HDT Bio and UTMB partner against CCHFV and NiV

HDT Bio and UTMB partner against CCHFV and NiV

In November 2022 HDT Bio Corp. and the University of Texas Medical Branch (UTMB) revealed that they had been awarded a project agreement worth up to $87.4 million. The US Department of Defence’s (DOD) Joint Programme Executive Office for Chemical, Biological, Radiological, and Nuclear Defence (JPEO-CBRND) and BARDA have awarded this for the “development of a vaccine technology against advanced and emerging viral threats”. The two viruses that will be targeted specifically are Crimean-Congo haemorrhagic fever virus (CCHFV) and Nipah virus (NiV) for their “significance to military personnel”.  

Phase I funding 

UTMB has reportedly partnered with HDT Bio to “leverage the company’s self-amplifying RNA (saRNA) vaccine platform technology and proprietary LION delivery system”. The project will cover the development of vaccine candidates, HDT-321 (CCHFV) and HDT-331 (NiV) through Phase I clinical trials. HDT Bio will receive $49 million as a “sub-performer” for the development of these vaccine candidates.  

HDT Bio CEO Steve Reed is “grateful” to DOD and HHS for their support.  

“We look forward to working with our partners and the MCDC to protect our military personnel and the American people as a whole from biological threats”.  

Two zoonotic threats 

The CDC states that CCHF is caused by infection with a tick-borne virus (Nairovirus) of the Bunyaviridae family. It was first identified in the Crimea in 1944 and later recognised in 1969 as the cause of illness in the Congo. It is found across Europe, Africa, the Middle East, and the Indian subcontinent. The death rate ranges from 9% to 50%.  

NiV is associated with mild illness to encephalitis to death. Fruit bats are the animal reservoir. The CDC suggests that outbreaks occur “almost annually” in parts of Asia. HDT Bio indicates that death rates can be up to 61%.  

“Both of the viruses contain multiple antigen targets that have previously been associated with protective immunity, which affords an opportunity to design and develop vaccines against more than one vulnerability using a multi-antigen approach.” 

Shifting vaccination approaches 

UTMB Co-PI Dr Robert Cross suggests that the COVID-19 pandemic has “clearly demonstrated” a “shift” in vaccination approaches. RNA-based vaccines were “instrumental” in this pandemic and can be applied to “other high priority viruses with pandemic potential”. For HDT Bio’s PI, Dr Jesse Erasmus, “next-generation technologies are urgently needed” to fight diseases in a “safe and tolerable manner”.  

“With the recent emergency use authorisation of our LION/saRNA platform for COVID-19, the first saRNA technology to reach this milestone, we are poised to unlock this modality’s dose-sparing capacity to achieve multi-target protective immunity in humans.”  

For more on emerging infectious diseases and how vaccines can address them, come to the World Vaccine Congress in Washington next year.  

 

PharmaJet announces grant from NIH for HPV

PharmaJet announces grant from NIH for HPV

In November 2022 PharmaJet announced that it had received an NIH grant of $800,000 towards their Phase II investigation of the immunogenicity of intradermal administration of a human papillomavirus (HPV) vaccine. Using PharmaJet’s Tropis intradermal (ID) needle-free injection system (NFIS), the study will compare this method against traditional needle and syringe administration.  

HPV in Indonesia 

The study takes place in Indonesia, in collaboration with Padjadjaran University. The WHO suggests that more than 95% of cervical cancer is due to HPV. In Indonesia, cervical cancer is the 2nd leading cause of female cancer, according to HPV Information Centre. An estimated 36,600 new cervical cancer cases are diagnosed each year in Indonesia.  

Of the 342,000 deaths believed to be caused by cervical cancer in 2020, roughly 90% occurred in low- and middle-income countries. PharmaJet suggests that this is due to “limited access to preventative measures” and late identification. Furthermore, treatment options may be limited in these areas.  

The study 

The study will aim to recruit around 900 girls, between the ages of 9 and 14, at the start of 2023. This comes after preliminary studies have evaluated intradermal delivery for HPV vaccines. Intradermal administration is already “widely used” for polio vaccine delivery. It has been found to be “safe, effective, and immunogenic”.  

Why PharmaJet? 

PharmaJet identifies its mission as to “enable greater access to life improving pharmaceuticals.  

“We are committed to helping our partners realise their research and commercialisation goals while making an impact on public health.” 

Vice President of Clinical and Regulatory Affairs, Dr Erin Spiegel, is “pleased to receive this grant from the NIH”.  

“Intradermal administration of vaccines can provide benefits for low resource settings including lower costs, increased coverage, and increased acceptability.”  

Dr Spiegel outlined some of the benefits of PharmaJet’s system in our recent interview at the World Vaccine Congress in Europe 2022. To learn more, watch it here.  

We look forward to hearing more from PharmaJet at the World Vaccine Congress in Washington in April 2023. Get your tickets to join us there.  

CEPI collaboration with UQ on Disease X platform

CEPI collaboration with UQ on Disease X platform

In November 2022 CEPI announced an investment of U$5.7 million towards the development of a second-generation molecular clamp vaccine platform at the University of Queensland (UQ). This platform will be aimed at “combatting the next Disease X”. The funds will contribute to the testing of “promising technology” for use in a global response to future disease outbreaks.  

Clamp 2 

Molecular clamp technology works by “locking viral proteins” into a shape that facilitates “optimal immune response”. It requires the sequence of the viral protein, determined from its genome, which is then “coupled with an optimised ‘clamp’ sequence”. CEPI describes how the “resulting synthetic antigen” can be purified and “rapidly manufactured” into a vaccine.  

The team at UQ has spent months re-engineering a previous molecular clamp technology and demonstrating its safety in lab tests.  

Previous clamp attempts 

In January 2019 CEPI entered a partnering agreement with UQ to develop a molecular clamp vaccine platform. With the arrival of SARS-CoV-2 in late 2019, CEPI and UQ began work on vaccines against the virus. In July 2020 the team had started clinical testing of a vaccine candidate. Unfortunately, scientists at UQ discovered that a “constituent of the vaccine” also resulted in “diagnostic interference with some HIV tests”. Thus, further development was halted.  

“Nevertheless, CEPI believed that the concepts underlying UQ’s molecular clamp technology showed great promise.”  

Vaccine equity through technology 

Committed to equitable access, CEPI has ensured that UQ agrees to make vaccine candidates available in outbreak situations to “populations at risk”. Jane Halton, Chair of CEPI, described the important role that the Australian Government and R&D sector are playing in “bolstering future pandemic preparedness”. Dr Melanie Saville, Executive Director of Vaccine R&D at CEPI identified the “true grit” and the “power of the scientific process” at play in this research.  

“This second-generation molecular clamp vaccine technology could provide the world with an invaluable tool to rapidly respond to future pandemic threats.”  

She hopes to “mitigate the devastating” effects of future pandemics with this collaboration. The leader of UQ’s Rapid Response Vaccine Pipeline is Associate Professor Keith Chappell. He displayed gratitude for the “continuing support from CEPI” as well as the governments and “philanthropic partners”.  

