2023-09-14
Preventing heart failure with extracellular vesicles and purified mitochondria
It was announced in July 2023 that MitoSense, a research and development company aiming to treat disease with Mitochondria Organelle Transplantation (MOT™️), has joined CAMP. This makes MitoSense the 43rd partner in CAMP and the 3rd international small biotech, along with VivaBioCell S.p.A. and Cellastra Inc.
MitoSense will participate in the ”Extracellular vesicles (CARMEV) for prevention of heart failure” project lead by Karl-Henrik Grinnemo, Professor of Cardio-thoracic surgery at Uppsala University. The goal of the project is to develop extracellular vesicles (EVs) from bone marrow mesenchymal stromal cells (MSCs) to inhibit ischemic reperfusion (I/R) injury after myocardial infarction (MI) to prevent heart failure.
MitoSense, located near Boston, Massachusetts, USA, builds on research in mitochondrial dysfunction in cancer towards treating degenerative disease with their MOT™️ technology purified from cultured fibroblasts. Their initial focus is the treatment of neurodegenerative diseases such as ALS, Parkinson’s and Alzheimer’s. However, in joining CAMP, the project explores combining the MOT™️ technology with immunomodulatory EVs derived from MSCs for inhibition of I/R.
MitoSense has demonstrated proof of concept for their MOT™️ technology in neurodegenerative disease (REF), however purified mitochondria lose activity outside of cells. To improve the stability of the transplanted mitochondria the project aims to mix the purified mitochondria with purified extracellular vesicles, increasing the stability of the mitochondria at room temperature prior to administration. The second objective of the collaboration is to administer the mitochondria along with the extracellular vesicles to explore a synergistic effect of the components on disease modulation.
”It’s a real win-win collaboration”, says Karl-Henrik (pictured right). Karl-Henrik’s team have already commenced process development towards GMP manufacture of their extracellular vesicles. ”We hope to see patients receiving the EV/MOT product in clinical trials within the next 3 years”, says Karl-Henrik.
ATMP DISCLAIMER
The CAMP project includes studies on different types of ’advanced medicines’, including medicines that are not ATMPs, for example vaccines against infectious disease and extracellular vesicles like the ones in this project that are purified from cultured cells and do not contain a recombinant nucleic acid. In February 2023 it was also determined by the European Committee for Advance Therapies (CAT) scientific recommendation that mitochondria purified from mesenchymal stem cells were not ATMPs as the active substance does not contain or consist of a recombinant nucleic acid, cells or tissues. Thus the products to be developed from this project and collaboration, while classified as medicinal products and biologics by EMA regulations, are not classified as ATMPs.
References
https://www.scirp.org/journal/paperinformation.aspx?paperid=104602