Veeva Systems | September 24, 2021
Veeva Systems announced that ConvaTec, a global medical products company providing therapies focused on the management of chronic disease, has selected Veeva Vault CDMS , which will provide electronic data entry ( EDC ), coding and data cleaning for its upcoming study on wound infection detection.
ConvaTec and its partners have developed a new infection biomarker detection technology based on the combined measurement of the following three biomarkers: wound pH, and the activity of host enzymes, human neutrophil elastase (HNE) and myeloperoxidase (MPO). This proof of concept study will explore the efficacy of a novel combination of biomarkers, pH, HNE and MPO, in detecting wound infection.
One of the secondary objectives of the assay is to explore the relationship between molecular microbiological analysis of swab samples and wound biopsies with the biomarkers pH, HNE and MPO.
This is a multi-center international analytical performance study that is expected to take approximately 20 weeks and aims to recruit between 75 and 90 subjects.
Veeva MedTech is proud to support companies like ConvaTec with Vault CDMS, a unified data management solution for capturing, cleaning and encoding clinical data.
About Veeva Systems
Veeva is the global leader in cloud software for the life sciences industry. Committed to innovation, product excellence and customer success, Veeva has more than 1,100 customers, from the world's largest pharmaceutical companies to emerging biotechnology companies. As a public benefit company, Veeva is committed to balancing the interests of all stakeholders, including customers, employees, shareholders and the industries it serves.
CELL AND GENE THERAPY
Moderna, Aldevron | May 25, 2021
Moderna, Inc., a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, and Aldevron, LLC, the leading provider of high-quality plasmid DNA, mRNA, and recombinant proteins used for vaccines, gene and cell therapy, gene editing, and diagnostic applications, have announced an expanded collaboration in support of the Moderna COVID-19 Vaccine and additional programs in mRNA therapeutics and vaccines.
Aldevron will specifically provide plasmid DNA to act as the genetic template for the COVID-19 mRNA vaccine and other investigational programs in Moderna's pipeline.
“Aldevron has been a long-standing Moderna partner. We value their cooperation and expertise in the biologics space,” said Juan Andres, Moderna's Chief Technical Operations and Quality Officer. “We are looking to continue our work in this extended partnership.”
“Aldevron's support for the Moderna pipeline spans nearly a decade, and we're incredibly proud of the trust they've got in us,” said Kevin Ballinger, Aldevron's Chief Executive Officer. “Our extensive experience, combined with improved operational efficiencies and recent capacity expansion, puts us in an excellent position to support Moderna's efforts – especially at this critical stage. We look forward to extending our strategic partnership in the future to serve a pipeline of important new programs.”
Aldevron's DNA production continues in its 70,000 square foot GMP facility in Fargo, North Dakota. The design and validation of an additional 189,000 sq ft expansion to Aldevron's 14-acre Breakthrough Campus's GMP facility have been completed, allowing for increased production capability.
Aldevron is a world-class manufacturing partner in the area of genetic medicine. Michael Chambers and John Ballantyne founded the company in 1998, and it offers essential nucleic acids and proteins used in gene and cell therapies, DNA and RNA vaccines, and gene editing technologies. Aldevron's 600 employees assist thousands of scientists who are working to develop revolutionary treatments for millions of people.
Moderna has evolved from a science research-stage company advancing programs in the field of messenger RNA (mRNA) to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio in areas such as mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant. Moderna maintains partnerships with a wide range of domestic & global government and commercial collaborators, allowing for the pursuit of both groundbreaking science and accelerated manufacturing scaling. Recently, Moderna's capabilities came together to allow the authorized use of one of the earliest and most effective COVID-19 vaccines.
CELL AND GENE THERAPY
Tevogen Bio | January 13, 2022
Tevogen Bio, a clinical stage biotechnology company specializing in cell and gene therapies in oncology and viral infections, announced that the U.S. Patent and Trademark Office has granted a new patent for the method of preparing COVID-19 peptide specific cytotoxic T cells for the treatment of COVID-19 infection. The patent further reinforces the biotech pioneer’s expanding IP portfolio.
“Omicron’s extensive mutations and its subsequent ability to evade antibodies highlights the importance of Killer T cells, which can still recognize and eliminate virus-infected cells. Millions among us suffer from inadequate T cell response for various reasons. After two years of the pandemic and witnessing the challenges posed by the ever-evolving virus, we must explore scientific options beyond our current approaches. CTL therapeutics for large patient populations is not an easy undertaking, but Tevogen’s ability to manufacture hundreds of doses from a single donor gives me hope,”
Tevogen CEO Ryan Saadi, M.D., M.P.H
The granted patent covers Tevogen’s investigational allogeneic SARS-CoV-2 specific Cytotoxic CD8+ T Lymphocytes therapy, TVGN-489, for high-risk COVID-19 patients. The product is currently undergoing a proof of concept clinical trial at Jefferson University Hospitals in Philadelphia. Trial details are available at Clinical Trials - Tevogen.
TVGN-489 is a highly purified, SARS-CoV-2-specific cytotoxic CD8+ T lymphocyte product, which detects targets spread across the entire viral genome. These targeted CTLs are expected to recognize and kill off virally infected cells, allowing the body to replace them with healthy, uninfected cells. TVGN-489 demonstrated strong antiviral activity toward SARS-CoV-2 targets in preclinical studies.
About Tevogen Bio
Tevogen Bio is driven by a team of distinguished scientists and highly experienced biopharmaceutical leaders who have successfully developed and commercialized multiple franchises. Tevogen’s leadership believes that accessible personalized immunotherapies are the next frontier of medicine, and that disruptive business models are required to sustain medical innovation in the post-pandemic world.