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.
FibroGenesis Reports COVID-19 Breakthrough Using Fibroblast Cell Therapy (Pre-Clinical Trial Phase)
PneumoBlast™ Reduces Pathology and Lung Fluid Accumulation in Model of COVID-19
HOUSTON, May 21, 2020 — FibroGenesis announced significant efficacy of its PneumoBlast™ product in an animal model of lung inflammation which resembles COVID-19. Mice immune systems were stimulated to enter hyper-activation mode, which causes symptoms similar to COVID-19. Once COVID-19 simulation was achieved, administration of PneumoBlast™ resulted in significant reduction in lung fluid accumulation. Additionally, reduction was observed from infiltration of inflammatory cells, as well as suppression of chemical mediators such as interleukin-6 (IL-6), which are associated with poor survival in COVID-19 patients. [Read more…]
Immunicum Wins RMAT for Ilixadencel, Its Dendritic Cell Immunotherapy Against Kidney Cancer
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Immunicum AB has received an FDA RMAT for Ilixadencel, its allogeneic dendritic cell immunotherapy for the treatment of metastatic renal cell carcinoma (mRCC).
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Ilixadencel is the 43rd FDA RMAT to be announced.
Immunicum AB (publ; IMMU.ST) has received and FDA Regenerative Medicine Advanced Therapy (RMAT) designation for the Company’s lead product candidate, ilixadencel, a cell-based, off-the-shelf immune primer for the treatment of metastatic Renal Cell Carcinoma (mRCC). [Read more…]
Novartis’ Kymriah® Wins Latest FDA RMAT (42 Announced)
Novartis Kymriah® receives FDA Regenerative Medicine Advanced Therapy designation in follicular lymphoma.
- If approved, relapsed or refractory (r/r) follicular lymphoma would become the third B-cell malignancy indication for Kymriah, joining approvals in children and young adults with r/r ALL, and adults with r/r DLBCL
- The Regenerative Medicine Advanced Therapy (RMAT) designation reflects the unmet need for patients with r/r follicular lymphoma
- US regulatory filing for Kymriah in r/r follicular lymphoma anticipated in 2021
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