Biomica | October 13, 2020
Biomica, an emerging biopharmaceutical company developing innovative microbiome-based therapeutics, and a subsidiary of Evogene Ltd. (NASDAQ: EVGN) (TASE: EVGN), announced today the advancement to large-scale production of BMC128, its Live Bacterial Product (LBP) candidate consortium. The microbes, which will be produced in large-scale are expected to support Biomica's first-in-man proof-of-concept clinical trials for its immuno-oncology program, anticipated to begin in 2021. BMC128 is advancing to the GMP production stage following the successful completion of the initial R&D stage of drug product development and manufacturing, conducted by Biose Industrie (Aurillac, France). Biomica's immuno-oncology program is focused on its leading 4-strain candidate consortium BMC128. Biomica recently announced positive results in the program, demonstrating the efficacy of BMC128 in potentiating the response to immune-checkpoint inhibitors (ICI) in preclinical studies. In these studies, BMC128 was administered to mice bearing cancer tumors prior to and during ICI therapy, and the results showed that treatment with BMC128 significantly improved anti-tumor activity. Biose Industrie is a drug-GMP certified manufacturer of bacteria-based APIs and clinical and commercial products. As previously announced earlier this year, Biomica engaged Biose for the scale-up development and GMP production of a clinical batch of its drug candidates.
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AI
eureKARE | July 07, 2021
eureKARE, a pioneering new company focused on financing and building next-generation biotechnology companies in the disruptive fields of the microbiome and synthetic biology, today announced an agreement with DNAlytics, a Belgian company applying data sciences to healthcare, to develop eureKARE's proprietary Artificial Intelligence (AI) platform to support its Biotech start-upstart-up studios, eureKARE.
Unlike conventional start-upstart-up incubation methods, which begin with new science and then attempt to find an issue to address with it, eureKARE's methodology reverses this. eureKARE is committed to first finding an unmet need and then enlisting the best scientists and experts to provide an innovative solution to launch exciting new ventures.
This process will be aided by eureKARE's one-of-a-kind AI platform, which will assist the business in identifying top academic researchers, locating new ideas and approaches in development, and scaling existing portfolio companies.
About eureKARE
eureKARE is a ground-breaking new company focusing on financing and establishing next-generation biotechnology start-ups in the microbiome and synthetic biology cutting-edge areas. eureKARE employs a two-step investing strategy to create long-term value. Through its biotech start-upstart-up studios eureKABIOME (Microbiome) and eureKASYNBIO, the company promotes translational research by developing and financing new companies based on high-value European science (Synthetic biology). In addition, the company aims to engage in more mature biotech companies. It will systematically propose to provide some liquidity to early investors, thus fulfilling a crucial demand in the European biotech sector. EureKARE has a fast-expanding portfolio of companies with the potential to disrupt the life sciences sector, led by its prominent founder, Alexandre Mouradian, and a pan-European team.
About DNAlytics
DNAlytics is based in Louvain-la-Neuve, Belgium, specializing in data science for the healthcare sector, including data management, bioinformatics, biostatistics, Machine Learning, and other Artificial Intelligence methods. DNAlytics products are utilized in clinical research, the creation of biotech drugs and medical devices, public health studies, and the monitoring and optimization of bio-manufacturing processes. In addition, DNAlytics assists a wide range of clients and partners in extracting scientifically sound observations and practical conclusions from complex data sets.
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CELL AND GENE THERAPY
Kaneka Eurogentec | February 23, 2022
Kaneka Eurogentec, an FDA inspected contract development and manufacturing organization announced today that its mRNA manufacturing facility has successfully produced a 25 g batch of mRNA for a US customer.
Eurogentec’s GMP mRNA manufacturing service offers in vitro transcription (IVT), purification, quality control and batch release of GMP material up to 25 g scale in its current facility in Belgium. In this project Eurogentec successfully produced and purified 25 g of material in one batch that will be tested by the customer. This quantity is equivalent to 100,000’s to millions of doses of mRNA, potentially sufficient for late clinical and commercial uses.
Ingrid Dheur, Vice President Biopharma Development at Kaneka Eurogentec stated, “This successful production confirms our ability to produce mRNA at large scale and with a quantity and purity level that exceeds the targets requested by the customer.”
“The rapid growth in cell and gene therapy products is driving the need for plasmid DNA and mRNA production. Our existing pharma and biotech customers have already expressed the need for such large-scale manufacturing capabilities, and we have developed methods to respond to these needs. Additionally, we are currently in the planning stages for a 2nd manufacturing facility to further expand our GMP mRNA manufacturing offering”.
Lieven Janssens, President and CEO at Kaneka Eurogentec
About mRNA
Messenger RNA (mRNA) is a molecule that encodes for a protein which will have a beneficial effect in patients. Rather than producing complex proteins, producing mRNA is a convenient way to deliver the protein as a precursor. The production of mRNA is much simpler than producing a recombinant protein and thus mRNA molecules have the advantage of enabling a shorter production time to clinic. For example, current mainstream therapies for the protection against COV-SARS-2 infections are based on mRNA and have been developed in record time. The success of these COVID-19 mRNA vaccines has opened the evaluation of mRNA for other infectious diseases, for example influenza or HIV, and the need for custom large-scale production of GMP mRNA.
About Kaneka Eurogentec
Eurogentec was founded in 1985 as one of the first biotech companies in Belgium. Kaneka Eurogentec contributes to improving health and fighting diseases by supplying products and services to scientists involved in life science research, molecular diagnostics, and therapeutic developments. The Liège-based company is recognized as one of the major suppliers in the field of genomics and proteomics as well as a trusted Contract Development and Manufacturing Organization (CDMO) for the bio-production of pharmaceuticals.
Eurogentec is one of a few CDMOs capable of manufacturing GMP oligonucleotides, mRNA, plasmid DNA and recombinant proteins for human injectable use, with commercial products sold in USA, Europe and Japan.
In 2010, Eurogentec, renamed Kaneka Eurogentec in April 2017, became part of Kaneka Corporation, a large Japanese chemical company focusing on technology and innovation.
About Kaneka Corporation
Kaneka is an innovation-oriented chemical company. Traditionally the company has been active in polymers, fermentation, biotechnology, and electronics, as well as other fields. Business activities now span a broad spectrum of markets ranging from plastics, EPS resins, chemicals and foodstuffs to pharmaceuticals, medical devices, electrical and electronic materials, and synthetic fibers. The life science related activities are currently one of the strategically important domains for Kaneka. The company has been a pioneer among Japanese chemical companies in establishing overseas operations, beginning in 1970 with a subsidiary in Belgium.
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