Periodic Reporting for period 2 - Simecos (A New Adjuvant Nutraceutical from the North Atlantic Ocean for Breast, Lung and Pancreatic Cancer Patients)
Reporting period: 2019-02-01 to 2020-07-31
Genis is a biotechnology company founded in 2005 in Iceland. We develop health products based on chitin-derived products made from the North Atlantic shrimp exoskeleton, which is a waste product of the fishing industry which we transform into a valuable product. Our economic activity is exclusively related to products from a natural marine source. All of our production processes are designed to ensure the highest product quality. Our policy when it comes to production is to deliver greater value to the local society with less input, using resources in a sustainable way while minimizing environmental impact.
Genis’ approach to the nutraceutical market started with the development and commercialization of Benecta®, the food supplement composed by T-ChOS™ molecules of short-chain chitosan purified from shrimp exoskeleton. Genis obtained a purer T-ChOS™ composition derived from Benecta® to develop the novel nutraceutical, SIMECOS, which will improve the quality of life of cancer patients when combined with chemotherapy treatments.
In Europe, there were an estimated 3.9 million new cancer cases in 2018, thereof 523,000 patients with breast cancer (https://canceratlas.cancer.org/wp-content/uploads/2019/09/CA3_Europe.pdf(opens in new window)). To alleviate the side effects of the current treatments for cancer, many patients turn to dietary supplements and nutraceuticals to control the symptoms of cancer, alleviate the unwanted side effects of certain therapies, preventing future disease, and aid in the treatment of current disease. However, it is good to note that none of them have advanced to the point of clinical trial validation as we reach with SIMECOS. The results of our extensive research in various biological models, in vitro and in vivo, strongly suggest anti-inflammatory, tissue-protective activity, and enhancement of response to chemotherapy in selected cancer cell lines without any adverse effects, morbidity, or mortality in these pre-clinical studies.
Because of these evidences, Genis will bounce into the nutraceuticals market with SIMECOS, the first nutraceutical used as an adjuvant in breast cancer-derived from a marine natural source and the first nutraceutical with scientifically proved and clinically validated health benefits. With SIMECOS™, we will give a response to the urgent need for better treatments to increase the life expectancy of these cancer patients.
Genis’ approach to the nutraceutical market started with the development and commercialization of Benecta®, the food supplement composed by T-ChOS™ molecules of short-chain chitosan purified from shrimp exoskeleton. Genis obtained a purer T-ChOS™ composition derived from Benecta® to develop the novel nutraceutical, SIMECOS, which will improve the quality of life of cancer patients when combined with chemotherapy treatments.
In Europe, there were an estimated 3.9 million new cancer cases in 2018, thereof 523,000 patients with breast cancer (https://canceratlas.cancer.org/wp-content/uploads/2019/09/CA3_Europe.pdf(opens in new window)). To alleviate the side effects of the current treatments for cancer, many patients turn to dietary supplements and nutraceuticals to control the symptoms of cancer, alleviate the unwanted side effects of certain therapies, preventing future disease, and aid in the treatment of current disease. However, it is good to note that none of them have advanced to the point of clinical trial validation as we reach with SIMECOS. The results of our extensive research in various biological models, in vitro and in vivo, strongly suggest anti-inflammatory, tissue-protective activity, and enhancement of response to chemotherapy in selected cancer cell lines without any adverse effects, morbidity, or mortality in these pre-clinical studies.
Because of these evidences, Genis will bounce into the nutraceuticals market with SIMECOS, the first nutraceutical used as an adjuvant in breast cancer-derived from a marine natural source and the first nutraceutical with scientifically proved and clinically validated health benefits. With SIMECOS™, we will give a response to the urgent need for better treatments to increase the life expectancy of these cancer patients.
