by Charlotte Kilpatrick | May 16, 2024 | Technology |
In May 2024, researchers at Duke University School of Medicine’s Duke Human Vaccine Institute (DHVI) shared that they have developed a vaccine approach that “works like a GPS” to guide the immune system through specific steps to develop broadly neutralising antibodies against HIV. Their work, in Cell Host & Microbe (not open access), demonstrates the process for “designing boosting immunogens for a V3-glycan bnAb B cell lineage”. The team believes that their results demonstrate the ability of “both protein and mRNA prime-boost immunogens for selection of rare B cell lineage intermediates with neutralising breadth after bnAb precursor expansion”.
A long-standing goal
Dr Kevin Wiehe, associate professor and lead author, describes HIV as the “fastest-evolving virus known”.
“It’s been a long-standing goal in HIV research to create a vaccine that can generate broadly neutralising antibodies that can recognise diverse HIV strains.”
To make progress on this goal Dr Wiehe and team used an engineered version of a broadly neutralising antibody prior to any mutations. They then added sequential mutations one at a time to determine which were critical to the broadly neutralising goal. This allowed them to figure out the “exact points” along the “route” to broadly neutralising antibodies. Then, they developed a vaccine that presents “turn-by-turn directions” to the immune system to follow the mutational route.
The vaccine was tested in mice that were “specially bred to encode for the original version of the antibody”. Results suggest that the guidance system triggered the immune system o “start churning out the sought-after antibodies”. Dr Wiehe suggests that, not only does the paper support their work against HIV, but it could be used in vaccines for other diseases.
“This strategy potentially gives us a way to design vaccines to direct the immune system to make any antibody we want, which could be a broadly neutralising antibody for all coronavirus variants, or an anti-cancer antibody.”
For the Duke team, the next challenge is reproducing these results in primates and humans.
To join us at the Congress in Barcelona in discussions about achieving broader vaccine technologies, click here to get your tickets. For the latest vaccine development updates, why not subscribe to our weekly newsletters here?
by Charlotte Kilpatrick | Apr 30, 2024 | Technology |
Our next interview from The World Vaccine Congress in Washington this April is a conversation with Mabtech’s Dr Tyler Sandberg, who joined us at the event to present in the Immune Profiling track on “Characterising vaccine-induced immune responses with ELISpot and FluoroSpot assays”. Dr Sandberg is Mabtech’s Product Manager for ELISpot and Fluorospot, overseeing “day-to-day things” with the assays and working across the team to “improve our products” and understand how customers are using these products.
Assays to characterise vaccine-induced immune responses
We began by considering Dr Sandberg’s session at the Congress, and asked for an insight into some of the key concerns here. He emphasises that both are “now very well established assays”. The first ELISpot assay was done in the “late 80s”!
“It’s an assay that’s been around for a long time, but it’s a really great standardised assay.”
ELISpot has contributed to the assessment of HIV vaccines in the 90s and, more recently, has been “essential” in evaluating new COVID-19 vaccines. Dr Sandberg suggests that in the “early 2000s” people began to explore replacing the enzymatic development with Fluorophore detection, which also facilitates “multiplexing”. This is a “powerful” way to “get a lot more data”.
Mabtech: a one-stop shop
Evidently, Mabtech (certainly as represented by Dr Sandberg!) has plenty of information and product understanding as it enables customers to meet various needs. We asked about the distinguishing factors in a competitive space; is Mabtech meeting an unmet need or standing above competition?
“What makes us unique, I think, is that we are very much a one-stop shop.”
Monoclonal antibodies are developed “in house” in Stockholm, where the organisation was founded by 3 PhD students who decided to start a business after researchers identified them as “really good” at mAb development. This was “around the same time” that ELISpot started “taking off”.
“Because we control everything, we produce everything in house…we offer the best instruments in the market.”
Furthermore, Dr Sandberg believes that the team is “really good at the customer support side of things”.
“We love getting in contact with the researchers, hearing how they’re using our kits, and how they’re using ELISpot and FluoroSpot in ways that we didn’t think possible at first.”
Applications
Our penultimate question invited Dr Sandberg to share some recent uses or applications of the products his team is supplying. He shared the example of a 2023 publication covering a new neoantigen cancer vaccine for pancreatic patients. ELISpot was used throughout the vaccine evaluation process.
“It was really nice to see this standardised assay still being used today in brand new vaccine fields.”
Mabtech’s website has a great publication database for anyone who wants to look closer at other examples.
Why WVC?
As always, we conclude by asking about the event, and why our experts are joining us for the Congress. Dr Sandberg shares that “it’s really fun just going round and meeting everyone”. He reflects that, in the “age of remote work”, in-person events provide opportunities to learn and network.
“Overall, the networking is really great!”
It was a pleasure to speak to Dr Sandberg about his work; we hope that you enjoy the conversation!
For more conversations with our experts from the Congress in April do make sure you subscribe for weekly updates here!
by Charlotte Kilpatrick | Apr 10, 2024 | Technology |
The Royal Berkshire Foundation Trust announced in April 2024 that initial results from a long-term follow-up study of the safety and effectiveness of an oral spray-based vaccine against urinary tract infections (UTIs) are promising. The study reveals that in both men and women with “recurrent UTIs”, 54% of participants remained UTI-free for up to nine years after the vaccine was administered. Furthermore, they reported no notable side effects.
UTIs
UTIs are described as a “common” bacterial infection, often treated by antibiotics. Around half of women and one in five men experience these “painful and uncomfortable” infections. However, as antibiotic resistant UTIs are “on the rise” and drugs become less effective, there is a need for new ways of preventing and treating the infections.
MV140 in trial
A new solution could be emerging in the form of an oral vaccine: MV140. MV140 is administered through two sprays under the tongue every day for three months. The vaccine was developed by Spain-based pharmaceutical company, Immunotek, and contains four bacterial species in a suspension with water. It has been studied for short-term safety and effectiveness, but this is the first long-term follow-up study. It involved 89 patients who were originally treated privately at The Urology Partnership Reading.
The follow-up study allowed researchers to analyse data from the electronic health records of the original cohort from 2017. They interviewed participants about their experience of UTIs and asked them about side effects. 48 participants remained “entirely infection free” during the nine-year follow-up. The average infection-free period across the cohort was 54.7 months (four and a half years). 40% of participants reported having repeat doses of the vaccine after one or two years.
Safe and effective
Dr Bob Yang is a Consultant Urologist at the Royal Berkshire NHS Foundation Trust and co-led the research, commenting that prior to taking the vaccine “all our participants suffered with recurrent UTIs, and for many women, these can be difficult to treat”.
“Nine years after first receiving this new UTI vaccine, around half of participants remained infection free. Overall, this vaccine is safe in the long term and our participants reported having fewer UTIs that were less severe.”
Indeed, if participants did report UTIs, they were able to treat these infections by “simply drinking plenty of water”. Not only is the vaccine effective, but it is “a very easy vaccine to administer” and “could be given by GPs as a 3-month course”.
“Many of our participants told us that having the vaccine restored their quality of life. While we’re yet to look at the effect of this vaccine in different patient groups, these follow-up data suggest it could be a game changer for UTI prevention if it’s offered widely, reducing the need for antibiotic treatments.”
Professor of Urology at the Alta Uro Medical Centre for Urology in Switzerland, and EAU Chair of Guidelines on Urological Infections, Gernot Bonkat, thinks the “findings are promising”.
