Read highlights from the latest installment of Dusko Ilic’s industry news, which discuss the latest developments and news in regenerative medicine and stem cell research, and are published every month in Regenerative Medicine.
Every month, Dusko comments on regenerative medicine industry news of note. Read the full update for July 2020 in Regenerative Medicine here>>
What happened this month that you were expecting?
Cynata Therapeutics (Australia) has announced positive results from the 2-year follow-up of patients enrolled in the Phase I clinical trial of CYP-001, Cynata’s lead iPSC-derived Cymerus™ mesenchymal stem cell (MSC) product. The Phase I trial, which was the world’s first clinical trial of an allogeneic iPSC-derived MSC product, evaluated the safety and efficacy of CYP-001 for the treatment of patients with steroid-resistant acute graft-versus-host disease (GvHD). With overall survival rate of 60% (9/25 patients), the Cymerus was better than any other approach. Looking forward to Phase II!
What happened that surprised you this month?
It is highly unusual for companies to publish details of their proprietary technology or manufacturing process. Allele Biotechnology (CA, USA) is, apparently, taking the opposite route. The Company has published a step-by-step protocol for manufacturers of iPSC and other types of stem cells with streamlined cleanroom practices for growing clinical grade cell products. The manuscript also provides sources of cGMP-grade culture media, key reagents, equipment, as well as the critical steps taken during splitting, stocking and thawing of frozen iPSC stocks.
If we only read about one story this month, what should it be?
iPSC-based therapeutics is slowly gaining momentum. Fate Therapeutics (CA, USA) has announced that the US FDA has cleared the Company’s IND application for FT819, an off-the-shelf allogeneic CAR-T therapy targeting CD19+ malignancies. FT819 is the first-ever CAR-T therapy derived from a clonal master iPSC line and is engineered with several first-of-kind features designed to improve the safety and efficacy of CAR-T therapy. Fate’s iPSC platform enables mass production of off-the-shelf, engineered, homogeneous cell products that can be administered with multiple doses to deliver more effective pharmacologic activity, including in combination with cycles of other cancer treatments.
Dusko Ilic is a Senior Lecturer in stem cell science, coordinator of the cross-divisional postgraduate program in stem cells and regenerative medicine, and Head of the Induced Pluripotent Stem Cell Core Facility at King’s College London (London, UK). He is also Head of the Assisted Conception Unit’s Human Embryonic Laboratories at Guy’s Hospital (London, UK). He is also a member of the editorial board of the journal Regenerative Medicine, where he writes the Industry Report, a regular feature compiling information from non-academic institutions in the field of stem cells and regenerative medicine.