Bordeaux, France /October 11th, 2022TreeFrog Therapeutics,a biotechnology company developing stem cell-derived therapies in regenerative medicine and immuno-oncology based on the biomimetic C-Stem technology platform, and Invetech, a global leader in the development and production ofautomated manufacturing solutionsfor cell and advanced therapies, today announced the delivery of a GMP-grade cell encapsulation device using theC-Stem technology. The machine will be transferred in 2023 to a contract development and manufacturing organization (CDMO) to produce TreeFrogs cell therapy candidate for Parkinsons disease, with the aim of a first-in-human trial in 2024. Over 2023, Invetech will deliver three additional GMP encapsulation devices to support TreeFrogs in-house and partnered cell therapy programs in regenerative medicine and immuno-oncology.

Blending microfluidics and stem cell biology, TreeFrogs C-Stem technology generates alginate capsules seeded with induced pluripotent stem cells (iPSCs) at very high speed. Engineered to mimic the in vivo stem cell niche, the capsules allow iPSCs to grow exponentially in 3D, and to differentiate into ready-to-transplant functional microtissues. And because alginate is both porous and highly resistant, encapsulated iPSCs can be expanded and differentiated in large-scale bioreactors without suffering from impeller-induced shear stress.

TreeFrog Therapeutics introduces a breakthrough technology for cell therapy, which impacts scale, quality, as well as the efficacy and safety potential of cellular products. Automating this disruptive technology and turning it into a robust GMP-grade instrument is a tremendous achievement for our team. This deliverable is the result of a very fruitful and demanding collaboration with TreeFrogs engineers in biophysics and bioproduction over the past four years. Were now eager to learn how the neural microtissues produced with C-Stem will perform in the clinic. Anthony Annibale, Global VP Commercial at Invetech.

Started in 2019, the collaboration between TreeFrog and Invetech led to the delivery of a prototype in October 2020. With this research-grade machine, TreeFrog demonstrated the scalability of C-Stem, moving within six months from milliliter-scale to 10-liter bioreactors. In June 2021, the company announced the production of two single-batches of 15 billion iPSCs in 10L bioreactors with an unprecedented 275-fold amplification per week, striking reproducibility and best-in-class cell quality. The new GMP-grade device delivered by Invetech features the same technical specifications. The machine generates over 1,000 capsules per second, allowing to seed bioreactors from 200mL to 10L. However, the device was entirely redesigned to fit bioproduction standards.

With the GMP device, our main challenge was to minimize the learning curve for operators, so as to facilitate tech transfer. Invetech and our team did an outstanding job in terms of automation and industrial design to make the device both robust and easy to use. As an inventor, I am so proud of the journey of the C-Stem technology. Many elements have been changed and improved on the way, and now comes the time to put the platform in the hands of real-world users to make real products. Kevin Alessandri, Ph.D., co-founder and chief technology officer, TreeFrog Therapeutics

In October 2020, we announced that we were planning for the delivery of a GMP encapsulation device by the end of 2022. Exactly two years after, were right on time. I guess this machine testifies to the outstanding execution capacity of TreeFrog and Invetech. But more importantly, this machine constitutes a key milestone. Our platform can now be used to manufacture clinical-grade cell therapy products. Our plan is to accelerate the translation of our in-house and partnered programs to the clinic, with a focus on immuno-oncology and regenerative medicine applications. Frederic Desdouits, Ph.D., chief executive officer, TreeFrog Therapeutics

About Invetech

For pathfinders in cell and gene therapy striving to accelerate next-generation care, Invetech delivers robust, scalable and cost-effectivemanufacturing systemsfor clinical through to high-volume commercial production. Since 2003, Invetechs Cell Therapy Group has provided Assured Pathways to the commercial manufacturing of cell, gene and tissue therapies, including peripheral and precursor materials such as viral vector and media. Invetech configures manufacturing systems to address client process demands, building from portfolio of proven modules and platform technology. Invetech is a globally recognized leader in life science automation, and a member of the Fortive (NYSE: FTV) group of companies.invetechgroup.com

About TreeFrog Therapeutics

TreeFrog Therapeutics is a French-based biotech company aiming to unlock access to cell therapies for millions of patients. Bringing together over 100 biophysicists, cell biologists and bioproduction engineers, TreeFrog Therapeutics raised $82M over the past 3 years to advance a pipeline of stem cell-based therapies in immuno-oncology and regenerative medicine. In 2022, the company opened technological hubs in Boston, USA, and Kobe, Japan, with the aim of driving the adoption of the C-StemTM platform and establish strategic alliances with leading academic, biotech and industry players in the field of cell therapy.

http://www.treefrog.fr

Media Contact

Pierre-Emmanuel Gaultier

TreeFrog Therapeutics+ 33 6 45 77 42 58

pierre@treefrog.fr

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BREAKTHROUGH TECHNOLOGY FOR IPS-DERIVED CELL THERAPIES TURNED INTO GMP PLATFORM BY TREEFROG THERAPEUTICS & INVETECH - BioSpace