Ciloa SAS secures €6.5m to advance lead candidate APN-sEV into clinical development

Montpellier-based Ciloa SAS, a spin-out founded in 2011 by CEO Robert Mamoun (INSERM) and CSO Bernadette Trentin (University of Montpellier), has secured €6.5m under Bpifrance’s “Innovation in Biotherapies and Biomanufacturing” initiative, part of the France 2030 programme. The funding will support the clinical development of its lead candidate, APN-sEV, for the treatment of type 2 diabetes and obesity.

The French biotechnology company utilises small extracellular vesicles (sEVs) as a drug delivery platform for  recombinantly manufactured adiponectin, a hormone involved in energy metabolism. In preclinical studies, this approach has demonstrated therapeutic potential across a range metabolism-related disorders, including type 2 diabetes and obesity—conditions that affect an estimated two billion people globally.

Ciloa intends to allocate the funding to support large-scale, GMP-compliant manufacturing of APN-sEV, ahead of planned Phase I/IIa clinical trials starting in 2027/2028 in patients with type 2 diabetes and obesity. The grant will also fund preparation of the necessary regulatory submission dossier.

Adiponectin is recognised for its anti-inflammatory, antioxidative, antiapoptotic, and insulin-sensitising properties, and is often referred to as the “Guardian Angel” of metabolic regulation. It has shown first-line therapeutic potential in several metabolic disorders, including type 2 diabetes, obesity, liver fibrosis, cardiovascular and dermatological diseases, multiple forms of retinopathy (age-related macular degeneration, retinopathy of prematurity, and diabetic retinopathy), as well as hormone-related cancers.

“For over two decades, efforts to produce a stable and functional form of adiponectin have not succeeded,” said Mamoun. “We are the first to achieve this by combining adiponectin with small extracellular vesicles, unlocking its considerable therapeutic potential.”

Ciloa has developed a proprietary bioengineering platform for producing protein-engulfing sEVs. The platform’s versatility is demonstrated by its capacity to incorporate more than 130 proteins either on the surface or within the vesicles. Drawing on its extensive expertise, the company has optimised the full sEV manufacturing process, including production, purification, and characterisation. Using this technology, Ciloa has generated multiple batches of APN-sEV, each of which remains stable at 4°C for several months.

Preclinical data indicate that APN-sEV leads to significant weight reduction, elimination of ectopic fat deposits, improved insulin sensitivity, and enhanced glucose control. Notably, APN-sEV preserves muscle mass, even when administered in combination with existing antidiabetic therapies.

“We have demonstrated that APN-sEV operates via specific metabolic pathways that differ from those targeted by current antidiabetic treatments,” said Trentin. “As a result, APN-sEV can complement existing therapies, offering a potentially safer and more holistic approach to treating metabolic disorders.”

The funding was awarded under the DIADEME project, through which Ciloa aims to develop a first-in-class, first-in-human therapeutic based on adiponectin delivered via sEVs. The company plans to implement the manufacturing process for APN-sEV, conduct regulatory preclinical safety studies, and initiate a Phase I clinical trial in 2027, followed by Phase IIa in 2028.

The DIADEME project has received certification from the Eurobiomed competitiveness cluster.