Cebiotex is a Barcelona‐based biotech company focused on developing biomedical nanofibers to deliver therapies locally.
Our first medical need targeted is in the field of oncology: to reduce local recurrence and spreading of tumour cells, by improving local control of cancer after surgery.
For cancer patients, an optimal local control reduces local recurrence after surgery. Moreover, clinical epidemiological evidence associates local control and improved survival rates.
However, a complete resection with clean margins is not always possible. And, even if surgery appears successful, undetected malignant cells may remain in surrounding tissues. Adjuvant radiotherapy and chemotherapy may be considered in some cases, however, they cannot be administered until approximately 4 weeks after surgery.
Altogether, this highlights a clear need for improving local control after surgery.
Technology Features, Specifications and Advantages
Cebiotex's proprietary platform allows the generation of biocompatible and biodegradable 3D nanofibers loaded with different drugs, while avoiding chemical interaction between the nanofiber polymer and the agent that is applied. This is a technology with special usefulness for low water solubility drugs.
Our first product, CEB-01,is composed of our nanofiber membrane and the chemotherapeutic drug SN-38 (active metabolite of Irinotecan). The membrane is placed over the surgical bed after tumour removal, and immediately starts delivering SN-38 locally.
CEB-01 will solve the unmet medical need for local control of tumours after resection. It is compatible with current Standard of care. It will not modify any neo-adjuvant or adjuvant treatment, requires very little training or change in surgical procedures, while offering a treatment option during a period of time when no other therapy can be administered (first weeks right after surgery).
Other potential competitor technologies being developed faced serious issues related to manufacturing of a pharmaceutical product and scaling-up of production. Cebiotex have already solved these, and GMP certification has been granted by AEMPS (Spanish Agency of Medications and Health Products) for manufacture of CEB-01 pharmaceutical form.
At Cebiotex we leverage textile engineering to create a new medical product that rises to the rigorous standards of pharma. Our membrane can be infused with multiple useful agents available in the market, with special usefulness for low water solubility drugs.
We have first focused on oncology applications, with our first product CEB-01 directed to local control of tumours after resection. CEB-01 has shown efficacy against several of tumour types, and we have successfully tested our membranes in animal models of soft tissue sarcoma (STS), pancreatic cancer, and glioblastoma multiforme (GBM).
The technology behind the solution is widely transversal and has many potential applications in the oncology sector, but also in other indications such as antibiotic local delivery or cell therapy.
Cebiotex's solution brings a number of benefits for both patients and physcians:
- Biocompatible and biodegradable
- Production process and final product are GMP certified.
- Combines textile engineering and a novel preparation of SN-38 to overcome technical barriers to effective administration.
- Very low or zero systemic toxicity to patients
- Demonstrated efficacy against tumour cells.
- Attack cancer cells during the 4-week window directly after tumour surgery.
- Provides a semi-logarithmic release rate consistent with malignant cell elimination immediately following the surgical procedure (highest concentrations upon insertion, decreasing until depletion after the 4-week critical gap has been closed).
- Perfectly compatible with the current Standard of Care.
- Requires little training or change in surgical procedures.
- Economic, reducing the need for adjunct therapies and preventing costly recurrences.
- Able to be adapted to other cancer and health indications; general and flexible.
- Reduction of margins of tissue that needs to be removed from the tumour site.Preventing mutilating surgeries that may drastically affect functionality of a limb (e.g. mobility in STS located inside a muscle bundle).
- Reduction of the risk or even avoiding local tumour recurrence.
- Decreasing the use of adjuvant radiotherapy and reduction of the post-surgical chemotherapy.
- Reduction in the overall treatment costs.
- Increasing the life expectancy of patients and quality of life (QoL) by extending the time they are free of disease.