“Recurrent UTIs are a substantial economic burden and the overuse of antibiotic treatments can lead to antibiotic-resistant infections.”
Although Professor Bonkat highlights the need for “further research”, the study “reveals encouraging data”.
“While we need to be pragmatic, this vaccine is a potential breakthrough in preventing UTIs and could offer a safe and effective alternative to conventional treatments.”
Could this vaccine offer hope to the many people who experience UTIs and contribute to the fight against AMR? For more like this, don’t forget to subscribe to our weekly newsletters here.
by Charlotte Kilpatrick | Apr 10, 2024 | Technology |
In April 2024 YS Biopharma announced positive interim results from an ongoing Phase III clinical trial of its next-generation PIKA Rabies Vaccine. These results suggest that the Pika Rabies Vaccine has “successfully met” the primary endpoints of the trial, with the potential to achieve best-in-class accelerated protection and meet WHO’s goal of a one-week rabies vaccine regimen to replace the conventional approach, which demands three- or four-week regimens. The vaccine uses YS Biopharma’s proprietary PIKA adjuvant technology.
PIKA technology
YS Biopharma’s PIKA technology comprises synthetic biologic complex from the team’s research, synthesised based on their proprietary GMP manufacturing technology. It can induce a “prompt production” of interferon, cytokines, chemokines, and costimulatory factors through TLr3, RIG-I, and MDA-5 signalling pathways. Administration of PIKA facilitates antigen cross-presentation by dendritic cells and “augments” CD4+ T-cell, CD8+ T-cell, and natural killer-cell responses.
The vaccine in trial
The Pika Rabies Vaccine is designed to produce a more robust immune response in a shorter time than existing rabies vaccines. It was granted orphan drug designation by the US FDA for the prevention of rabies virus infection, including post-exposure prophylaxis for rabies.
The Phase III trial is a randomised, comparator-controlled, double-blind, multicentre trial. It includes 4,500 participants from the Philippines and Pakistan. It has been designed to assess the immunogenicity, safety, and lot-to-lot consistency of three lots of the vaccine in healthy adults through a 7-day vaccine schedule.
The primary immunogenicity endpoints of the study were geometric mean titers (GMTs) of rabies virus neutralising antibodies (RVNA) and RVNA seroconversion rate at Day 14 in the first 900 participants. The secondary immunogenicity endpoints were RVNA seroconversion rate and GMTs of RVNA at Day 28, Day 42, Day 90, and Day 180 in the first 900 participants and RVNA seroconversion rate at Day 7 and Day 365 in all participants.
So far, the Pika Rabies Vaccine demonstrates non-inferior immunogenicity compared to a globally marketed comparator, as well as helping patients achieve immunity in the shorter timeframe of 7 days. The data reveal that the RVNA seroconversion rate of the vaccine was “twice that of the comparator” by Day 7.
“This accelerated and higher seroconversion rate came at no cost to safety, with the safety profile of the PIKA Rabies Vaccine remaining highly tolerable.”
Compelling evidence
Dr Zenaida Mojares, Chief Medical Officer at YS Biopharma, states that the interim results “provide compelling evidence” of the “robust immunogenicity and favourable safety profile” of the vaccine.
“By providing a shortened treatment regimen without sacrificing safety or quality, the PIKA Rabies Vaccine has the potential to improve rabies treatment and compliance. At present, the long and inconvenient regimen length for existing rabies vaccines represents a major barrier to treatment completion.”
Dr Mojares is “eager to see how the enhanced speed” might have a “positive impact on patients”.
“We are proud of our team for the hard work and dedication which got us to this point, and we are excited to see how our advances will contribute to the ongoing global fight against rabies.”
Dr David Shao is Director, President, and CEO of YS Biopharma, and expressed “sincere gratitude” to the investigators and participants of the trial.
“Thanks to their dedication and efforts, animal bite patients are expected to have access to a new rabies vaccine, thereby reducing the rate of immune failure.”
Dr Shao and team “remain committed to working closely with drug regulatory agencies” in several countries, including the Philippines, Pakistan, Singapore, and China.
“We eagerly anticipate the early approval of this innovative therapy for the benefit of patients worldwide.”
For more on innovative technologies with life-changing implications, don’t forget to subscribe to our weekly newsletters here.
by Charlotte Kilpatrick | Mar 29, 2024 | Technology |
In March 2024 researchers at the University of Albany announced that they have developed a new method to test the integrity of COVID-19 vaccines. The method “could allow anyone with basic skills in vaccine handling to detect expired vaccines” without a need for specialised equipment and can be performed on sealed vials without disrupting the vaccine’s effects. The system, which uses laser-derived signals, can be contained in a portable unit to facilitate transport and handling.
The demands of mRNA
While mRNA proved to be a key player in the COVID-19 vaccine rollout, there were immediate “concerns” about transportation and storage. With exposure to sunlight or temperatures outside a precise window of –80°C to –20°C. Dr Lamyaa Almehmadi worked on the project as a PhD student at the RNA Institute and described the “unmet need” for a “quick and easy method to test the stability of mRNA vaccines”.
“To the best of my knowledge, our method is the first to enable an in-situ, non-destructive and reagent-free approach for mRNA stability analysis in mRNA-based vaccines.”
How does it work?
The method uses a Raman spectroscopy instrument developed by the university’s Professor Igor Lednev. The technique involves directing an ultraviolet (UV) laser into a liquid, which creates scattered light that can then be detected and analysed to reveal chemical signatures. The technology has been adapted and combined with advanced machine learning for “various applications” such as forensic science and disease detection.
The most recent application allows the team to detect small changes in the mRNA structure that indicate “loss of therapeutic functionality”. Dr Almehmadi commented that the scattered light is detected and processed to “yield the RNA signature”, which is known as the Raman spectrum.
“The mRNA Raman spectrum is then used for RNA degradation analysis. The test is rapid, typically taking just a few minutes to complete.”
Furthermore, the method can be “fully contained” in a handheld instrument and is non-invasive, so can be used to test multiple vials.
“Individuals with basic training in handling vaccine vials and operating the instrument could utilise our method effectively in a variety of settings outside a lab…with the assistance of advanced software, the process of data collection and results interpretation can be automated, making it accessible to a wider range of users.”
Professor Lednev believes that the technology is “universal in several important ways”.
“It allows for obtaining mRNA spectral characteristics in situ without disintegrating the vaccine capsule. It is also nondestructive; should the test result be positive the vaccine could then be used.”
Thus, the technology “might find numerous applications” for mRNA vaccines and therapeutics.
How might this technology help your work? Would it be applicable in all settings? For more on vaccine technology and RNA vaccines at the Congress this April do get your tickets to join us here! Don’t forget to subscribe to our newsletters here.
by Charlotte Kilpatrick | Mar 28, 2024 | Technology |
In March 2024 Intravacc announced that it has entered a strategic partnership with Primrose Bio to enhance the development and supply of conjugate vaccines. The statement suggests that the companies will “leverage their combined experience” in the development of conjugate vaccines; Primrose Bio will supply its “industry-leading” carrier protein, PleiCRM197, for vaccine development, and Intravacc will bring “IP and know how” in vaccine conjugation and manufacturing. This will provide clients with a “seamless solution” across development and manufacturing.
“Third parties engaged in developing conjugate vaccines will have access to a seamless solution for vaccine conjugation, manufacturing, and supply.”
