Pharmaceutical Technology Editors

Alvea, a US-based startup biotechnology company, announced on Feb. 16, 2022 that it will begin to develop, test, and deliver DNA vaccines at scale to low- and middle-income countries that have limited access to existing vaccine options. The company has begun preclinical animal studies on a candidate.

Alvea aims to develop scalable, affordable, shelf-stable SARS-CoV-2 DNA vaccines, reduce vaccine inequity, and mitigate the risk of future global health threats, the company stated in a press release. Alvea is building a DNA vaccine platform with a specific focus on medical resource-limited settings. The company plans to complement current efforts and achieve global distribution.

The company’s platform is designed for massive scale-up of manufacturing and deployment using existing technologies and global facilities. The company has begun animal studies for a new vaccine candidate tailored to the BA.2 subvariant of the Omicron variant. The candidate is the first announced BA.2-specific vaccine to enter animal testing anywhere, according to the company press release. Overall, Alvea has two vaccine candidates in preclinical testing. The candidates are expected to enter human trials as early as April 2022.

Similar to messenger RNA (mRNA) vaccines, DNA vaccines cause a patient's cells to produce an antigen protein. DNA instructs patient cells to produce an antigen-coding mRNA. Unlike mRNA vaccines, however, DNA vaccines are stable at room temperature, thus making them easier to store and transport. This characteristic makes DNA vaccines a more viable solution for distributing and rapidly immunizing populations. In comparison, mRNA alternatives are inherently fragile and have proven difficult to deliver to remote parts of the globe.

DNA vaccines have been shown since the 1980s to be:

Simple: work with just two components—saline buffer and plasmid DNA

Scalable: take advantage of existing commodity plasmid DNA manufacturing capacity that exists around the world

Shelf-stable: are stable at room temperature for more than three months

Alvea is also working with partners and advisors to identify and address the complex technical, logistical, regulatory, and commercial issues that have slowed the distribution of other vaccines in low-income countries.

"What matters above all else is the time it takes to vaccinate the people most in need. Omicron/SARS-CoV-2 and future variants are a global problem and so long as a part of the world is left to wait, the suffering of this pandemic will continue and new variants will emerge," said Ethan Alley, co-CEO of Alvea, in the press release. "We are working day and night to develop Alveavax as fast and safely as humanly possible. We're aiming to have our platform be an option in the pandemic preparedness toolkit of countries that have not seen many doses."

"The Omicron variant spreads faster than the original SARS-CoV-2 and is deadly for the unvaccinated. While existing vaccine manufacturers have plans underway to develop Omicron-specific vaccines, several obstacles remain in their path, including distribution challenges in regions that have not seen vaccine doses yet," said Grigory Khimulya, co-CEO of Alvea and CEO of Telis Bioscience, a pandemic preparedness startup partnering with Alvea's vaccine development efforts, in the press release. "Speed is the decisive factor in pandemic response, and mRNA and other current vaccine efforts fall short of solving this. Proprietary methods and materials slow down manufacturing scale-up, and the need for low-temperature storage substantially delays distribution. In part because of these limitations, we're two years into the pandemic, and only 10 percent of people in low-income countries have had at least one vaccine dose."

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Alvea has begun preclinical testing of a scalable, shelf-stable DNA vaccine against SARS-CoV-2 variants.

Alvea to Develop New DNA Vaccine Against SARS-CoV-2 Variants

Moderna and Thermo Fisher announced on Feb. 23, 2022, that they have entered into a 15-year strategic collaboration agreement for the dedicated, large-scale manufacturing of Spikevax, Moderna’s COVID-19 vaccine, in the United States. The agreement also applies to other investigational messenger RNA (mRNA) therapeutic candidates in Moderna’s pipeline.

Thermo Fisher has been partners with Moderna over the past several years to support Moderna’s development pipeline with both clinical research and contract manufacturing services. The partnership included the quick scale-up of aseptic fill/finish services and packaging of Moderna’s COVID-19 vaccine.

As part of the current, expanded agreement, Thermo Fisher will now provide dedicated capacity for a range of aseptic fill/finish services. These services include lyophilized and liquid filling. Furthermore, Thermo Fisher will provide inspection, labeling, and final packaging services.

“We are pleased to further expand our collaboration with Thermo Fisher as a long-term manufacturing partner that will enable us to continue to build on our mRNA platform and pipeline,” said Juan Andres, Moderna's chief technical operations and quality officer, in a company press release.

"Moderna’s innovation in mRNA technology has been pivotal in the global response to the pandemic and we are proud and privileged to support Moderna over the [p]ast decade,” said Michel Lagarde, executive vice-president and chief operating officer of Thermo Fisher Scientific, in the press release. “In expanding our strategic partnership, Moderna will further leverage our scale and depth of capabilities to continue to transform its mRNA platform and bring new breakthrough medicines to patients around the world."

Moderna and Thermo Fisher Scientific have formed a collaboration to leverage dedicated commercial fill/finish manufacturing capacity in the US for mRNA vaccines and therapies.

Moderna and Thermo Fisher Scientific Form Long-Term Strategic Manufacturing Collaboration

Sanofi and GlaxoSmithKline (GSK) announced on Feb. 23, 2022 that they intend to submit data from both their booster and Phase 3 efficacy trials to support regulatory authorizations applications to FDA and the European Medicines Agency (EMA) for a COVID-19 vaccine.