“Pre-clinical testing had shown the ‘Clamp2’ platform was meeting all expectations, producing stabilised antigens, and inducing strong neutralising immune responses”.  

To hear more about global preparations for Disease X at the World Vaccine Congress in Washington in April, get your tickets now.  

Exclusive interview with Dr Ariel Weinberger

Exclusive interview with Dr Ariel Weinberger

With the World Vaccine and Immunotherapy Congress kicking off in San Diego today we are delighted to share another exclusive interview with the community. We were lucky to hear from Dr Ariel Weinberger, founder and CEO of Autonomous Therapeutics since 2017. Autonomous is a “scientist-led company” working on the development of the “first variant-proof RNA therapeutics”. Looking ahead, the team is hoping to create “effective countermeasures” before the next pandemic.

The consequences of the mRNA revolution for therapeutics

As mRNA entered its heyday during the COVID-19 pandemic, scientists and industry leaders rushed to make the most of the emerging potential. We asked Dr Weinberger about how the storming success of the mRNA vaccines might influence therapeutic interventions, and what challenges might be associated with an mRNA-based future. He began by suggesting that the “comparison to mRNA vaccines highlights a number of the challenges faced by mRNA therapeutics”.

Vaccines vs therapeutics

“If you think about vaccines, a core idea is to harness the body’s adaptive immune system for both signal amplification and memory. So, a relatively small vaccine dose can, in principle, confer immunity for years—although, of course, that hasn’t yet been the outcome for COVID-19 vaccines.”

Dr Weinberger explained that “the barriers for mRNA therapeutics arise, in large part, because they cannot leverage the body’s adaptive immune system for amplification and persistence”.

 “As a result, you often need to administer far higher therapeutic doses—a recent review noted that mRNA doses are often 100 to 1000-fold higher for therapeutics than vaccines. And you may need to administer those doses repeatedly, because current RNA technologies can degrade in hours to days. And there’s another barrier: current RNAs, including those delivered in lipid nanoparticles, can lead to substantial immunogenicity. This may provide an adjuvant advantage for vaccines, but it’s unfortunately an additional way to accelerate the loss of therapeutic RNA.”

Despite the challenges, Dr. Weinberger believes that mRNA therapeutics are likely to succeed.

“It’s worth noting that these challenges were previously overcome for siRNA therapeutics. The drug that comes to mind is Alnylam’s Onpattro. So, there’s a clear precedent for believing that we’ll find solutions for mRNA therapeutics, too.”

Mining opportunities

We then asked Dr Weinberger about the opportunities for mRNA therapeutics, and how he understands a next-generation approach will enable us to use them. In his answer he highlighted the importance of “novel technologies” to “tackle the barriers” he explored above. He is particularly excited to encounter some of these next-generation mRNA technologies at the Congress (he gets brownie points for being enthusiastic about other people’s sessions)!

For example, self-amplifying RNAs are being developed to directly amplify RNA in vivo, circular RNAs are being developed to enhance RNA persistence, and novel transcription and purification strategies are being developed to minimise inherent RNA immunogenicity. But I also think that some of the greatest opportunities of mRNA technologies may be paradigmatically different. If you think about it, current mRNA therapies are often focused on producing proteins in vivo. I think a fair question is: “why don’t you just deliver the protein directly’? We may not like asking that question in the mRNA field, but we clearly have to—since some of our competitors are in the protein field.

Asking the right questions

Once this question has been asked, Dr Weinberger has another for his colleagues: “what can we do with mRNA therapeutics that we can’t do with proteins?” He suggests that “if we can answer that question, we have a potential path to developing next-generation drugs that weren’t previously possible”.

“Here are some examples. I think about proteins that are extremely difficult to produce, purify, or effectively deliver—for example, transmembrane proteins. Or therapeutic proteins that you don’t want to express constitutively and systemically, but that are life-saving in certain contexts. Ultimately, I think about how mRNA could be used as a circuit board to precisely control therapeutic protein production both temporally and spatially.

For Dr Weinberger, mRNA “2.0” moves from “plug-and-play production to plug-and-play control”.

“There are a few companies already thinking about this in the cancer context—imagine if we could localise chemotherapies or immunotherapies—and I think there will be more from cancers to autoimmune diseases.”

Autonomous’ pandemic protection against the unknown

We identified on Autonomous’ website the intention to develop countermeasures “before” the next pandemic. So, naturally, we were curious to understand how this works. First and foremost, Dr Weinberger was keen to emphasise that they’re not trying to “predict the future”.

“Before I started Autonomous, I spent years mathematically modelling the evolution and spread of pandemic viruses. And the lesson I kept learning is that you can’t predict a stochastic process with scores of unmeasurable parameters and “heavy” tails to the level of detail that you need to develop an effective precision therapy in advance. And even if we could know the random genotype of a future viral variant, we wouldn’t have a way to map its pandemic potential. Some have proposed using new AI approaches to solve these problems—but the pandemic prediction problem is likely a lot less tractable (and deterministic) than problems in, say, computer vision where AI has changed the world.”

For Dr Weinberger, the solution is “to develop broad-spectrum or variant-proof countermeasures that can control whatever viral variant ultimately emerges—even if the precise genomic confirmation of that variant is frankly unpredictable months to years in advance”.

How can we do this?

“One option is to target the part of the system that doesn’t change from virus to virus: the host.  And we’ve seen a ton of recent interest in host-directed therapeutics; I think it’s an extremely promising avenue. The concern has always been that targeting the host means targeting the host, and raises the spectre of toxicity”.

 

“The other approach is to find the kernels of viral genomes or proteins that don’t change from virus to virus. These conserved viral elements are not likely to be in the Spike or receptor-binding proteins of a virus that vaccines generally target—those proteins are under too much diversifying selection from the immune system. In fact, the conserved regions that we want to target are often the regions that are the least well-suited for vaccine and antibody approaches.  But these regions can be targeted using RNA technologies.”

Although there is “too much viral genomic diversity” for us to be able to develop a single virus-targeted drug, Dr Weinberger suggests that we “find elements that are conserved within a viral genus or species”.

“For example, we can find targets that are conserved across all the variants of SARS-CoV-2 or across all influenza variants. And then we have the possibility of developing countermeasures that don’t lose efficacy every 6 months—and that can be effectively administered for lifetimes. More broadly, we have the possibility of pre-developing an armamentarium of pan-variant countermeasures for each major viral family. That’s what Autonomous uses RNA to do.”

Money matters

As terribly vulgar as it is to discuss money, in some situations curiosity just gets the better of us. Particularly in a post-pandemic world, we wondered what the funding landscape looks like for early-stage companies. Dr Weinberger thinks that “substantial funding will remain in the space, at least in the near term”. Although there is “always some reversion”, as the money moves where the “next hottest thing” is, he believes that “financial incentives are hard to ignore for an investor”.

“You’re talking about $75B that’s likely to be grossed for COVID this year alone by just two companies (and we keep hearing that the pandemic is over). At the same time, these numbers were clear before the pandemic. The market sizes for viral pathogens with pandemic potential are (unfortunately) massive. And there were already blockbuster returns for earlier antivirals and vaccines—from HIV and HCV to HPV.”

