Mesoblast is developing biotherapeutics based on its proprietary cell-based and protein technologies. The Company’s technology platforms have the potential to deliver a diverse portfolio of clinical-stage products to treat major conditions with unmet medical needs.
The Company’s product development focus is in four major and distinct areas - systemic diseases with an underlying inflammatory and immunologic etiology which may be addressed by intravenous delivery of cell therapy for immunomodulation; cardiac and vascular diseases where cell therapy products are being developed for both local and systemic application; orthopedic diseases of the spine where cell therapy products can be locally administered to potentially repair intervertebral discs or generate new bone; and improving outcomes of bone marrow transplantation associated with oncology or genetic conditions.
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Mesoblast’s cell-based core technologies include its highly purified, immunoselected Mesenchymal Precursor Cells (MPCs), culture-expanded Mesenchymal Stem Cells (MSCs), Dental Pulp Stem Cells (DPSCs), and expanded Hematopoietic Stem Cells (HSCs). Mesoblast’s protein technologies are based on factors derived from its proprietary cellular platforms, including Stromal Derived Factor-1 (SDF-1).
MPCs are rare cells found around blood vessels in various tissues and are characterized by specific surface markers, the expression of which facilitates their isolation and purification by immunoselection. MPCs give rise to and are the precursors of all culture-expanded multi-potential fibroblastoid colony forming units (CFU-F), which typically characterize all in vitro cultured MSCs derived from adult tissues.
Highly purified, immunoselected MPCs and the cultured MSCs they give rise to share very important technical characteristics – both populations can be expanded in large numbers in culture, are well tolerated when used allogeneically in unrelated recipients, and can differentiate to greater or lesser degrees into bone, fat and cartilage.
In addition, these cell types release a series of factors which can act on target tissues to induce blood vessel formation, prevent heart muscle death, reduce fibrous scar tissue, improve bone and cartilage growth, and modulate the key elements of the immune system, including monocytes and T cells.
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Lead clinical products using highly purified, immunoselected MPCs are being developed to take advantage of the potency of the MPCs in order to generate sustained clinical outcomes following single-dose or intermittent administration locally or systemically. Products using culture-expanded MSCs are being developed to induce rapid clinical responses following frequent repeat-dose administration systemically.
Mesoblast’s intellectual property covers the Company’s cellular therapy compositions, efficient processes for their extraction, purification and manufacturing scale-up, and the broad range of applications for which they are being developed. Together, Mesoblast’s intellectual property and state-of-the-art manufacturing processes facilitate the Company’s commercial model to develop cost-effective biotherapeutics across multiple clinical indications.
Mesoblast's approach to product development has been to ensure rigorous science is performed using well characterized cell populations in order to understand mechanisms of action for each potential indication. Extensive preclinical translational studies are used to appropriately guide clinical trials. Using well characterized cellular populations has also facilitated proprietary manufacturing processes which ensure reproducibility and batch to batch consistency. The Company’s manufacturing, translational, and clinical activities are structured to meet stringent criteria set by regulatory agencies in each jurisdiction the Company operates.
Mesoblast is partnered with Teva Pharmaceutical Industries Ltd. for the development and commercialization of its MPC products in a number of fields, including cardiovascular diseases and neurologic conditions.
Mesoblast is collaborating with JCR Pharmaceuticals Co. Ltd. to manufacture and market the cultured MSC product in Japan for acute graft versus host disease in children and adults.
Mesoblast has established an alliance with Lonza Group for the clinical and long-term commercial manufacturing of its allogeneic MPC products.
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