CELL AND GENE THERAPY

Kaneka Eurogentec Announces the Successful Production of 25g of mRNA in One Batch

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.

Spotlight

Tardigrades, also known as water bears, are small aquatic animals. Some tardigrade species tolerate almost complete dehydration and exhibit extraordinary tolerance to various physical extremes in the dehydrated state. Here we determine a high-quality genome sequence of Ramazzottius varieornatus, one of the most stress-tolerant tardigrade species.

Spotlight

Tardigrades, also known as water bears, are small aquatic animals. Some tardigrade species tolerate almost complete dehydration and exhibit extraordinary tolerance to various physical extremes in the dehydrated state. Here we determine a high-quality genome sequence of Ramazzottius varieornatus, one of the most stress-tolerant tardigrade species.

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DIAGNOSTICS

Oxford BioTherapeutics Announces Research Collaboration with ImmunoGen to Develop Novel Antibody-Drug Conjugates

Oxford BioTherapeutics | June 14, 2022

Oxford BioTherapeutics (OBT), a clinical stage oncology company with a pipeline of immuno-oncology and Antibody Drug Conjugate (ADC)-based therapies, today announced a multi-year collaboration to research, develop and commercialize novel, first-in-class ADCs with ImmunoGen (IMGN), a leader in the expanding field of ADCs for the treatment of cancer. The companies will utilize ImmunoGen's linker-payload technology directed to novel targets identified via OBT's proprietary OGAP® discovery platform. The companies will support these R&D efforts through joint funding and by combining their respective proprietary technologies. "I am very enthusiastic about our new partnership with ImmunoGen, a leader in the development of ADCs," said Christian Rohlff, PhD, Chief Executive Officer (CEO) of Oxford BioTherapeutics. "The company's expertise, in combination with the unique targets from our OGAP® database, provides potential to strengthen our respective drug pipelines with novel and highly differentiated ADCs for cancer patients in need of novel therapeutic options." As part of the agreement, OBT will receive an upfront payment from ImmunoGen, reflecting OBT's preclinical programs to be included in the partnership. In addition, once antibodies generated by OBT have been coupled with ImmunoGen's proprietary linker-payload technology, each company will have the opportunity to select one or more development programs to further develop on its own. Each company is eligible to receive milestone payments based on the achievement of pre-specified development, regulatory, and commercial milestones, as well as tiered royalties as a percentage of worldwide commercial sales, with respect to each program selected by the other company. Once a company has chosen a given program, it will be solely responsible for all R&D costs associated with the specific program. "OBT has demonstrated expertise in identifying novel targets for the development of specific antibodies – two key components to generating successful ADCs," said Stacy Coen, ImmunoGen's Senior Vice President and Chief Business Officer. "This expertise, combined with ImmunoGen's portfolio of cancer-killing payloads and linkers, will be instrumental as both companies work to develop novel ADCs designed to address cancers with high unmet need. We look forward to working with OBT as we expand and diversify our investment in ADC research capabilities, deepen our pipeline, and transition to a fully-integrated oncology company." ImmunoGen's portfolio is comprised of next-generation maytansinoid, DNA-acting, and novel camptothecin toxins and proprietary linkers. This collaboration will utilize novel targets identified by OBT combined with ImmunoGen's proprietary toxins and associated linkers. OBT has clinical experience with ImmunoGen's ADC platform and DM4 payload, which is utilized in OBT's lead program OBT076, an ADC currently in clinical trials as a monotherapy, as well as in combination with checkpoint inhibitors, in patients with advanced or refractory solid tumors, including gastric, bladder, ovarian, and lung cancer. About Oxford BioTherapeutics Oxford BioTherapeutics is a clinical stage oncology company based in Oxford, UK; San Jose, CA and Morristown, NJ, USA; with a pipeline of first-in-class immuno-oncology (IO) and antibody-drug conjugate (ADC) based therapies designed to fulfil major unmet patient needs in cancer therapeutics. OBT's lead clinical program, OBT076, an ADC utilizing an Immunogen toxin, initiated expansion in a U.S. Clinical Trial in 2021 in patients with advanced or refractory solid tumors, including gastric, bladder, ovarian and lung cancer, where CD205 is overexpressed. Infiltration of tumors by immunosuppressive cells correlates with adverse outcomes (lower progression free and overall survival), suggesting that this process contributes to the progression of several cancers.

