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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - UNIBIO (TK210 ELISA â€“ universal serum protein biomarker for cancer screening, diagnosis, treatment response monitoring and early detection of relapse (UNIBIO))

Teaser

Summary

The feasibility study has shown that TK210 ELISA as a cancer biomarker is both commercially and clinically viable. AroCell will therefore pursue further validation of the biomarker.
Based on the market assessment and the benchmarking against the established biomarkers, both blood-based and the TK-based, we are confident that there will be a willingness to pay for TK 210 ELISA and that our biomarker provides better value added for clinicians than other available assays.
The overall objectives of the innovation project have not changed. The main idea is still to clinically validate and commercialize TK210 ELISA â€“ a serum and plasma biomarker for cancer diagnosis and treatment response, first within prostate cancer and thereafter within breast cancer and hematologic malignancies.

The expected impact is the same as described in the grant agreement. TK 210 will be based on measurement of the enzyme Thymidine kinase (TK). TK210 will be the only cell-related growth biomarker that can measure levels of TK protein directly in blood, irrespective of whether the enzyme is active or not. This will enable the biomarker to become an easy-to-deploy biomarker for cancer prognostic and for monitoring of treatment response. The feasibility assessment has confirmed that TK210 can successfully address the key EU cancer related challenges by providing a reliable and replicable test for tumor growth. The impacts of the validated TK 210 will be considerable, as it will allow clinicians to rapidly assess the efficacy of drugs for patients undergoing treatment and limit treatments based on inefficient drugs and allow payers to optimize the costs of treatment by a more personalized medicine approach.

In terms of concept and approach, the main conclusion from the feasibility study us that the biomarker validation activities should be first focused on the prostate cancer (first market application area), where the need for new biomarkers enabling improved diagnosis and patient management decisions is apparent. This will be reflected in application to SME Instrument, Phase 2.

Building on the results of the feasibility study, we have concluded that the next step is to engage in the clinical validation of the biomarker through retrospective and prospective clinical investigations. The clinical validations to be performed will confirm the sensitivity, specificity and clinical utility of the biomarker. To boost market penetration possibilities, AroCell will seek partnerships with distributors with established contact networks within the targeted cancer communities.

The total funding requirements required to establish TK210 on the market are estimated to EUR 5 million. To secure this financing, AroCell is planning to acquire new investors through structures issues. The company also intends to apply for funding within SME-instrument, Phase 2 financing.

Work performed

The expected impact is the same as described in the grant agreement. TK 210 will be based on measurement of the enzyme Thymidine kinase (TK). TK210 will be the only cell-related growth biomarker that can measure levels of TK protein directly in blood, irrespective of whether the enzyme is active or not. This will enable the biomarker to become an easy-to-deploy biomarker for cancer prognostic and for monitoring of treatment response. The feasibility assessment has confirmed that TK210 can successfully address the key EU cancer related challenges by providing a reliable and replicable test for tumor growth. The impacts of the validated TK 210 will be considerable, as it will allow clinicians to rapidly assess the efficacy of drugs for patients undergoing treatment and limit treatments based on inefficient drugs and allow payers to optimize the costs of treatment by a more personalized medicine approach.

In terms of concept and approach, the main conclusion from the feasibility study us that the biomarker validation activities should be first focused on the prostate cancer (first market application area), where the need for new biomarkers enabling improved diagnosis and patient management decisions is apparent. This will be reflected in application to SME Instrument, Phase 2.

Building on the results of the feasibility study, we have concluded that the next step is to engage in the clinical validation of the biomarker through retrospective and prospective clinical investigations. The clinical validations to be performed will confirm the sensitivity, specificity and clinical utility of the biomarker. To boost market penetration possibilities, AroCell will seek partnerships with distributors with established contact networks within the targeted cancer communities.

The total funding requirements required to establish TK210 on the market are estimated to EUR 5 million. To secure this financing, AroCell is planning to acquire new investors through structures issues. The company also intends to apply for funding within SME-instrument, Phase 2 financing.

Final results

Building on the results of the feasibility study, we have concluded that the next step is to engage in the clinical validation of the biomarker through retrospective and prospective clinical investigations. The clinical validations to be performed will confirm the sensitivity, specificity and clinical utility of the biomarker. To boost market penetration possibilities, AroCell will seek partnerships with distributors with established contact networks within the targeted cancer communities.

The total funding requirements required to establish TK210 on the market are estimated to EUR 5 million. To secure this financing, AroCell is planning to acquire new investors through structures issues. The company also intends to apply for funding within SME-instrument, Phase 2 financing.