Newsletter December 2020
As the year is coming to a close, Cline Scientific would like to share with you the exciting projects and updates we have been working on.
A look into Cline surface production
As we have previously mentioned, a project is underway to establish a robust and semi-automated production process for our gradient surfaces. The goal is to reduce the manual handling of the surface which will lead to less batch variation. This, we believe, will be crucial for a later GMP-adapted production. Through this work, cost savings are made possible through increased precision and production capacity, and optimal analysis of the production process at critical stages is facilitated. Work on the production process is progressing with a focus on accuracy and quality. As we see it, this step is vital for future clinical studies.
This project has four phases:
- A comprehensive evaluation of existing production design and steps.
- A re-design and optimization of the production process of nano gradients
- Manufacture & test of components in the new production process
- Validation of and approval to start using the new process
Steps 1 and 2 have been completed and step 3 is underway, targeted to be completed during the first quarter of 2021.
This is an exciting step in the development of Cline’s ability to provide products to, for instance, clinical trials!
A Growing Market for Advanced Therapies
There has been a growing amount of interest and investment in Advanced Therapy Medicine Products (AMTP) and regenerative medicine recently. Multinational pharma company Catalent acquired Bone Therapeutics’ cell therapy manufacturing division Skeletal Cell Therapy Support, Novartis acquired gene and cell therapy company Vedere Bio, and Sana Biotechnology acquired Oscine to develop stem cell therapies for CNS conditions such as myelin disorders and neurodegenerative disease.
Closer to home, ATMP Sweden released their baseline landscape report of Swedish AMTP industry. The report is part of the AMTP Milieu project, which aims to make Sweden a leader in advanced therapies by 2030. The report outlines the landscape of R&D activity, academic research and SME companies in Sweden and shows Sweden’s strength in the region. The report highlights that Sweden is ranked first for EU funding given to companies developing ATMP therapies. In the areas of gene therapy, cell therapy and tissue engineering, research output in Sweden is among the highest levels in Europe.
StemCART
In November, we celebrated another exciting publication from our team and collaborating researchers at The Sahlgrenska Academy, titled “Differentiation of induced pluripotent stem cells into definitive endoderm on Activin A-functionalized gradient surfaces". The paper is related to the previous results which were published in July. Further, it shows the importance of Cline's surface gradients in a critical process to cell differentiation. Cline's methods lead to an accurate and effective method for differentiating stem cells into targeted developmental stages, which is utilized in StemCART, Cline's stem cell therapy for osteoarthritis.
The StemCART product development is progressing, and we are excited to be collaborating with Chalmers Department of Chemistry and Chemical Engineering in developing a matrix for the cell-based product to maximise cartilage healing and biocompatibility. In addition to our own efforts, Chalmers will provide two masters students who will work on the engineering aspects of this matrix development project.
We are also in discussions with several new clinical contacts with the goal of connecting them to the StemCART project in order to prepare for the first clinical trials. Watch for further news on this.
CellRACE
We are continually testing the CellRACE prototype to optimize for different tumor cells. The focus of the past months has been to develop the factors and rules for an algorithm that can be used to analyze the massive number of data points we record when studying the behavior of the tumor cells. We believe that this feature, an algorithm, will be a key, patentable, aspect of the CellRACE project which is why we are now giving it a strong focus.
The challenge for the project is to find additional fresh, patient material due to the COVID situation. It is still difficult to get access to biopsies due to a reduced number of operations made and hospital lockdowns. As we have previously mentioned, we are looking at the possibility of receiving biopsy material from other types of tumors than breast tumors in order to continue with the prototype tests we started in the beginning of the year.
On a more positive note, the team has submitted a new paper to Journal of Clinical Breast Cancer. The review explores the state of the art of breast cancer diagnostics and the gaps when it comes to the prediction of metastasis in breast cancer. It will be available to read once published.
All in all, 2020 has been a challenging year for most people around the globe, but we feel that we have managed to stay on our path and kept Cline moving at almost the same pace as before the pandemic started. With a small, flexible organization we are able to adapt to the new reality by alternating days at the office (only one person at the time), using our lab facilities as much as possible, and efficient use of digital tools from home offices. And, despite the pandemic, we will be able to not only go forward but also communicate good, exciting news in the future.
We wish you all the best for a safe and Happy Holidays, and a fruitful 2021!
The Cline Team
Cline Scientific AB (publ) Telefon: 031-387 55 55
Argongatan 2 C E-post: info@clinescientific.com
431 53 MÖLNDAL Hemsida: www.clinescientific.com
About Cline Scientific
Cline Scientific develops advanced cancer diagnostics and regenerative medicine treatments. The company is working heavily with R&D through joint collaborations with pharmaceutical companies and academic researchers around the world. The focus is on projects in the cancer diagnostic and stem cell therapy fields since Clines nanotechnology here provides unmet solutions to critical challenges and functions. The unique patented surface nanotechnology is used in cell-based products and processes to drive projects within Life Science into and through the clinical phase.