San Antonio, Texas, July 25, 2024 – ALS, or amyotrophic lateral sclerosis, is defined by the ALS Association (als.org) as a progressive neurodegenerative disease that affects nerve cells in the brain and spinal cord. ALS symptoms vary and patients may lose the ability to speak, eat, move and breathe. There is no cure. The Mayo Clinic reports (mayoclinic.org) that no treatments can reverse ALS damage, but they may slow the progression of disease symptoms or help prevent complications. INCELL is committed to tackling innovative ALS therapy. [Read more…]
From Feeder-free to Coating-free, DuoGenic StemCells corporation has developed the next generation hPSC culture medium: DuoESy.
1. Introduction: Regenerative Medicine in Taiwan
Taiwan is famous for its semiconductor, night markets and pearl milk tea. But few people know that the public health insurance, medical technique and cell therapy are also flourishing.
In 2018, Taiwan government partially lifted the regulation on cell therapy with a positive list according to the “Regulations of Special Medical Techniques”. The permitted cell types include autologous immune cell (NK, CIK etc.), chondrocyte, fibroblast, ADSC and BM-MSC for specific indications respectively. [Read more…]
Organizations Who are Conducting Human Trials with iPSC-Derived Cellular Therapeutics
Induced pluripotent stem (iPS) cells are a type of stem cell that can be generated directly from adult cells. They were first developed in 2006 by Shinya Yamanaka and his team. iPS cells are engineered by reprogramming adult cells, such as skin cells, to revert to a pluripotent state, meaning they have the ability to differentiate into any cell type in the body. This reprogramming is typically achieved by introducing a combination of specific genes or gene factors into the adult cells, which resets their developmental clock. [Read more…]
BlueRock Therapeutics exercises exclusive option to license iPSC cell therapy candidate OpCT-001 for treating Primary Photoreceptor Diseases from FUJIFILM Cellular Dynamics and Opsis Therapeutics
First iPSC therapy candidate to be licensed from the strategic R&D collaboration forged between BlueRock, FUJIFILM Cellular Dynamics, and Opsis Therapeutics in 2021
Primary photoreceptor diseases affect the structure and function of the photoreceptor cells in the retina, leading to irreversible vision loss in children and adults
IND filing for OpCT-001 is planned for 2024
CAMBRIDGE, Mass., Jan. 23, 2024 — BlueRock Therapeutics LP, a clinical stage cell therapy company and wholly owned, independently operated subsidiary of Bayer AG, announced today that it has exercised its option to exclusively license OpCT-001, an induced pluripotent stem cell (iPSC) derived cell therapy candidate for the treatment of primary photoreceptor diseases, from FUJIFILM Cellular Dynamics and Opsis Therapeutics. OpCT-001 is the lead cell therapy candidate being developed under the strategic R&D collaboration between BlueRock, FUJIFILM Cellular Dynamics, and Opsis Therapeutics that was forged in 2021. Under the terms of the agreement FUJIFILM Cellular Dynamics, and Opsis Therapeutics receive an undisclosed license fee and are eligible to receive payments upon achievement of certain development and commercial milestones.
“We believe that cell therapy has great potential for restoring vision in patients who are living with retinal diseases,” said Ahmed Enayetallah, Senior Vice President and Head of Development at BlueRock Therapeutics. “Our collaboration with the FUJIFILM Cellular Dynamics and Opsis Therapeutics team has allowed us to execute important IND-enabling activities, and we are excited to advance OpCT-001 toward the clinic, with an IND filing planned for this year.”
Primary photoreceptor diseases are a subgroup of inherited retinal disorders that includes retinitis pigmentosa and cone rod dystrophies. These diseases affect the structure and function of the photoreceptor cells in the retina, leading to irreversible vision loss in both children and adults. No treatment options currently exist for this patient population. OpCT-001 aims to restore vision loss caused by these diseases by replacing degenerated tissue in the retina with functional cells.
About BlueRock Therapeutics LP
BlueRock Therapeutics LP is a clinical stage cell therapy company focused on creating cellular medicines to reverse devastating diseases. We are harnessing the power of cell therapy to create a pipeline of new medicines for patients suffering from neurological, cardiovascular, immunological, and ophthalmic diseases. Our lead clinical program, bemdaneprocel, (BRT-DA01) is in Phase I clinical trials for Parkinson’s disease. We were founded in 2016 as a joint venture of Versant Ventures and Leaps by Bayer, the impact investing arm of Bayer AG that invests in paradigm-shifting breakthrough innovation. In late 2019, BlueRock became a wholly owned, independently operated subsidiary of Bayer AG as a cornerstone of its newly formed Cell & Gene Therapy platform. Our culture is defined by the courage to persist regardless of the challenge, the urgency to transform medicine and deliver hope, integrity guided by mission, and community-mindedness with the understanding that we are all part of something bigger than ourselves.
