BioInformant

Your Global Leader in Stem Cell Market Research

Home » cynata therapeutics » Page 3

FDA Meeting Provides Clear Path for Cynata US Development Plans

By 1 Comment

  • 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

Cynata TherapeuticsMelbourne, 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

By Leave a Comment

  • 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

[Read more…]

Cynata Introduces Critical Innovation into MSC Manufacturing

By Leave a Comment

In the context of cell therapy, product innovation is the introduction of a cellular product that is new or has significantly improved characteristics or intended uses. Over the past decade, a great deal of attention has been given to cell therapy product innovation, as demonstrated by the thousands of cell therapy products that have now entered clinical trials worldwide.

In contrast, process innovation refers to the implementation of a new or significantly improved production or delivery method. In the context of cell therapy, process innovation has received much less attention from the marketplace. [Read more…]

Cynata Therapeutics Initiates Patient Treatment in World 1st Clinical Trial

By Leave a Comment

In breaking news released earlier this month, Cynata Therapeutics (ASX: CYP) announced a major world first. The company treated a patient with steroid resistant acute graft-versus-host disease (GvHD) as part of a phase 1 clinical study of its first mesenchymal stem cell (MSC) product, CYP-001 .

This is an important value catalyst for Cynata and also for the regenerative medicine industry, because it is the first time ever that a patient has been treated with an allogeneic induced pluripotent stem cell (iPSC)-derived therapeutic mesenchymal stem cell (MSC) product.

[Read more…]

Cynata Inks Deal with FUJIFILM, $3.97M Plus Potential Payments of $60M+

By Leave a Comment

Cynata and FUJIFILM Sign Development and Commercialisation Partnership Agreement

  • Fujifilm takes A$3.97 million strategic equity stake in Cynata
  • Parties to collaborate on the further development and commercialisation of Cynata’s lead Cymerus™ therapeutic MSC product CYP-001 for graft-versus-host disease (GvHD)
  • Potential future upfront and milestone payments in excess of A$60 million
  • Double-digit royalties on CYP-001 product net sales
  • Strategic relationship for potential future manufacture of CYP-001 and certain rights to other Cynata technology

[Read more…]

BioInformant's World-Class Clients