Taking responsibility

“I think that some of the historical shortfalls for antiviral and vaccine funding have also been on us: the companies. We haven’t always been developing new classes of approaches that offer major benefits over state-of-the-art strategies. How many similar monoclonal antibody or Spike vaccine approaches can we keep funding? More fundamentally, some of the issues have been at the Government and academic level. If we keep funding the same sorts of basic science studies, we’ll get more of the same translational products, and less of the same investment funding.”

 

“My view is that new classes of drugs and vaccines for major market indications will always have substantial investor interest—and that’ll especially be the case in the ID space after COVID. It’s just that you have established biopharma companies that have already developed and clinically tested existing products. The bar is high: you have to disrupt and supplant these existing approaches to enable the kinds of potential returns that would really excite investors.”

Future threats

Eventually our conversation turned to the future, and what we should be most worried about, or invested in. As Dr Weinberger specialises in viruses, he believes, for “good reason” that these the “critical global health threats”. Previously, he suggested that “we can’t predict the next outcome of a random process”. We don’t know if the next pandemic will be “another flu, COVID, or an entirely different pathogen”.

“I think that we can fairly assume that there are going to be more viral pandemics – we’re still in one. And many of the pandemic strains that emerge will likely be close relatives (i.e. variants) of viruses that have previously infected large numbers of humans. After all, these viruses have already crossed the major evolutionary barrier: transmission across humans. To me, the critical threat is that the next pandemic variant is again untreatable or is resistant to all approved therapeutics and vaccines. In other words, after years of COVID and millions of deaths, we could be back in March 2020 all over again.”

 

“Sure, new platform technologies (including mRNA) could speed up response times—so maybe we’ll have an authorised vaccine or monoclonal antibody in 6 months. But we know that’s six months too late and that it’s fundamentally impossible to develop, clinically test, and manufacture a new countermeasure faster than a pandemic virus can spread.”

Final thoughts

So, fail to prepare and prepare to fail. Thankfully, Dr Weinberger and his colleagues are working to prepare for future threats. It’s encouraging to hear that some of hard lessons from COVID-19 have been taken on board.

“We were based in New York City in March 2020. Being in that environment is something that you never forget. People felt helpless and knew that there were few medical countermeasures for them or their families if an infection took a turn for the worse. It’s incumbent on us to do everything possible to make sure that doesn’t happen again.”

It was a pleasure to hear from Dr Weinberger, and we are so grateful that he put so much thought into his answers. To participate in his roundtable at the World Vaccine and Immunotherapy Congress this week make sure you sign up in advance – it is surely not to be missed!

To read the full interview see here:

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Exclusive interview with Dr Erin Spiegel

Exclusive interview with Dr Erin Spiegel

While we were in Barcelona this year for the World Vaccine Congress 2022 we had the exciting opportunity to meet Dr Erin Spiegel, Vice President of Clinical and Regulatory affairs at PharmaJet. We have previously encountered PharmaJet’s technology in efforts against Polio, so it was fantastic to learn a bit more about the potential it offers. Dr Spiegel’s session at the Congress explored some of the challenges (and solutions) associated with nucleic acid vaccine delivery. We are grateful that she was able to make time to speak to us!

PharmaJet

We began by asking Dr Spiegel a little bit about herself and PharmaJet for anyone who might not know what they are working on. As VP of Clinical and Regulatory affairs she brings a wealth of scientific and regulatory experience to the role. She told us that PharmaJet’s needle-free devices are “used pretty widely” but are most effective for “nucleic acid based vaccines”.

 

Needle-free technology

Needle-free technology sounds like an exciting prospect, and we asked Dr Spiegel about its potential applications. As a “geneticist by training” she is most excited about the “impact” that it can have on “DNA based vaccines in particular”. She tells us that “historically, DNA based vaccines and therapeutics, and gene therapies even have needed a vehicle or delivery device system”. However, PharmaJet is hoping to sidestep this, avoiding the need for electricity, for example. Furthermore, handheld devices can be used in more “remote locations” for a “much bigger” reach.

 

Addressing vaccine hesitancy

Another potential benefit to needle-free technology is the potential to address genuine vaccine fears. These contribute to vaccine hesitancy. For Dr Spiegel, the “intradermal platform” creates a “basically pain free” process. On top of this, it provides a work around the fear of needles, leaving “not a lot to be afraid of”. Finally, the “small handheld device” is unthreatening, and will have benefits for vaccinating children in particular.

 

Sustainability

One of the most pressing challenges that faces the whole vaccine industry is sustainability. As innovation is clearly part of the process for PharmaJet, we wanted to learn how this factors in. Dr Spiegel told us that they consider themselves to be operating in a “pretty sustainable” fashion. Working in two different countries, or continents even, they have established “high throughput manufacturing” of the systems. The injectors themselves are “reusable through 20,000 injections”.  This is far better than single-use solutions!

 

Technological advances

For a company like PharmaJet, things are moving quickly, and as many of us have recently become aware, the vaccine space is responding to frequently developing scientific knowledge with amazing technology. We asked Dr Spiegel what recent advances have shaped her work. She identifies advances in both DNA and RNA based technologies. As we saw in COVID, the RNA is moving quickly, but she suggests DNA is not far behind.

For example, “modifications” can be made to plasmids, and the DNA itself. In some instances, the “bacterial origins of replication” can be eliminated. The effects of these advances are great both for the “cold chain portion of delivery” but also the “cost of manufacturing”. Thus, the overall vaccine product can become “much more accessible”.

 

The Congress

As always we love to know what brings our amazing scientist and industry representative to us. For Dr Spiegel, the panel discussion was the big draw. It was an opportunity to discuss some of the ideas she explored in this interview, such as advancing DNA based vaccines, and taking things to the “next stage”. She seemed particularly enthused about working with colleagues to get vaccines to people, particularly children, in “every remote location” with “not much trouble”.

 

It was a privilege to speak to Dr Spiegel at this year’s event. We look forward to hearing from PharmaJet again in April next year at the World Vaccine Congress in Washington. Get your tickets now to join us there!

A very modern challenge: The Human Immunome Project

A very modern challenge: The Human Immunome Project

“Pioneering a new era of human health”, scientists at the Human Immune Project are tackling “one of the greatest remaining frontiers”: the human immune system. Formerly known as the Human Vaccines Project, and modelled after the Human Genome Project, they are “unlocking the mechanisms of human immunity”. Their aim is to “transform how we fight our most devastating diseases” and their methods combine systems biology and artificial intelligence. In this piece we take a closer look at who they are and what they do.  

The future of immunity 

The HIP identifies a major challenge in vaccine research: the “limits of scientific knowledge”. Fighting “insidious and biologically complex diseases” is no mean feat, and examples of HIV, tuberculosis, and various cancers underpin the difficulty we face. Furthermore, as we prepare blindly for the next pandemic, we can only make (reasonably scientific) guesses at what it might bring.  

