- Patient dosing commenced in world-first Phase I trial of stem cell therapy CYP-001 in graft-versus-host disease; recruiting at six centres in the UK and Australia
- Secured $60-million-plus FUJIFILM partnership and license option for CYP-001 in GvHD
- Raised additional $10 million: $4 million equity investment from FUJIFILM and $6 million placement
- Reported positive pre-clinical data in heart attack and asthma; expanded pre-clinical pipeline to acute respiratory distress syndrome
- Filed two new patent applications with IP Australia to expand opportunities in cancer immunotherapy
- Completed pre-Investigational New Drug meeting with U.S. Food and Drug Administration Office of Cellular, Tissue and Gene Therapy; written recommendation expected by July 2017
Flagship Pioneering Launches Sigilon to Advance Encapsulated Cell Therapies
Flagship Pioneering Launches Sigilon Therapeutics to Advance Afibromer™ Encapsulated Cell Therapies
– Category-defining platform to engineer biocompatible encapsulated cell therapeutics to treat serious diseases
– Company assembles leadership team with extensive success in cell biology, translational materials science, medical research and biopharmaceutical development
Cambridge, Mass. (June 21, 2017) – Flagship Pioneering, a fully-integrated life science innovation enterprise, announced the launch of Sigilon Therapeutics Inc. Sigilon Therapeutics is a biopharmaceutical company that discovers and develops category-defining biocompatible encapsulated cell therapies. Sigilon Therapeutics’ discovery platform combines cell engineering and revolutionary biocompatible Afibromer™ technology, a new class of implantable biomaterials that do not trigger fibrosis. [Read more…]
Cynata Files New Patent Application for Cymerus™ Stem Cell Technology in Oncology
- Application filed with IP Australia would expand patent estate to immunotherapy
- Creates new opportunities in the growing field of immunotherapy and reinforces a position in oncology
PolarityTE(TM) Regenerates Full-Thickness Hair-Bearing Skin in Burns & Wounds Using Revolutionary Platform Technology
First ever known successful regeneration of full-thickness skin and hair; Company poised to initiate human trial in the third quarter of 2017; Management to host conference call Thursday, June 8th at 4:30pm ET
SALT LAKE CITY, UT, 06/08/17 — PolarityTE™, Inc. (NASDAQ: COOL) today announced pre-clinical results demonstrating that the Company’s lead product, SkinTE™, regenerated full-thickness, organized skin and hair follicles in third degree burn wounds. The findings represent the first known successful regeneration of skin and hair in full-thickness swine wound models, the standard animal model for human skin. The Company expects to initiate a human clinical trial evaluating the autologous homologous SkinTE™ construct in the third quarter of 2017. [Read more…]
FDA Draft Guidance On “Minimal Manipulation Of HCT/Ps”
In September 2016, the FDA hosted a public hearing to review draft guidances pertaining to the FDA regulation of stem cells. It addressed the regulation of human cell and tissue-based products (HCT/Ps), defined by the FDA in § 1271.3(d) as “articles containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient.”
FDA Draft Guidance for HCT/Ps
In this article:
- FDA Regulations on Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products
- FDA Guidance Documents
- FDA Draft for Manipulating HCT/Ps
- Additional FDA Guidelines for Medicine with HCT/Ps
Since that time, we have not heard from the FDA about how they have integrated the public feedback. [Read more…]
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