The Sanofi-GSK vaccine is refrigerator temperature-stable and protein-based. The Sanofi-GSK booster vaccine induced a significant increase in neutralizing antibodies across vaccine platforms and age groups in participants who had already received an authorized mRNA or adenovirus vaccine. When the Sanofi-GSK vaccine was used as a two-dose primary series followed by a booster dose, neutralizing antibodies increased significantly compared to pre-boost levels.

“We’re very pleased with these data, which confirm our strong science and the benefits of our COVID-19 vaccine,” stated Thomas Triomphe, executive vice president of Sanofi Vaccines, in the press release. “The Sanofi-GSK vaccine demonstrates a universal ability to boost all platforms and across all ages. We also observed robust efficacy of the vaccine as a primary series in today’s challenging epidemiological environment. No other global Phase 3 efficacy study has been undertaken during this period with so many variants of concern, including Omicron, and these efficacy data are similar to the recent clinical data from authorized vaccines.”

Sanofi and GSK announce they are seeking regulatory authorization for COVID-19 vaccine.

Sanofi and GSK to Seek Regulatory Authorization for COVID-19 Vaccine

Novavax, a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, announced on Feb. 23, 2022 that the first doses of its Nuvaxovid COVID-19 vaccine have begun shipping to European Union (EU) member states. Nuvaxovid is the first protein-based COVID-19 vaccine authorized for use in Europe.

Nuvaxovid doses are shipping from Novavax’ Netherlands distribution center to EU member states. The first wave of shipments includes several countries, such as Germany, France, and Austria, with shipments to additional EU member states to quickly follow.

The European Commission (EC) granted conditional marketing authorization (CMA) for Nuvaxovid to prevent COVID-19 caused by SARS-Cov-2 in individuals 18 years of age or older. The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) recommended authorization of the vaccine in all 27 EU member states in 

"Today's announcement paves the way for vaccination with Nuvaxovid to begin in Europe within the coming days. The Novavax COVID-19 vaccine provides a differentiated option to bolster vaccination rates across Europe," said Stanley C. Erck, president and CEO of Novavax, in the press release. "Nuvaxovid has demonstrated efficacy, a reassuring safety and tolerability profile, and is built on a well-understood protein-based vaccine platform used for other vaccines for decades."

Novavax announces the first doses of Nuvaxovid COVID-19 vaccine have begun shipping to European Union member states.

Novavax Begins Shipping its COVID-19 Vaccine to European Union Member States

The Center for Breakthrough Medicines (CBM) announced on Feb. 23, 2022 that it has formed a strategic alliance with BioAnalysis LLC (BIA) to provide CBM’s clients with direct access to BIA’s advanced testing capabilities, including characterization of viral vectors using BIA’s proprietary sedimentation velocity approach to analytical ultracentrification, as well as other advanced biophysical methods and analytics.

CBM is a horizontally integrated cell and gene therapy (CGT) contract development and manufacturing organization (CDMO). Bioanalysis LLC is a non-clinical contract research organization (CRO) that specializes in biophysics and mass spectrometry applications for gene therapy, monoclonal antibodies, therapeutic proteins, antibody drug conjugates, and nanoparticles.

Through the alliance, CBM will gain scientific and data analysis from BIA founder and principal scientist, Dr. Lake Paul. The agreement will be a resource for CBM’s clients in need of assay and method development as well as a current good manufacturing practice compliant laboratory for characterization and advanced analytical methods.

"We could not be more delighted to partner with Dr. Paul and the BIA team—the next generation testing capabilities they bring to the table for CBM's innovator clients will be a game-changer," said Dana Cipriano, Senior Vice President of Testing and Analytical Services at Center for Breakthrough Medicines, in the press release.

"As a CDMO collaborator, BIA has found the perfect match in CBM," added Dr. Paul. "Our testing capabilities are unrivaled, and the sophisticated innovator clientele CBM connects with BIA will be a true differentiator in the CGT analytical testing space."

The Center for Breakthrough Medicines and BioAnalysis LLC have formed a strategic alliance to offer novel analytical testing services for CGT clients.

Center for Breakthrough Medicines and BioAnalysis LLC Form Partnership to Offer Novel Analytical Testing Services for CGT Clients

Semarion Ltd, a University of Cambridge spin-out company from the Cavendish Laboratory combining materials engineering and cell biology to tackle unmet drug screening needs, announced that it has closed a £2.14 million GBP seed funding round on Feb. 22, 2022. Parkwalk Advisors led the investment round, alongside contributors Martlet Capital, the University of Cambridge Seed Funds, and angel investors.

The funding will support recruitment, commercial partnerships, and further development of Semarion’s SemaCyte cell assaying platform, which turns adherent cells into liquid reagents to enable novel drug screening methodologies.

SemaCytes, developed by Semarion, are a novel class of cell carrier materials, created using microchip fabrication technologies, nanomagnetism, and smart materials. These assaying microcarriers function as ultra-miniaturized, magnetically steerable wells that carry small colonies of adherent cells into suspension to improve cell-based experiments. They enable the controlled movement of cell types, which need to stick to a surface, namely those typically used for in vitro drug screening work.

According to the press release, this technology improves the quality and reproducibility of cell screening data while reducing the time and cost to deliver research outputs.

“This is a crucial step towards the commercialization of our SemaCyte cell assaying platform,” said Jeroen Verheyen, co-founder and CEO of Semarion, in the press release. “We were excited to see our product testers appreciate its truly unique features. We aim to keep working closely with biopharma partners to address their unmet cell screening needs. I would like to thank all our investors and supporters for believing in the Semarion team and the SemaCyte technology.”

Semarion raises £2.14 million GBP (US$2.89 million) seed funding to support the commercial development of Semarion’s SemaCyte cell assaying platform.