The partnership will harness the “synergistic strengths” of each company, “fostering innovation and efficiency in vaccine development”. Intravacc will bring “comprehensive technical expertise, state-of-the-art facilities, and robust capabilities”. This will be complemented by Primrose Bio’s “ultra-pure production, supply chain, and regulatory support” for the PeliCRM197 carrier protein. This is “vital ingredient” in conjugate vaccine formulations. It is the only commercial CRM197 used in commercial vaccines for purchase.
“The partnership signifies a strategic alignment aimed at advancing vaccine development and accessibility for researchers and industry clients.”
Dr Jan Groen, CEO of Intravacc, is “excited” to announce the partnership.
“By combining our expertise with Primrose’s cutting-edge technologies, we aim to revolutionise the landscape of conjugate vaccine development, ultimately benefiting millions worldwide.”
Dr Helge Zieler, CEO of Primrose Bio, agreed that by “expanding the capability of our PeliCRM197 franchise” through the partnership, they will create a “full-service solution” for early-stage customers and parnters needing vaccine conjugation development.
“With both companies having direct product experience in preclinical, manufacturing, and clinical development, the combined know-how of the two firms fills a gap that is needed by the vaccine industry.”
We look forward to meeting and hearing from representatives of both Intravacc and Primrose Bio at the Congress in Washington this April so do get your tickets to join us there or subscribe for more insights into the latest vaccine partnerships!
by Charlotte Kilpatrick | Mar 26, 2024 | Technology |
With the Congress in Washington just around the corner, VaccineNation is gearing up and getting ready to return to the US to meet our wonderful attendees. Among them are two organisations who met during the event last year, whose story caught our attention. CastleVax and Jurata Thin Film joined us in the start-up zone for our 2023 Congress and, after discovering shared interests and goals, have formed a successful partnership.
We are thrilled that Dr Michael Egan and Ms. Megan Livingston were able to share their perspectives, and hope you enjoy learning more about their work!
Introducing: CastleVax and Jurata
Dr Michael Egan is the CEO and Chief Scientific Officer of CastleVax, with “more than 30 years” of experience in the vaccine research and development space. His team has a state-of-the-art platform for developing first-in-class vaccines to “enable rapid development of safe and highly immunogenic viral vectors” that can be easily delivered and stored.
Ms. Megan Livingston is Vice President, Business Development for Jurata Thin Film, having joined as “the first employee” in September 2020! Jurata’s thin film technology “enables the long-term storage of vaccines and biologics at ambient or elevated temperatures”. She is responsible for the business strategy development, client and partner recruitment, investor relations, and corporate growth.
Start-up neighbours
When we asked about how they met, Michael explains that they “happened to be neighbours” in the start-up zone.
“After speaking briefly and learning what each other’s companies were focused on, we realised that we had very complementary approaches.”
Megan echoes that there was a “clear alignment in our intents and interests”. Furthermore, Megan was able to introduce Michael to Rachel Rath, Director of the BARDA Alliance for Johnson & Johnson Innovation, who leads BLUE KNIGHT™. BLUE KNIGHT™ is a “joint initiative” between Johnson and Johnson Innovation (JLABS) and the US Biomedical Advanced Research and Development Authority (BARDA). It is dedicated to “anticipating potential health security threats, activating the global innovation community, and amplifying scientific and technological advancements”.
“Obvious” potential for a partnership
Many of our attendees at the events encounter tens, if not hundreds, of new organisations or people, so how did Michael and Megan establish that this relationship had potential? Michael reflects on how Jurata’s technology was an “obvious area for collaboration” to “reduce our vaccine platform’s cold chain requirement”.
“Jurata’s thin film technology immobilizes vaccines into a pliable film matrix without lyophilisation, preserving biological efficacy at ambient temperature and facilitating the distribution and delivery of thermostable vaccines to people around the world.”
Megan describes CastleVax’s platform as a “very new and interesting viral vector platform”, agreeing that “collaboration seemed obvious”. Megan also had experience with BLUE KNIGHT™ that was to become useful for CastleVax.
BLUE KNIGHT™
Megan explains how, when BLUE KNIGHT™ announced the QuickFire Challenge: Accelerating Project NextGen at its 2023 Symposium, she and Michael spoke about applying to fund the collaboration they had in mind.
“CastleVax’s live-attenuated next-generation booster vaccine against COVID-19 is the ideal candidate to show Jurata’s formulation’s ability to stabilise and deliver a vaccine without needles.”
Michael states that their project was awarded $1 million for the development of a “next generation vaccine against newer variants of COVID-19, inducing mucosal immunity through needle-free administration”.
How is the project progressing?
Already, the partnership has developed several formulations to stabilise CastleVax’s live-attenuated COVID-19 vaccine.
“The on-going collaboration will show that the room temperature thin film stabilised vaccine retains the potency and performance in animals relative to the original deep-freeze vaccine product.”
Next steps
Megan and Michael are “confident” that they will find the right formulation to “reduce, if not remove the cold chain requirements” soon, which means preclinical studies can begin to assess if Jurata’s formulation supports mucosal immunity after administration via intranasal or sublingual routes. They will also submit for funding through Project NextGen to “continue the clinical development” of CastleVax’s reformulated vaccine.
“The intention is to continue this collaboration and show that a thermostable vaccine can induce mucosal immunity, providing protection against new strains of COVID-19, as well as other respiratory infectious diseases.”
Be friendly and patient
Our final question for Michael and Megan invited them to share any advice that they might have for organisations, particularly start-ups, who are looking to create powerful partnerships. Michael kindly recommends participation in the start-up zone, which we naturally encourage!
“Be friendly to your neighbours. Participate in the WVC start-up zone. Talk to everyone who will listen. You never know where the next great connection will come from.”
Megan also highlights that “conferences have been our most successful way to meet like-minded partners”.
“A powerful partnership is equally beneficial to all parties involved.”
While partnerships are exciting, Megan also reflects that “a partnership needs a well-timed opportunity to be successful”.
“Be patient because the perfect opportunity could be imminently available, like ours was with CastleVax, or it could take years.”
It was a privilege to get these insights from Michael and Megan, and we hope to learn more about their progress at the event this year! If you’re interested in participating in the start-up zone, click here to learn more or email isabella.aung@terrapinn.com to introduce yourself. For more information on BLUE KNIGHT™ or to secure your place at the 2024 BLUE KNIGHT™ Symposium in June, click here! Finally, if you’re looking to connect with vaccine movers and shakers in Washington this April, do get your tickets here and don’t forget to subscribe for more vaccine stories.
by Charlotte Kilpatrick | Mar 26, 2024 | Technology |
In March 2024 Altamira Therapeutics announced that it has entered a collaboration with Univercells to evaluate the use of its SemaPhore platform to deliver mRNA vaccines. The agreement ensures that Univercells will test a proprietary mRNA vaccine delivered with SemaPhore nanoparticle platform in vitro and in vivo. If these prove successful, the companies will discuss and negotiate a commercial agreement for the development and manufacturing of nanoparticle-based mRNA vaccines through Univercells’ production platform.
SemaPhore
Altamira’s SemaPhore platform is “versatile” and designed to “enable safe and effective delivery of mRNA into target cells” through systemic or local administration. It is based on a proprietary 21 amino acid peptide that can engage “any type” of RNA in rapid self-assembly into a polyplex, which has a size, charge, and other physical features. These allow it to escape hepatic clearance to reach target tissues other than the liver.