“A new approach is necessary now, one that is rooted in identifying and understanding the common elements of the human immune system that overlap across global populations and that allow us to harness this knowledge and the collective intelligence of scientists”  

Recognising this need, the HIP is putting “breakthrough advances in biomedicine merged with AI” into the hands of the “world’s top scientists”.   Across a worldwide network, partners are “compiling the biggest dataset of biomedicine at a population scale”. With this, an AI model of the immune system can be created, to accelerate and reduce the cost of vaccine and treatment development.  

“Our goal is nothing short of enabling people to live much healthier – and longer – lives.”  

A helping hand from AI  

Dr Wayne Koff is the President and CEO of the Human Immunome Project. He describes everyone’s immune system as “unique” but asks why vaccines can be 90% effective at protecting against disease.  

“Our task is to develop a model or a series of models that will eventually be able to explain this and that will eventually allow us to predict how the immune system will respond to pathogens, vaccines, drugs, and immunotherapies.”  

The task will be made possible with the power of AI and deep learning. A platform known as AlphaFold is already solving protein structures in rapid time. Further possibilities include ever improving interpretation of retinal imaging to predict risks of disease. For Dr Koff, this is “extraordinary”.  

“All of this is giving us new opportunities.” 

Writing for the Human Immunome Project, Kristen Jill Abboud suggests that AI can “accelerate and vastly improve the use of in silico studies to prioritise vaccines or therapies without the need for large clinical trials”. The Project is therefore working to “develop and implement” a plan with partners. The future looks bright for the project but will need careful consideration and collaboration. Part of this will involve a “consensus on how immunome data should be generated, accessed, and managed”. With “social and ethical implications”, the project certainly has its work cut out! 

Dr Wayne Koff is on the Scientific Advisory Board for both the World Vaccine and Immunotherapy Congress in November 2022, and the World Vaccine Congress in April 2023. To join us at either event get your tickets now.  

 

GSK Shingrix vaccine success drives ¾ revenues

GSK Shingrix vaccine success drives ¾ revenues

A November press release from GSK indicates a rise in revenue and profit, attributed to its Shingrix vaccine for shingles. Pharmaphorum suggests that, since the “spin-off” from Haleon in July it has “exceeded analysts’ estimates”.  

Positive quarter 

GSK recorded an 18% increase in revenue to £7.8 billion and an 18% operating profit increase to £2.6 billion. It now predicts further sales growth of between 8% and 10%. Pharmaphorum describes how Shingrix “generated sales of £760 million” in the quarter. This is up 51% and “around $75 million ahead of expectations”.  

Shingrix 

Shingrix is a shingles (herpes zoster) and post-herpetic neuralgia vaccine that the EMA recommends for adults over the age of 50 or for adults at higher risk over the age of 18. The EMA suggests that it is designed to “prevent shingles in people who have been in contact with the varicella zoster virus and have already developed antibodies against the virus”. With surface antigens and an adjuvant, the vaccine is expected to encourage faster antibody development in patients. GSK expects “strong double-digit growth and record sales in 2022” for Shingrix. This is based on demand in existing markets and continued geographical expansion”.  

Dame Emma Walmsley, GSK’s CEO, described the quarter’s performance as “excellent”. She looks forwards to “Shingrix global expansion” and “expected new launches including our new RSV vaccine”.  

“We are also making good progress to strengthen our early-stage pipeline and will continue to invest in targeted business development to build optionality and support growth in the second half of the decade.” 

For more from GSK at the World Vaccine Congress in Washington 2023 get your tickets now.
 

Vaxxinity platform aims to conquer chronic diseases

Vaxxinity platform aims to conquer chronic diseases

Migraines affect an estimated 10% of people worldwide, causing severe headaches and other symptoms such as light sensitivity, nausea, and vomiting. The WHO reports that migraines are “more common in women, usually by a factor of about 2:1”. This is attributed to “hormonal influences”. However, labiotech.eu suggests that, like other diseases that “primarily affect women”, migraines have been “overlooked” for several reasons such as “gender biases in research and diagnoses”. Hoping to change the narrative is US-based biotech Vaxxinity. Using novel technology and the benefits of vaccine delivery, Vaxxinity is targeting chronic conditions like migraines with the intention of producing affordable solutions.  

What do we currently have? 

At present, treatment for migraines will generally involve anti-inflammatory painkillers, but these are often “discontinued” by 80% of patients after 12 months. Other therapeutic options include monoclonal antibodies (mAbs), which block calcitonin gene-related peptide (CGRP). This is an effective but inaccessible solution. Labiotech.eu suggests that mAbs are “dominating the drug development landscape”, particularly in the US.  

“However, mAbs are difficult to manufacture and administer, and carry a hefty price tag that has made them globally inaccessible”.  

Thus, the need for new and more financially sustainable options is pressing. 

Vaxxinity’s mission 

Speaking to PharmaVoice’s Woman of the Week podcast, Hu described Vaxxinity’s “North Star”.  

“we want to bring the efficiency of vaccines to chronic diseases – basically a third biologic revolution…And these vaccines would be accessible to everyone.” 

In order to make this a reality, Hu’s team is using a platform that uses synthetic peptides to provoke the immune system to develop antibodies. She suggests that the “concept is very similar to other vaccines”. 

“The difference is that traditional vaccines will fight against foreign infections. Our vaccines are designed to harness the immune system.”  

Implementing the mission

Vaxxinity’s platform “turns the body into its own antibody factory against self-antigens of chronic diseases”, Hu explained to labiotech.eu. Although the immune system is “very smart” and avoids self-destructive attacks, they have overcome this protective mechanism by “presenting the self-antigen as a threat”.  

“If we imagine the sheep as the self-antigen, which the body does not respond to, we can dress it up in just enough wolf’s clothing that when the body first sees it, it sounds alarm bells”.  

In Hu’s metaphor the wolf’s clothing is borrowed from Vaxxinity’s “proprietary library of synthetic T helper cells”. These “mimic highly promiscuous epitopes” that the body recognises as a threat. Instead of manufacturing mAbs outside the body, this approach “teaches your body to become [a] bioreactor and produce these antibodies on its own”. 

Migraines solutions 

This approach can be applied to the blocking of CGRP. The UB-313 vaccine “teaches your body” to target and suppress this, which is associated with a reduction in migraine frequency. CGRP is also connected to other functions in the body, so there might be safety concerns. However, Hu is confident in the data that is already available, which shows “very good safety”.   

Why vaccines? 

Compared to mAbs, vaccines have a greater durability and lower cost. Furthermore, the synthetic peptide-based vaccines are easier, and more stable, to scale up.  

“Generally, our cost of goods is less than 1% that of mAbs.”  

Although there are drugs that have been shown to work quickly and effectively, they are simply too expensive. Hu describes “Vaxxinity’s vision” as allowing patients to “reclaim their lives”. With an infrequent and less expensive treatment, she hopes they will be the go-to solution.

“The convenience and longer lasting effectiveness makes the vaccine attractive”.  

