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.

ESMH - Alternative approaches to animal testing

In 1959, The Principles of Humane Experimental Technique was published by Russell and Burch, introducing the 3Rs concept (replacement, reduction, and refinement) regarding animal use in the scientific community. Just over 60 years later, it is timely to review progress to date and the future outlook regarding alternative approaches to animal testing. The US Environmental Protection Agency (EPA) announced elimination of all mammal study requests and funding by 2035, and the Dutch Minister for Agriculture aims for the Netherlands to become the ‘world leader in innovations without laboratory animals by 2025’. These ambitious objectives by the Netherlands and the US are backed also at an EU level, with both citizens and industry anticipating significant reductions in the coming years.Read more

November is Pancreatic Cancer Awareness Month


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

Rigenerand scientific founder Massimo Dominici recognized as one of the Global Cell and Gene Therapy Opinion Leaders

Medolla (Modena) - 03 May 2019. The Medicine Maker a global publication in cell and gene therapy, lists the world’s top 100 thought leaders and opinion shapers who have carried out life-changing work in the biopharmaceutical industry. This year, The Medicine Maker’s Power List 2019 has included Massimo Dominici MD, Rigenerand Scientific Founder and Professor of Oncology at the University of Modena & Reggio Emilia, in the category Champions of Change. “It is really a honor to be recognized in the list amongst such company of global KOL and Nobel Prize winners,” says Dr. Dominici also Past President of the International Society of Cell and Gene Therapy (ISCT) and current Chair of the ISCT Presidential Task Force on the Use of Unproven and/or Unethical Cell and Gene Therapy. The annual Medicine Maker Power List recognizes the most inspiring and influential people across the entire global life sciences sector – from entrepreneurs and CEOs, to industry experts, researchers, and regulators. Reaching a diverse, broad audience around the world, The Medicine Maker is a tier-one publication that celebrates the people, processes and vision that bring new drugs and biologics to the public. The extensive Power List was compiled based on the votes of Medicine Maker readers as well as the input of an expert judging panel made up of influencers in the biopharmaceutical industry.     Related Links   - https://themedicinemaker.com/power-list/2019#champions%20of%20change - https://www.celltherapysociety.org/news/448122/3-ISCT-Leaders-Recognized-as-Global-Cell-and-Gene-Therapy-Influencers.htm - https://finance.yahoo.com/news/3-isct-leaders-recognized-global-090000112.html - https://eprnews.com/3-isct-leaders-recognized-as-global-cell-and-gene-therapy-influencers-403804