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MEDTECH

Insempra Announces Strategic Investment in Solena Materials

Insempra, | July 26, 2022

Insempra, a biology-powered company enabling businesses to make superior products in partnership with nature, today announces a strategic investment in Solena Materials Ltd a synthetic biology company. Solena, a spin-out from Imperial College London, develops synthetic proteins for high-performance clothing fibers. The investment will allow Insempra, formerly Origin.Bio, to accelerate its strategy of harnessing new technologies to advance biological production processes, creating naturally superior products to drive the regenerative revolution. Solena will be a major part of Insempra’s platform to deliver high-performance, intrinsically sustainable ingredients for a broad array of industries. Solena is using computational design to develop new classes of synthetic proteins to produce high-performance clothing fibers, which can absorb large amounts of kinetic energy. Insempra will accelerate the development and production of these synthetic proteins on an industrial scale, offering better, biobased solutions to the petrochemically sourced, non-biodegradable materials or fibers extracted from nature or animals, such as silk, currently used in the textile and clothing industries. This technology also reduces other environmental impacts such as the rise of microplastics in water bodies coming from washing petrochemically-sourced textiles. “We are hugely excited by this investment in Solena, which will help to accelerate our market-first approach to develop superior, intrinsically sustainable ingredients. We look forward to fast-tracking Solena’s development and production of their unique synthetic proteins to develop customized, high-performance fibers for a variety of applications.” Jens Klein, founder and CEO of Insempra and CEO of Solena Materials Dr James MacDonald, inventor, co-founder and CTO of Solena Materials, added: “The team and I are very excited to make this technology a huge success.” Professor Paul Freemont of Imperial College London, added: “This investment from Insempra recognizes the potential of our technology to revolutionize high-performance fabrics, and their supply chains. Together, we can harness our synthetic biology capabilities to develop, produce and manufacture a new class of superior, more sustainable fiber technology.” Insempra, a co-founder of Solena, will be the sole contributing shareholder in Solena, which is based at Imperial College’s Translation & Innovation Hub (I-HUB) in White City, London. Solena’s Board will be comprised of Dr James MacDonald of Solena, Professor Paul Freemont and Professor Milo Shaffer of Imperial College London, and Jens Klein and Andreas Heyl of Insempra. About Insempra Insempra is a biology-powered company enabling businesses to make superior products with nature. We combine bioscience and technology to grow matter for new and better products. For too long, businesses have relied on chemical industrialization processes and petrochemicals, depleting our planet’s limited resources. That’s why we are committed to drive the regenerative revolution to manufacture at scale in collaboration with nature. Led by a hand-picked team of biologists, technologists and entrepreneurs with rebel hearts, Insempra is here to create a new school of thought and collective action. The time to restore the balance between people and the planet is now. We don't wait for change. We do what needs to be done to grow a better future. About Solena Materials Solena is a protein materials design company. We use world-leading computational design, machine learning, and automation to accelerate the development of bespoke materials targeted at multiple sectors, from fashion apparel to medical textiles. Our new protein-based fibers will replace materials extracted from nature such as silk and petrochemically-derived materials, to create a new world of biodegradable, functional and sustainable smart materials for consumers, industry, and the planet.

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INDUSTRIAL IMPACT

Sartorius Stedim Biotech to acquire Albumedix, strengthening its portfolio of innovative advanced therapy solutions

Sartorius Stedim Biotech | August 09, 2022

Sartorius Stedim Biotech, a leading international partner of the biopharmaceutical industry, has agreed to acquire 100 percent of Albumedix Ltd. from private investors. The Nottingham, UK-based company provides best-in-class recombinant albumin-based solutions. Recombinant human albumin is an important component for the biopharmaceutical industry required for various applications, for example as an animal-free additive to cell culture media and for the stabilization of vaccines and viral therapies. The business, founded in 1984, has more than 100 employees and is expected to generate revenue of approximately £33 million in 2022 with a significant double-digit EBITDA margin. The agreed purchase price amounts to approximately £415 million. The transaction is subject to regulatory approval and is expected to close before the end of the third quarter of 2022. "Albumedix will be an important addition to Sartorius Stedim Biotech's advanced therapy solutions, particularly regarding our cell culture media business, as it will enable us to strengthen our position as a relevant supplier of innovative chemically defined media and critical ancillary materials. This market offers high growth potential due to the increasing regulatory requirements as well as rising demand for the use of recombinant human albumin in near-patient applications. Albumedix will also add important formulation excipients to our vaccine production solutions, allowing us to expand our existing customer relationships and forge new ones," René Fáber, member of the Board of Directors and Deputy CEO of Sartorius Stedim Biotech "We are delighted to be joining forces with Sartorius Stedim Biotech and look forward to accelerating our ambitious growth plans in delivering critical solutions to our global customers. We have been highly impressed with Sartorius Stedim Biotech's knowledge and capabilities in the bioprocessing markets, and we are excited to join this purposeful journey. We believe Sartorius Stedim Biotech will bring tremendous value in strengthening our market reach and broadening our innovation capacity, as well as significantly scaling up our existing platform. We remain focused on our promise of empowering excellence in the life science industry," said Jonas S. Møller, CEO of Albumedix. The existing 72,000-square-foot Albumedix site in Nottingham will be established as a center of excellence for innovation and GMP-compliant production of critical raw materials in Sartorius Stedim Biotech. Milbank LLP provided legal counsel to Sartorius Stedim Biotech in this transaction. William Blair acted as financial advisor to Albumedix, and Eversheds Sutherland provided legal counsel. This press release contains forward-looking statements about the future development of the Sartorius Stedim Biotech Group. Forward-looking statements are subject to known and unknown risks, uncertainties and other factors that could cause actual results to differ materially from those expressed or implied by such statements. Sartorius Stedim Biotech assumes no liability for updating such statements in light of new information or future events. This is a translation of the original French-language press release. Sartorius Stedim Biotech shall not assume any liability for the correctness of this translation. The original French press release is the legally binding version. A profile of Sartorius Stedim Biotech Sartorius Stedim Biotech is a leading international partner of the biopharmaceutical industry. As a total solutions provider, the company helps its customers to manufacture biotech medications safely, rapidly and economically. Headquartered in Aubagne, France, the shares of Sartorius Stedim Biotech S.A. are quoted on the Euronext Paris. With its own manufacturing and R&D sites in Europe, North America and Asia and an international network of sales companies, Sartorius Stedim Biotech has a global reach. The Group has been annually growing by double digits on average and has been regularly expanding its portfolio by acquisitions of complementary technologies. In 2021, the company employed more than 10,400 people, and earned sales revenue of around 2.89 billion euros.

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