With other chronic diseases on the table, this technology has the potential to support millions of patients. To hear more from Mei Mei Hu on Vaxxinity’s progress and plans at the World Vaccine Congress in Washington 2023, get your tickets now.  

Sanofi deploys Dassault’s virtual twin experiences

Sanofi deploys Dassault’s virtual twin experiences

In October 2022 Sanofi and Dassault Systemes announced a partnership to optimise Sanofi’s “EVolutive Facilities” (EVF). These are “state-of-the-art” manufacturing sites powered by “big data and digital”, and Sanofi describes them as the “future of vaccine manufacturing”.  

EVFs 

Sanofi is currently constructing two EVFs in Singapore and France. The company indicates that these will increase capacity at the same time as “making production more flexible and respectful of the environment”. The benefits that Sanofi identifies range from efficiency to sustainability.  

  • Up to 4 vaccines can be produced simultaneously on the same production site 
  • It will take about 12 days to go from producing one vaccine to another 
  • Nearly carbon-neutral using green electricity or power from the site’s own solar panels 
Dassault Systemes 

Dassault’s “Made to Cure for BioPharma” industry solution experience will “design, implement, qualify, and operate modular production lines” at the EVFs. Dassault indicated that a “virtual twin” will allow Sanofi to “visualise and simulate the recipe, equipment, and consumables that a particular process requires”. Dr Claire Biot of Dassault Systemes suggests that the pandemic highlighted the importance of BioPharmas being able to “maximise efficiency and quickly provide high-quality, innovative therapeutics to patients worldwide”.  

“Sanofi is responding to this challenge with next generation modular manufacturing that can transform the speed at which products reach patients.”  

Ana Alves, EVolutive Facility GLobal Project Head & Site Head of Neuville sur Saone, Sanofi, emphasised the importance of giving people “faster access to vaccines and treatments while minimising the environmental impacts of our activities”.  

“Dassault Systèmes delivers the technology we need to accelerate the introduction of new products in the facility by supporting the collaborative works of our teams and by strengthening the standardization of designs and models. It will also bring capabilities to reach our objective to produce several products in the EVF in an optimized schedule, thanks to the digital twin.  Then, the 3DEXPERIENCE platform will help us to address the complexity of the product lifecycle management in a highly regulated environment and for the benefit of our patients.”

To hear from Sanofi at the World Vaccine Congress in Washington 2023 get your tickets now.

On Polio Day PharmaJet announces USAID grant

On Polio Day PharmaJet announces USAID grant

The 24th of October 2022 was World Polio Day, which draws attention to the continued global fight against polio. This year, PharmaJet, the developer of a needle-free delivery platform, announced that it had received a multi-year grant from the United States Agency for International Development (USAID).  

Polio project 

The grant total comes to $1.5 million. This will contribute to the evaluation of the effect of intradermal (ID) vaccine administration using the Tropis Needle-free Injection System (NFIS). A comparative study between “standard intramuscular delivery using needle and syringe (N/S)” and the Tropis platform will measure “vaccine coverage and cost” for fractional inactivated poliovirus vaccine (IPV).  

Fractional dose IPV (FIPV) was previously only delivered through the Mantoux method, using “traditional N/S”. This can be “difficult, slow, and painful”. Furthermore, it demands a high level of training for healthcare workers.  

In collaboration with local governments and Jhpeigo, PATH, and Sydani Group, PharmaJet intends to conduct a stratified-pair, cluster randomised study.  

Tropis 

Tropis is a hand-held device. It delivers a “pressurised liquid stream without a needle”. Previous studies have demonstrated “cost savings, ease and consistency of delivery, and the ability to extend limited vaccine stocks”. It is also proven to increase vaccination coverage compared to “historical N/S” delivery.  

Paul LaBarre is VP of Global Business development at PharmaJet, and the Principal Investigator of the study. He hopes this study will be seen as a restatement of PharmaJet’s “commitment” to wider global efforts against polio.  

“We are pleased to receive this grant from USAID Development Innovation Ventures. It is a great privilege to be working with PATH, Jhpiego, and Sydani Group on this important work.” 

For more on PharmaJet’s technology, stay tuned for our exclusive interview with Dr Erin Spiegel at the World Vaccine Congress in Barcelona. If you are coming to the World Vaccine Congress in Washington in 2023, you can hear more from PharmaJet in person!  

WHO and IDIA renew agreement for health impact

WHO and IDIA renew agreement for health impact

In October 2022 the WHO announced the renewal of a strategic Collaboration Agreement with the International Innovation Alliance (IDIA) to “support the scaling of health innovations to the end of 2023”. The WHO outlined a shared goal: “to jointly accelerate health impact”.  

IDIA 

IDIA was formed in 2015 with support from The Rockefeller Foundation. It brings together the world’s “leading development innovation funders” in response to the challenges faced by developers.  

“Innovation and scaling require a commitment to doing things differently, and to find new ways of working together that transcend traditional boundaries to deliver greater impact at pace.”  

This agreement was established in 2021 to “promote and facilitate the demand, supply, assessment, and scale-up of health innovations for the benefit of low- and middle-income countries.”  

Areas for attention 

The collaboration covers 5 areas: 

  1. Innovation demand – to “enhance the identification and articulation of demand for innovation responding to national health needs and priorities and global targets”. 
  2. Innovation supply – contributing “relevant innovations” to meet the demands specified by WHO Member States. 
  3. Innovation assessment – sharing expertise and tools to “support the efficient assessment and clustering of scale-ready innovations surfaced through the supply pipeline”.   
  4. Innovation scale-up – identifying opportunities to “support the demand-led scale-up of health innovations”.  
  5. Innovation and scaling skills development – supporting the “continuous development of innovation and scaling knowledge and skills”.  
Collaboration and complementation  

Dr Alain Labrique, Director of Digital Health and Innovation at WHO, believes that progress towards “health for all” involves leveraging health innovations “effectively”. This agreement shows “partners with complementary expertise working together to scale innovations, building on each other’s strengths”. Head of WHO Innovation Hub, Louise Agersnap, is “excited” to move this forward.  

“With innovation in health – whether digital, health products, or social innovation – we can improve or save more lives by providing health to people in faster, better, and more affordable ways.”  

The WHO will encourage Member States to “link impactful innovations” to areas where they can make the greatest difference. Using IDIA’s “unique experience” and “status” they hope to accelerate “collective impact”.  Dr Karlee Silver is an IDIA Founding Member. She looks forward to “reap[ing] the rewards of investing in innovation”.  

“WHO operates at scale and brings legitimacy, so can enable ready-to-scale health innovations reach impact at scale.”  

For more from the WHO at the World Vaccine Congress in Washington 2023 get your tickets now. At the Congress we will also shine a light on some innovative start-ups who are changing the vaccine industry. To meet examples from Europe 2022 click here and here.

 

 

Airfinity predicts jab price increase to meet demand

Airfinity predicts jab price increase to meet demand

In October 2022 the health analytics specialist Airfinity predicted that the COVID-19 vaccine market will generate $60 billion for this year, despite a drop in sales. Airfinity suggests that this will come at a cost for buyers, who will face an increase in price per dose.  

