Periodic Reporting for period 4 - AURORAX (Advancing cancer detection through metabolism-based diagnostics)
Okres sprawozdawczy: 2022-06-01 do 2022-12-31
Former cancer patients receive regular follow-ups to detect recurrences at early stages and optimize treatment outcomes. The follow-up frequency is currently limited by costs and radiation risks of imaging approaches used to surveil for recurrences, resulting in recurrences being detected too late– often resulting in terminal disease. Of the 139.000 annual Renal Cell Carcinoma (RCC) patients,20% are diagnosed with a metastatic recurrence within 5 years after surgery. Once metastatic, RCC survival rates drop to 12% over 5 years survival. Elypta, Sweden, has developed the first metabolism based liquid biopsy to detect early-stage recurrences. The quantification of a metabolite signature in blood or urine and an algorithmic analysis allows for exceptional sensitivity, a low cost of the platform and significantly improves on imaging approaches in cost and risk, enabling frequent patient follow-up. Elypta’s technology has been demonstrated in small clinical trials and its cost effectiveness assessed by two independent companies. Elypta’s platform is easily scalable to other cancer indications and applications such as treatment monitoring, as demonstrated in multiple small trials. Starting in the niche RCC market with limited competition, Elypta now requires clinical evidence for a product launch within RCC. The business strategy focuses on distribution and sales through clinical laboratories, which will benefit financially off sales. As users of the platform, oncologist and urologists have all signed letters of support. A pharmaceutical partner has also signed a letter of support, expressing their interest in RUO use of the platform, providing a solid basis in the emerging liquid biopsy market (€200B market). In AURORAX, Elypta set out to 1) perform a clinical validation trial (AUR87A) to generate strong clinical evidence, 2) submit for regulatory clearance in the EU and the US and 3) introduce the product for research use only (RUO) and after clinical validation enter the RCC diagnostics market in EU. The project has been concluded with successful progress on all three objectives: AUR87A was launched in 2019, successfully completed recruitment in 2021 despite the challenges imposed by the COVID-19 pandemic in global clinical research efforts and generated the first evidence of clinical data in 2022; the regulatory submission process has been successfully started in 2022; and an RUO product has been marketed since 2020.
The project revolves around the AURORAX-0087A (AUR87A) trial, a clinical study to validate the use of Elypta’s platform for early diagnosis of RCC recurrence. This project consists of 4 work packages (WPs):
WP1: Project Management and Communication - is dedicated to overall management of the project and regular updates on AURORAX can be found on our LinkedIn account: https://www.linkedin.com/ company/elypta and in our website at https://www.elypta.com/studies/kidney-cancer-recurrence-surveillance. Elypta has disseminated the progress and achievement of the various milestones in AURORAX according to plan, thereby successfully completing this work package.
WP2: Clinical trial AUR87A – relates to the execution of the AUR87A trial. Study set-up including a selection of the contract research organization (CRO), ethical approval submissions, preparation of all study documents, and feasibility/initiation visits to the sites involved in AUR87A has been successfully carried out between May 2019 and November 2019 according to plan. First patient first visit (FPFV) was accomplished in January 2020. AUR87A suffered a major delay due to the outbreak of COVID-19 and resulting in the amendment of the grant period with an extension of 14 months and an expansion in the number of recruitment sites. AUR87A included 26 sites across 10 countries (CA, DK, ES, FI, FR, IT, PT, UK, SE and US). Enrollment of the primary cohort was completed in December 2021. Monitoring and status reporting was performed according to plan resulting in an overall satisfactory execution of the study. The first evidence of clinical data was produced in 2022. This evidence was analyzed in accordance with the pre-specified statistical analysis plan, thereby completing the work package. Elypta decided to sponsor a follow-up study after the end of the AURORAX project to strengthen the clinical evidence on its platform.
WP3: Regulatory affairs - to ensure that Elypta’s platform can be commercialized within the applicable law in the focus markets for Elypta. Elypta met with the FDA in June 2019. The meeting was productive and resulted in a shared view on the design and objectives of AUR87A towards regulatory approval in the US. Elypta has since worked towards achieving compliance for its liquid biopsy platform according to the new regulation on in vitro diagnostics in the EU (CE-IVDR). Elypta successfully started the regulatory process in December 2022 with a submission to the Notified Body selected to achieve market clearance, thereby successfully completing this work package according to plan.
