Curia | June 10, 2022
Curia, formerly AMRI, a leading contract research, development and manufacturing organization, and Replicate Bioscience, a company pioneering ways to prevent drug resistance in cancer and to treat autoimmune and inflammatory disorders and other diseases using self-replicating RNA (srRNA), today announced that they will collaborate on a robust development platform for Replicate’s srRNA therapeutics.
As part of the collaboration, Curia’s experienced process development team will support the GMP production of Replicate Bioscience’s srRNA vectors up to eight-liter scale (8L), which can be used in Phase 1 through pivotal clinical trials. Curia’s global mRNA development and manufacturing facility is ISO-13485 certified and located near Boston, Massachusetts. This facility also supports innovators engaged in vaccine and other mRNA therapy development and manufacture through Phase 2 and 3, including GMP assays. Additional Curia facilities support manufacture of srRNA through commercial production scales.
“Replicate’s approach to srRNA is unique, in that we create our own virally-derived synthetic vectors to customize srRNAs to deliver specific proteins,” said Replicate Co-founder and Chief Development Officer Andrew Geall, Ph.D., who previously has set up srRNA CMC frameworks for companies including Novartis, Synthetic Genomics, and Precision Nanosystems. “This customization has important therapeutic. advantages—versatility of application, lower dosing, and longer duration of therapeutic effect compared to other RNA modalities—but requires built-for-purpose processes to solve the challenges of manufacturing longer RNAs. Curia’s unprecedented expertise in process development and end-to-end integration of longer RNAs makes them a perfect partner for us as we transition from research into clinical development and the production of our srRNA for trials in patients.”
“The manufacture of these longer mRNAs is more technically challenging than non-replicating mRNAs and to date we have succeeded with mRNAs up to 16,000 bases. Curia’s platform offers versatility and streamlined manufacturing times that can handle such complex molecules. Our collaboration with Replicate Bioscience is enabling us to create entirely new methods of manufacturing longer RNAs. We have built our platform from the ground up, using our combined experience in biologics and chemistry to create end-to-end solutions covering mRNA synthesis, lipid synthesis, formulation, and liquid nanoparticle fill-finish. We are proud to apply our capabilities and expertise to support the Replicate Bioscience team and its innovative approach.”
Norman Garceau, Ph.D., Vice President, Global R&D Technology, Curia
Curia, formerly AMRI, is a leading contract research, development and manufacturing organization providing products and services from R&D through commercial manufacturing to pharmaceutical and biopharmaceutical customers. Curia’s 3,700 employees at 29 locations across the U.S., Europe and Asia help its customers advance from curiosity to cure. Learn more at CuriaGlobal.com.
About Replicate Bioscience
Replicate Bioscience, an ATP company, is designing and delivering srRNA immunotherapies to revolutionize the practice of medicine and improve and save lives. Replicate applies advanced srRNA technology in its work to prevent drug resistance in cancers. The company is also developing srRNA injections for sustained therapeutic protein expression to treat autoimmune and inflammatory disorders and other conditions. Replicate believes that srRNA will bring about the next big breakthroughs in RNA therapeutics and is working to realize the promise of srRNA for all patients.
Kedrion Biopharma | October 19, 2021
Kedrion Biopharma, the rapidly growing international biopharmaceuticals company that produces and distributes plasma-derived treatments for rare diseases, has announced that it has completed the acquisition in North America of the Prometic life sciences business.
Prometic, which has a team of 130 employees in Laval, Québec, has developed the first ever FDA-approved treatment for Congenital Plasminogen Deficiency. The new drug, called Ryplazim®, , has been approved for the treatment of all the clinical manifestations of Plasminogen Deficiency, which can lead to blindness, respiratory failure and other severe complications.
The company is now working toward a launch in the United States in early 2022.
"We are very pleased to have completed this important and strategic acquisition, which will bring badly needed therapies to patients who suffer from this rare disease,"
- Paolo Marcucci, Chairman of Kedrion Biopharma.
With the acquisition of Prometic BioTherapeutics Inc., Kedrion has finalized a series of transactions that began last June with the announcement that it was acquiring from the Nasdaq-quoted Liminal Biosciences Inc. the plasma purification plant at Laval in Quebec, and the license to distribute the new product in the United States.
"Ryplazim is very significant because it really allows us to fulfil our mission of putting patients first. This is the first drug to ever be approved by the FDA for the treatment of the rare Congenital Plasminogen Deficiency, Type 1, so we are very honored to help speed the product to market."
- Val Romberg, Kedrion's CEO
Porton Advanced | April 25, 2022
Suzhou Porton Advanced Solutions Ltd. and Guizhou Sinorda Biomedicine Co. Ltd. announced a long-term strategic relationship in cell and gene therapy research and development and platform development.
Porton Advanced provides plasmids, cell therapy, gene therapy, oncolytic virus, mRNA treatment, and bacterial therapy as part of an end-to-end gene and cell therapy CDMO service platform. Sinorda Biomedicine focuses on the R&D of revolutionary drugs for digestive tract disorders, tumor immunotherapy, and oncolytic virus therapy and has multiple new drug projects in the clinical stage, thanks to its extensive expertise in domestic and international new drug filing. Jiangsu Tairui Sinorda Biomedicine Pharmaceutical Technology Co. Ltd., a subsidiary, conducts pre-clinical and clinical research on tumor immune pharmacology and efficacy.
Under the terms of the agreement, Porton Advanced will help Sinorda Biomedicine speed up the development, production, and registration of breakthrough cell therapies, such as its T-cell immunotherapy product for colorectal cancer, SND002 and other pipelines. Sinorda Biomedicine will partner with Porton Advanced to support its cell and gene therapy R&D and production.
The first collaborative initiative, SND002, has been approved for Phase II clinical trials in Europe. The product had previously been recognized by the Chinese National Science and Technology Major Project for "the Breakthrough New Drugs." The beginning of this key initial initiative allows Porton Advanced and Sinorda to combine resources and expertise, promising increased synergy in the clinical development and approval of Sinorda's SLN-T program.
"Sinorda Biomedicine has a proven track record in drug development in China, US and Europe. The company possesses great expertise in immunology and oncolytic viruses, as well as cutting-edge immune functional assays, technologies, and capabilities. I am excited to see how our end-to-end cell and gene therapy CDMO platforms and quality systems can complement these capabilities and enhance Sinorda's pipeline. Supporting Sinorda's development, production and regulatory filing and accelerating its cell therapy drugs to market is a great cause and a great opportunity. We look forward to the opportunity to help Sinorda establish advanced therapies that benefit patients globally."
Dr. Yangzhou Wang, CEO of Proton Advanced