchronisation required for a Common Operating Picture across both sites have not been implemented.
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This is an independent analysis prepared by A4BEE from publicly available information as of January 2026. It reflects A4BEE's own interpretation and opinion, is not affiliated with, endorsed by, or verified with Acrivon Therapeutics AB, and may be incomplete or inaccurate. All company names and trademarks are the property of their respective owners. To request a correction or removal, contact [email protected].