Chinese Patent for Biomarkers to Monitor Disease Progression for Stem Cell Therapy
ASX Announcement 3 December 2018
- Chinese Patent to issue covers use of biomarkers to monitor disease progression for mesenchymal stem cell (MSC) therapy for inflammatory conditions
- Grant of patent application No. 201480060270.X will provide commercial rights in China until 2033
- Patent covers use of a broad range of allogeneic and autologous MSC therapeutics for inflammatory conditions in combination with biomarkers and is not limited to MSCs sourced from adipose tissue
- Patent will provide protection for licensing the Company’s Progenza allogeneic MSC therapeutics in China
Regeneus Ltd (ASX: RGS) (Regeneus or the Company), a clinical-stage regenerative medicine company, is pleased to announce the State Intellectual Property Office of China has granted the Company a patent for the use of biomarkers to monitor disease progression in a patient having mesenchymal cell therapy for inflammatory conditions.
The granted Chinese Patent Application No. 201480060270.X, entitled “Biomarkers for cell therapy”, will provide the Company with commercial rights in China until 2033.
The patent covers use of a broad range of MSC therapeutics for the treatment of inflammatory conditions in combination with the biomarkers. The therapeutics include allogeneic and autologous cells where the MSCs can be sourced from any tissue type such as adipose, bone marrow or placental tissue and includes MSCs sourced from induced pluripotent stem cells and embryonic stem cells.
MSCs have well recognised anti-inflammatory effects and are used and being developed to treat a range of chronic inflammatory conditions including graft versus host disease, Crohn’s disease, cardiovascular disease and osteoarthritis.
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. The patent covers the biomarkers MIF (Macrophage Migration Inhibitory Factor), COMP (Cartilage oligomeric matrix protein) and CTX II (crosslinked 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.
This patent will provide protection for licensing the Company’s Progenza allogeneic stem cell therapy platform in China.
There is increasing interest in China for in-licensing cell therapy technology platforms like Progenza. In December 2017, the Chinese government announced new laws to accelerate the approval pathway for cell therapy products. Under the new regime, cell therapy products will need to go through 2 clinical phases: an early phase focused on safety and a confirmatory phase to demonstrate probable efficacy. These new cell products will be available for government reimbursement.
Regeneus has over 80 patents or patent applications across multiple patent families, providing the Company’s product pipeline with a significant competitive advantage.
Progenza – European Patent Office issues Notice of Intention to Grant European Patent
ASX Announcement 18 October 2018
- Patent to issue provides coverage for the use of Progenza in up to 38 European member states, including the UK, Germany, France and Italy
- The grant of a patent for EP 2 744 892 will provide commercial rights to Progenza in Europe until 15 March 2032
- The European patent will join corresponding patents in Australia, New Zealand, Japan and the USA, providing significant commercial protection in some of the world’s largest regenerative medicine markets
- Significant step in bringing Progenza to Europe as a regenerative therapy for the treatment of osteoarthritis and other inflammatory indications
Regeneus Ltd (ASX: RGS) (Regeneus or the Company), a clinical-stage regenerative medicine company, is pleased to announce it has received a Notice of Intention to Grant a European patent covering the use of Progenza by the European Patent Office.
The patent to be granted for EP 2 744 892 entitled “Therapeutics using adipose cells and cell secretions” will provide Regeneus with the commercial rights to Progenza in up to 38 European member states of the European Patent Office, including the UK, Germany, France and Italy, until 15 March 2032.
The patent will join corresponding patents already secured in Australia, New Zealand, Japan and the United States of America1 , providing significant protection of the Company’s commercial rights to the Progenza technology platform in some of the world’s largest regenerative therapy markets. The Company continues to progress additional patent applications for Progenza in other key territories.
Regeneus has over 70 patents or patent applications across multiple patent families, providing the Company’s product pipeline with a significant competitive advantage. John Martin, CEO of Regeneus comments: “This is a significant milestone for Progenza, enabling further protection of our commercial rights over the Progenza technology platform. The addition of patent protection for the European market delivers another key milestone as we look to bring Progenza to Europe and other key markets.”
