Rigenerand commences 3D bioreactor development for cGMP extracellular vesicle exosomes (EV) production

Development supported by part of Horizon 2020 consortium grant

Modena, Italy, July 8, 2020 - Rigenerand SRL, the biotech company that both develops and manufactures medicinal products for cell therapy applications, primarily for regenerative medicine and oncology, today announces it has commenced development of a novel 3D bioreactor and pipeline, specifically designed for the incremental production of extracellular vesicles exosomes (EVs) in a cGMP environment. Rigenerand’s project development will be supported with part of a grant of EUR 4.4 million from Horizon 2020 for the H2020-EU.1.2.2.-FET Proactive program, awarded to the Biogenic Organotropic Wetsuits project. This project comprises a consortium of companies involving Rigenerand. 

The Biogenic Organotropic Wetsuits (Grant Agreement ID: 952183) project involves eleven organizations across seven countries in Europe. Rigenerand will contribute to the consortium its combination of expertise, technology and innovation focused on biomaterials, prototypes production and industrialization of cell culture devices and 3D cell cultures. Rigenerand will start developing novel ways of improving current EV cGMP production technologies.  These technologies ultimately aim to EV clinical batches to be used as drug substances for cell-free therapies medicinal products. 

The project is due to start activity in Q4 2020. By Q2 2021, Rigenerand is planning to have developed the isolation and expansion of a human cellular source (EDT-MSC) suitable for the production of immune-ghost EVs as well as the separation and production of suitable amounts of EV for characterization and pre-clinical application. 

“This project will contribute to the urgent medical need of increasing EV production. It will enable Rigenerand to develop pre-conditioning approaches that are critical to providing solutions to these challenges,” said Massimo Dominici, scientific founder, Rigenerand. “The activity for this consortium will also enable Rigenerand to develop platforms for new therapeutic solutions, covering a range of clinical applications, including oncology and regenerative medicine to medical devices.” 

The Rigenerand 3D bioreactor for EV production will be based on its proprietary VITVO technology. VITVO is a handheld bioreactor, with an integrating scaffold for the establishment of a 3D cell culture model. It is already used for highly predictive pre-clinical testing. It has been specifically designed to offer an increase to the market in usability, sizing, closed system, and flexibility for 3D cell culture technologies. 

VITVO has been extensively used for pre-clinical development of its autologous gene therapy medicinal product RR001, contributing to evaluation of the action and efficacy of the drug. It also allows the reduction of the number of animals employed in the experimentation for dose finding studies. VITVO has also been used in a variety of assays focusing on oncology. The efficacy of chemotherapy, biologics and cell-based anti-cancer agents has been tested by comparing VITVO with an in vivo preclinical xeno-transplant model. Notably, the system was challenged using primary tumor cells harvested from lung cancer patients as an innovative predictive functional assay for cancer responsiveness to a checkpoint inhibitor, such as nivolumab. The results suggest VITVO as a 3D in vitro model for pre-clinical testing with a possible relevant impact in other areas external to oncology. 

“Despite a high demand in the market for 3D cell culture models to improve increased information compared to 2D models, 3D models are not yet routinely deployed,” said Giorgio Mari, Rigenerand CEO. “We will continue to develop 3D technologies, and maintain our market leading position by increasing collaborations with HTS technology developers and pharmaceutical firms who have technology that can work with VITVO. We are also collaborating with academic research units to develop new applications.”

About Rigenerand

Rigenerand SRL is a biotech company that both develops and manufactures medicinal products for cell therapy applications, primarily for regenerative medicine and oncology and 3D bioreactors as alternative to animal testing for pre-clinical investigations.

Rigenerand operates through three divisions: 

1) a proprietary pipeline, developing and GMP manufacturing of cell and gene therapies for cancer treatment, 

2) a CDMO division, providing GMP support for scale-up of cell based medicinal products for clinical and commercial purposes within fully equipped Grade A/B cleanrooms, and 

3) a division developing 3D technologies for cell culture, developing and manufacturing 3D solutions for R&D diagnostics and pre-clinical purposes (VITVO®). 

Rigenerand is developing RR001, a proprietary ATMP gene therapy medicinal product for the treatment of pancreatic ductal adenocarcinoma (PDAC). RR001 has been granted an Orphan Drug Designation (ODD) by US-FDA and from the European Medicine Agency. The Clinical trial is expected to start in Q1 2021. 

Rigenerand is headquartered in Medolla, Modena, Italy, with more than 1,200 square metres of offices, R&D and quality control laboratories and a cell factory of 450 square metres of sterile cleanroom (EuGMP Grade-B) with BSL2/BSL3 suites for cell and gene therapies manufacturing. It combines leaders and academics from biopharma and medical device manufacturing sectors.