Mesoblast (ASX:MSB; Nasdaq:MESO) has one of the most mature cell therapy product pipelines in the field of cellular medicines.
The Company has initiated a rolling Biologics License Application (BLA) with the United States Food and Drug Administration (FDA) for its lead product candidate remestemcel-L for the treatment of steroid-refractory acute graft versus host disease (aGVHD) in children. It has another product candidate that has achieved clinical outcomes in line with the FDA guidance for a registrable clinical indication for market authorization, and two additional Phase 3 assets with blockbuster potential.
Two commercial products have already been approved and marketed by the Company’s licensees in Japan and in Europe. Mesoblast’s royalty income and milestone payments from licensees continues to grow. The Company has sufficient cash to achieve key commercial milestones, and access to additional non-dilutive sources of capital from strategic financial institutions whose extensive due diligence provides further third party validation of the strength of the product portfolio and patent estate.
Substantial Commercialization Opportunities
Lead product candidates under investigation are:
- Remestemcel-L for aGVHD
- Revascor for advanced and end-stage heart failure
- MPC-06-ID for chronic low back pain due to degenerative disc disease
Additionally, Mesoblast has a promising emerging pipeline of products and next generation technologies.
Mesoblast is developing immuno-selected, culture expanded cellular medicines based on mesenchymal recursor cells (MPCs) and their progeny, mesenchymal stem cells (MSCs). Rare mesenchymal lineage cells (approximately 1:100,000 of bone marrow cells) are found around blood vessels and are central to blood vessel maintenance, repair and regeneration. Preclinical studies have shown that these cells respond to damaged tissue, secreting mediators that promote tissue repair and modulate immune responses. This mechanism of action enables the targeting of multiple disease pathways in a number of complex diseases where inflammation plays a central role and are resistant to conventional standard of care. A key feature of Mesoblast’s patented mesenchymal lineage cells is that they are administered without the need for donor–recipient matching or recipient immune suppression, and therefore are often referred to as ‘off-the-shelf’ cellular medicines.
Diverse Portfolio of Advanced Cellular Medicines
Each of Mesoblast’s product candidates has its own distinct technical characteristics, target indications, individual reimbursement strategy, separate commercialization potential and partnering opportunities.
Mesoblast Corporate Backgrounder (2MB)