“SemaPhore protects the RNA payload from degradation in the circulation and allows for rapid and effective cell entrance. Efficient delivery and positive treatment outcomes have been demonstrated in multiple murine models of disease so far.”
Dr Covadonga Pañeda, Altamira’s Chief Operating Officer, is “thrilled to initiate this collaboration”.
“SemaPhore has shown to be an efficient delivery vehicle for therapeutic RNA in many different disease models. With this collaboration we will explore for the first time its potential utility in delivery mRNA vaccines.”
Dr Pañeda highlights that current delivery vehicles that are used in the field “suffer from significant rates of mRNA loss during cell entrance”. Furthermore, they can cause “local or systemic side effects”.
“SemaPhore reduces mRNA loss during cell entrance, which may allow for using lower doses. This feature, together with its favourable tolerability profile could make SemaPhore a compelling alternative to conventional delivery vehicles.”
Chief Technology Officer of Univercells is Dr José Castillo who is “delighted to be partnering with Altamira to explore better ways to deliver mRNA to patients”.
“mRNA vaccines, and mRNA in general, have proven to be a game-changer in how we prevent, treat, and cure diseases in a range of fields from oncology to infectious diseases. To unlock its full potential, however, we need constant innovation to make mRNA products more effective, efficient, and affordable. One key step is to develop platforms that use lower doses.”
For all things RNA and innovation, why not join us at the Congress in Washington this April to attend the RNA workshop and more, or subscribe to our newsletters here?
by Charlotte Kilpatrick | Mar 26, 2024 | Global Health |
In March 2024 the University of Oxford announced that researchers from the university, the Francis Crick Institute, and University College London have been granted £1.7 million funding from Cancer Research UK and the CRIS Cancer Foundation to develop a lung cancer vaccine. The vaccine, ‘LungVax’ uses technology like that used to develop the “highly successful” Oxford/AstraZeneca COVID-19 vaccine. The team is set to receive funding for a study over 2 years to support lab research and initial manufacturing of 3,000 doses at the Oxford Clinical BioManufacturing Facility.
The burden of lung cancer
Each year there are around 48,500 cases of lung cancer in the UK. 72% of lung cancers are caused by smoking, the biggest preventable cause of cancer worldwide. Professor Tim Elliot, Kidani Professor of Immuno-oncology and research lead for the project, described cancer as “a disease of our own bodies”.
“It’s hard for the immune system to distinguish between what’s normal and what’s cancer. Getting the immune system to recognise and attack cancer is one of the biggest challenges in cancer research today.”
Professor of Experimental Oncology at the University of Oxford and founder of the LungVax project is Sarah Blagden, who emphasises that “anti-cancer treatments are more likely to be successful” when deployed “at its earliest stages”.
“We are developing a vaccine to stop the formation of lung cancer in people at high risk. This is an important step forward in preventing this devastating disease.”
Professor Mariam Jamal-Hanjani from University College London and the Francis Crick Institute will be leading the trial and commented that “fewer than 10% of people with lung cancer survive their disease for 10 years of more”.
“That must change. This research complements existing efforts through lung health checks to detect lung cancer earlier in people who are at greatest risk. We think the vaccine could cover around 90% of all lung cancers, based on our computer models and previous research, and this funding will allow us to take the vital first steps towards trials in patients.”
While LungVax “will not replace stopping smoking as the best way to reduce your risk of lung cancer” it could be a “viable route to preventing some of the earliest stage cancers” before they emerge.
Tackling lung cancer
The LungVax vaccine carries a strand of DNA that trains the immune system to recognise neoantigens on abnormal cells, activating the immune system to kill these cells and stop lung cancer. The study will test the vaccine in the lab to see if it triggers an immune response. If this works, the vaccine will progress to clinical trial, after which the vaccine could be scaled up to bigger trials for “people at high risk of lung cancer”. This could include people between the ages of 55 and 74 who are current smokers or previously smoked, and currently qualify for targeted lung health checks in some parts of the UK.
Professor Elliot hopes that the technology that “proved itself in the COVID-19 pandemic” can “deliver an off-the-shelf vaccine”.
“If we can replicate the kind of success seen in trials during the pandemic, we could save the lives of tens of thousands of people every year in the UK alone.”
An exciting future
Michelle Mitchell, Chief Executive of Cancer Research UK, hopes that the “science that successfully steered the world out of the pandemic could soon be guiding us toward a future where people can live longer, better lives” without the “fear of cancer”.
“Projects like LungVax are a really important step forward into an exciting future, where cancer is much more preventable. We’re in a golden age of cancer research and this is one of many projects which we hope will transform lung cancer survival.”
President of CRIS Cancer Foundation, Lola Manterola, describes the “crucial moment in the history of cancer research and treatment”.
“For the first time, technology and knowledge of the immune system are allowing us to take the first steps towards preventing cancer. This groundbreaking study represents a firm step in that direction, and we at CRIS consider it essential to support it.”
For more on cancer strategies with vaccine technology, why not join us at the Congress in Washington this April by getting your tickets here, or subscribe to our newsletters here?
by Charlotte Kilpatrick | Mar 20, 2024 | Therapeutic |
In March 2024 Nykode Therapeutics announced “key updates” to the inverse vaccine platform with the potential to treat autoimmune diseases at a conference in the US. During the event, Nykode “demonstrated for the first time” a “significant effect” in a therapeutic setting in a preclinical model for Multiple Sclerosis (MS) with the inverse vaccine platform.
The data shared at the conference also “illustrate the strong contribution” of the specific targeting unit and confirm that the disease protection is antigen-specific, which highlights the potential that the technology has in the autoimmune diseases field.
The next step in Nykode’s technology
Dr Agnete Fredriksen, Chief Business Officer and Co-founder of Nykode, commented that “demonstrating effect in a therapeutic setting has been the next important step for Nykode”.
“In addition to stopping the disease development, the data show that the disease protection is antigen-specific. This supports our technology’s potential to offer future treatments that precisely target specific autoimmune disorders without negatively affecting a fully functional immune system, a common side effect associated with today’s available treatments.”
The results bring “additional motivation” for Dr Fredriksen’s team to “pursue a completely new approach” to the treatment of autoimmune diseases. These “affect around every tenth person globally”, says Dr Fredriksen. In September 2023, Nykode announced that the inverse vaccine platform had prevented serious disease in MS and type 1 diabetes models in mice, which showcased the “broad disease-modifying potential in an antigen-specific manner”.
To participate in discussions about how vaccine technologies can revolutionise disease management do get your tickets to join us at the Congress in Washington this April or subscribe to our newsletters here!
by Charlotte Kilpatrick | Mar 11, 2024 | Technology |
In March 2024 CEPI announced that it is providing up to $1.9 million to Ghent University to support investigations into a “pioneering vaccine stabilisation technique” that could end the need for frozen storage of mRNA vaccines and support faster responses within the 100 Days Mission. The University will test the preclinical performance of optimised mRNA vaccines using a specialised Galsomes platform after “spin-freezing”. This approach has been pioneered by a spin-off from Ghent University, RheaVita.
