CELL AND GENE THERAPY
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.
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.
Alloy Therapeutics | December 10, 2021
Alloy Therapeutics, a biotechnology ecosystem company, announced it has acquired deepCDR Biologics, a Basel, Switzerland-based developer of deep learning technology for antibody discovery and optimization. The team and technology stack will form new bioinformatics and machine learning capabilities for Alloy and will be fully integrated into Alloy Discovery Services complementary workflow and processes. Alloy will expand the Basel deepCDR site as a permanent Alloy research facility and will hire additional computational scientists and developers as it grows with the Alloy network.
The deepCDR engine combines deep sequencing and deep learning methods with a proprietary mammalian display process to select from a wide range of antibodies and rapidly identify candidates with the highest possible affinity and developability profiles. The company was a spinoff of ETH Zurich and Department of Biosystems Science and Engineering and was founded by Sai Reddy, an Associate Professor of Systems and Synthetic Immunology at ETH Zurich and an expert in immunogenomics and machine learning-guided protein engineering.
“Uniting deepCDR and Alloy reflects our conviction in the power of network effects and scientific collaboration—together our companies’ capabilities are amplified to better serve the global scientific community in its pursuit of finding the best medicines for patients. Our network of partners will be able to work with deepCDR’s machine learning engine in a way that otherwise would have been cost prohibitive or inaccessible. The ongoing technology improvements will enhance the output of Alloy platforms and Alloy Discovery Services for the benefit of all of our drug discovery partners.”
Alloy Therapeutics CEO and Founder Errik Anderson
DeepCDR’s technology will strengthen Alloy Discovery Services capabilities with patent-pending machine learning-powered antibody repertoire screening, in silico library screening, and mammalian display. DeepCDR thoughtfully integrates wet lab antibody screening and characterization with the computational tools to enable a powerful learning loop generating real world results. The deepCDR team will form Alloy’s new Basel, Switzerland operations and comprises expertise in antibody engineering and optimization, bioinformatics, and in silico library screening.
“We are thrilled to join Alloy on its mission of empowering scientific entrepreneurs and democratizing foundational drug discovery capabilities,” said deepCDR founder Sai Reddy. “The data sets and infrastructure within Alloy unlock powerful new opportunities for the deepCDR technology and team that will in turn enable us to help drug discovery teams more effectively and efficiently find the best antibody candidates. We envision a future where Alloy will be a leader in unifying real-world patient, genomic, and protein sequence data to empower integrated AI and ML drug discovery and engineering.”
About Alloy Therapeutics
Alloy Therapeutics is a biotechnology ecosystem company empowering the global scientific community to make better medicines together. Through a community of partners, Alloy democratizes access to tools, technologies, services, and company creation capabilities that are foundational for discovering and developing therapeutic biologics. The company facilitates affordable, non-exclusive access to the entire drug discovery community from academic scientists, small and medium biotech, to the largest biopharma. Alloy’s lead offering, the ATX-Gx™ platform, is a human therapeutic antibody discovery platform consisting of a growing suite of proprietary transgenic mice strains. Alloy is a leader in bispecific antibody discovery and engineering services, utilizing its proprietary ATX-CLC common light chain platform integrating novel transgenic mice and phage display. Alloy is headquartered in Boston, MA with labs in Cambridge, UK; Basel, CH; San Francisco, CA; and Athens, GA. As a reflection of Alloy’s relentless commitment to the scientific community, Alloy reinvests 100% of its revenue in innovation and access to innovation.
Maravai Lifesciences | August 25, 2020
Maravai LifeSciences, a global provider of life science reagents and services to researchers and biotech innovators, is expanding its contract development and manufacturing organization (CDMO) capabilities at TriLink BioTechnologies for the second time in less than a year. The expansion is expected to be completed in the first quarter of 2021 and will increase TriLink's small molecule manufacturing capacity with a focus on additional scale-up of CleanCap®, its proprietary messenger RNA (mRNA) capping technology, for global mRNA vaccine and therapeutic programs. To further address the increasing demand for mRNA development and clinical programs, the company is currently completing the construction of its plasmid DNA production facility as well. Last November, TriLink opened their new headquarters in San Diego, CA and expanded mRNA and small molecule capacity as it opened five Current Good Manufacturing Practice (cGMP) suites. The current investment will further expand the operation with an additional three cGMP suites and four cGMP manufacturing support suites.