Funding: European Regional Development Fund (ERDF), Measure 1.2.1. Specific support goal “To Increase the Private Sector Investments R&D”; measure 1.2.1.2. “Support for Improvement of Technology Transfer System” “Industry‑Driven Research”

Project Title: „ Precision medicine test for the therapeutic decisions and monitoring of treatment response in breast cancer”

Project No.: KC-PI-2017/23

Project first period: 19th July 2017 – 23th July 2018

Project second period: 1 October 2018 – 30 September 2021

Project costs: 333 333,33 EUR

Principle Investigator: Dr. biol. A. Linē

The main aim of the current project is to develop a precision medicine test for molecular profiling of breast cancer that helps to choose the best treatment option for each patient and a personalised liquid biopsy for monitoring the treatment response and early detection of recurrence.

The commercialisation strategy will contain a detailed plan for bringing the precision medicine tool described in this project to the market.

The commercialisation measures will consist of industrial research and experimental development aiming to demonstrate the clinical validity of the proposed precision medicine approach.        

The main objective of this project is to demonstrate the clinical validity of such a precision medicine approach in breast cancer patients. After the end of this project, these tests will be registered as laboratory developed tests and offered as molecular diagnostics services that can help in a clinical decision making.

This project will provide an opportunity to create a new in vitro diagnostics service that will be the first of its kind in Latvia and may turn out to be internationally competitive.

Published 24.07.2017.

19.07.2017.-19.10.2017.

In the period from 19.07.2017. until 19.10.2017. Within the framework of the project, a market research was conducted on potential bidders for the procurement of development of a commercialization strategy.

The procurement regulations for procurement “Development of a commercial strategy” were prepared. The purpose of the service is to define the steps to develop a product or technology from conception to market introduction, and also to analyze the choice of a more advantageous solution between assigning the right to use industrial property to another person (licensing agreement, patent sale) or creating a new business on a scientific basis, and make recommendation what information should be prepared to get potential licensees or investment funds attention and offer them the technology. The above-mentioned procurement was announced on the website of the Procurement Monitoring Bureau on 12.10.2017.

Published 19.10.2017.

19.10.2017-18.01.2018

The procurement resulted in concluding a contract with “Enixus Baltija” for the development of Commercialisation Strategy. Several meetings between the contractor and BMC team were organised to discuss the technological aspects, potential markets, IPRs, choice of commercialisation strategy and the next steps to the market. The contractor, in a close collaboration with the BMC team, is working on the development of the Commercialisation Strategy. In parallel, we were working on the development of the technical-economic feasibility study.

Published 31.01.2018.

19.01.2018-18.04.2018.

In reporting period was agreed project 1st period extension whit Latvian Investment and Development Agency to ensure quality of a Technical feasibility and commercialisation strategy development.  Was prepared procurement rules for “Technical feasibility and commercialisation strategy development service” as part of which is planned to purchase individual previously undrafted Technical feasibility study section as well as Commercialisation strategies for project. The above procurement was announced in Procurement Monitoring Bureau web page in 20.03.2018.

The offer was submitted and as the winner in the procurement was recognized KPMG Baltics Ltd

Published 18.04.2018.

19.04.2018-18.07.2018

During the reporting period continue work to the development of the Technically Economic feasibility study and the Commercialisation strategy with “KPMG Baltics”.

Published 18.07.2018.

1 October 2018 – 31 December 2018

LIAA has completed the evaluation of the Commercialisation strategy and Technical and economic feasibility study and took the decision to continue funding of this project on 28.09.2018. Implementation of the second stage of the project was started on 01.10.2018. We have accomplished the following tasks during this reporting period:

• We have developed a protocol for the enrolment of breast cancer patients and collection of the clinical samples and prepared the application to CMĒK and GIP to obtain the permission to carry out the study.
• We have started to work on the development of technology for somatic mutation profiling and Mutation-drug database.
• We are currently exploring the regulatory requirements and planning the commercialisation activities.

Information published 28.12.2018.

1 January 2019 – 31 March 2019

We proceeded with the development of technology for somatic mutation profiling and Mutation-drug database.

We completed the preparatory work required to start the enrolment of patients in the project;

We carry on the exploration of the regulatory requirements and planning the commercialisation activities;

Members of the team participated in the Research commercialisation workshop organised by LIAA and visited SciLifeLab at Karolinska Institutet and Uppsala Innovation Centre.

Information published 29.03.2019.

Progress of the project:

1 April 2019 – 30 June 2019

• Assessment of the analytical performance of the somatic mutation profiling technology using cell cultures has been started;
• Optimisation of the liquid biopsy technology is in progress;
• A contract on the biobanking has been concluded and the enrolment of the patients has been started;
• Genetic testing of clinical samples has been approved by CMĒK.
• The exploration of the regulatory requirements and planning the commercialisation activities is in progress.