A novel approach
CEPI states that the process of freeze-drying dehydrates and stores vaccines and other products as powder at heat-stable temperatures to “inhibit spoilage, extend shelf life, and increase access” particularly in settings that are remote or lower-resource. Spin-freezing is a technique that works by “rapidly rotating” vials of vaccine along an axis while the flow of an inert and cold gas solidifies the vaccine into a “thin powder film” around the side of the vial.
“This allows for a much faster drying process and offers manufacturers more control of the process, which can help improve the quality of vaccines being produced.”
Vaccines can also be frozen continuously, vial by vial, which reduces the risk of “expensive and time-consuming bottlenecks and delays”, which often occur during traditional freeze-drying when vaccines are manufactured in batches. Although batch manufacturing “has long been the industry standard”, CEPI suggests that continuous manufacturing could bring “improved efficiency”, with raw materials “constantly fed into the production line” to bring more vaccines to market at a faster rate. Furthermore, this approach could reduce labour and waste, bringing cost benefits.
Flipping the process
Ingrid Kromann, Acting Executive Director of Vaccine Manufacturing and Supply Chain at CEPI, commented that “investors are increasingly looking to meet the challenge of rapidly scaling up thermostable mRNA vaccine doses” to ensure “wider global delivery”.
“In addition to making mRNA vaccines thermostable, spin-freezing has the potential to flip the usual batch production process utilised by pharmaceutical manufacturers and instead offer continuous manufacturing, which, if successful, could promote fast and flexible mRNA vaccine production in response to future outbreaks.”
From Ghent University Dr Ine Lentacker and Professor Thomas De Beer are “excited” by the collaboration, which provides them with “a great opportunity to improve the thermostability” of mRNA Galsomes.
“We believe that our efforts to address challenges posed by cold chain distribution could significantly contribute to equitable access to mRNA vaccines globally.”
We’re looking forward to hearing more from representatives of CEPI with insights into how the organisation is encouraging innovation and accelerating pandemic preparedness at the Congress in Washington this April. Do get your tickets to join us at this link and don’t forget to subscribe to our newsletters here.
by Charlotte Kilpatrick | Mar 11, 2024 | Technology |
A study in Science Advances in March 2024 reports the Toll-like receptor agonist activity of a nanoscale adjuvant zeolitic imidazolate framework-8 (ZIF-8). This is a kind of nanoparticle known as a metal organic framework (MOF). MIT News reports that the research demonstrated that this MOF can “successfully encapsulate and deliver” part of the SARS-CoV-2 spike protein, also acting as an adjuvant once the MOF is “broken down” inside cells. The researchers believe that their work demonstrates that this type of structure can be helpful in generating a strong immune response.
Novel delivery for better immunity
The authors comment that, while subunit protein antigens are “safer and easier to manufacture than traditional whole pathogen vaccines”, they often require coadministration with an adjuvant to “potentiate antigen presentation” and generate effective immune outcomes. Concerns about the safety and tolerability of pattern recognition receptors (PRRs) can be “potentially mitigated by novel delivery approaches” such as nanoparticle (NP)-based methods.
Zeolitic imidazolate framework-8 (ZIF-8) is a “subclass of metal organic frameworks” that encapsulates the antigen through a biomimetic mineralisation process. This affords “exceptional protection” from various forms of degradation whilst “maintaining bioavailability”. It is also established as an “efficient vaccine delivery platform”. While studies demonstrated that ZIF-8 modulates vaccine-induced immune responses and stimulates high antibody responses, the contribution of ZIF-8’s composition to its adjuvant properties is “poorly characterised”.
In the study, the researchers investigate how ZIF-8 NPs can “modulate innate immune activation” to “enhance adaptive immune responses to protein antigens” with a SARS-CoV-2 spike protein receptor-binding domain (RBD) trimer as a model antigen. With biodistribution studies, immunological techniques, and transcriptome sequencing, they were able to better understand how ZIF-8 “improves immunogenicity”.
“We investigated the influence of ZIF-8 accumulation, distribution, retention, and efficacy on immune response, which are important determinants for successful clinical translation.”
The team demonstrated that the “chemical and physical properties” of ZIF-8 “modulate immune responses” at cellular and molecular levels at the same time as facilitating “multivalent antigen display” and lymph node drainage in a pathogen-mimetic approach. They also found that the “specific chemical building blocks” of ZIF-8 have a “major role” in “augmenting the immunogenicity of the encapsulated antigen”.
Old vaccines and better access
Dr Ana Jaklenec, a principal investigator at MIT’s Koch Institute for Integrative Cancer Research and a senior author, commented on the importance of “understanding how the drug delivery vehicle can enhance an adjuvant immune response”, which would be “very helpful in designing new vaccines”.
“Not only are we delivering the protein in a more controlled way through a nanoparticle, but the compositional structure of this particle is also acting as an adjuvant. We were able to achieve very specific responses to the COVID protein, and with a dose-sparing effect compared to using the protein by itself to vaccinate.”
The team emphasise that more work is needed to evaluate the particles’ safety and potential for scale-up. If it’s not developed a vaccine carrier, the study findings could help to “guide researchers” in the development of similar nanoparticles that could be used to deliver subunit vaccines.
“Most subunit vaccines usually have two separate components: an antigen and an adjuvant. Designing new vaccines that utilise nanoparticles with specific chemical moieties which not only aid in antigen delivery but can also activate particular immune pathways have the potential to enhance vaccine potency.”
An advantage to pursuing this avenue is that these vaccines are often cheaper and easier to manufacture than mRNA vaccines, which could accelerate global distribution.
“Subunit vaccines have been around for a long time, and they tend to be cheaper to produce, so that opens up more access to vaccines, especially in times of pandemic.”
To learn more about innovative approaches to vaccination against COVID-19 and other infectious diseases, why not join us in Washington for the Congress this April, or subscribe to our newsletters here?
by Charlotte Kilpatrick | Mar 7, 2024 | Technology |
CEPI announced in March 2024 that it is providing up to $1 million funding to researchers at Amplitude Therapeutics in the US to support preclinical studies to assess the potential benefits of their trans-amplifying mRNA vaccine approach. This partnership comes under CEPI’s call for innovations to support the 100 Days Mission for pandemic preparedness.
A new approach
While “conventional” mRNA vaccines found fame during the COVID-19 pandemic as safe and effective ways to save lives, self-amplifying mRNA designs are also becoming “more prominent”. Self-amplifying mRNA vaccines are “more specialised”, containing genetic instructions for the antigen and replicase, an enzyme that “serves as a built-in photocopier” to teach the body to replicate mRNA. This design present “important advantages” over “conventional mRNA vaccines”, such as the possible reduction of a dose. However, there are limitations. As the additional genetic instructions make the vaccine sequence “at least three times longer” than standard mRNA vaccine sequences, manufacturing and delivery challenges can arise.
Trans-amplifying mRNA vaccines comprise two separate, shorter RNA fragments: one encodes the antigen, and one encodes the replicase. This separation could facilitate easier production and mean up to 100 times less antigen-encoded RNA required per dose. Furthermore, the replicase enzyme can be produced before an outbreak.
From one pandemic to another
Dr In-Kyu Yoon, Acting Executive Director of Vaccine R&D at CEPI identifies “many exciting technologies” coming out of the COVID-19 pandemic.
“We must investigate whether they fit the bill of developing vaccines against future viral threats within a 100-day timeline. We already know mRNA is fast and flexible, and now new techniques like trans-amplifying mRNA vaccine technologies may further enhance its offering by significantly extending antigen supply while also allowing for key components of the vaccine to be made ahead of time.”