The overall objectives of the SIMECOS project is to chemically design, optimize manufacturing, validate through clinical trial and bring to market the SIMECOS™ product: A nutraceutical for cancer patients derived from T-ChOS™ molecules. Genis had planned the project to complete technical, legal and commercial activities needed to ensure a success entry into the market of the SIMECOS™ product. Technically, we designed, manufactured and characterized the SIMECOS™ product. Optimization on the SIMECOS™ production line has been carried out and scale-up is finished. Legally, we carried out toxicology studies based on requirements for approval of Health Claim by the EC (EFSA) and filed two new patent applications. The original plan was to execute the clinical validation of SIMECOS as an adjuvant to chemotherapy for lung, breast and pancreatic cancer, in collaboration with Herlev Hospital in Denmark. During 1st period of the project, the expected lung and pancreatic adjuvant therapeutic of clinical studies were cancelled due to changes in therapeutic regime unrelated to the SIMECOS project. Breast cancer clinical trial was executed according to plan, however, as recommended by Herlev Hospital based on power calculations, number of patients was increased up to 400 in order to get statistically reliable results. The pandemic COVID-19 had a major impact on our breast cancer clinical trial, subcontracted to Herlev Hospital. COVID-19 was set to top priority at the Hospital and our breast cancer study was temporarily stopped because of the situations that arose in the Hospital. Due to this increase in number of patients and COVID-19, the clinical validations could not be finished before the end of the SIMECOS project, and thus, no clinical results are available from the project. However, the breast cancer clinical trial is currently ongoing and we have planned to prepare a new grant application with the breast cancer clinical trial with increased number of patients.
During the project, we have updated our SIMECOS™ webpage and investigator brochure alongside the projects progress, and prepared scientific articles to present our solution to stakeholders, European specialists, and cancer patients where we share results and explain benefits to our target end-users. One of the key aspect of the original commercialization plan was to use the outcome of clinical trials to market the SIMECOS™ product through European specialists and clinics, starting in Herlev Hospital in Denmark, and to apply for a health claim with EFSA in order to facilitate direct-to-consumer marketing approach of the product. In collaboration with regulatory consultancy, Medfiles, we updated our market and commercialization plan according to the most suitable scenarios as needed underway with the projects progress. Given the delay of our clinical validation results, Genís has set up and is currently following an updated commercialization plan including 3 scenarios for the marketing of SIMECOS™ with the key goal to identify a commercialization strategy which allows a faster time-to-market of the product parallel to the clinical validation .
During the project, we have updated our SIMECOS™ webpage and investigator brochure alongside the projects progress, and prepared scientific articles to present our solution to stakeholders, European specialists, and cancer patients where we share results and explain benefits to our target end-users. One of the key aspect of the original commercialization plan was to use the outcome of clinical trials to market the SIMECOS™ product through European specialists and clinics, starting in Herlev Hospital in Denmark, and to apply for a health claim with EFSA in order to facilitate direct-to-consumer marketing approach of the product. In collaboration with regulatory consultancy, Medfiles, we updated our market and commercialization plan according to the most suitable scenarios as needed underway with the projects progress. Given the delay of our clinical validation results, Genís has set up and is currently following an updated commercialization plan including 3 scenarios for the marketing of SIMECOS™ with the key goal to identify a commercialization strategy which allows a faster time-to-market of the product parallel to the clinical validation .
We have developed methods to isolate and purify T-ChOS™ from chitin extracted from the exoskeleton (skin) of North Atlantic shrimps, using as raw material a by-product of the fishing industry.
Genis has also developed a production line, which is located at Siglufjörur. It is comprised of pharmaceutical grade stainless steel equipment and operated in a closed system with no connection to open air. There, the chitin biopolymer is chemically modified through controlled partial deacetylation; enzyme catalyzed hydrolysis, and finally refined by series of filtration steps and spray dried to form refined T-ChOS™ powder.
Genis has conducted extensive biological evaluation of T-ChOS™ in various biological models, in vitro and in vivo. The results from these studies strongly suggest anti-inflammatory and tissue protective activity on cartilage and bone tissues in osteoarthritis, osteoporosis and rheumatoid arthritis and enhancement of response to chemotherapy in selected cancer cell lines.
Genis has also developed a production line, which is located at Siglufjörur. It is comprised of pharmaceutical grade stainless steel equipment and operated in a closed system with no connection to open air. There, the chitin biopolymer is chemically modified through controlled partial deacetylation; enzyme catalyzed hydrolysis, and finally refined by series of filtration steps and spray dried to form refined T-ChOS™ powder.
Genis has conducted extensive biological evaluation of T-ChOS™ in various biological models, in vitro and in vivo. The results from these studies strongly suggest anti-inflammatory and tissue protective activity on cartilage and bone tissues in osteoarthritis, osteoporosis and rheumatoid arthritis and enhancement of response to chemotherapy in selected cancer cell lines.