2017-02-001 - Platform-02 - Bioadhesive platform to perform bioactive gastrointestinal cancer treatment

Platform-02

2017-02-001

New platform composition with funcions of drug delivery for the treatment of gastrointestinal cancers. Two patents supporting the development

With almost 1.4 million4 new cases of colorectal cancer (CRC) each year worldwide, CRC represents 9.7% of all cancer cases worldwide. The increase in the number of cases is driven by population growth and aging, as well as poor diet and lifestyle. Thus, · Colorectal cancer is the third most common cancer in men and the second most common cancer in women worldwide, with almost 55% of cases occurring in the most developed regions · In Europe it is the second most common cancer with more than 470,000 European citizens diagnosed with the disease each year · Colorectal cancer kills 228,000 Europeans each year with the highest estimated mortality rates located in Central and Eastern Europe for both sexes. · This disease is preventable in many cases and is highly treatable if diagnosed in its early stages · Colorectal cancer is a disease that mainly affects people over 50 years of age, and there are more than 175 million citizens in Europe between 50 and 69 years of age

It is estimated that 35% of colonoscopies performed find lesions that are susceptible to therapeutic endoscopies1. In relation to its application in colon cancer, colorectal cancer (CRC) is the most common cancer in both sexes in Catalonia. Due to the impact of CRC in Western countries, Early Detection Programs for this disease have been established in recent years to try to control it2, through the detection and treatment of colorectal adenomas and cancer in the initial stages. These types of programs lead to an increase in the number of therapeutic colonoscopies, which allows us to deduce an increase in the market in the coming years.

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With almost 1.4 million4 new cases of colorectal cancer (CRC) each year worldwide, CRC represents 9.7% of all cancer cases worldwide. The increase in the number of cases is driven by population growth and aging, as well as poor diet and lifestyle. Thus, · Colorectal cancer is the third most common cancer in men and the second most common cancer in women worldwide, with almost 55% of cases occurring in the most developed regions · In Europe it is the second most common cancer with more than 470,000 European citizens diagnosed with the disease each year · Colorectal cancer kills 228,000 Europeans each year with the highest estimated mortality rates located in Central and Eastern Europe for both sexes. · This disease is preventable in many cases and is highly treatable if diagnosed in its early stages · Colorectal cancer is a disease that mainly affects people over 50 years of age, and there are more than 175 million citizens in Europe between 50 and 69 years of age

Having local adjuvant therapies would allow the stabilization of primary tumors and the treatment of metastases in the case of stages 3 and 4, while in the case of stages 0, 1 and 2 a local adjuvant therapy could be established that would avoid or minimize systemic chemotherapy, reducing the costs of the system and the discomfort for the patient. No product has been found on the market that allows the implementation of a drug delivery system for colon cancer like the one described. On the other hand, existing state-of-the-art solutions do not allow the implementation of the designed solution either, which is why the technology is considered to be a first-in-class one.

The target market for this technology, an intestinal dressing with drug delivery functions for the treatment of gastrointestinal cancers and other inflammatory diseases, can be defined as follows: Hospitals and medical centers specializing in gastrointestinal treatments: Mainly those that perform treatments for gastrointestinal cancers (such as colon, rectal, stomach cancer, etc.) and surgical interventions such as tumor resection through endoscopy. These centers could use this technology to administer drugs locally after an intervention, improving post-surgical treatment. Endoscopy clinics: The dressing can be administered through an endoscope, so clinics specializing in endoscopy could be an important target. This includes those clinics that treat not only cancer, but also inflammatory diseases such as inflammatory bowel disease (IBD) or ulcerative colitis. Pharmaceuticals and biotechnologies: Companies dedicated to the development of anti-cancer and anti-inflammatory treatments could be interested in collaborations to develop and adapt drugs that can be administered through this drug delivery platform. Patients with gastrointestinal cancers and inflammatory diseases: At a clinical level, patients who have undergone resection of gastrointestinal tumors and need prevention of tumor recurrence or control of inflammation could be direct beneficiaries of the technology. This includes people with diseases such as ulcerative colitis, Crohn's disease or other inflammatory gastrointestinal conditions. Researchers in oncology and gastroenterology: Research centers focused on developing new treatments for gastrointestinal cancers or inflammatory diseases could be an indirect target, especially for clinical studies and validation of the technology.

The project has currently been transferred to the spinoff Inmedical Therapeutics, so we are not seeking funding.

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Continue developing the project and carrying out the relevant validation tests in order to reach the market

It is estimated that 35% of colonoscopies performed find lesions that are susceptible to therapeutic endoscopies1. In relation to its application in colon cancer, colorectal cancer (CRC) is the most common cancer in both sexes in Catalonia. Due to the impact of CRC in Western countries, Early Detection Programs for this disease have been established in recent years to try to control it2, through the detection and treatment of colorectal adenomas and cancer in the initial stages. These types of programs lead to an increase in the number of therapeutic colonoscopies, which allows us to deduce an increase in the market in the coming years.

Regulation: Need to comply with strict regulations and obtain approvals from health authorities such as the FDA or EMA High costs: Significant investments required for research, development and production of medical devices Competition: Presence of well-established players in the market for treatments for cancer and inflammatory diseases Medical adoption: Difficulty in convincing health professionals to adopt new technologies Clinical evidence: Need to conduct clinical studies to demonstrate efficacy and safety beforel'adopció​

Study 1 completed: Use of the COVERGEL platform for the treatment of inflammatory bowel disease. Preclinical study in a murine model of experimental colitis with treatment through the sustained and local release of biological drugs (infliximab(R), vedolizumab(R)) with the COVERGEL platform. with favorable results. Study 2 completed: Demonstration of the effectiveness of the local treatment of chronic experimental colitis using COVERGEL with infliximab with a significantly lower production of anti-infliximab antibodies than in the standard treatment (subcutaneous infliximab). Study 3 completed: Use of the COVERGEL platform to locally treat colon tumors through intratumoral injection of the platform with various antitumor drugs (Aflibercept, Bevacizumab, panitumumab, cetuximab) in an experimental model of colon carcinogenesis in rats with favorable results.

Patented European Application – EP16382365 – 27/07/2016 - Abandonada PCT application – PCT/EP2017068876 – 26/07/2017 – Activa National Phase – 22/01/2019

European Application – EP16382365 – 27/07/2016 - Abandonada PCT application – PCT/EP2017068876 – 26/07/2017 – Activa National Phase – 22/01/2019 GETECCU - Otsuka Grant 2017 – 12.000€ CaixaImpulse 2018 Fundación “La Caixa” – 75.000€ We have a license with the startup Inmedical Therapeutics

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Patents: WO2016135219A1 ; WO2018019881A1 - Date: Sep 1st, 2016 Status: Granted URL: https://patents.google.com/patent/WO2016135219A1/en ; https://patents.google.com/patent/WO2018019881A1/e