Dr Cory Sago, CEO of Amplitude Therapeutics is “grateful” for CEPI’s support as the team works to “advance trans-amplifying RNA vaccines for pandemic preparedness”.
“Our data suggest that trans-amplifying RNA may have some distinct advantages over existing mRNA technologies, including improved expression and flexibility of manufacturing.”
To hear more on the revolutionary platforms and technologies the vaccine community is exploring to improve pandemic preparedness why not join us at the Congress in Washington this April by getting your tickets here? If you can’t make it, don’t forget to subscribe here.
by Charlotte Kilpatrick | Mar 6, 2024 | Technology |
In February 2024 Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) announced that it is awarding GlyProVac $467,000 in support of efforts to develop a maternal vaccine targeting Escherichia coli (E. Coli), which is the bacterial species responsible for a “large portion” of neonatal sepsis infections. GlyProVac is a spin-out of the University of Southern Denmark in Odense that seeks to reduce the burden of bacterial infections and antimicrobial resistance worldwide.
Neonatal sepsis
Neonatal sepsis is a life-threatening response to bloodstream infections that occurs in newborns younger than 28 days old. Their immature immune systems mean they are “particularly susceptible” to infections. A recent study estimated that 2.5 million neonates or infants in the first month of lie die each year from sepsis; the greatest burden is suffered in low- and middle-income countries. With rapid disease progression, neonatal sepsis requires immediate treatment.
GPV02
The award will contribute to the development of GlyProVac’s maternal vaccine GPV02. GPV02 uses a selected bacterial protein, “naturally decorated” with small sugar molecules, to trigger an immune response. This contrasts to previous attempts to generate protein-based bacterial vaccines. GlyProVac uses BEMAP technology to ensure that the vaccine “correctly imitates” E. coli to prepare the immune system to recognise the bacterium when infection occurs.
The BEMAP technology is a “powerful sample enrichment method” based on mass spectrometry that allows comprehensive identification of any type of O-linked protein glycosylation. Through the technology the team has discovered that bacterial O-linked glycosylation is “much more extensive than previously thought and is especially important to Enterotoxigenic E. coli.
Dr Erin Duffy, CARB-X’s R&D Chief, commented that GlyProVac’s maternal vaccine could be important to prevent neonatal sepsis, the “leading cause of death among infants”.
“Because newborns at risk for neonatal sepsis are too young to be immunised, the vaccine would be administered to expectant mothers and target bacteria that cause neonatal bloodstream infections in babies. The vaccinated mothers would pass antibodies on to their babies in utero and through breastmilk after birth to strengthen their newborns’ immune systems, helping them ward off infections.”
Dr Anders Boysen, CEO and Co-founder of GlyProVac and Co-inventor of BEMAP is pleased that the award enables the “strengthening” of the team’s “scientific approach, strong team, and commitment to tackle the AMR crisis”.
“E. coli can cause a range of infections in humans, including urinary tract infections and neonatal sepsis in newborns, and poses a major challenge for public healthcare systems. We are grateful for the invaluable support, network, and resources provided by CARB-X, which will give us the opportunity to expand the potential of our E. coli vaccine to accelerate the fight against neonatal sepsis.”
To participate in important discussions about the role that vaccines can play in tackling the threat of AMR do get your tickets to join us at the workshops before the Congress in Washington this April and don’t forget to subscribe here.
by Charlotte Kilpatrick | Mar 5, 2024 | Technology |
A study in Nature scientific reports explores the use of machine learning in predicting vaccine ingestion rate among wild boars in support of efforts to control classical swine fever. Using Random Forest modelling based on vaccine dissemination data, the authors created prediction surfaces for the probability of vaccine ingestion by wild boar through “spatial interpolation techniques”. They found that the distance from the vaccination point to a water source was the “most important variable”, with areas of high probability identified in northern, eastern, and western areas in Gifu.
Classical swine fever (CSF)
The paper states that classical swine fever (CSF), caused by classical swine fever virus of the genus Pestivirus in the Flaviviridae family, is an infectious viral disease of domestic and wild pigs. The disease is “one of the most transboundary swine diseases” because of its potential to “severely impact the swine industry”.
Transmission most commonly occurs through direct contact between a “healthy susceptible host and infected animals”, but it can also be spread through the “discharge of infected animals and contaminated pork products”. Therefore, contaminated food residues, vehicles, and clothing are “important sources of indirect transmission routes”. The disease has both acute and chronic forms, and ranges from severe with high mortality to mild or no symptoms. Clinical presentations are “very similar to those of African swine fever (ASF)”.
CSF in Japan
Although Japan successfully eradicated CSF through vaccination in the twentieth century, it re-emerged in 2018. Since then, the infected area has expanded due to large outbreaks in wild boar populations and “sporadic” outbreaks at pig farms.
“The current CSF virus epidemic strain in Japan is considered moderately virulent, with a mix of individuals dying from infection and those surviving, contributing to the large-scale expansion of infection.”
Vaccination is “encouraged” across most regions, yet the control of the epidemic among wild boars “remains a major challenge”.
Wild boar vaccination
Wild boars are omnivorous and have a “wide range of food choices”; they are “widely distributed” in Japan. They dig up the ground to feed on plant roots and rhizomes but also eat acorns and insects and reptiles. A study by the Ministry of the Environment identified that the distribution range of wild boars has expanded about 1.9 times over the past 40 years, from which the authors infer that CSF could “further expand and have a more serious impact of the Japanese swine industry”.
The introduction of oral vaccination has been recognised as a “key strategy for controlling diseases” in populations where interventionist management is “more challenging compared to livestock”. In Gifu Prefecture, ongoing outbreaks have demanded efforts to control the disease “diligently”. The authors draw on insights from local hunters and wild boar experts to suggest that the oral vaccine was dispersed at around 14,000 sites over the three seasons each year from 2019 to 2020.
At each site around 20 vaccines were spread and buried in holes about 10-15cm deep with lure food. To understand the effectiveness of the vaccination application, the leftover vaccine or vaccine packet was collected 5 days after application. Vaccine ingestion was confirmed in approximately 30% of the dispersal sites.
“The expansion of infected areas and the prolonged infection period will burden the economy as will the cost of control measures. Therefore, the development of effective vaccination strategies is an urgent priority.”
Research in context
A previous study presented a generalised linear mixed model (GLMM) analysis on data from sensor cameras across around 10% of dispersal points to identify areas where the animals were most likely to appear. This revealed a “positive correlation” between the emergence of other wildlife and the emergence of wild boar. Furthermore, road density and vegetation were believed to influence wild boar emergence. However, areas of high wild boar emergence don’t necessarily coincide with areas of high vaccine feeding.
Machine learning algorithms can analyse large, complex data sets and identify patterns and trends that are harder to detect for humans. Thus, more studies are applying them to the prediction of infectious disease outbreaks. For this approach, Random Forest is a “commonly used” and “powerful” machine learning technique.
For this study the authors predicted the wild boar vaccine ingestion rate at each site based on a Random Forest model. The results of this were combined with spatial interpolation techniques to “output a prediction surface showing the vaccine ingestion probability of wild boars” in Gifu Prefecture.
“Effective vaccination strategies for wild animals can be summarised in two aspects: high efficacy of the vaccine itself and efficient vaccine delivery to each individual. This study aimed to contribute to the control of CSF in wild boars by focusing on the latter.”
