Procella has during the first half of 2023 finalized the manufacturing of cells for so called GLP Tox (animal study required prior to Phase I clinical study), which allows the start of clinical studies in humans. These Phase I trials will begin in 2024. The main focus now is to start manufacturing of cells needed to conduct those clinical trials. We are extremely proud to have the clean room and the capabilities to be a supplier to AstraZeneca, who will be responsible for the clinical trials.
To be able to restore a damaged heart muscle following a heart attack, and thereby improve the symptoms of heart failure, is both an important development for patients suffering from this debilitating condition, and a highly attractive market given the large number of patients worldwide, as well as costs and suffering associated with heart failure. The fact that we have proven ourselves as a reliable and competent partner to AstraZeneca in developing and producing the cells at scale, and that we will now also be trusted with the task of producing the full volumes needed for the Phase I trials, as well as assist in developing the processes for the even larger volumes needed in the Phase II trials, is a strong testament to SmartCella’s advancement. This is also a great platform for partnering with other companies around additional stem cell projects, where we are in advanced discussions as we keep building our pipeline of projects.
In SmartWise, the development of the unique and patented Extroducer continues. The ability to deliver therapies directly into an organ or a tumor opens up a lot of possibilities and we are excited about soon being able to conduct the first trials in humans.
We are also gearing up to start reaching out to other potential partners at scale, as well as starting our own clinical trials on inoperable pancreatic tumors. In those trials, we will be using an old chemotherapy drug that is effective at killing cancer cells, but has a lot of systemic side effects when administered in the traditional way which limits its practical use significantly. The theory is that by administering it directly into the tumor, we will be able to retain the efficacy, while avoiding the systemic side effects, and thus give new hope to patients that today have very few options.
In SmartCella Solutions, the development of a cell mediated delivery platform has continued and shown promising results. As new mRNA therapies are being developed, one of the constant challenges facing biotech and big pharma companies active in this exciting field of research is how to make the mRNA get to and survive in the organ it is intended to reach and produce enough of the intended protein to have the desired effect. The problem they face, besides the actual delivery to the target organ, is that the immune system attacks the foreign material and kills the mRNA before it has produced enough protein. Our data shows that with our cell mediated delivery platform, we can protect the mRNA from attack by the immune system inside a stem cell and thus produce both much higher volumes of proteins and over a longer period of time. We will gradually start reaching out to potential partners for licensing of this powerful platform. We are also exploring an early stage pipeline of proprietary therapies utilizing this technology.