Today, we are facing a crisis that is unlike anything most of us have seen in our lifetimes. COVID-19 has brought health systems across the world to the fringe and forcefully closed schools, restaurants, events, and many other places around the world where we gather. The pandemic has killed countless lives and caused havoc in the lives of millions of workers. The ramifications of the pandemic are social and economic and will likely be felt for some time to come. [Read more…]
Why is Healthy Donor Tissue So Important for Cell and Gene Therapies?
Brad Taylor, PhD and Dominic Clarke, PhD
HemaCare Corporation 8500 Balboa Boulevard Suite 130 Northridge CA 91325
Public discourse on cell and gene therapy is focused on novel approaches to long-established procedures such as bone marrow transplants, as well as on truly innovative treatments such as cancer immunotherapy and stem cell therapy for autoimmune disorders and other serious ailments. Positive clinical trial results and the demonstrated success of advanced therapies such as Kymriah® and Yescarta® are fueling a sense of excitement on what could be accomplished with these medicines—and driving a significant increase in the number of cell therapies in the clinical trial pipeline. As of last year, there were nearly 300 different cell and gene therapies in development, and that number is on target to grow.[1] [Read more…]
Celltex Therapeutics Receives Another FDA Approval: Phase II Clinical Trial Using MSCs a Prophylactic Against COVID-19
June 26, 2020, HOUSTON — Celltex, a Houston, Texas-based biotechnology company, announced that it has received approval from the U.S. Food and Drug Administration (FDA) to proceed with the Company’s Investigational New Drug application (IND 22055) to investigate the Prophylactic Efficacy of Autologous Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs) Against Coronavirus Disease 2019 (COVID-19). [Read more…]
Orca Bio Raises $192M Series D to Develop High Precision Allogenic Cell Therapies
Company aims to safely and effectively regenerate a healthy blood and immune system for patients with hematological malignancies, genetic diseases and autoimmune disorders
High precision cell therapies manufactured by Orca Bio have the potential to replace conventional bone marrow transplants and expand the eligible patient population
Cynata to Launch World’s First Phase 3 Trial with an iPSC-Derived Cell Therapeutic
With an anticipated enrollment of 440 patients, it will be the world’s largest trial ever completed with an iPSC-derived cell therapeutic.
It’s official. Australian stem cell company Cynata Therapeutics is preparing to test its iPSC-derived cell therapeutic, CYP 004, in a Phase 3 clinical trial enrolling up to 440 patients. Led by the University of Sydney and funded by the Australian Government National Health and Medical Research Council (NHMRC), the historic trial will assess whether Cynata’s cell therapeutic, CYP-004, has the capacity to improve patient outcomes in osteoarthritis (OA).
CYP-004 is an allogeneic, iPSC-derived mesenchymal stem cell (MSC) product derived using Cynata’s proprietary Cymerus™ technology. The clinical trial is set to achieve two world-firsts:
- It will be the world’s first clinical trial involving an iPSC-derived cell therapeutic product to enter Phase 3.
- It will be the largest trial ever completed with an iPSC-derived cell therapeutic, with an anticipated enrollment of 440 patients.
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