AvantGen | January 12, 2021
AvantGen, Inc., a San Diego-based biotechnology organization with a variety of innovation stages for neutralizer revelation and enhancement, and novel NK and T cell engager age, today reported permitting of a board of its anti-SARS-CoV-2 antibody clones to IGM Biosciences for COVID-19 therapy development.
Utilizing its novel yeast show framework and huge different human antibody response libraries, AvantGen has distinguished a board of high partiality human monoclonal antibody clones that quandary to two unmistakable epitopes on the receptor restricting space of the SARS-CoV-2 spike protein. After official, the antibodies block the spike protein from cooperating with ACE2 and subsequently forestall infection prompted cell-slaughtering, otherwise called cytopathic impact. Furthermore, one gathering of immune response clones can likewise obstruct ACE2's cooperation with SARS-CoV-1, showing that the epitope perceived by this gathering of clones is rationed between SARS-CoV-1 and - 2, conceivably presenting more extensive killing action against this family of coronaviruses.
In a recognized animal model of SARS-CoV-2 contamination, AvantGen's lead applicant antibody has been appeared to fundamentally diminish viral load in, and macrophage infiltration of, the lungs, as well as reduce disease severity.
Legend Biotech Corporation | February 14, 2022
Legend Biotech Corporation, a global, clinical-stage biotechnology company developing and manufacturing novel therapies, has achieved two milestones under its collaboration agreement with Janssen Biotech, Inc. for ciltacabtagene autoleucel (cilta-cel), resulting in aggregate payments to Legend Biotech of $50 million. Cilta-cel is a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T-cell (CAR-T) therapy.
Legend Biotech entered into the agreement with Janssen to develop, manufacture and commercialize cilta-cel for the treatment of multiple myeloma. Under the agreement, Legend Biotech received an upfront payment of $350 million and is entitled to receive additional payments upon achievement of landmarks for development, production performance, regulatory and sales.
The global agreement specifies a 50-50 cost and profit-sharing agreement in all markets, excluding Greater China, where the split is 70 percent for Legend and 30 percent for Janssen. Including the payments announced above, Legend has achieved $250 million in milestone payments during the collaboration.
Cilta-cel is an investigational chimeric antigen receptor T cell (CAR-T) therapy, formerly identified as JNJ-4528 in the United States and Europe and LCAR-B38M CAR-T cells in China, that is being studied in a comprehensive clinical development program for the treatment of patients with relapsed or refractory multiple myeloma and in earlier lines of treatment. The design consists of a structurally differentiated CAR-T with two BCMA-targeting single domain antibodies. In addition to a Breakthrough Therapy Designation (BTD) granted in the United States in December 2019, cilta-cel received a Priority Medicines (PRiME) designation from the European Commission in April 2019, and a BTD in China in August 2020. In addition, Orphan Drug Designation was granted for cilta-cel by the U.S. Food and Drug Administration (FDA) in February 2019, and by the European Commission in February 2020. A Biologics License Application seeking approval of cilta-cel was submitted to the U.S. FDA and a Marketing Authorization Application was submitted to the European Medicines Agency.
About Legend Biotech
Legend Biotech is a global, clinical-stage biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide.
We are currently engaged in a strategic collaboration to develop and commercialize our lead product candidate, ciltacabtagene autoleucel, an investigational BCMA-targeted CAR-T cell therapy for patients living with multiple myeloma. Applications seeking approval of cilta-cel for the treatment of patients with RRMM are currently under regulatory review by several health authorities around the world, including the U.S. Food and Drug Administration and the European Medicines Agency.
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.