About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2022, the Group employed around 101,000 people and had sales of 50.7 billion euros. R&D expenses before special items amounted to 6.2 billion euros.
To learn more about this rapidly expanding market, view the “Global Induced Pluripotent Stem Cell (iPSC) Industry Report – Market Size, Trends, and Forecasts.”![iPS Cell Market Report](data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAASwAAADhAQAAAABaB7UGAAAAAnRSTlMAAHaTzTgAAAAdSURBVGje7cEBAQAAAICQ/q/uCAoAAAAAAAAAABoiRwABa9w6IwAAAABJRU5ErkJggg==)
CytoMed Therapeutics Acquires Cord Blood Banking Licence and Assets to Entrench Its Strategy in Allogeneic, Off-the-shelf Donor-derived Gamma Delta (γδ) T Cells Technology for Solid and Liquid Cancers
Another Patent Granted for CytoMed’s Allogeneic Induced Pluripotent Stem Cell (“iPSC”)-derived Hybrid Gamma Delta Natural Killer T (γδ NKT) cells technology
SINGAPORE, July 17, 2024 — CytoMed Therapeutics Limited (NASDAQ: GDTC) (“CytoMed” or “Company”), a Singapore-based biopharmaceutical company focused on harnessing its proprietary technologies to develop novel donor blood-derived, cell-based allogeneic therapies for the treatment of various cancers and aging-related diseases, has, through its wholly owned subsidiary, IPSC Depository Sdn Bhd acquired the licence and certain assets of Cellsafe International Sdn Bhd (In Liquidation) (“CISB”), a Malaysian cord blood bank for a cash consideration of approximately RM 2.3 million or US$ 490,000 to be funded from internal cash resources.
The price consideration includes a cord blood banking licence issued by Malaysia’s Ministry of Health, cryopreservation equipment with more than 12,000 cord blood units (“CBUs”) and two freehold real estate properties totalling 189 square metres in which the operation is situated.
Unlike conventional alpha beta (αβ) T cells, γδ T cells are rare accounting for 1% to 5% of body T cells but possess innate tumor recognition capabilities and exhibit robust cytotoxic activity against a variety of cancer types. Many clinical trials support this discovery.
CytoMed aims to be the pre-eminent biotech with capabilities to produce clinically relevant numbers of Good Manufacturing Practice (“GMP”)-grade γδ T cells from three key sources namely from adult peripheral blood mononuclear cells and from induced Pluripotent Stem Cells both of which we have significant experience, and soon, from cord blood. Once considered medical waste, cord blood has emerged as a valuable raw material with immense therapeutic potential in cell therapies. In recent years, researchers have made significant strides in harnessing the unique properties of cord blood derived cells for combating cancer and promoting healthy aging.
Traditionally, cord blood banks cryopreserve the CBUs with the purpose to use them for mainly blood disorders. However, cord blood banks are plagued by limited usage, currently only used for haematopoietic stem cell transplant for blood disorders and further restricted by conditions such as haplotype matching as well as inadequacy of cells. With the advancement and development of stem cell science and therapies, CytoMed intends to add significant value to CBUs customers by repurposing and expanding the use and application of such CBUs to a more extensive range of therapies including but not limited to the treatment of solid cancers.
Recent advances in cell science and technology have enabled researchers to produce specialized cellular therapies using mononuclear stem cells found in CBUs. Amongst these are the invaluable immune γδ T Cells, a rare subset of white blood cells which may be expanded from the CBU. Another cell type that is under investigation is cord blood derived Natural Killer (“NK”) cells which would be a cell of interest to be expanded from CBU. There are presently many ongoing international clinical trials using immune cells with abundant scientific papers published. γδ T Cells and engineered γδ T Cells i.e. chimeric antigen receptor T-cells (“CAR-T cells”) have garnered immense therapeutic interest in the treatment of a host of life-threatening diseases, in particular, solid cancers, which is CytoMed’s core focus. CytoMed has received approval for and is conducting the ANGELICA Trial, an on-going first in human phase 1 clinical trial in Singapore focused on CAR-T.
