RANCHO CORDOVA, Calif., July 10, 2017 – Cesca Therapeutics Inc. (NASDAQ:KOOL), a market leader in automated cell processing and point-of-care, autologous cell-based therapies, today announced that its wholly-owned subsidiary, ThermoGenesis Corp., has entered into an asset acquisition agreement (the “Agreement”) with SynGen Inc., a privately-held Sacramento, CA-based technology company active in the cellular processing field.
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FDA Meeting Provides Clear Path for Cynata US Development Plans
- Cynata Pre-IND meeting with the US FDA completed successfully
- FDA confirms CymerusTM manufacturing dossier meets expectations
- Clear path determined for preclinical and clinical protocol requirements for product development in US
- Potential to take advantage of fast-track provisions under the new 21st Century Cures Act
Melbourne, Australia; 5 July 2017: Australian stem cell and regenerative medicine company, Cynata Therapeutics Limited (ASX: CYP), has received written advice from the United States Food and Drug Administration (FDA) regarding the regulatory approval path for Cynata’s proprietary CymerusTM mesenchymal stem cell (MSC) products in the US. This advice follows a pre-Investigational New Drug (pre-IND) meeting (announced 19 April 2017), which Cynata recently held with the FDA’s Office of Cellular, Tissue and Gene Therapies.
The FDA confirmed that the scope and substance of Cynata’s “Chemistry, Manufacturing and Controls” (CMC) dossier is commensurate with its expectations, which indicates that CymerusTM MSC products are expected to be of suitable quality for clinical trial use in the US. [Read more…]
Cynata Therapeutics GvHD Clinical Trial and Corporate Progress
- 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
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