The Centre for Regenerative Medicine "Stefano Ferrari" of the University of Modena and Reggio Emilia, that hosts Holostem Terapie Avanzate. Credit: Stefano Dal Pozzolo/Contrasto/eyevine.
After a precipitous year, the Italian biotech Holostem Advanced Therapies has been saved from bankruptcy at the very last minute when the minister of enterprises and Made in Italy, Adolfo Urso, announced the green light for the use of public funds to keep the company afloat.
The rescue of the Modena-based company, that uses stem cells for the treatment of rare diseases, comes exactly a year after the start of its financial woes. Its previously owner, pharmaceutical company Chiesi, announced it would discontinue investment due to poor financial returns. Holostem has managed to cling on for one more year thanks to a final financial contribution from Chesi, but it was going to have to cease operations permanently unless a solution was found by 30 November.
Created in 2008 as a spinoff the University of Modena and Reggio Emilia, in 2015 Holostem launched Holoclar, the first stem-cell based advanced therapy approved in Europe. Holostem’s founders, Graziella Pellegrini and Michele De Luca, are world-renowned leaders in regenerative medicine. In 2017, Holostem developed Hologene 5, a genetically corrected stem cell-based therapy that cured a 7-year-old boy suffering from epidermolysis bullosa, a rare genetic disease affecting the skin. The clinical trial of Hologene 5 was due to start at the end of 2022 but was delayed due to the company's risk of bankruptcy.
In the past few weeks, scientists, patients, and their families had been pressuring the government to find a solution.
Urso revealed Holostem will be acquired by Fondazione Enea Tech & Biomedical, an investment fund launched in 2020 and supervised by the Ministry of Enterprises, tasked with financing the national biotechnology industry and supporting technology transfer from universities to companies. Urso told parliament the public rescue comes with three mandatory conditions: a renewed management for the company, the development of a new industrial plan within the next 6 months that includes a clear strategy to contain costs and increase revenues, and the company’s commitment to seek private investors and industrial partners.
“Of the three conditions highlighted by the Minister, the third one is the most challenging,” says Elena Cattaneo, a stem-cell scientist and senator for life, “but I am confident that Holostem, an excellence in the field of regenerative medicine, will be able to attract the interest of industrial partners. Its skills are almost unique in the world.”
According to Cattaneo, the story has demonstrated that therapies for incurable rare diseases must be treated as a public good and supported by international public health agencies that can go beyond the industrial approach.
Neither the Ministry of Business or Enea Tech & Biomedical returned Nature Italy’s request for comments, and Holostem replied that it prefers to wait for the acquisition procedure to be completed before commenting.
