Cutting edge umbilical cord lining stem cell therapy developed by Singaporean biotech granted Innovation Passport by UK regulators
- Awarded to Singaporean biotech CellResearch Corporation, the Innovation Passport will facilitate accelerated access to CorLiCyte™, an umbilical cord lining stem cell therapy, for patients suffering with a Diabetic Foot Ulcer (DFU) in the UK.
- DFUs affect more than 30 million people globally and have a 50% mortality rate over 5 years.
- The Singapore government has recently awarded CellResearch Corporation (CRC) grant funding totalling S$16 million to support the development of a number of these projects utilizing CRC’s patented stem cell technology.
Singapore, 13 October: CellResearch Corporation’s (CRC) stem cell therapy CorLiCyte™ has been awarded an ‘Innovation Passport’ under the UK Medicines and Healthcare products Regulatory Agency’s (MHRA) Innovative Licensing and Access Pathway (ILAP), becoming the first Singapore-based company, and one of only around 20 companies globally, to announce it has received the designation.
Awarded for the treatment of chronic Diabetic Foot Ulcers (DFUs), this treatment had its Investigational New Drug (IND) application accepted by the U.S. Food and Drug Administration (USFDA) in December 2018. CorLiCyte™ is currently undergoing Phase 1 of a USFDA trial to close chronic DFUs at the University of Colorado Anschutz Medical Campus under the identifier NCT04104451.
This award will facilitate accelerated access to CorLiCyte™ for patients suffering with a DFU in the UK. Globally, DFUs affect more than 30 million people and have a 50% mortality rate over 5 years. In Singapore, there is an average of four lower extremity amputations (LEA) a day in people with diabetes1. About 3 in 4 LEA are preceded by DFU2.
The UK’s ILAP was introduced by the MHRA in January 2021. ILAP aims to accelerate the time to market, facilitating patient access to medicines and involves close engagement with other stakeholders including the National Institute for Health and Care Excellence (NICE), the Scottish Medicines Consortium (SMC) and, importantly, patients. By incorporating patient views, both on the benefits and risks of medicines in the pathway, and on how to improve patient outcomes throughout the product lifecycle, medicines can be developed to meet patient requirements more successfully. Such medicines include new chemical entities, biological medicines, new indications and repurposed medicines.
This is a significant development for CRC. It is a recognition by the UK regulatory authorities that CorLiCyte™ is a highly innovative technology platform, is addressing a vast unmet need and has the potential to benefit patients suffering from life threatening or debilitating illness. It is also a commitment on the part of the regulators to collaborate with CRC on the development of this therapy and to facilitate its access to the UK market.
Chief Executive Officer Gavin Tan says, “We are delighted with this development – it is an important step closer to treating patients with this serious and debilitating disease. This is, I believe, the first Innovation Passport granted to an asset born in Singapore and helps strengthen our country’s position as a leader in biotechnology on the global stage”.
Chief Scientific Officer Dr Phan Toan Thang says, “Umbilical cord lining technology is exciting because its applications range from chronic diabetic foot ulcers to other difficult to heal wounds such as venous ulcers and burns. There is also the promise of future treatments for other diseases such as lupus, age related macular degeneration and other auto-immune conditions”.
The Singapore government has recently awarded CRC grant funding totaling S$16 million to support the development of a number of these projects utilizing CRC’s patented technology. Part of the agreement involves the establishment of a joint laboratory with the Institute of Molecular and Cell Biology (IMCB), to which the government will contribute S$6 million. IMCB is a national research institution based in Singapore and funded by the Agency for Science, Technology and Research (A*STAR).
The two groups have been collaborating since 2016 across a broad range of therapeutic targets and the Joint Lab will host four existing projects: Age-related Macular Degeneration (AMD), diabetes, haematopoietic stem cell expansion and Pre-clinical investigation of CL- MSCs using humanized mice disease models. The main objective of the Joint Lab will be to enable these high potential therapies to proceed from the pre-clinical stage through to clinical.
This is the first time CRC has been granted a fast-track designation by a major regulator and is an exciting next step for the company. However, CRC has already had great success with the commercialization of its cosmetic brand CALECIM® Professional. These cosmetic products leverage similar stem cell technology (cell-free media derived from the umbilical cord lining stem cells of red deer). Applied topically on healthy skin, they improve visible signs of aging. This product is sold in over 600 premium aesthetic clinics and online via the company’s own website.
CRC will seek similar regulatory designations in the EU via the PRIME scheme and in the U.S. via the Regenerative Medicine Advanced Therapy (RMAT) designation in the coming months.
1 Ministry of Health, Singapore. Lower extremity amputation, including toe amputation, in people with diabetes. 2016. Unpublished.
2 Pecoraro RE, Reiber GE, Burgess EM. Pathways to diabetic limb amputation.
Basis for prevention. Diabetes Care. 1990;13(5):513-521
Notes to Editors
About CellResearch Corporation (CRC)
CellResearch Corporation was founded in 2002 initially as a contract research provider focusing on skin cells. In 2004, the company made the discovery that the umbilical cord lining of mammals was an abundant source of both mesenchymal and epithelial stem cells. Today, the company owns this technology through a family of patents and holds the rights to commercialise this technology in most of the major markets globally. While the closure of diabetic foot ulcers is the company's first allogeneic therapy to make it to Phase 1 USFDA clinical trials, CellResearch has a broad therapeutic pipeline at the pre-clinical stage. Further therapies include solid tumour therapy, inflammatory diseases, cardiac muscle repair, Parkinson's Disease, Age-related Macular Degeneration and Diabetes.
Calecim Cosmeceuticals is a wholly owned subsidiary of CellResearch. It produces an innovative range of skincare products using cord lining stem cell media to power its products. The products are used post-procedure in-clinic, and as part of an at-home anti-aging skincare regime. It is distributed globally through over 600 aesthetic physicians and online via their own website. It has a key distribution partnership with Menarini Group across South East Asia.
CellResearch partner, Cordlife offers parents the opportunity to bank their child's umbilical cord tissue alongside their cord blood. Cordlife have what is believed to be the largest licensed bank of umbilical cord tissue globally. As cell therapies move into the clinic, Cordlife will have the ability to expand stem cells from a banked umbilical cord for autologous and donor-related uses.
https://calecimprofessional.com
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