Flash Therapeutics

Description of the legal entity:

Flash Therapeutics (FTX) is a gene therapy company developing gene and cell-based therapies by leveraging its proprietary lentiviral platform and bioproduction technologies. The Company is built around the lentiviral platform, which includes regular integrative LV and its patented non-integrative LentiFlash® technology.  Such platform covers both current gene-addition and future gene-editing needs. The platform technologies will be leveraged not only in expanding a growing portfolio of candidates through the LentiFlash® technology, but also in supporting the development of partnership programs through out-licensing or co-development agreements. Therefore, the TheraLymph project is clearly in line with the business model of Flash therapeutics.

Curriculum Vitae:

Régis Gayon (Male): Viral Vectors Production & Cell Engineering Manager

Régis joined Vectalys in 2005 as head of the Cell Models team. Since September 2012, he is also in charge of production development, purification and concentration of viral vectors, bringing his expertise in cellular biology to ensure performance and reliability of viral vectors produced at Vectalys. As head of the Vectors and Cell Models Teams, and strong of his experience of over 12 years in cellular and molecular biology, he oversees the viral vector production process and its enhancements, as well as manages the generation of new cellular models, from design to delivery, for use in the fields of bioproduction, gene target validation and drug discovery.

List of the five most relevant publications and/or products, services (including widely-used datasets or software), or other achievements

1. 1. Highly efficient in vitro and in vivo delivery of functional RNAs using new versatile MS2-chimeric retrovirus-like particles. Prel A, Caval V, Gayon R, Ravassard P, Duthoit C, Payen E, Maouche-Chretien L, Creneguy A, Nguyen TH, Martin N, Piver E, Sevrain R, Lamouroux L, Leboulch P, Deschaseaux F, Bouillé P, Sensébé L, Pagès JC. Mol Ther Methods Clin Dev. 2015 Oct 21; 2:15039. doi: 10.1038/mtm.2015.39.

3. Retroviral Particle carrying at least two encapsidated non-viral RNA. This patent family (WO2016185125) was filed on 13/05/2016 under the priority of the French patent application FR3036118 filed on 15/05/2015.  This patent family includes application under examination in the USA (US2018135025), Canada (CA2986051), Europe (EP3294756), Israel (IL255566), China (CN107624131), Japan (JP2018516558), Singapore (SG11201709336S), Hong-Kong (HK1244818).

FTX Main tasks in the project per WP

• WP5: FTX will provide the LentiFlash vectors for the in vitro studies (all tasks)
• WP6: Production of lentivectors and LentiFlash (Task 6.1), Validation of biodistribution and toxicity in preclinical models (Task 6.2) – FTX will work closely with Inserm providing the LentiFlash vector

WP9 FTX will contribute to dissemination and communication activities

List of up to 5 relevant previous projects or activities, connected to the subject of this proposal

Collaboration with Dr Jean-Christophe Pagès (University of Tours, France) for the creation and development of the Lentiflash particle, leading to the patent filed in 2015.

Infrastructure and/or major items of technical equipment

Our Lentiviral plaform, producing highly purified and concentrated lentivectors (titer scale of about 1E9 TU/mL) is divided into two parts:

• the first one to produce R&D and preclinical batches of both integrative and non-integrative lentiviral vectors, from small-scale (1mL) to large scale (30mL) batches. This R&D platform is based in our facilities, in Toulouse.
• the second one to produce clinical batches, from 15mL up to 50mL, is expected to become fully operational by the end of 2019, and is being established through a recently signed, three-year partnership with Hospital Saint-Louis, Lariboisière, Fernand-Widal (Assistance Public hospitals of Paris – AP – HP) to develop and produce gene and cell therapy drugs. Additionally, we have launched the building of a second large-scale GMP bioproduction facility, in Toulouse, comprising 3 suites of production. This new facility will be available by the end of 2021.

The whole lentiviral platform includes all the vectorology steps, going from the design of the expression cassette, to the quality controls of the final lentiviral batches. This platform comprises 4 people in gene engineering, 8 people in lentiviral vectors production, and 3 people in quality controls.

Operational capacity

Fully operational