New plant-based vaccine at the forefront of more affordable HPV prevention

Medical Xpress | March 15, 2019

Do you change the channel when you see an ad for the Gardasil vaccine? Maybe you are a man and don't think you are at risk of acquiring cancer from HPV, maybe you aren't sexually active, or maybe you don't have the resources to get the vaccine. But research shows that in addition to causing cervical cancer in women, certain strains have been linked to head and neck cancers in men. The Gardasil-9 vaccine protects against nine of the most cancer-associated strains of HPV, though there are more than 100 strains of HPV with possible adverse effects. In light of this, Arizona State University is aggressively pursuing research aimed at understanding the underlying mechanisms behind the HPV infection and exploring preventative measures to stave off the virus.

Spotlight

The BioGENEius Challenges provide high school students the opportunity to compete and be recognized for outstanding research in biotechnology. Joining us on the set of Good Day BIO at #BIO2019 are three contestants competing for a prize that could help shape their future.

Spotlight

The BioGENEius Challenges provide high school students the opportunity to compete and be recognized for outstanding research in biotechnology. Joining us on the set of Good Day BIO at #BIO2019 are three contestants competing for a prize that could help shape their future.

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CELL AND GENE THERAPY

Valneva and IDT Biologika Announce Collaboration for Production of Inactivated COVID-19 Vaccine VLA2001

Valneva SE, IDT Biologika | November 30, 2021

Valneva SE, a specialty vaccine company, and IDT Biologika announced their collaboration for the production of Valneva’s inactivated COVID-19 vaccine candidate VLA2001. This follows last week’s announcement that Valneva signed an Advance Purchase Agreement with the European Commission to supply up to 60 million doses of VLA2001, over two years. Under the collaboration, IDT Biologika will produce VLA2001’s drug substance at its Biosafety Level 3 facilities in Dessau-Roßlau, Germany, in addition to Valneva’s manufacturing site in Livingston, Scotland. “IDT is a well-established partner within Valneva’s manufacturing network. As such we are extremely pleased to extend this partnership to supply VLA2001. This collaboration will help ensure our inactivated vaccine is available for rapid deployment as we continue to believe that our differentiated vaccine candidate can make an important contribution to the global fight against the COVID-19 pandemic.” Thomas Lingelbach, Chief Executive Officer of Valneva Dr. Jürgen Betzing, Chief Executive Officer of IDT Biologika, added, “This is great news for our company. This assignment shows the importance of the role played by IDT in the fight against COVID-19. It is a great achievement and demonstrates the trust that Valneva has placed in us and our employees. The expansion of our production capacity combined with our expertise were key factors in the choice of IDT.” Valneva has continued to review its manufacturing strategy following discussions with the UK Government in the summer and again after the termination of the UK contract in September 2021. Valneva plans to operate a combination of external and internal production of VLA2001 and will further review its manufacturing plans based on demand. The Company’s sites in Livingston, Scotland and Solna, Sweden will continue to form part of the Company’s core manufacturing strategy. Valneva reported positive Phase 3 results for VLA2001 in October 20211. Delivery of the vaccine in Europe is currently expected to begin in April 2022, subject to approval by the European Medicines Agency which is expected to start a rolling review of VLA2001 shortly. About VLA2001 VLA2001 is currently the only whole virus, inactivated, adjuvanted vaccine candidate against COVID-19 in clinical trials in Europe. It is intended for active immunization of at-risk populations to prevent carriage and symptomatic infection with COVID-19 during the ongoing pandemic and potentially later for routine vaccination including addressing new variants. VLA2001 may also be suited for boosting, as repeat booster vaccinations have been shown to work well with whole virus inactivated vaccines. VLA2001 is produced on Valneva’s established Vero-cell platform, leveraging the manufacturing technology for Valneva’s licensed Japanese encephalitis vaccine, IXIARO®. VLA2001 consists of inactivated whole virus particles of SARS-CoV-2 with high S-protein density, in combination with two adjuvants, alum and CpG 1018. This adjuvant combination has consistently induced higher antibody levels in preclinical experiments than alum-only formulations and shown a shift of the immune response towards Th1. CpG 1018 adjuvant, supplied by Dynavax Technologies Corporation (Nasdaq: DVAX), is a component of the US FDA- and EMA-approved HEPLISAV-B® vaccine. The manufacturing process for VLA2001, which has already been upscaled to final industrial scale, includes chemical inactivation to preserve the native structure of the S-protein. VLA2001 is expected to conform with standard cold chain requirements. About Valneva SE Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. The Company takes a highly specialized and targeted approach to vaccine development and then applies its deep understanding of vaccine science to develop prophylactic vaccines addressing these diseases. Valneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19. About IDT Biologika IDT Biologika is an innovative biotech company with a successful history dating back 100 years. On the basis of modern technologies and high levels of expertise, we support customers in the development and manufacture of innovative virus vaccines, gene and immune therapy products as well as biologics employed worldwide as protection against diseases. German sites are the BioPharmaPark in Dessau-Roßlau and Magdeburg. In the US, the IDT Corporation has a manufacturing site for clinical test samples in Rockville, Maryland.

