Regenerative medicine company Regeneus (ASX: RGS) has reached a significant milestone in its mission to market its proprietary biomarkers in China.
The company is developing a portfolio of innovative cellular therapies targeting “significant unmet medical needs” and is currently progressing a licence-driven strategy to commercialise its product portfolio which already has in excess of 80 patents or patent applications across multiple patent families.
This morning, Regeneus announced that it had been granted a patent which allows the use of its biomarkers by China’s State Intellectual Property Office, allowing Regeneus to monitor disease progression in a patient having mesenchymal cell therapy (MSC) for inflammatory conditions.
According to China’s regulatory body, the granted patent application entitled “Biomarkers for cell therapy” will provide Regeneus with commercial rights in China until the year 2033.
The company said that the newly-granted patent will provide protection for licensing the company’s Progenza allogeneic stem cell therapy platform in China.
The granted patent covers three specific biomarkers: MIF (Macrophage Migration Inhibitory Factor), COMP (Cartilage oligomeric matrix protein) and CTX II (cross-linked C-telopeptides of type II collagen) in MSC therapies.
“MIF is recognised as a key modulator in promoting and modulating the magnitude of the inflammatory response, while COMP and CTX-II are degradation products of joint tissues, especially the cartilage extracellular matrix,” according to Regeneus.
Chinese market scope
There is increasing interest in China for in-licensing cell therapy technology platforms like Progenza.
Exactly one year ago, the Chinese government announced new laws to accelerate the approval pathway for cell therapy products.
Under the new regime, cell therapy products must go through two clinical phases: an early phase focused on safety and a confirmatory phase to demonstrate probable efficacy.
The patent announced today covers use of a broad range of MSC therapeutics for the treatment of inflammatory conditions in combination with the biomarkers.
Research scientists have recognised that MSCs have anti-inflammatory effects and are used to treat a range of chronic inflammatory conditions including graft versus host disease, Crohn’s disease, cardiovascular disease and osteoarthritis.
Regeneus intends to make use of its newly-granted patent to harness MSCs to create therapeutics that utilise “allogeneic and autologous cells” where the MSCs can be sourced from any tissue type including adipose, bone marrow or placental tissue and includes MSCs sourced from induced pluripotent stem cells and embryonic stem cells.
According to Regeneus, biomarkers associated with inflammatory disease are a useful way to measure the effects of MSC therapies and can be analysed simply in a patient’s blood or other body fluids.
As part of its mission statement for future market commercialisation, Regeneus says that “our initial focus is on osteoarthritis (OA) and other musculoskeletal disorders, oncology, dermatology and chronic pain. Our allogeneic stem cell and secretions technologies have the ability to be clinically developed to treat multiple indications.”
This morning’s Chinese patent news helped Regeneus shares to trade up almost 8%, up to $0.21 per share.