Amniotics is a biopharma company focusing on mesenchymal stem cells (MSC) from amniotic fluid. The company was born out of the discovery of a novel source of stem cells in full-term amniotic fluid. Based on a decade of research at the internationally recognized Lund University Stem Cell Centre and the Skåne University Hospital of Lund, the company is pioneering the harvesting and propagation of tissue specific neonatal quality mesenchymal stem cells (MSC). These stem cells have unique properties for applications in regenerative medicine. Amniotics has also an, by Läkemedelsverket (Swedish MPA), approved Good Manufacturing Practice (GMP) facility to produce Advanced Therapy Medicinal Products (ATMPs). With the GMP facilities operational since 2020, Amniotics is now in clinical phase with the leading drug candidate PulmoStem™. The company is looking to establish strategic partnerships with researchers and companies that are interested in developing stem-cell-based therapies targeting diseases with high unmet needs.
- The cell and gene therapy market are fast expected to reach a multi-billion dollar valuation fueled through accelerated investments and reach USD 59 billion in 2026.
- Amniotics develops their stem cell therapies based on mesenchymal stem cell (“MSC”) from the extracted amniotic fluid. The fluid has several qualities that make it superior in the production of stem cell therapies e.g., multiple tissue-specific stem-cells can be extracted, with unique therapeutic features (regeneration of new tissue or stimulating cells for enhanced self-repair) and being neonatal, meaning that they are better than MSC from adult individuals in several important aspects (e.g. virus burden, growth capacity), resulting in approx. 6000 individual doses from one extraction, significantly higher than competitors whilst maintaining the biological effects. MSC treatments are evasive for the immune system, and once they accomplish their desired task they dissolve without trace in the body.
- Several platform candidates – with special focus on two tracks: (ii) MSC Stem cells, with tissue-specific origin; lung/kidney/nervous system/skin, with special focus on PulmoStem, which targets lower respiratory infections/ COVID-19, and (ii) Enhanced Natural Killer Cells (“NK cells”) from induced Pluripotent Stem Cells (iPSC) for “off-shelf” cancer treatment of solid tumors (Glioblastoma, Pancreatic Cancer).
- Several patented technologies together with GMP facility provides value chain control and streamlined development of novel Cell Therapeutics. Significant value lies in the scientific knowledge, development processes, technology and know-how developed by Amniotics, but also in the production facility that awards Amniotics a high degree of competitive advantage, control and ability to manufacture the final medicinal products on a large scale.