Modelling for 2023 predicts that the number of doses sold will “fall” to 1.6 billion doses. This is a further drop from 5.7 billion in 2021 to roughly 3 billion in 2022. However, despite this apparent decrease in sales, companies are predicted to experience only a 22% decrease in revenue. This is due to higher prices. The analysis by Airfinity shows a doubling in price from 2021 to 2023.  

Big names  

Thanks to Airfinity’s insights it seems that Pfizer and Moderna will “maintain dominance of the market” with a 94% market share in 2023. For Pfizer/BioNTech 2021 saw a revenue of $37 billion, which has fallen to $32 billion this year. Moderna, on the other hand, is set to see sales up this year from $17 billion in 2021 to $21 billion. Next year a drop is predicted to $12 billion.  

Big prices 

An increase in prices is expected across the board, but according to Airfinity “mRNA vaccines have gone up the most”. The prices will also vary according to the country purchasing them. Doses of Pfizer/BioNTech will range from $22-$42. Moderna is estimated to be selling doses at a rate of between $32 and $50, but Airfinity suggests that the US is “potentially paying even more”. Other manufacturers, including AstraZeneca and Novavax, are estaimted to be selling shots for $5-$16.  

Private market emergence 

In the coming year Airfinity expects to see the “emergence of a private market” for these vaccines, largely in the US. Analysis of G7 and EU supply deals demonstrated that “all countries except the US have secured supply” greater than population demand.  

Interpreting the data 

For Airfinity’s CEO, Rasmus Bech Hansen, the numbers reveal a “persistent and longer-term demand” for the vaccines. Furthermore, it “illustrates that COVID-19 is a continued large health threat and significant disease burden”. 

“It’s also a clear sign that the vaccine market has been completely transformed by the pandemic and we can expect continued significant innovation in the space.” 

However, Dr Matt Linley, Analytics Director at Airfinity, believes that President Biden’s recent announcement that the “pandemic is over” will push manufacturers to raise the price to “non-pandemic levels”. Although this supports future revenue, the implied costs on national purchases are significant.  

“Pfizer and Moderna are continuing to benefit from first to market advantage and will continue to dominate the market for the foreseeable future. The duos’ new variant targeting jabs are set to cement this status. mRNA technology has proven to be the quickest to update for new variants of concern and therefore demand higher prices.”  

As we tentatively emerge from pandemic life, with warnings that we must keep running towards the finish line, we will continue to see increases in prices to compete with decreasing demand. To hear more about market trends and COVID-19 vaccines at the World Vaccine Congress in Washington 2023 get your tickets now. 

GSK announces positive results for RSV candidate

GSK announces positive results for RSV candidate

In a press release on 13th October 2022 GSK plc announced “positive pivotal phase III trial results” for a vaccine candidate against respiratory syncytial virus (RSV). The vaccine is for adults of 60 years and older and is in direct competition with Pfizer’s RENOIR results.  

RSV  

As we explored in our previous post on Pfizer’s earlier results, RSV is particularly threatening to infants and older adults. It is defined by respiratory symptoms and hospitalises thousands of older adults each year. There are no vaccines in the world for RSV, but Pfizer is also working towards a successful candidate.  

GSK’s candidate 

The AReSVi-006 phase III trial is randomised, placebo-controlled, observer-blind, and multi-country. It investigates the efficacy of a single dose of GSK’s adjuvanted RSVPreF3 OA investigational vaccine in adults aged 60 years and older. The candidate contains a “recombinant subunit prefusion RSV F glycoprotein antigen (RSVPreF3) combined with GSK’s proprietary AS01E adjuvant.” Across 17 countries around 25,000 participants were involved in the trial.  

The vaccine candidate is described as “highly efficacious” against RSV-lower respiratory tract disease (LRTD) with overall vaccine efficacy of 82.6%, meeting the trial’s primary endpoint. Furthermore, consistent high efficacy was observed across a “range of pre-specified secondary endpoints”. This efficacy against LRTD was reportedly “consistent” for both RSV-A and RSV-B subtypes. The trial will continue to evaluate “an annual revaccination schedule and longer-term protection” throughout the year.  

It was “well tolerated” and demonstrated a “favourable safety profile”. Adverse effects range from injection site pain to fatigue and a headache but remained “typically mild-to-moderate and transient”. GSK anticipates regulatory submissions in the “second half of 2022”.  

The race begins 

Dr Tony Wood, GSK’s Chief Scientific Officer, described these results as “truly exceptional”. 

“We believe that with the high vaccine efficacy demonstrated in this pivotal trial, our vaccine candidate has the potential to help reduce the significant global burden of RSV-associated disease in older adults”.  

The race is now on between GSK and Pfizer, with companies like Johnson & Johnson and Bavarian Nordic following closely behind. Citeline, a pharmaceutical intelligence company, suggests that the market for older adult RSV vaccination could grow to $5.2 billion by 2030. However, experts are warning that the two studies are not directly comparable due to variations in design and participant profiles.  

To hear more from GSK and Pfizer at the World Vaccine Congress in Washington 2023 get your tickets here.  

Japan’s 100-day ambitions funded in SCARDA

Japan’s 100-day ambitions funded in SCARDA

In September 2022 Japan’s Strategic Centre of Biomedical Advanced Vaccine Research and Development for Preparedness and Response (SCARDA) announced its investment in future vaccine research. An article in Nature suggested that this comes after Japan recognised it was “slow” to develop vaccines for COVID-19.  

The Japanese government announced that it intends to invest US$2 billion in a research initiative to ensure that it is ready to respond to future threats. The eight target pathogens include coronaviruses, monkeypox, dengue virus, and zika virus. The technologies also vary, encompassing mRNA technology, viral vectors, and recombinant proteins.  

Lessons from the pandemic 

Dr Ken Ishii from the University of Tokyo described Japan as “too slow to catch up” with the global rate of vaccine production. Nature suggests that the “three most advanced COVID-19 vaccine candidates are still in late-stage clinical trials” and none is approved for use. Thus, in March the government established SCARDA, with a formal launch taking place in November.  

Dr Toshihiro Horii of Osaka University hopes that this “tremendously huge amount of money” will give the Japanese vaccine scene a much-needed boost. For Dr Yoshihiro Kawaoka, University of Tokyo and head of the central SCARDA research centre, the initiative promises to unite key players in a “unique” way. The central facility will be based in Tokyo and supported by 4 “core institutes”: Osaka University, Nagasaki University, Hokkaido University, and Chiba University. A further 5 institutions will offer “support services” like animal models.  

100-day target for the future 

The aim of this new centre will be to “produce diagnostic tests, treatments, and vaccines” within the first 100 days of a pathogen with pandemic potential being identified. First targeted by the UK in 2021, this 100-day figure was supported by other in the G7 group. Dr Michinari Hamaguchi is the director-general of SCARDA. He believes that it has “much to learn from BARDA” as well as other funding initiatives like CEPI.  

