CELL AND GENE THERAPY
Thermo Fisher Scientific | March 01, 2021
Thermo Fisher Scientific Inc. (NYSE: TMO), the world chief in serving science, today reported it has finished its recently declared obtaining of Mesa Biotech, Inc., a secretly held purpose of-care sub-atomic analytic organization.
Plateau Biotech has built up the Accula System, a moderate, simple to-utilize, purpose of-care PCR-based testing stage for irresistible infection conclusion. The stage empowers fast, exceptionally precise testing at doctor workplaces, drug stores and different settings, giving outcomes quickly. Past COVID-19 testing, Mesa Biotech's current stage incorporates tests for influenza, respiratory syncytial infection (RSV), and Strep A.
"The Accula System complements our existing offerings and immediately provides our clinical customers with more options and flexibility for COVID-19 testing. And, as the point-of-care diagnostic market expands globally, we're well-positioned to deliver a broader menu of tests to meet increasing demand," Stevenson continued.
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $30 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 80,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon.
BioNTech SE | February 22, 2022
BioNTech SE and Medigene AG a clinical-stage immuno-oncology company focusing on the development of T cell immunotherapies, announced that they have entered a multi-target research collaboration to develop T cell receptor (TCR) based immunotherapies against cancer. The initial term of the collaboration is three years.
Medigene will contribute its proprietary TCR discovery platform for the development of TCRs against multiple solid tumor targets nominated by BioNTech. Medigene’s automated, high throughput TCR discovery platform is designed to bypass central tolerance to yield high affinity TCRs. T cell therapy has become a disruptive medical innovation in the treatment of patients with cancer. Engineered TCR-modified T cells (TCR-T cells) are reprogrammed to express a TCR that can recognize specific antigens only present on tumor cells, thereby enabling a precise and potent immune response to attack a patient’s tumor.
“This collaboration with Medigene expands our cell therapy portfolio and TCR discovery capabilities, and further strengthens our ability to be a leader in the rapidly emerging field of engineered cell therapies. We look forward to working closely with Medigene to develop new treatments which address solid tumors with high unmet medical need.”
Ugur Sahin, M.D., Chief Executive Officer and Co-Founder of BioNTech
Prof. Dolores Schendel, Chief Executive Officer and Chief Scientific Officer at Medigene: “Medigene is at the forefront of the development of TCR-T therapies for oncology. The sale and licensing deal with BioNTech is an important validation from a global leading biotech company of our proprietary technologies to discover and characterize highly specific TCRs and empower resulting TCR-T cells to fight solid tumors. This partnership provides Medigene with meaningful financial resources to fuel our next generation development programs targeting potentially novel tumor-specific “dark matter” antigens, further tools to enhance T-cell-based immunotherapies, as well as additional potential strategic deals with future milestone payments and royalties.”
BioNTech will acquire Medigene’s next generation preclinical TCR program, which combines TCR-4 of Medigene’s MDG10XX program targeting PRAME with Medigene’s proprietary PD1-41BB switch receptor technology. BioNTech will also obtain the exclusive option to acquire additional existing TCRs in Medigene’s discovery pipeline and will receive licenses to the company’s PD1-41BB switch receptor and precision pairing library. This has the potential to augment TCR cell therapy efficacy and can be applied to all BioNTech cell therapy programs.
Under the terms of the agreement, Medigene will receive EUR 26 million upfront, as well as research funding for the period of the collaboration. BioNTech will be responsible for global development and hold exclusive worldwide commercialization rights on all TCR therapies resulting from this research collaboration. Medigene will be eligible to receive development, regulatory and commercial milestone payments up to a triple digit million EUR amount per program in addition to tiered deferred option payments on global net sales for products based on TCRs arising from the collaboration and royalties on products utilizing at least one of the licensed technologies.
Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Bayer Animal Health, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma and Pfizer.
Medigene AG (FSE: MDG1, ISIN DE000A1X3W00, Prime Standard) is a publicly listed biotechnology company headquartered in Planegg/Martinsried near Munich, Germany. With its scientific expertise, Medigene is working on the development of innovative immunotherapies to enhance T cell activity against solid cancers in fields of high unmet medical need. Medigene’s pipeline includes preclinical as well as clinical programs in development.
Medigene’s strategy is to develop its own therapies towards clinical proof-of-concept. In addition, the Company offers selected partners the opportunity to discover and develop therapies on the basis of its proprietary technology platforms. In return for such partnerships, Medigene expects to receive upfront and milestone payments as well as research and development funding and royalties on future product sales.
About Medigene’s TCR-T cells
T cells are at the center of Medigene’s therapeutic approaches. With the aid of Medigene’s immunotherapies the patient’s own defense mechanisms are activated, and T cells harnessed in the battle against cancer. Medigene’s therapies arm the patient’s own T cells with tumor-specific T cell receptors (TCRs). The resulting TCR-T cells should thereby be able to detect and efficiently kill cancer cells.
About Medigene’s PD1-41BB switch receptor
Checkpoint inhibition via PD1-PDL1 pathway: Solid tumor cells are known to be sensitive to killing by activated T cells. Tumor cells can escape this killing activity by expressing inhibitory molecules, so-called ‘checkpoint proteins’, such as Programmed Death Ligand 1 (PD-L1) on their surface. When this occurs, activated T cells which express PD-1, the natural receptor for PD-L1, are inactivated. The expression of PD-L1 by tumors represents an adaptive immune resistance mechanism that can lead to tumor survival and growth.
About Medigene’s precision pairing library
T cell receptors (TCRs) consist of an alpha and a beta chain, which together act as a receptor on the cell surface of T cells. Medigene's therapies aim to equip the patient's own T cells with tumor-specific TCRs. The resulting TCR-T cells should thereby be able to detect and efficiently kill cancer cells.
The precision pairing library allows selection of specific modifications in each chain of a TCR so that the alpha and beta chains preferentially pair with each other, with the result that improved TCR surface expression and/or functionality is achieved.
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
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.