Newsletter January 2023 – Kicking off the New Year
The Cline team is excited to bring you the first newsletter of 2023 and look to the year ahead. In this newsletter, we will share some highlights of what is happening across the Life Science industry and within Cline’s two projects StemCART and CellRACE.
Looking to a brighter 2023
2023 is hopefully going to be a good year for investment and partnerships in the Life Science industry. Industry experts and analysts are predicting a bounce-back in 2023, with more M&A deals, investment, and optimism in the biotech market.
ATMP landscape continuing to develop
2023 is also looking to be a big year for Advanced Therapy Medical Products (ATMP) sector. Several large investment rounds and acquisitions have occurred recently such as AstraZeneca acquiring Neogene, a cell therapy oncology company for 200M.
In the regulatory space, there have also been several steps forward for ATMP products. 2022 saw several important approvals at the FDA and EMA for cell and gene therapies. The number of approvals is expected to increase in 2023. This “wave” helps clear the path for the regulatory and commercial success of StemCART. Additionally, the FDA has recently revised its rule requiring costly animal model studies where newer innovative methods are available. Examples include advanced computer modelling, microfluidic “organ-on-a-chip” devices, and stem cell-based 3D clusters of cells called organoids. The changing landscape for safety testing is relevant for Cline as we prepare the necessary preclinical safety studies ahead of clinical trials. To avoid developing an animal model for the testing of StemCART would significantly reduce the time and cost during the preclinical phase.
StemCART
Looking to Cline’s cell therapy project, StemCART, Cline is planning on building on the significant work of 2022 to an even more fruitful 2023.
In 2022, Cline started the exvivo preclinical testing of StemCART with human cartilage tissue which led to positive results and has enabled continued development progress, read more in our September newsletter. This testing is carried out with the help from two collaborating orthopaedic clinics, Sahlgrenska University Hospital and Varberg Hospital Region Halland. Also in 2022, Cline added two more clinicians to its board of advisors. Other work within the StemCART project includes the development of the support matrix and vital QA processes to validate our cells and product.
In 2023, Cline will continue with more preclinical tests of StemCART that are needed as well as a strong focus on the regulatory and manufacturing work that is necessary to bring StemCART to First-in-Human trials.
AI-based diagnostics are red hot
Diagnostics, in particular AI-based, continues to be a big area of interest and growth in oncology. A large and well-invested area of cancer diagnostics is genetic testing. The whole genome sequencing liquid biopsy company Caris Life Sciences has financed 400M USD after more than 1B in lifetime funding.
Pathology is another area of cancer diagnostics that is being revolutionized by AI. Ibex Medical Analytics announced a collaboration with AstraZeneca and Daiichi Sankyo to develop an AI-based HER2 scoring product. HER2 expression is used to segment breast cancer types and identify patients who are likely to benefit from HER2 therapies. The algorithm will automate this process and remove subjectivity in visual assessment by pathologists. Also in the area of pathology, Paige AI has developed the first FDA-approved digital pathology algorithm and recently partnered with Microsoft Cloud for Healthcare.
Google is another Big Tech company focussing on healthcare, as it recently announced a deal to commercialize its mammography AI model and personalized risk assessment technology with iCAN. A similar machine-learning mammography product QmTriage recently was approved by the FDA for use in breast cancer in December.
CellRACE
Despite this progress in the field of cancer diagnostics, there is still a distinct gap in the ability to provide a definitive answer to whether a tumor will metastasize. Based on Cline’s proprietary surface nanotechnology and cutting-edge deep learning, CellRACE aims to become the gold standard for predicting metastasis and therefore saving lives.
2022 was focused on developing software which could accurately and automatically track tumor cell movement using deep learning techniques. You can read more about the project and our collaborators IFLAI here. This initial project was successful and Cline is now able to use the software, conduct tests, and continue an accelerated development to the next stage.
In 2023, Cline will further optimize the CellRACE product, test more types of cancer cells and continue to transition the project to a product that can be tested in a clinical setting.
The Cline team is looking forward to a strong year ahead and thanks our shareholders for their continued interest and support. Stay up to date with Cline by subscribing to our news and following us on Twitter, Facebook, and LinkedIn for future updates!
Warmest regards,
The Cline Team
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About Cline Scientific
Cline Scientific develops advanced cancer diagnostics and regenerative medicine treatments. Cline’s unique patented surface nanotechnology provides solutions to critical challenges for cell-based products and process in Life Science. Cline is driving two projects through to a clinical stage, StemCART - a stem cell therapy for joint repair, and CellRACE- a cancer diagnostic to predict metastasis.