Regulatory approval to make gene therapies from its site in Modena, Italy has enabled biotech Rigenerand SRL to enter the advanced therapy CDMO space.
Rigenerand announced last week that the Italian Medicine Authority (AIFA) has granted authorization to produce gene therapy medicinal products for clinical purposes from its site in Modena.
This will allow the advancement of the firm’s lead candidate RR001 – an autologous gene therapy being investigated to treat pancreatic cancer – into Phase I trials but will also launch the company into the contract development and manufacturing organization (CDMO) sector.
Image: iStock/klenger
“This is part of our philosophy and business model,†Simona Guidi, as spokesperson from the firm told us. “Rigenerand derives from a spin-off of the Cell Therapy laboratories of University of Modena and Reggio Emilia (Modena, Italy) as a joint venture with RanD, a biomedical company developing anti-cancer locoregional therapies. From the beginning, Rigenerand mission was to design, develop and commercialize cell therapeutics and avant-garde biomedical devices.â€
Guidi said the “expertise generated†in its own product RR001 and the GMP status of its facility will be capitalized to support other companies and academia within CDMO services.
“This hybrid model could increase the occupancy rate of our facility without disturbing our own proprietary process development. Institutions and companies could take advantage of this know-how to expand their process capability or to develop early-stage cell and gene therapy medicinal products for clinical purposes.â€
| RR001
“RR001 is a gene therapy medicinal product consisting of autologous human adipose derived cells genetically modified to secrete soluble TRAIL. In layman’s terms RR001 is produced starting from a minimum amount of adipose tissue from cancer-patient. The patient cells are isolated, expanded and ex-vivo genetically modified by an aseptic manufacturing process within a certified cGMP facility. The final product is a preparation of gene modified patient’s cells aiming to induce tumor cell death after delivery. RR001 has been granted the status as Orphan Drug by EMA and FDA.†|
The biotech/CDMO has five multipurpose sterile cleanrooms and the facility is suitable and approved to expand, manipulate gene modify cell based medicinal products.
“The layout and the flow of manufactured products/reagents have been conceived to support own products and be a service for others,†Guidi said, adding that the manufacturing area could be expanded in the future to support demand. “In any case, the capability to host new processes will be evaluated case by case in order to provide the best support to customer from both the manufacturing area availability and the technical/regulatory standpoint.â€
Rigenerand has been authorized as cGMP facility at the same time as the coronavirus lockdown. Thus, like others, we have been unfortunately affected by this in all customers relationship. With Rigenerand facilities now approved and expertise in place we expect to take advantage of this new status imminently.
We asked Guidi if Rigenerand has any customers already on its books.
“Rigenerand has been authorized as cGMP facility at the same time as the coronavirus lockdown. Thus, like others, we have been unfortunately affected by this in all customers relationship. With Rigenerand’s facilities now approved and expertise in place we expect to take advantage of this new status imminently.â€