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. Contact Information: Image Box PR Neil Hunter / Michelle Boxall Tel +44 (0)20 8943 4685 neil@ibcomms.agency / michelle@ibcomms.agency

Massimo Dominici, scientific founder of Rigenerand, in the Power List 2020 of World Opinion Leaders for Advanced Medicine (ATMP)

  Rigenerand’s founder, Massimo Dominici MD, has been listed once again by The Medicine Maker, leading international magazine for pharmaceutical development, as one of the 60 best leaders and opinion makers in the industry. Prof. Massimo Dominici is the only Italian of the 20 honored in the category Advanced Medicine this year (which includes therapies based on cells, also genetically modified ones). For Prof. Dominici this is an affirmation as he had been already listed in 2019. The Medicine Maker is a leading international magazine for cell and gene therapy that creates an annual list of the world’s 60 best leaders and opinion makers whose work has contributed to a significant progress in the biopharmaceutical industry and therefore in medicine. “I am honored by this recognition – commented Prof. Massimo Dominici – that celebrates the work accomplished by me and my coworkers in the Laboratories for Cell Therapy Research of the University Hospital Modena and the company Rigenerand. Our goal is to transfer years of research on cells to various branches of medicine and surgery, also thanks to a wide range of international collaborations. Our vocation is to serve as platform for the development of cell therapies by ourselves and as CDMO for all of those who believe in cells as medicinal products.” The Power List of The Medicine Maker is created by a group of experts who analyze the work done in the industry, the visibility and the number of citations of the scientific pubblications of those authors. This year’s categories were Small Molecules, Advanced Medicine and Biopharmaceuticals, with 20 leaders for each category. https://themedicinemaker.com/power-list/2020

Rigenerand receives regulatory approval for gene therapy production

Authorization enables Rigenerand to enter into clinic and offer CDMO services and consultancy to cell and gene therapy sector

Modena, Italy, June 2, 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 received authorization from the Italian Medicine Authority (AIFA) to produce gene therapy medicinal products for clinical purposes. This authorization enables Rigenerand to manufacturer its own autologous gene therapy medicinal product (RR001) for the treatment of pancreatic cancer. It also authorizes the company to start its phase I first-in-man clinical trial of RR001, now expected to start in Q1, 2021. RR001 has been granted Orphan Drug Designation (ODD) by both the US FDA (Food and Drug Administration) and European Commission COMP (Committee for Orphan Medicinal Products). This ODD offers the opportunity for Rigenerand to request an accelerated assessment procedure and quicker development pathways towards a marketing authorization in the US and EU. Rigenerand will also now offer direct GMP CDMO services to international and Italian partners in clinical development of cell and gene therapy products (ATMPs). The company will utilise its experience from its drug development and diagnostic arms to deliver a science-based approach to its GMP manufacturing services and cell-based medicinal products development. Rigenerand plans to expand its manufacturing facility from five sterile clean rooms suits. This will be by implementing further closed system and isolator technology in pre-designated areas in its facilities. The five sterile cleanrooms are within the Rigenerand GMP facility, which contains a Biosafety Level 3 (BSL3) negative pressure area, suitable to handle genetically modified microorganisms (MOGM), viruses and Risk Group 3 microorganisms, as well as a Biosafety Level 2 (BSL2), positive pressure area: suitable to manipulate non-infectious cell based products and Risk Group 2 microorganisms. Rigenerand’s cleanroom technology offers the flexibility to scale-up the processes from academic / hospital laboratories, and the feasibility of technology transfer of manufacturing processes from other cell factories in order to expand their process capability. In addition, Rigenerand is now authorized to deliver consultancy to biotechnology and pharmaceutical companies on cell and gene therapy development and manufacturing. This consultancy includes expanding process capabilities and developing early-stage cell and gene therapy  medicinal products for clinical purposes. As the cell and gene therapy sector continues to grow, with increased numbers of therapies moving through clinical development and onto commercialization, demand for CDMO services will continue to grow. There is an increased demand for global networks of CDMO GMP cell and gene therapy manufacturing. This calls for an improved capacity to treat patients whilst reducing logistical complexities, issues, risks, and costs. “The regulatory approval for Rigenerand to produce gene therapies for clinical development now enables Rigenerand to enter the clinic with its own gene therapy product to target pancreatic cancer,” said Massimo Dominici, scientific founder, Rigenerand. “Combined with the Orphan Drug Designation, the approval will enable Rigenerand to choose an accelerated pathway to bring a gene therapy approach to pancreatic cancer patients with little alternative therapeutic option.” “The authorization is also essential in allowing Rigenerand to offer its much needed GMP CDMO services to the wider cell and gene therapy sector,” said Giorgio Mari, Rigenerand CEO. “We will be expanding our CDMO facility to cater for increasing demand. Operating as both a developer with a clinical pipeline as well as a CDMO has resulted in an unrivalled blend of expertise for us to offer to partners and the wider cell and gene therapy industry.” 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 fullyequipped 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.

Massimo Dominici on "Panorama" January 22

Massimo Dominici on "Panorama" January 22 talks about pancreatic cancer


VITVO at Therapeutic nanoproducts: from biology to innovative technology conference organized by Istituto Superiore di Sanità and AICC on June, 19-20 2019

Rigenerand is proud to present VITVO at Therapeutic nanoproducts: from biology to innovative technology conference organized by Istituto Superiore di Sanità and AICC on June, 19-20 2019. Dr. Olivia Candini, R&D Manager of 3D-Culture Technologies division, will have a talk about VITVO applications and potentials on June 20th. For more infos about the event: https://www.aicc.website/eventi-aicc/therapeutic-nanoproducts-from-biology-to-innovative-technology/

Rigenerand VITVO published on Scientific Reports

Medolla – 10 May 2019. Scientific Reports just published the Rigenerand new technology to culture cells in 3D for pre-clinical studies from gene therapy to immunotherapy. “We are proud to present this novel and breakthrough technology on this prestigious academic Journal” says Massimo Dominici MD, Rigenerand founder and scientific coordinator, “VITVO is contributing to fill gaps between in silico hypothesis/in vitro results and in vivo settings also significantly impacting on the 3R rules”. Olivia Candini PhD, the first author of the manuscript and head of Cell and Tissue Engineering R&D, underlines that “VITVO is having a relevant impact in 3D-cultures due to novel features that will empower the most advanced research in cancer additionally boosting other approaches in drug developments”. “Starting from a start-up perspective, Rigenerand is now positioning as leader in the 3D-cultures with published peer-reviewed data that solidly support the proposed technology as tool that allows unprecedented in vitro investigations“ closes Giorgio Mari, Rigenerand CEO. Further Readings Candini O, Grisendi G, Foppiani E, Brogli M, Aramini B, Masciale V, Spano C, Petrachi T, Veronesi E, Conte P, Mari G & Dominici M. A Novel 3D In Vitro Platform for Pre-Clinical Investigations in Drug Testing, Gene Therapy, and Immuno-oncology. Sci Rep. 2019; 9:7154. Available if you like to read it