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2021-07-07

Cline: Newsletter July 2021 - Summertime updates and reading

July means that summer has officially come here in Sweden, and we would like to share with you some updates and industry news.

Recent presentations and analyses
Previously in June, Analyst Group published a Q&A with Patrik Sundh and updated their analysis of Cline's share price. You can read the analysis here (https://www.analystgroup.se/kommentarer/analyst-group-kommenterar-senaste-handelserna-i-cline/) https://www.analystgroup.se/kommentarer/analyst-group-kommenterar-senaste-handelserna-i-cline/.
Last Thursday, Cline presented in a live event with Aktietips. You can see the recorded event on youtube (https://www.youtube.com/watch?v=qP5TqQ06Uyg&ab_channel=LHmedia) https://www.youtube.com/watch?v=qP5TqQ06Uyg&ab_channel=LHmedia (In Swedish).
V.A. Cure
As we communicated in previous updates, we have been participating in the EU project V.A. Cure, together with AstraZeneca throughout 2021. We are able to report that the project is going well and has reached the progress stage that was hoped for by the end of Q2 according to the plan. Further progress and results of the project will be published when possible, according to AstraZeneca and V.A. Cure.In this project, Cline is contributing our knowledge and methods of stem cell differentiation. The method is based on our unique surfaces and differentiation methods which have been previously successfully used to stimulate induced pluripotent stem cells (iPSCs) into chondrocytes, found in cartilage. Like StemCART, this project also aims to differentiate iPS cells into new cell types, in V.A. Cure's case, epithelial cells, with the goal of creating a cell line and disease model to be used in research and drug development.

In the meantime, you can read more at the V.A. Cure website (https://vacure.eu/) and follow their updates on the entire consortium. You can also watch a 1-minute "elevator pitch" of the PhD student working with AstraZeneca on the project about using iPS stem cells and why this is an important step in the treatment of vascular disease https://www.youtube.com/watch?v=vVrYtPIOJUE&t=64s. 

StemCART
Last newsletter, we dived into StemCART, how it works, what makes it unique and recent progress surrounding its matrix development. In the coming months, we will work towards an ethical permit application and the following ex vivo testing. For the ethical permit application, we are currently finalizing the road map for the ex vivo testing, securing the participation of clinical collaborators, and planning for all the materials need to complete the study.

In this month's newsletter, we will have a look at the landscape of the market for Osteoarthritis treatment and some regulatory aspects of the cell therapy segment.

OA is a large market without a cure
Osteoarthritis (OA) is caused by the breakdown of cartilage and most commonly affects the knees, hands, hips, and spine. Patients suffering from OA is often experiencing decreased mobility, joint stiffness and persistent pain. Non-surgical options such as pain medication, intra-articular injections and lifestyle modifications only alleviate pain and are not able to slow or reverse the disease.

The disease is estimated to affect nearly 10 % of the population worldwide, with costs for significant markets (such as US, Europe, Australia) with a high incidence of OA reaching 0.5 % of national GDP. For example, in the US, osteoarthritis is estimated to affect 32.5 million adults and expected to rise to 78.4 million by 2040 due to age and increasing obesity.

Cell therapies continue to heat up
The number of investments and therapy pipeline news surround cell therapies is continuing to rise, with many big players coming into the market. In particular, Bayer continues to build their place in the stem cell therapy and gene therapy market, as part of its Cell and Gene Therapy Platform and focus on iPSC technology (https://media.bayer.com/baynews/baynews.nsf/id/Bayer-establishes-Cell-and-Gene-Therapy-Platform-to-accelerate-pharmaceutical-innovation). In June, Bayer's allogeneic pluripotent stem cell-derived dopaminergic neurons for Parkinson's Disease is starting its first clinical trial (https://www.fiercebiotech.com/biotech/bayer-s-billon-dollar-parkinson-s-disease-bets-land-clinic) through their recently acquired subsidiary BlueRock. They have also invested 200 million in a new plant in Berkeley, USA (https://www.fiercepharma.com/manufacturing/bayer-plots-200-million-cell-therapy-plant-at-overhauled-berkeley-campus-report).

Also utilizing allogeneic iPSC-derived cells is Heartseed and Novo Nordisk's HS-001. Novo Nordisk has signed a $598 million deal (https://www.fiercebiotech.com/medtech/heartseed-collects-new-venture-round-following-598m-heart-failure-stem-cell-deal-novo) for exclusive rights to commercialize the cardiac disease therapy which works by injecting the cardiomyocyte spheroids directly into the myocardium, where they grow and electrically couple with other heart cells.

CellRACE
Work on the CellRACE product development is continuing at our labs. Right now, the team is conducting work on optimizing the surface and developing improved methods for quantifying the response of the live cells. This work is required to be completed before the final design is developed and validation studies can be evaluated, which is planned for 2022.

Cancer diagnostics market
Breast cancer is the most commonly occurring cancer in women, and cases are rising each year. In Sweden, there was an estimated 137.8 cases per 100,000. The average five-year survival rate for patients with non-metastasized breast cancer is 99 %, if there is metastasis within regional lymph nodes, 86 %, and 27 % where there is distant metastasis, according to the American Cancer Society. Our goal is that CellRACE can identify tumors metastasis-potential before it spreads and to improve life expectancy through more tailored treatment.

According to a recent report into the global in-vitro diagnostics market (https://www.prnewswire.com/news-releases/ivd-market-reaches-83-billion-says-new-report-301120941.html), the market is valued at $83B USD and continues to grow, with large numbers of acquisitions and capital investment worldwide. 66% of treatment decisions were based on a diagnostic test and makes up 2.3% of healthcare expenditure. Tissue-based and molecular testing for cancer is a key driver in this growth, with the rate being 50% higher than the average growth across the area.

Cancer diagnostics in the news
Last week, it was announced (https://www.theguardian.com/society/2021/jun/25/blood-test-that-finds-50-types-of-cancer-is-accurate-enough-to-be-rolled-out) that the National Health Service (NHS) in England will start a pilot of US-based Grail's multicancer liquid biopsy test, Galleri. This follows the news of recent positive final study results and the start of sales of the test. The blood test can detect 50 types of cancer by detecting cell-free DNA in the blood. Until 2023, the pilot will test 140,000 patients who are 50 years and older and are high risk. The pilot is a big step in bringing earlier and more personalized cancer diagnostics to the clinic. This trial is part of a larger goal of the NHS with a target of finding three quarters of cancers at an early stage, and highlights the importance of the field that Cline is working in.  

We hope you have a great summer, and we will be back in the fall with more updates. 

Warmest regards,

The Cline team

Cline Scientific AB (publ)                                                 Phone: 031-387 55 55

Argongatan 2 C                                                                   Email: info@clinescientific.com
431 53  MÖLNDAL                                                              Website: www.clinescientific.com

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