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CELL AND GENE THERAPY

Sysmex and ThinkCyte Have Entered into An Agreement for Joint Development and Capital Alliance

Sysmex Corporation | May 17, 2021

Sysmex Corporation and ThinkCyte, Inc. announced today the signing of joint development and investment agreements for the commercialization of an AI-based cell analysis technology in May 2021. The development of novel testing and diagnostic technologies of high clinical utility is being pursued to improve the precision of diagnoses and maximize treatment as healthcare becomes more accurate and personalized at an increased pace - in combination with the advancement of technology. Meanwhile, telehealth, AI-powered medical imaging analysis, and automated testing of robots are all gaining traction in the healthcare industry. Sysmex has been acquiring technologies for studying cells, genes, and proteins with high accuracy and sensitivity on a proactive basis. A cell analysis platform is one of the technologies that has been used in a variety of Sysmex products. In this field, Sysmex's current emphasis is on developing technologies that specifically analyze cells using different types of information such as cell function and responsiveness, as well as seeking faster cell analysis. ThinkCyte has "Ghost Cytometry technology," which analyses morphological information of cells in a quick and simple process, while the information gathered by this technology is much richer than what can be collected using conventional flow cytometry (FCM) technique. This technology, in addition to counting and analyzing cells based on their basic morphological features, helps users to identify each cell based on its specific morphological details in terms of its characteristics and functions. This high-resolution analysis will allow for highly accurate clinical condition determination using body fluids such as blood, improve precision in a wide variety of cell-based diagnoses, and contribute to more personalized healthcare. On March 31, 2021, Sysmex and ThinkCyte signed a memorandum of understanding to begin full-fledged joint development of the novel AI-based cell analysis technology as a result of ongoing collaborative research between the two companies to increase the viability of applying Ghost Cytometry technology to diagnostic techniques of high clinical value. In addition, on May 1, 2021, the two companies agreed to collaborate on joint development, with the aim of commercializing cell analyzers and testing techniques based on Ghost Cytometry technology for cell analysis (including research) in the field of in-vitro diagnostics (IVD). Meanwhile, on May 11, 2021, Sysmex agreed to make an equity investment in ThinkCyte, which will enable the two companies to enhance their strong partnership. Sysmex and ThinkCyte have formed an alliance to develop novel cell analysis technology and research techniques by combining Sysmex's IVD capabilities with ThinkCyte's proprietary Ghost Cytometry technology, thereby contributing to the advancement and evolution of healthcare around the world. About Sysmex Corporation Sysmex works to contribute to the development of healthcare and people's healthy lives in accordance with its goal of "shaping the advancement of healthcare," as described in the Sysmex Group's corporate ideology, the "Sysmex Way." Sysmex performs integrated R&D, manufacturing, and sales, as well as providing support services for its in vitro blood, urine, and other bodily fluids testing instruments, reagents, and software. Sysmex's products are sold to medical institutions in over 190 countries and regions around the world. Sysmex has been expanding its business in the life science domain in recent years, using proprietary technologies to develop new testing and diagnostic value, provide healthcare personalized to individual patients, and help patients minimize burdens and improve quality of life.

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MEDTECH

Halo Labs Launches the Aura GT™ for Gene Therapy Product Quality

Halo Labs | October 05, 2021

Halo Labs, a life science instrumentation company developing tools for biologics researchers, today announced it has launched its latest product, Aura GT. Aura GT is part of the next generation in Halo Labs' popular family of instruments. Using Backgrounded Membrane Imaging (BMI) and Fluorescence Membrane Microscopy (FMM), Aura GT can distinguish aggregated capsids from contaminants, carrier proteins, and other particles that might adversely harm patients. Unique to Aura GT is the fact that it can also identify DNA leakage in gene therapy products so the mechanism of aggregation can be determined and corrected. Aura GT is going to completely revolutionize gene therapy product development. Gene therapy products are inherently unstable, which is a huge challenge. Up until now, there has been no effective way to correlate capsid aggregation with DNA leakage or empty and full capsids, In one assay, Aura GT can quantify capsid aggregates, distinguish them from protein aggregates, and determine if the aggregation is exacerbated by DNA leaking. - Bernardo Cordovez, Chief Science Officer at Halo Labs. We are very excited to be launching our second instrument this year specifically developed for the cell and gene therapy market, Halo Labs has quickly become a leader in gene therapy analytics because we can answer many questions with very little volume. While other subvisible particle analyzers only do one thing, Aura systems offer a complete multi-assay platform that can be used to fully characterize gene therapy products from early development through lot release. - Rick Gordon, CEO of Halo Labs. About Halo Labs Halo Labs in Burlingame, CA is a venture-backed scientific instrumentation and consumable company that commercializes high throughput biopharmaceutical formulation, stability, and product quality control tools for aggregate and subvisible particle analysis using state-of-the-art custom optics and image processing techniques. Biopharmaceutical companies around the globe depend on Halo Labs for unprecedented insights into their drug products.

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