“The role of INTEXTER in the development of the anti-tumour membrane of Ceobitex has been key”
“We are the only research group that has reached the clinical phase with an implantable membrane manufactured from nanofibers”
“At INTEXTER, we have extensive experience of developing nanofibers with biomedical applications”
The news that the Hospital Sant Joan de Déu has successfully implanted an anti-tumoral biomembrane in a patient highlights the relevance of technology centres in the development of R&D projects, in this case that of the Institute of Textile Research and Industrial Cooperation of Terrassa (INTEXTER), which has been working on the technological part of the project since 2010. José Antonio Tornero, one of the architects of the success, explains how the device works and the leading role of the centre in its development.
A patient with soft tissue sarcoma has been successfully operated on at the Hospital Sant Joan de Déu de Barcelona. In the intervention, the surgeons implanted an anti-tumour biomembrane whose function is to ensure that the area from which the tumour is extracted remains free of malignant cells. The device releases a very powerful drug – which is not water soluble and therefore is difficult to administer – in very localised areas. It does this without causing the secondary effects that result from the usual chemotherapy and radiotherapy techniques. Once its mission has been completed, the biomembrane degrades and disappears naturally.
How did the collaboration of INTEXTER in this project start?
In 2010, Joan Beltrán, founder and CEO of the company Cebiotex, got in touch with us when he found out that we had experience in working with nanofibers. He had started to collaborate with the Hospital Sant Joan de Déu and needed a technology partner to launch its project. In 2012, we created the company, which was set up as a spin-off of the UPC and the hospital, and we began to make progress and register the first patents.
What were the main technology challenges of the project?
They were related to use: developing a technology that could create a three-dimensional matrix, so that the anti-tumour drug could get caught between the nanofibers. This is a technique that does not currently exist on the market. Secondly, all this had to be achieved while heath standards were met to obtain accreditation from the regulator, the Spanish Agency of Medicines and Medical Products (AEMPS). Between 2015 and 2019, the preclinical phase was carried out and at the start of 2020 we were given authorisation to start clinical trials.
What are the next steps?
As it distributes a chemotherapy product, the membrane is regulated as a pharmaceutical device, so it must pass the highest safety requirements to be able to be manufactured. We have started clinical phase 2a, testing the dose and assessing the toxic effects in 21 patients, and then we will start 2b, to analyse the efficacy of the biomembrane. If we pass this phase successfully, phase 3 remains, in which the minor secondary effects and interaction with other drugs shall be assessed.
Why was soft tissue sarcoma chosen to test this new technology?
Because of the probability that the device would be effective, which is very high, and because the results can be measured more quickly. The drug that the biomembrane releases, SN38, is extremely powerful in certain tumour cell lines, but it is not water soluble so cannot be administrated by traditional methods. Potentially, our system could be applied to various types of cancer, such as pancreatic, colon or breast cancer.
How many people from INTEXTER have participated in the project?
Most of the research has been carried out by the Systems Laboratory, in which we work on the development of manufacturing machinery and products. Four researchers have participated permanently, and another four have collaborated occasionally as well as a few more researchers from other laboratories in the centre.
Is the health sector important in INTEXTER?
Absolutely. In addition to what we do in the traditional textile field, we work in a sector that has become cross-cutting, providing solutions in areas such as the automobile industry, security, and of course biohealth, through the use of fibres and nanofibers. We have extensive experience in the development of nanofibers with biomedical applications.
The profile of the researchers that INTEXTER has brought to this project is that of engineers. Are you comfortable working in an area like health?
Yes. It is very gratifying and stimulating for an engineer to participate in a project of this type, which contributes directly to saving lives. In fact, we are the only research group that has reached clinical phase with an implantable membrane manufactured with nanofibers, although it is a technology that has already come a long way. Precisely our skills as engineers have made it possible for part of this technology to be able to respond to the proposals of biochemists.
If the project is considered as a whole, has the role of INTEXTER been a determining factor?
I think so. The success has been based on the joint work of the three parts: biohealth, provided by Sant Joan de Déu, Cebiotex, which incorporates business criteria and mechanics, and the technology of our centre. However, we could say that the role of INTEXTER has been key in the development of the anti-tumour biomembrane.
What remains to be done for the membrane to be launched on the market?
We have to complete the regulatory phase, for which we need resources. Specifically, we need 1.6 million euros to pass phase 2a. Part of these funds will be provided by the partners of the company and some public grants have been applied for, but we also need contributions from small investors and donors. That is why a funding round has been established, which includes a crowdfunding campaign that is already active on the Cebiotex website.