French scale-up Ciloa raises €6.5 million to advance exosome therapy for metabolic diseases

Montpellier-based Ciloa, an innovator in bioengineering extracellular vesicles to develop a new generation of therapeutics and preventive solutions, announced it has secured €6.5 million of funding.

The funding was secured via the France 2030 ‘Biotherapies and Biomanufacturing of Innovative Therapies’ call for proposals, organised by Bpifrance on behalf of the French government.

“For over twenty years, people have tried and failed to produce a stable and functional form of adiponectin. We are the first to succeed, by combining adiponectin with small extracellular vesicles (sEV, or exosomes) to unlock its great therapeutic potential,” said Robert Z Mamoun, CEO of Ciloa.

Founded in 2011, Ciloa is a French biotechnology company that spun out of the French National Centre for Scientific Research (CNRS) and the University of Montpellier. It is focused on the vivobioengineering of small extracellular vesicles for therapeutic and preventative purposes.

Ciloa has a patented proprietary technology supported by its EVENGI platform, which has produced more than one hundred sEVs containing different proteins of medical interest. Currently, the main applications are metabolic diseases, vaccines against emerging viral threats and oncology.

The funding will enable clinical development of Ciloa’s candidate APN-sEV (Adiponectin associated with exosomes) up to phase IIa in type 2 diabetes and obesity, and the implementation of large-scale manufacturing under GMP conditions (Good Manufacturing Practices).

Adiponectin is a hormone known as the ‘Guardian Angel’ of the metabolic system, due to its anti-inflammatory, antioxidative stress, antiapoptotic and insulin-sensitising properties. It demonstrates first-line therapeutic potential in several metabolic diseases, such as type 2 diabetes, cardiovascular and skin diseases, several retinopathies (ARMD, retinopathy of prematurity and diabetic retinopathy) and hormonal cancers; it could also reportedly help slow the ageing process.

Ciloa has developed a unique bioengineering technology for small extracellular vesicles with all types of proteins; the technology’s robustness is demonstrated by a portfolio of over 130 proteins targeted on or within the sEV. Thanks to its experience in producing sEVs, Ciloa has addressed and optimised the entire sEV production, purification and characterisation process.

By implementing its proprietary sEV bioengineering technology, and due to its reliable procedure, Ciloa has produced several batches of Adiponectin associated with exosomes (or APN-sEV) that have remained stable at 4°C for several months.

This APN-sEV is functional and has reportedly demonstrated effectiveness in preclinical trials against obesity, type 2 diabetes and some of its implications for liver impairment. APN-sEV greatly reduces excess weight, clears fat storage in the tested organs, significantly increases insulin sensitivity and contributes to glucose regulation.

Uniquely, APN-sEV helps to preserve all muscle mass, even in co-treatment with anti-diabetic products currently on the market.

“We have shown that the properties of APN-sEV stem from its action on specific metabolic pathways other than those targeted by current anti-diabetic products,” said Bernadette Trentin, CSO at Ciloa. “APN-sEV is therefore highly effective in complementing these medications, paving the way for a safer, more comprehensive and sustainable treatment of many metabolic diseases.”

With this funding, secured via the ‘DIADEME’ project, Ciloa will work on developing a first-in-human drug composed of adiponectin introduced via small extracellular vesicles. Ciloa will implement production of its candidate, APN-sEV, and conduct the regulatory preclinical trials required to ensure its safety.

Ciloa will then launch phase I clinical trials in 2027, with phase IIa planned in 2028.

Ciloa will produce the biomedicine using its production line developed for bioengineered small extracellular vesicles. This includes the creation of stable lines, upstream processing (USP), downstream processing (DSP), and quality controls specific to engineered small extracellular vesicles and added proteins.

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