Mesoblast is a world leader in developing innovative allogeneic cellular medicines.
The Company has leveraged its proprietary mesenchymal lineage cell therapy technology platform to establish a broad portfolio of commercial products and late-stage product candidates. Mesoblast’s proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf, cellular medicines. These cell therapies, with defined pharmaceutical release criteria, are planned to be readily available to patients worldwide.
Lead Product Candidates
Mesoblast has filed a Biologics License Application (BLA) to the United States Food and Drug Administration (FDA) to seek approval of its product candidate RYONCIL™ (remestemcel-L) for steroid-refractory acute graft versus host disease (acute GvHD). Remestemcel-L is also being developed for other rare diseases.
The Company’s Phase 3 product candidates are REVASCOR® for advanced chronic heart failure and MPC-06-ID for chronic low back pain due to degenerative disc disease, both major diseases with high unmet medical needs.
Additionally, Mesoblast has a strong emerging pipeline of product candidates.
Diverse Portfolio of Advanced Cellular Medicines:
Mesoblast has established commercial partnerships in Europe and China for certain Phase 3 assets.
Scalable Manufacturing
The inherent technical properties of Mesoblast’s mesenchymal lineage cells allow for scalable culture expansion to produce anticipated commercial quantities with batch to batch consistency and reproducibility. Proprietary media formulations, advances in development of 3D bioreactor technology and automation are intended 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.
Global Operations
Mesoblast has locations in Australia, the United States and Singapore and is listed on the Australian Securities Exchange (MSB) and on the Nasdaq (MESO).