With exclusive licensed patents, knowledge and experience in the technology and engineering of γδ T Cells, CytoMed hopes to benefit the many CBUs stored all over the world by repurposing the cryopreserved assets and thus changing the basic business model of cord blood banking.
“This acquisition is to unlock the therapeutic potential of umbilical cord blood and adds strategic capital to our vision to develop cytotoxic γδ T cells for cancer treatment” said Peter Choo, Chairman of CytoMed “We aim to be the pre-eminent player in the γδ T cell technology with capabilities to produce highly viable γδ T cells from three key sources namely from adult peripheral blood mononuclear cells, from iPSC and soon, from the small amount of cord blood from the cryopreserved CBUs.”
Co-CEO Dr Tan Wee Kiat added “Mononuclear cells in the CBU are the starting raw material from which many cell therapies can be derived and it makes sense to focus on deriving immune T cells from them to fight both haematological and solid cancers especially in anticipation of future rapid development of this new medical science of cell therapy. We own our state-of-the-art cGMP lab to ensure quality and cost-control, and have patented technologies to actually manufacture clinical grade CAR-T cells as adjunctive therapies should the no-option patient’s doctor recommend it.”
The Company is only acquiring certain assets of CISB, free from encumbrances and will not be responsible for, amongst other things, the quality and/or viability of the CBUs or past liabilities. As such, the financial impact of the acquisition is not expected to be material. The Company intends to seek strategic partners in the future to jointly develop and grow this subsidiary as a specialised umbilical cord blood-derived immune cell bank offering cancer-fighting γδ T cells and NK cells.
The management of CytoMed has obtained board approval to jointly invest up to 7% stake in this venture at a valuation of RM 5 million which is twice the valuation paid by the Company to fund the operational costs, reflecting their commitment and confidence. This constitutes an interested party transaction which requires disclosure and annual review by the Company’s Audit Committee.
New patent award
In another separate development, the Company is pleased to announce that the Intellectual Property Corporation of Malaysia has granted a patent for its licenced iPSC-derived hybrid γδ NKT cells technology, which targets solid and haematological cancers.
The patent titled “Methods and Kits for Generating Mimetic Innate Immune Cells from Pluripotent Stem Cells” with Grant No.MY-202222-A, covers the generation of iPSCs and differentiation into a hybrid γδ NKT cell without gene editing in the entire process, leaving the genome untouched. The generation of an iPSC line means that there would be infinite starting material, as well as a platform that would be open for gene editing if the need arises. The generation of a hybrid γδ NKT cells expressing receptors of both cell types on a single cell translates to enhanced recognition capabilities against cancer cells selectively while sparing healthy cells. This enables the differentiated cell type to recognise and target a wide range of cancers, including both solid and haematological cancers. The Company holds an exclusive worldwide license to use this patent pursuant to the License Agreement dated June 1, 2018, filed with the Securities and Exchange Commission as an exhibit to the registration statement on Form F-1 (File No.: 333-268456) on March 30, 2023.
This grant adds to the breadth of our tumor-targeting therapy patent portfolio, alongside a Japanese and China patent in respect of this iPSC-derived hybrid γδ NKT cell technology. This patent grant is timely as Malaysia is attracting more biomedical innovators amidst an ageing population and reputation as a medical tourism hub. CytoMed’s IPSC- γδ NKT cell program is under active GMP development and will be commencing animal studies as the next milestone.
About CytoMed Therapeutics Limited (CytoMed)
Incorporated in 2018, CytoMed was spun off from the Agency for Science, Technology and Research (A*STAR), Singapore’s leading research and development agency in the public sector. It is a biopharmaceutical company focused on harnessing its licensed proprietary technologies, namely gamma delta T cell and iPSC-derived gamma delta Natural Killer T cell, to create novel cell-based allogeneic immunotherapies for the treatment of various human cancers. The development of novel technologies has been inspired by the clinical success of existing CAR-T therapies in treating haematological malignancies, as well as the current clinical limitations and commercial challenges in extrapolating the CAR-T principle into the treatment of solid tumours.
To learn more about this rapidly evolving market, view the “Global Cord Blood & Tissue Banking Industry Report – Market Size, Segmentation, & Forecasts, 2024.”![Cord blood market report](data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAASwAAADhAQAAAABaB7UGAAAAAnRSTlMAAHaTzTgAAAAdSURBVGje7cEBAQAAAICQ/q/uCAoAAAAAAAAAABoiRwABa9w6IwAAAABJRU5ErkJggg==)
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