Palo Alto, California, August 22, 2024 – I Peace, a pioneering CDMO in induced pluripotent stem (iPS) cells, and iCamuno Biotherapeutics, a biotech company developing iPS cell-based therapies, today announced a significant milestone with the dosing of the first patient in a clinical trial using iPS cell-derived natural killer (iNK) cells for ovarian cancer immunotherapy. iCamuno will lead the trial, which will test the safety and efficacy of NK cells made from I Peace’s cGMP-compliant iPS cells using iCamuno’s NK cell differentiation technology. [Read more…]
iPSC Market Leaders and their Business Models
Today, induced pluripotent stem cells (iPSCs) are being exploited for uses in drug discovery and development, toxicology screening, disease modelling, personalized medicine, cell-based therapeutics, and beyond. A fascinatingly diverse range of business models have been developed by market competitors to provide iPSC specific products, services, technologies, and therapies across the life science sector. [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
iRegene Receives IND approval from U.S. FDA to Start Clinical Trial for Parkinson’s Disease
WUHAN, China, June 24, 2024 — On June 20 (UTC-4), the U.S. Food and Drug Administration (FDA) approved the IND application for NouvNeu001, a cell therapy product from iRegene therapeutics targeting Parkinson’s Disease. This marks a significant milestone as NouvNeu001 becomes the world’s first chemically induced allogeneic cell therapy product to enter clinical stages for Parkinson’s disease in the US. Previously, the “Combined Phase I/II Clinical Study” of NouvNeu001 had already received approval from China NMPA in August 2023 and demonstrated positive safety and efficacy data in its Phase I trials. On June 20, 2024, iRegene further announced IND approval of NouvNeu001 by the U.S. FDA for the treatment of mid-to-late stage of Parkinson’s disease. [Read more…]
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