Nature reports that two of the early projects aim to “develop universal coronavirus vaccines” and vaccines against the SARS group or coronavirus. Further goals include a fast-track system for evaluating candidates. The centre will hire around 30 staff members and has funding for around 5 years. The article in Nature provides some insight into the financial breakdown.  

  • $1.2 bullion will go to vaccine research and development projects 
  • $400 million will support start-ups in drug development 
  • $400 million will be spent on setting up a virtual network of centres of excellence for basic research in vaccine science, and testing vaccine candidates in early-stage trials 

 For more on how to prepare for future disease threats come to the World Vaccine Congress in Europe 2022

CEPI announces funding for intranasal vaccines

CEPI announces funding for intranasal vaccines

In October 2022 CEPI and the Dutch vaccine developer Intravacc announced funding to for broad protection against variants of COVID-19 and other Betacoronaviruses. This is part of CEPI’s $200 million programme for broad protection vaccines.  

CEPI announced that it will provide seed funding of “up to” $4.8 million to Intravacc, which is described as a “world leader in translational research and development of preventative and therapeutic vaccines”. It is hoped that this contribution will advance the development of an intranasal vaccine candidate.  

Dr Richard Hatchett, the CEO of CEPI, thinks that the virus “still poses a seroius threat to a still fragile global recovery.” In order to “mitigate the need for regular variant boosters” he hopes to find a candidate that provides “broad protection”.  

“Investing in, initiating the development of, and enabling equitable access to broadly protective coronavirus vaccines should be an integral part of the world’s long-term strategy out of the COVID-19 pandemic and defence against future threats.”  

Avacc 101 

Intravacc’s subunit vaccine candidate is called Avacc 101 and is based on its Outer Membrane Vesicle (OMV) platform. It will be designed to offer “broad protection against SARS-CoV-1, SARS-CoV-2, and MERS-CoV”. Furthermore, the platform will enable “presentation of universal Spike molecules and will include ‘epitopes’ that can also elicit T-cell responses”.  

The intranasal method of administration could help to provoke mucosal immunity, thus reducing person-to-person transmission. Dr Jan Groen is CEO of Intravcc and believes that this is the “real beginning of a new era” for intranasal vaccines.  

“Teaming up with CEPi is a big step forward: from ‘best alone’ to ‘better together’. In this way, we can leverage Intravacc’s OMV platform for the vaccine the world so desperately needs.”  

For more on novel COVID-19 vaccines come to the World Vaccine Congress in Europe 2022, where we will also hear more from a representative of Intravacc.  

South African vaccine attempt slammed by pharma giants

South African vaccine attempt slammed by pharma giants

During the COVID-19 pandemic the stark inequalities of our world were highlighted by disparities in vaccine development, production, and distribution. Despite the WHO goal of 70% coverage across the world by mid 2022, the reality was very different. Thus, a plan to reproduce Moderna’s successful mRNA vaccine attracted WHO support.  

Afrigen Biologics and Vaccines 

Afrigen is a biotechnology company based in Cape Town, with the goal of “local development and production of adjuvants for human and animal vaccines” and “biologicals critical for Africa’s healthcare challenges”. Working with scientists at the University of Witwatersrand, they deconstructed the Moderna vaccine in a feat of reverse engineering that is legal in South African law. The Guardian reports that this law “contains a provision for carrying out research and development regardless of patent protection”.  

Why Moderna? 

As we explored in a previous article, the company decided not to enforce its COVID-19 patents during the pandemic. Furthermore, WHO identified an “abundance of public information”, according to The Guardian.  

Initial success 

Thanks to promising preliminary results in mice trials, human testing is expected to begin in the next year. The Cape Town centre will share its knowledge with up to 20 “spokes” across Africa, Latin America, and parts of Europe. Representatives from these spokes have already started training at the centre in South Africa.  

“It is intended to provide a solution to vaccine inequity, ending the reliance of low- and middle-income countries on manufacturers in richer countries.” 

Charles Gore is the executive director of the Medicines Patent Pool (MPP). This is supporting the South African centre and believes that instead of “some kind of donation programme”, the key to addressing inequality is “empowerment”.  

“The silver lining of COVID is that it has focused people’s attention on access. The tragedy is that a lot of people died to get that focus.”  

Moderna steps in 

Despite the positive steps being taken at the hub, representatives at Moderna are concerned by the process. CEO Stephane Bancel was quoted in the Financial Times as having reservations.  

“It is like when somebody makes a copy of a Louis Vuitton bag. Does it look like a Louis Vuitton bag? Does it last like a Louis Vuitton bag? I don’t know.” 

Moderna has not shared technology or cooperated with the programme, and its legal action against Pfizer and BioNTech has created tension around the development of these vaccines. However, Gore suggests that the efforts will not infringe Moderna’s patents.  

“Clearly, we’re not wanting to enter into disputes with the pharmaceutical industry.” 

It remains to be seen whether Moderna will take legal action as the project continues. If this is a positive step for vaccine development in Africa, the future holds much greater potential for local development. 

To learn more about facilitating greater vaccine equity at the World Vaccine Congress in Europe 2022, get your tickets now.  

Moderna denies China access to vaccine technology

Moderna denies China access to vaccine technology

In October 2022 the Financial Times reported that Moderna had refused China’s request for the intellectual property behind its revolutionary COVID-19 vaccine. This resulted in a “collapse in negotiations” for its sale in the country. Although Moderna is still hoping to move forward with a deal, it is unwilling to hand over the mRNA secrets due to “commercial and safety concerns”.  

China’s rules 

Despite evidence that the mRNA technology used in Moderna and BioNTech/Pfizer’s vaccines is more effective and longer-lasting, China has not approved them, instead opting for its own inactivated vaccines. The FT suggests that there are currently two options for developers hoping to see their vaccine enter the Chinese system. The first is a “full technology transfer to a domestic drugmaker”. The other is “establishing a manufacturing facility in China with a local partner”, without losing command over the technology.  

Moderna applies the brakes 

Although Moderna has expressed its hope of reaching an agreement with the Chinese authorities, it drew the line at giving away intellectual property. According to the FT’s sources, “two people with knowledge of the matter”, this is because it is concerned about reputational damage. If the required local partner was unable to deliver a high standard of manufacturing this would reflect poorly on Moderna.  

Is a truce possible? 

Moderna has indicated that it might be open to relaunching discussions with China, as Chief Medical Officer Dr Paul Burton emphasised how “eager” they would be to “collaborate”. However, a source at Moderna spoke to the Financial Times and suggested that there was no current engagement in supply talks. 

“We are open to speaking with countries on their supply needs for COVID-19 vaccines.” 

It is suggested that decreased demand in countries initially targeted has exaggerated Moderna’s interest in collaborating with China. Furthermore, the COVID-19 jab is Moderna’s “only approved product”, applying greater pressure on the company. Finally, the consequences of President Biden’s “the pandemic is over” statement on the vaccines market will have contributed to a possible sense of urgency.  

For more from Moderna at the World Vaccine Congress in Europe 2022 get your tickets here.  

