|Mesoblast Corporate Overview (2 MB)|
Mesoblast is using its proprietary technology platform to develop and commercialize innovative allogeneic cellular medicines to treat complex diseases resistant to conventional standard of care and where inflammation plays a central role.
The Company’s broad portfolio of late-stage product candidates comprises RYONCIL™ (remestemcel-L) for steroid-refractory acute graft versus host disease (acute GVHD), REVASCOR® for advanced chronic heart failure and MPC-06-ID for chronic low back pain due to degenerative disc disease. Mesoblast is developing remestemcel-L for rare diseases in adults and children. The Company also has a promising emerging pipeline of Phase 2 product candidates and next generation technologies.
In January 2020, Mesoblast filed a Biologics License Application (BLA) with the United States Food and Drug Administration (FDA) to seek approval of RYONCIL for acute GVHD in children.
Diverse Portfolio of Advanced Cellular Medicines
Mesoblast has established commercial partnerships in Europe and China for certain Phase 3 assets.
Innovative technology platform enables scalable manufacturing
Mesoblast’s novel allogeneic product candidates are based on rare (approximately 1:100,000 in bone marrow) mesenchymal lineage cells that respond to tissue damage, secreting mediators that promote tissue repair and modulate immune responses.
Mesenchymal lineage cells are collected from the bone marrow of healthy adult donors and proprietary processes are utilized to expand them to a uniform, well characterized, and highly reproducible cell population. This enables manufacturing at industrial scale for commercial purposes. Another key feature of Mesoblast’s cells is they can be administered to patients without the need for donor–recipient matching or recipient immune suppression.
Proprietary media formulations, advances in development of 3D bioreactor technology and automation are planned to deliver step-changes improvement in product yield. Clinical supplies and anticipated commercial manufacturing requirements will be produced by a specialized, contract manufacturing organisation under applicable Good Manufacturing Practices (GMP).
Robust Intellectual Property Estate
Mesoblast’s intellectual property portfolio encompasses approximately 1,000 patents or patent applications across 68 patent families, which the Company believes will provide substantial competitive advantages for the commercial development of its cell-based therapies in major markets including the U.S., Europe, Japan and China.
Evidence-based Science and Translational Medicine
Mesoblast’s approach to product development is to ensure rigorous scientific investigations are performed with well-characterized cell populations in order to understand mechanisms of action for each potential indication. Extensive preclinical translational studies guide clinical trials that are structured to meet stringent safety and efficacy criteria set by international regulatory agencies. All trials are conducted under the continuing review of independent Data Safety Monitoring Boards comprised of independent medical experts and statisticians. These safeguards are intended to ensure the integrity and reproducibility of results, and to ensure that outcomes observed are scientifically reliable.
Mesoblast has locations in Australia, the United States and Singapore and is listed on the Australian Securities Exchange (MSB) and on the Nasdaq (MESO).