WP4: Business development and product launch - relates to contractual and business activities for the commercialization of Elypta’s platform and the finalization of premarket Elypta’s platform development for a smooth market launch. Elypta has selected Merck KgaA as a partner to manufacture the kits needed to operate the liquid biopsy platform. The manufacturing, supply, and quality control of kits was deemed satisfactory and according to plan. Elypta launched a research-use only product in 2020 and initiated sales in February 2021. Elypta has since completed several purchase orders. Elypta has contracted the first commercial laboratories to operate the kits in other markets outside the Nordics completing the work package in May 2022 according to plan.
WP1: Project Management and Communication - is dedicated to overall management of the project and regular updates on AURORAX can be found on our LinkedIn account: https://www.linkedin.com/ company/elypta and in our website at https://www.elypta.com/studies/kidney-cancer-recurrence-surveillance. Elypta has disseminated the progress and achievement of the various milestones in AURORAX according to plan, thereby successfully completing this work package.
WP2: Clinical trial AUR87A – relates to the execution of the AUR87A trial. Study set-up including a selection of the contract research organization (CRO), ethical approval submissions, preparation of all study documents, and feasibility/initiation visits to the sites involved in AUR87A has been successfully carried out between May 2019 and November 2019 according to plan. First patient first visit (FPFV) was accomplished in January 2020. AUR87A suffered a major delay due to the outbreak of COVID-19 and resulting in the amendment of the grant period with an extension of 14 months and an expansion in the number of recruitment sites. AUR87A included 26 sites across 10 countries (CA, DK, ES, FI, FR, IT, PT, UK, SE and US). Enrollment of the primary cohort was completed in December 2021. Monitoring and status reporting was performed according to plan resulting in an overall satisfactory execution of the study. The first evidence of clinical data was produced in 2022. This evidence was analyzed in accordance with the pre-specified statistical analysis plan, thereby completing the work package. Elypta decided to sponsor a follow-up study after the end of the AURORAX project to strengthen the clinical evidence on its platform.
WP3: Regulatory affairs - to ensure that Elypta’s platform can be commercialized within the applicable law in the focus markets for Elypta. Elypta met with the FDA in June 2019. The meeting was productive and resulted in a shared view on the design and objectives of AUR87A towards regulatory approval in the US. Elypta has since worked towards achieving compliance for its liquid biopsy platform according to the new regulation on in vitro diagnostics in the EU (CE-IVDR). Elypta successfully started the regulatory process in December 2022 with a submission to the Notified Body selected to achieve market clearance, thereby successfully completing this work package according to plan.
WP4: Business development and product launch - relates to contractual and business activities for the commercialization of Elypta’s platform and the finalization of premarket Elypta’s platform development for a smooth market launch. Elypta has selected Merck KgaA as a partner to manufacture the kits needed to operate the liquid biopsy platform. The manufacturing, supply, and quality control of kits was deemed satisfactory and according to plan. Elypta launched a research-use only product in 2020 and initiated sales in February 2021. Elypta has since completed several purchase orders. Elypta has contracted the first commercial laboratories to operate the kits in other markets outside the Nordics completing the work package in May 2022 according to plan.
Elypta will disrupt the current practice of recurrence monitoring within RCC by delivering a metabolism-based diagnostic platform that goes far beyond current state-of-the-art approaches. The European and global market in recurrence monitoring diagnostics represents a high-potential business opportunity with over 27 million cancer survivors each year across the most common cancer types.
Elypta provides a highly competitive product within this market because:
➢ Its technology enables early detection of recurrences of cancer in all stages;
➢ At a sensitivity surpassing all other current or known upcoming technologies;
➢ And at a cost an order of magnitude lower than competing approaches;
➢ Using a highly scalable approach.
Elypta’s approach will be disruptive in the cancer diagnostics market because:
➢ The platform meets, for the first time ever, the clinical demand for frequent patient monitoring;
➢ The platform will replace current state of the art technologies for the purpose of patient monitoring;
➢ It will demonstrate the potential of metabolism-based liquid biopsies, an entirely new category of cancer diagnostics.
Elypta provides a highly competitive product within this market because:
➢ Its technology enables early detection of recurrences of cancer in all stages;
➢ At a sensitivity surpassing all other current or known upcoming technologies;
➢ And at a cost an order of magnitude lower than competing approaches;
➢ Using a highly scalable approach.
Elypta’s approach will be disruptive in the cancer diagnostics market because:
➢ The platform meets, for the first time ever, the clinical demand for frequent patient monitoring;
➢ The platform will replace current state of the art technologies for the purpose of patient monitoring;
➢ It will demonstrate the potential of metabolism-based liquid biopsies, an entirely new category of cancer diagnostics.