Australian collaborators awarded contract for TB vaccines

Australian collaborators awarded contract for TB vaccines

The Centenary Institute in Sydney and the University of Sydney announced in September that they, alongside collaborators, had been awarded a contract from the US NIAID. The contract, worth AU$19 million, will fund the development of the next generation of tuberculosis (TB) vaccines.  

Tackling TB 

The WHO estimated that a total of 1.5 million people died from TB in 2020. It is the 13th leading cause of death and the second most deadly infectious killer after COVID-19. Furthermore, although TB is preventable and curable, in 2020 the 30 high TB burden countries accounted for 86% of new TB cases. Ending the epidemic by 2030 is one of the United Nations’ Sustainable Development Goals (SDGs). The disease primarily affects the lungs and is caused by the bacteria mycobacterium tuberculosis (Mtb).  

AVART 

The contract is Advancing Vaccine Adjuvant Research for TB (AVART). It comes from NIAID, part of the US NIH. Over 5 years it will fund research and development of new TB vaccines. The contract was awarded to the University of Sydney and Centenary Institute. Professor Warwick Britton AO, Head of the Insitute’s TB Research Programme and lead investigator, emphasised the need for a more effective vaccine. 

“There’s only one licensed TB vaccine – the Bacille Calmette-Guerin (BCG) vaccine which is over a hundred years old. BCG is effective in reducing the risk of disease for infants but performs poorly in preventing infection in older children and adults.” 

Adjuvant assessments 

The programme will explore early immune responses to Mtb after inoculation with different adjuvant combinations. Up to 8 separate adjuvants and 3 specific antigens will be tested. The studies will use preclinical animal models, including “in-depth phenotypic and functional immunological studies in combination with transcriptomic analyses”. These will be supported by in vitro studies in primary human and animal cells. Professor Angelo Izzo is a principal investigator at the Centenary Institute. He said that the research is unique in its comparison of critical components.  

“The optimal antigen and adjuvant combination will be used as the basis for the new advanced TB vaccine.” 

Professor Jamie Triccas from the University of Sydney is another principal investigator who believes their work has great potential. Collaborating with research centres in Copenhagen, Oregon, and New Orleans, the work is set to begin soon. 

“The successful development of a new vaccine could be an absolute game-changer in terms of reducing the spread of TB and reducing deaths globally.”  

To hear about efforts to address the TB crisis come to the World Vaccine Congress in Europe 2022.  

Zika vaccine technology shows mouse model promise

Zika vaccine technology shows mouse model promise

Results published in Microbiology Spectrum by researchers from the US demonstrate that their Zika vaccine technology is safe and effective in preclinical mouse models. As it stands there are no approved vaccines or alternative treatments for virus, but these results indicate that there may be hope on the horizon for a responsive and effective vaccine. 

Zika virus 

The article describes Zika virus (ZIKV) as a mosquito-borne human pathogen that “causes dire congenital brain developmental abnormalities in children of infected mothers”. The authors refer to the 2015/16 outbreak of ZIKV, which attracted “global attention” after it caused “dire teratogenic effects”. These included microcephaly and foetal mortality. Consequently, “intense research efforts” have continued, although to “little avail”.  

The introduction explores how the “error-prone nature of RNA viral genome replication tends to promote evolution of novel viral strains”. Thus, the aim of this investigation was to develop a “replication-deficient ZIKV vector-based candidate”.  

The finer details 

The researchers, based at the University of California, Los Angeles (UCLA), described “generating a ZIKV vector containing only the nonstructural (NS) 5’-untranslated (UTR)-NS-3′ UTR sequences, with the structural proteins capsid (C), precursor membrane (prM), and envelop (E) (CprME) used as a packaging system.” They packaged replication-deficient Zika vaccine particles into human producer cells and “verified antigen expression” in vitro. In vivo studies concluded that after neonatal mice inoculation the candidate (ZVAX) was safe and “did not produce and replication-competent revertant viruses”.  

Following successful immunisation of adult, non-pregnant mice, in which ZVAX limited viral replication, they evaluated the safety and efficacy in pregnant mice. It was “shown to provide efficient maternal and foetal protection” against the disease. Mass cytometry analysis demonstrated that these animals had “high levels of splenic CD8+ T cells and effector memory T cell responses with reduced proinflammatory cell responses”.  

They also explored humoral immunity, potentially induced by “viral proteins present in ZVAX virions”. Finding “no significant difference” in neutralising antibody titer between vaccinated and unvaccinated animals, they inferred that “cellular immunity plays a major role in ZVAX-mediated protection”.  

“In conclusion, we demonstrated ZVAX as an effective inducer of protective immunity against ZIKV, which can be further evaluated for potential prophylactic application in humans.” 

Preventing future pandemics 

Although it has been several years since the previous outbreak devastated the Americas, the average time between periods of severe viral spread is 7 years, so experts are on the lookout for emerging signs but also protective measures. Alongside this cyclical timeline is the danger caused by climate change. Increased habitat spread for mosquitoes like the Aedes aegypti increases the risk for more people.  

To hear more about preparing for future pandemics at the World Vaccine Congress in Europe 2022 click here for tickets.  

 

Vaxxas to receive further funding for patch technology

Vaxxas to receive further funding for patch technology

Vaxxas announced in September 2022 that it will receive an AU$8.2 million grant from the Australian Federal Government as part of the Modern Manufacturing Initiative (MMI). This will promote the scale-up of its “potentially game-changing technology” that enables vaccine administration through a small patch on the skin.  

Who and what? 

Vaxxas describes itself as “commercialising novel technology that dramatically enhances the performance of existing and next-generation vaccines”. This needle-free technology offers myriad possibilities for vaccination. The approach “can enhance the efficiency and effectiveness of a vaccine’s immune response”.  

The HD-MAP, high-density microarray patch, uses an ultra-high-density array of micro projections. Applied to the skin this patch delivers the vaccine to the cells just below the skin’s surface. Through “production efficiencies, breadth and speed of access, and population coverage”, it is set to improve both routine and emergency vaccination programmes.  

First and second round funding 

In 2021 Vaxxas received AU$4.4 million to “support the specialised infrastructure” needed to manufacture its HD-MAP. This takes place at its biomedical facility in Brisbane. This is under construction and is expected to open in 2023. The opening will create several jobs and facilitates the “growth and development of the biotech and medtech sectors” in the area.  

The second round of funding allows Vaxxas to “develop and establish a sterile production line” with “proprietary aseptic fill and finish processes at the facility”. The production facility will also support clinical trials and commercial production.  CEO David Hoey remarked that the team are “incredibly grateful to the Australian Federal Government”.  

“It is fantastic to see the government backing innovations by local companies that have the potential to make a difference to lives in Australia and around the world.”  

The MMI launched in October 2020 with the intention of co-funding large manufacturing projects to drive “lasting change” in the sector. Vaxxas will be working with the Department of Industry, Science, and Resources to finalise further details.  

For more on vaccine administration methods read our article at this link. To hear from industry leaders, including a representative of Vaxxas, at the World Vaccine Congress in Europe 2022, get your tickets here.