c-GMP compliance of C-stem, an IPSc based cell therapies production technology

Project Information

C-stemGMP

Grant agreement ID: 881113

DOI

10.3030/881113

Project closed

EC signature date 28 November 2019

Start date 1 November 2019

End date 31 October 2021

Funded under

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Total cost

€ 3 382 855,00

EU contribution

€ 2 367 998,00

Coordinated by

TREEFROG THERAPEUTICS
France

Periodic Reporting for period 2 - C-stemGMP (c-GMP compliance of C-stem, an IPSc based cell therapies production technology)

Reporting period: 2020-11-01 to 2021-10-31

Summary of the context and overall objectives of the project

TreeFrog Therapeutics aims at providing access to cell therapies for millions of patients. The company has developed C-Stem, a high-throughput cell encapsulation technology allowing the mass-production and differentiation of stem cells in industrial bioreactors.
The european program, started in November 2019, is a global development plan including : Development of a cGMP encapsulation device, global Gmp validation of C-stem technology and deployment of Treefrog's co-development strategy with top therapeutic initiatives.
Today, cell therapy industry has no solution to insure safe and scalable production of its therapeutic cells. The technologies on the market today are either poorly reproducible or very limited in terms of scaling up. Some big initiatives like Resilience in the United states are now in line to develop production capacities and identify technologies that will unlock cell therapies market. In this perfect momentum, Treefrog is accelerating its development with the help of European commission.
The program must demonstrate that Treefrog's technology is fully adapted to cell therapy requirements and can be deploy in partnership with biotech and Pharmaceutical groups to accellerate availability of cell therapy products for patients.
Cellular therapy drugs represent a hope for cure for hundreds of millions of people around the world.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

Since the start of the project, Treefrog has made spectacular advances in demonstrating its technology on an industrial scale. With the support of Invetech, the company developed a functional and fully integrated encapsulator prototype and deployed it in its laboratory for the production of 5 types of micro-tissues. The company has also internalized the production of microfluidic glass chips and validated the use of GMP compatible compounds throughout its process. The company has also started the deployment of its technologies by contracting with international groups to test its technology in major indications. The company, which is preparing a fundraising of € 50M for 2021, is perfectly positioned to become the leading biotech in Europe and a gold-standard technology at world level in the field of cell therapies.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

Treefrog recently performed a comparative study of the quantitative and qualitative results of induced stem cell production in C-stem. The study was carried out using the technical results of the European project. The results of this study demonstrate a yield 5 times higher, a maintenance at an exceptional level of the pluripotency of the cells and an effective control of the mutations observed in the other methods of production (2D, aggregates). Treefrog's goal in 2021 is to consolidate its results on a scale never reached by the industry and to start 3 new collaborative programs. Until the end of the program, Treefrog should be able to propose to its clients a fully GMP compatible solution to perform their clinical studies.

Encapsulation device