For the first time ever, an antitumour biomembrane made up of nanofibres, biocompatible and biodegradable has been implanted into a patient and has proved safe. This medical and technological milestone is the result of the collaboration between the biotech company Cebiotex, the Sant Joan de Déu Hospital, the UPC’s INTEXTER and the Sant Pau Hospital in Barcelona. Cebiotex is now going to launch a funding round to raise 1.6 million euros to continue clinical trials.
The dream of Joan Bertran, a textile engineer and the co-founder of Cebiotex, is coming true: providing cancer surgeons with tools for applying non-invasive therapy in childhood cancer and rare diseases to ensure that the surgical site remains free of cancer cells after removing a tumour, to prevent the tumour from regrowing and to reduce the side effects of chemotherapy and especially radiotherapy in pediatric patients.
Almost 11 years after Cebiotex started its scientific, technological and clinical adventure in collaboration with the Sant Joan de Déu Hospital and the Terrassa Institute of Textile Research and Industrial Cooperation (INTEXTER) of the Universitat Politècnica de Catalunya · BarcelonaTech (UPC), a patient has been implanted with the CEB-01 biomembrane at the Santa Creu i Sant Pau Hospital. CEB-01 is made from biocompatible and biodegradable nanofibres. It locally and safely releases high doses of the SN-38 chemotherapeutic agent—currently used in conventional chemotherapy—onto the surgical site after tumour removal with the aim of eliminating any residual tumour cells.
The Cebiotex® technology platform and the CEB-01 biomembrane are patented in the United States, the European Union and China. In addition, Cebiotex has been awarded the GMP certificate (good manufacturing practices) by the Spanish Agency of Medicines and Medical Devices (AEMPS), which attests that the company manufactures under pharmaceutical quality standards and allows it to implement its biomembrane in humans. In 2019, the European Medicines Agency (EMA) and the European Commission granted the orphan designation—which confers market exclusivity in the EU—to the biomembrane for the treatment of soft tissue sarcoma to encourage its development for childhood cancer and rare diseases.
The collaboration of a multidisciplinary team from Cebiotex, the Sant Joan de Déu Hospital, the UPC’s INTEXTER and the Santa Creu i Sant Pau Hospital has been key to the project moving on to the marketing stage.
Paving the way for treating those who need it most
Cebiotex is going to launch a funding round to raise 1.6 million euros. The funds will support the development of this innovative cancer treatment by funding phase II trials, in which CEB-01 will be implanted in 21 adult patients with soft tissue sarcoma at the Santa Creu i Sant Pau Hospital, and then moving on to its major goal: clinical studies with pediatric cancer patients at the Sant Joan de Déu Hospital. In the future, the Cebiotex® technology platform, which is unique in the market, is expected to be applied to other types of cancer, infections and advanced therapies. Investments from a thousand euros and all types of contributions are accepted in the current funding round.
Joan Bertran, the founder and CEO of Cebiotex, explains that “there is an unmet medical need in oncology and surgery: to ensure that the surgical site remains free of cancer cells after removing a tumour.” According to Bertran, “the CEB-01 membrane, which is compatible with the standard of care, addresses this by providing strong local treatment during the period in which no other treatment can be given, up to 4 weeks after surgery. I think that investors are more and more aware of the extraordinary potential of the project in terms of social and economic impact, liquidity and profitability.”
José Antonio Tornero, a researcher at the UPC’s INTEXTER, explains: “First we had to consider the pharmacological nature of the biomembrane and the extremely stringent quality and sterilisation standards in the pharmaceutical industry. We chose PLGA, a biocompatible and biodegradable polymer, to produce the nanofibres for CEB-01 by electrospinning.” He adds: “We have proven that it is highly effective because it releases the drug locally in sustained high therapeutic doses. Then, once the drug has been completely released, the body absorbs and expels the membrane in a natural way.”
Lucas Krauel, the coordinator of the Surgical Oncology Programme at the Sant Joan de Déu Hospital, is certain that “with this innovative approach on which we have been working for some time, we will reduce the side effects of chemotherapy and especially radiotherapy in pediatric patients”. According to Krauel, “children have been largely neglected by the pharmaceutical industry, and the CEB-01 membrane paves the way for much more effective pediatric oncology.”
Cebiotex is a Catalan spin-off created within the framework of scientific and technology transfer between the Sant Joan de Déu Hospital and the UPC in 2012. It is accredited as an Innovative SME by the Spanish Ministry of Science and Innovation and an Innovative SME by the European Commission. It also received the 2018 CECOT award for innovation. Cebiotex has received financial support from equity crowdfunding campaigns on Capital Cell and from Ship2B Foundation, Inveready, family offices, the Centre for the Development of Industrial Technology (CDTI), the Spanish Ministry of Industry (ENISA), the Spanish Ministry of Science (Challenges, 2017-2020 National Scientific and Technical Research and Innovation Plan) and the European Commission (SME Instrument Phase I).