Ciloa has secured €6.5m in funding from the France 2030 Biotherapies and Biomanufacturing of Innovative Therapies proposal call.
Organised by Bpifrance on behalf of the French government, the funding will enable clinical development of Ciloa's type 2 diabetes and obesity therapeutic, APN-sEV.
APN-sEV, otherwise know as adiponectin associated with exosomes, harnesses the power of metabolic hormone adiponectin, which has been touted for its ant-inflammatory, antioxidant and insulin-sensitising properties.
Through this funding, Ciloa will both be able to progress APN-sEV through clinical trials up to Phase IIa, while also implementing large-scale GMP manufacturing of the product.
“For over twenty years, people have tried and failed to produce a stable and functional form of adiponectin," stated Ciloa's CEO, Robert Mamoun.
"We are the first to succeed, by combining adiponectin with small extracellular vesicles (sEV, or exosomes) to unlock its great therapeutic potential."
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 more than 130 proteins targeted on or within the sEV.
Thanks to its extensive experience in producing sEVs, Ciloa has addressed and optimized 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.
APN-sEV in preclinical trials
This APN-sEV is functional and has demonstrated remarkable 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 develop a first-in-class and 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.
To safely produce injectable APN-sEV for human use, the production line will be transferred under GMP conditions.