Information published 28.06.2019.

Progress of the project:

1 July 2019 – 30 September 2019

• The somatic mutation profiling technology was tested in breast cancer and fibroblast cell cultures in order to determine its analytical performance. The data analysis is in progress and SOPs for the processing and analysis of the data are being developed.
• The enrolment of patients was continued.
• Testing of somatic mutation profiling technology in patients’ tumour tissue samples has been started.
• Method for the isolation of cfDNA from plasma samples has been optimised.
• Analysis of commercialisation scenarios is in progress.

Information published 30.09.2019.

Progress of the project:

1 October 2019 – 31 December 2019

• The somatic mutation profiling technology was tested in breast cancer and fibroblast cell cultures in order to determine its analytical performance. The data analysis is in progress and SOPs for the processing and analysis of the data are being developed.
• The enrolment of patients was continued.
• Testing of somatic mutation profiling technology in patients’ tumour tissue samples has been started.
• Method for the isolation of cfDNA from plasma samples has been optimised.
• Analysis of commercialisation scenarios is in progress.

Information published 30.12.2019.

Progress of the project:

1 January 2020 – 31 March 2020

Testing of somatic mutation profiling technology in patients’ tumour tissue and the optimisation of methodology for the isolation of cfDNA from patients’ plasma were continued,

The implementation of the project is slowed down due to the restrictions set during the state of emergency due to the COVID-19 pandemic: the enrolment of patients has been slowed down, the delivery of reagents and materials is delayed and the planned visits and lobbying events were cancelled.

Information published 31.03.2020.

Progress of the project:

1 April 2020 – 30 June 2020

The enrolment of patients was resumed once the state of emergency due to the COVID-19 pandemic was ended. We continued to work on the testing of the technology for profiling of somatic mutations in the clinical samples, isolation of cfDNA from plasma samples and optimization of the data analysis pipeline. In parallel, we continued to work on the preparation of a file for submission to National Authority for approving and registering the tests.

Information published 30.06.2020.

Progress of the project:

1 July 2020 – 30 September 2020

During this period, the enrolment of new breast cancer patients and follow-up of previously enrolled patients was continued. We made an attempt to transfer the targeted sequencing technology for the detection of somatic mutations to higher throughput sequencing instrument that would allow decreasing the cost of testing, however, so far the attempt was unsuccessful. We continued to work on the development of two types of liquid biopsies – absolute quantification of tumour somatic mutations in plasma cell-free DNA by ddPCR and sequencing of EV-enclosed RNA. We got acquainted with the tools and guidelines for biomarker commercialization developed by Interreg project Biomarker Commercialization.

Information published 30.09.2020.

Progress of the project:

1 October 2020 – 31 December 2020

During this period, the enrolment of new breast cancer patients and follow-up of previously enrolled patients was continued. We continued to work on testing the technology for the detection of somatic mutations in tumour tissues using MiSeq instrument and development of Results form. We continued to develop and compare two types of liquid biopsies for monitoring of breast cancer. Furthermore, we continued to study the tools and guidelines for biomarker commercialization developed by Interreg project Biomarker Commercialization.

Information published 30.12.2020.

Progress of the project:

1 January 2021 – 31 March 2021

During this period, the enrolment of new breast cancer patients and follow-up of previously enrolled patients was intensified. We continued to work on the validation of the technology for somatic mutation profiling in tumour tissues using MiSeq instrument and developed a software tool for the identification of somatic mutations. We continued to develop personalised liquid biopsies for monitoring breast cancer. Furthermore, we re-assessed a plan for the commercialization activities and made amendments in the plan of commercialization activities.

Information published 31.03.2021.

Progress of the project:

1 April 2021 – 30 June 2021

During this period, the enrolment of new breast cancer patients and follow-up of previously enrolled patients was completed. We continued to work on the validation of the technology for somatic mutation profiling in tumour tissues as well as upgrading the software tool for the data analysis and generation of the report. We continued to develop personalised liquid biopsies for monitoring breast cancer. Regarding the commercialisation activities, the calculations for selecting the most profitable commercialisation scenario were done and the starting price for the auction was determined. Moreover, the pitch presentation has been prepared and currently, the video is being prepared.

Information published 30.06.2021.

Progress of the project:

1 July 2021 – 30 September 2021

The implementation of this project is completed. During this project we have developed a toolset for personalised diagnostics of breast cancer. The toolset includes three types of tests: somatic mutation profiling tool; a set of tests for the detection of gene amplification in tumour tissues and personalised liquid biopsies for the quantification of tumour-specific mutations in blood plasma. We have prepared handbooks for each test, description of their analytical performance and a summary of results obtained by testing the technologies in clinical samples. We have announced a public auction for the use of intellectual property rights.

Information published 30.09.2021.