The results of the model identified “important variables” such as distance to water source, elevation, season, road density, and slope, with distance to the water source “chosen as the most important variable”. The probability maps estimated “high probability areas” in the northeastern and southeastern parts of Gifu Prefecture, as well as the western region.
How does the study contribute to the progress of incorporating technological advances into vaccine research and development? For more on vaccine technologies don’t forget to get your ticket to the Congress in Washington this April or subscribe to our newsletters here.
by Charlotte Kilpatrick | Mar 4, 2024 | Technology |
A study published in Vaccine X in February 2024 presents an evaluation of freeze prevention of vaccines transported and stored in the WHO-prequalified freeze-preventive cold box (FPCB) in comparison with the current standard cold boxes (SCBs). The evaluation was conducted across five health facilitates in Nepal. The authors find several advantages to the FPCB but suggest that smaller and lighter models would be more appropriate for Nepal’s immunisation needs and similar immunisation programmes globally.
Transportation and storage
“Vaccines lose potency over time, and this loss is temperature dependent.”
The study highlights WHO guidelines for vaccine handling, which recommend “specific storage conditions” to “ensure quality is maintained throughout the vaccine life cycle”. Interestingly, while vaccine vial monitors to identify exposure to heat have been “available for decades”, there are no vial-level indicators for freezing.
Freezing is a particular concern for liquid vaccines with aluminium salt adjuvants, which have increased freeze sensitivity: “freezing can irreversibly damage these vaccines, reducing potency and compromising protective immunogenicity in recipients”.
“The importance of protecting vaccines from freezing will become even more pressing globally as introductions of new vaccines put pressure on already weak vaccine supply chain systems.”
The authors state that, in Nepal, cold boxes are “primarily used” to transport vaccines from “higher cold chain points to health posts”. Vaccine freezing can cause closed-vial vaccine wastage, with “financial implications for immunisation programmes”, or in cases where it goes undetected, can lead to “loss of vaccine potency and efficacy”.
“Freeze prevention at the equipment level mitigates these risks and eliminates the need for shake testing or vial-level freeze indicators, which have not yet proven cost-effective nor been implemented comprehensively.”
SBCs vs FPCBs in Nepal
The study presents the “first real-world evaluation” of a WHO Performance, Quality, and Safety (PQS)-prequalified freeze-preventative cold box (FPCB). Cold boxes have a greater capacity than vaccine carriers and transport vaccines between different levels of the supply chain. This increased capacity means that more vaccines are transported, which therefore presents a greater financial loss if the vaccines freeze.
Qingdao Leff International Trading Company was the first manufacturer to receive WHO PQS prequalification for an FPCB in 2020. The technology comprises a barrier liner between the ice packs and vaccine storage area to prevent direct contact of vials with ice packs.
The Himalayan terrain reportedly poses “major geographical challenges for vaccine distribution, transportation, and storage”. After a shift from a “highly centralised” system to a more decentralised model in 2015, Nepal has faced “both structural and operational issues”, from infrastructural weakness and shortage of skilled staff to delays and lack of coordination. Vaccination coverage “varies considerably across its diverse and geographically dispersed population”.
In response, Nepal has dedicated “significant resources” to improve the service delivery infrastructure of its national immunisation programme”. The authors comment that reaching underserved and widely dispersed populations will “boost vaccine coverage”.
Vaccines in Nepal are “typically” collected and distributed from regional and district cold chain points to health posts once a month for routine immunisations. Further trips are required for vaccination campaigns. Vaccines are transported by the alternate vaccine delivery (AVD) system or health workers. The former involves “local persons engaged in this activity on a part-time basis”, who use cold boxes or carriers in their own vehicles.
Performing to standards
The authors reflect that the primary purpose of the equipment is to prevent vaccines from freezing; in terms of this purpose the FPCB “performed to standards”. The SCBs cooled down “much more quickly” than the FPCBs, thanks to the thermal buffering. While this is “not much of an issue” for extended journeys or temporary storage, the slower cooldown can mean “exposure to elevated temperatures for most of the session” in short outreach sessions. Although the amount and level of thermal exposure is “relatively minimal”, it can be “very noticeable” for health workers trained to keep vaccines within the “acceptable” range: above 0 °C and below + 10 °C.
Additionally, the authors identified a “relatively long period of freezing” in SCBs, which is “not uncommon and can lead to loss of vaccine potency”. Despite “numerous high temperature excursions”, there was no reported incidence of vaccine wastage due to total heat exposure.
“The primary advantage of FPCBs over SCBs is prevention of freezing even when fully frozen, non-conditioned ice packs are used.”
This advantage is expected to “simplify logistics” because if health workers can use fully frozen ice packs, they will need less time to prepare cold boxes. A potential further advantage is a “reduced training burden”. The authors recommend further research and development in pursuit of “smaller and lighter FPCBs relative to their usable storage volume”. Furthermore, investing in FPCBs to prevent the freezing of expensive vaccine shipments would “potentially” be good value as the cost of procuring one FPCB is “much less” than the value of the vaccines that are prevented from freezing.
The paper concludes with recommendations for future research and development, including:
- Explicitly modelling, validating in real-world conditions, and publishing estimated vaccine degradation due to any additional heat exposure from demonstrated longer cooldown periods
- Further product development that might lead to lighter equipment with more storage space and a shorter cooldown period while still thermally protecting vaccine potency from both freezing and heat exposure
Did you read the paper? What useful contributions does it make to vaccine technology discourse? How might the FPCBs fare in your vaccination programmes? For more on novel vaccine technologies and strategies don’t forget to join us in Washington this April for the Congress or subscribe to our newsletters here.
by Charlotte Kilpatrick | Feb 28, 2024 | Technology |
In written evidence submitted to the Committee for Science, Innovation, and Technology for the inquiry into lessons from the pandemic Dr Clive Dix details recommendations from the Vaccine Task Force (VTF) from 2020. The evidence was made public in an “unusual step” in February 2024. Dr Dix, now Chief Executive Officer at C4X Discovery, was “instrumental” in the Task Force’s work and findings. The recommendations, initially prepared in December 2020 are annotated with comments from January 2024.
In the recommendations, Dr Dix stated that the pandemic demonstrates the need for the UK to “be part of a rapid response system to discover and develop vaccines” and ensure it has a “resilient supply of vaccines and antibodies new and old”.
“We need to act quickly to prevent pandemics occurring, so the UK needs a permanent ecosystem for rapidly developing, manufacturing, and supplying vaccines for future pandemics, ensuring domestic resilience and security, while also creating long term economic prosperity.”
To “cement” the UK’s position as a “global leader”, Dr Dix called for a “diverse, informed infrastructure for surveillance of adverse events, flexible capacity for manufacturing and testing vaccines, and a global funding facility for purchasing and distributing vaccines internationally”. To allow vaccines to “play an effective part of pandemic recovery and preparedness”, Dr Dix stated that they must be “available quickly and be manufacturable at scale”.
What are the recommendations?
The recommendations are intended to ensure the UK can address “capability gaps”, develop “system resilience and security” through the legacy of the VTF, and “deliver economic growth and the levelling up agenda” with “long term prosperity”.
- Create a National Vaccines Agency.
- Establish a National Centre for Formulation and Delivery to bring together capabilities across vaccine formulation, delivery, process development, and scale-up.