About Progenza Progenza is an allogeneic off-the-shelf stem cell technology platform developed for the treatment of osteoarthritis and other musculoskeletal diseases. It has the potential to be used for other inflammatory diseases that have limited treatment options.
Made from expanded mesenchymal stem cells (MSCs) from human adipose tissue, it contains the bioactive secretions of cells. Progenza cells work by secreting cytokines, growth factors and exosomes that act in concert to reduce inflammation and pain and encourage accelerated healing and repair of damaged or diseased tissue. It is a scalable technology that has demonstrated capability to produce millions of doses of cells from a single donor.
In December 2016, Regeneus signed a strategic collaboration and licensing agreement with leading Japanese biopharmaceutical manufacturer AGC for the exclusive rights to manufacture Progenza for all
On 10 October 2018, the US Patent Office released an Issue Notification for Patent Application No. 14/342479 (‘Therapeutics using adipose cells and cell secretions’) with projected US Patent No. 10,111,909 and issuance date of 30 October 2018, covering the commercial rights in the United States through to 2032.
clinical applications in Japan. The Company is currently in the advanced stages of discussion with several parties and anticipates entering into an agreement with a Japanese partner for the clinical development and commercialisation in Japan in Q2 FY19.
In February 2018, Progenza was granted an Advanced Therapy Medicinal Product (ATMP) classification by the Committee for European Commission, recognising it as a novel regenerative therapy within the legal and regulatory framework for ATMPs in the European Union.
Edison: Regeneus preparing for a clinical licence deal in Japan
Regeneus is aiming to sign one or more clinical development licence deals for Progenza in the current financial year. It is well placed to achieve this goal, having already granted AGC an exclusive licence to manufacture Progenza for Japan, reported promising signs of efficacy from the successful Phase I trial of Progenza in knee osteoarthritis and been granted a Progenza patent in Japan. Regeneus reported an A$3.3m profit in FY17, thanks to the US$5.5m upfront payment and US$1m milestone from the AGC licence deal; further milestone payments are likely to keep it in the black in FY18. Other potential catalysts for FY18 include results from the ACTIVATE Phase I cancer vaccine trial and the CryoShot Canine pre-pivotal trial. Our valuation is virtually unchanged at A$146m or A$0.70/share.
Successful Phase I arthritis trial supportive of a deal
The Phase I trial of Progenza in knee osteoarthritis (OA) met its primary safety endpoint and produced promising signs of efficacy, including clinically meaningful reductions in pain for the majority of patients and improvement in knee cartilage volume. Once AGC has commenced GMP manufacture of Progenza, we expect the next step to be a Phase II efficacy trial in patients with knee OA in Japan, which could support an application for conditional market approval in that country. The Regeneus Japan JV with AGC is in discussions with potential partners for the clinical development of Progenza for OA and other indications in Japan. Regeneus is also in discussions with potential partners to develop Progenza outside Japan.
High regenerative medicine deal values in Japan
We have seen several high-value regenerative medicine deals in Japan in the past 18 months, encouraged by its fast-track regulatory approval pathway. The most relevant example is the January 2015 licence deal between Kolon Life Science and Mitsubishi Tanabe Pharma for the Japanese rights to a cell and gene therapy for knee OA. That deal was worth US$24m upfront, plus US$410m in development, regulatory and sales milestones and a double-digit sales royalty.
Valuation: Adjusted to A$146m, A$0.70 per share
Our valuation increases slightly to A$146m (vs A$145m) or A$0.70/share (unchanged) due to the roll forward of the DCF model, partly offset by changed milestone timing and minor changes to near-term sales forecasts. A deal with a partner for the clinical development and commercialisation of Progenza in Japan is the main near-term valuation driver for the company. If the Regeneus Japan JV was to sign a deal with comparable financial terms to the Kolon/Mitsubishi deal (with half of milestone payments for sales and regulatory milestones) this would increase our valuation to around A$194m or A$0.93 per share.