- Clinical trial capability
- Formalise a network between partner organisations to support research and development in clinical immunology, to support increased rich immunological data generation.
- Launch a Human Challenge Study Centre of Excellence to further the UK’s clinical trial capability for respiratory infections and disease.
- Expand the UK vaccine registry, refine the registry by enabling the linking of NHS datasets of consenting individuals to the vaccine register, maintain active communications with registrants and the public, and enhance researcher access.
- Manufacturing capability, responsiveness, and breadth
- The UK should invest in plant-based manufacture of protein antigens to quickly and reliably generate the protein for protein-subunit based adjuvanted vaccines.
- Explore potential opportunities to partner with the most promising mRNA-based companies, academics, and others to provide state-of-the-art mRNA capability to address future pandemics.
- Establishing bulk antibody manufacturing capability to ensure capacity to manufacture sufficient neutralising antibodies to meet needs of UK’s immunosuppressed population and frontline workers.
- Assessing the UK’s vaccines supply chain capability and building a mechanism which monitors and quality assures the resilience of global supply chains.
- Explore potential arrangements with UK based sterile manufacture facilities (CDMOs or pharmaceutical companies) who could provide surge capacity to fill and finish vaccines.
- Develop a strategy to secure the supply of adjuvants.
- Launch a Future Vaccines Fund within UKRI/funded by private sector to advance innovation and support the research of novel formulations and formats.
- International engagement and collaboration
- Use the G7 chairman role to coordinate R&D funding into improved vaccine formats, promote expansion of global manufacturing capability, establish effective long-term information sharing, and encourage streamlining of global regulatory processes.
- Establish COVAX as an international multilateral organisation for future pandemic preparedness.
- Increase the proportion of STEM graduates in the civil service to 50%; develop closer ongoing industry links to improve industrial understanding.
Do you agree with the recommendations? Would they apply in your country as well or do you identify other areas for development? To join discussions on vaccine development, pandemic preparedness and response, and health security, don’t forget to get your tickets to the Congress in Washington this April here, and subscribe for more insights here.
by Charlotte Kilpatrick | Feb 27, 2024 | Technology |
The University of Buffalo shared in February 2024 that a team led by Buffalo researchers is developing a recombinant flu vaccine to “compete with existing vaccines”. Their work, published in Cell Reports Medicine, suggests that “hexaplex” liposomes perform “favourably in many areas” in comparison with other vaccines. The study authors attached six proteins to a nanoliposome and added two adjuvants for investigation in animal models of three common flu strains.
Seasonal vaccine demands
“Seasonal influenza epidemics generate a demand for safe and effective vaccines that can be produced to match evolving circulating viral strains on an annual basis.”
The authors estimate that 500 million vaccine doses are produced yearly to “combat” seasonal influenza viruses. A recent alternative to “traditional egg-derived production methods” has emerged thanks to “advances in recombinant antigen production”, but these vaccines “still possess drawbacks”. For example, they can “fall short of the immunogenic potential achieved by virus-derived antigens”, particularly in vulnerable populations. However, the authors identify “various ways” to overcome these issues, such as an increased quantity of antigens per dose or the inclusion of an adjuvant.
“To this end, we have investigated the application of cobalt porphyrin-phospholipid (CoPoP) liposomes, which feature antigen-display functionality that converts soluble antigens into a nanoliposome-decorated format with integrated adjuvants as an adjuvant system for a next-generation recombinant vaccine, with the ultimate goal of developing a vaccine that effectively protects against all seasonal influenza viruses”.
What does this research do?
The team evaluated the “hexaplex” nanoliposome with three common flu strains: H1N1, H3N2, and type B. They found that even low doses provided “superior” protection and survival in comparison with Flublok, the only licensed recombinant influenza vaccine in the US, and Fluaid, an egg-bsaed vaccine. Lead author Zachary Sia commented on the useful combination of two groups of proteins.
“In particular, the adjuvanted nanoliposomes excelled in the production of functional antibodies and the activation of T cells, which are critical to fighting off serious infection of the flu.”
Dr Jonathan Lovell, SUNY Empire Innovation Professor in the Department of Biomedical Engineering, stated that the “variable nature of the viruses that cause influenza” means that current vaccines are “not optimally effective among the overall population”.
“We believe our vaccine candidate has the potential to improve upon this by inducing stronger and broader immunity and reducing the likelihood of illness and death.”
Continued efforts
Dr Bruce Davidson, research associate professor of anaesthesiology at the Jacobs School of Medicine and Biomedical Sciences emphasised that the combination of haemagglutinin and neuraminidase antigens is “important” because it “translates into broader immunity”. Thus, “companies will be able to create more doses with less material”.
“That’s critical for not only the flu but also potential outbreaks like what we saw with COVID-19. There is still much work to be done in fully testing and validating this flu technology, but at this point these early results are quite promising.”
For more on innovative approaches to vaccine development for influenza, why not check out the influenza and respiratory diseases track at the Congress in Washington this April – get your tickets here or subscribe to our newsletter here!
by Charlotte Kilpatrick | Feb 26, 2024 | Technology |
In February 2024 London-based biotech Baseimmune announced the close of £9 million in Series A funding led by MSD Global Health Innovation fund and IQ Capital with participation from existing investors. The funding will support the development of three of Baseimmune’s vaccine candidates against African swine fever, coronavirus, and malaria. It will also contribute to the advancement of the technology and expansion of the team.
Baseimmune, founded in 2019, uses a vaccine design algorithm that “crunches genomic, epidemiological, immunological, clinical, and evolutionary data together”. This creates “entirely new synthetic antigenic proteins containing the parts of the pathogen that are most likely to evoke a strong protective immune response”.
AI algorithms and antigens
Baseimmune’s approach to antigens distinguishes itself from “conventional approaches” as the team creates synthetic antigens that “encompass all crucial elements of a pathogen” to increase the likelihood of “eliciting a robust immune response”.
“This revolutionary antigen design can seamlessly integrate into any vaccine technology platform for efficient lab testing and streamlined clinical trials.”
Big data, faster processes
Baseimmune states that the technology is based on a computational platform deciphering pathogen evolution to design cross-protective vaccines. Through big data and a design algorithm, the team has shortened the time it takes to develop a vaccine candidate.
“The antigen designs can be fed into any vaccine technology platform, including mRNA, DNA, and viral vectors, to create universal ‘future-proof’ vaccines engineered to be effective against current and potentially emerging variants.”
Dr Joshua Blight, CEO and Co-Founder of Baseimmune, is “thrilled to have the support of a top-tier investor syndicate”.
“This funding will enable us to accelerate the development of our technology, scale our programmes, and expedite the delivery of impactful vaccines against future viruses.”
Dr Blight is “more excited than ever” about the possibilities but remains “focused” on the commitment to “disrupting the future of pandemic readiness”. Dr David M. Rubin, Managing Director, MSD Global Health Innovation Fund, is “excited to support this forward-looking team”.
“We believe Baseimmune’s technology marks a significant advancement in proactive, adaptable vaccine solutions.”
Dr Alex Wilson, Partner, IQ Capital, is also excited by the investment.
“By using a computational platform and innovative AI prediction algorithm, Baseimmune is pioneering the next generation of universal vaccines against a spectrum of human and animal health threats, from COVID to malaria and African swine fever.”
It was great to welcome Baseimmune to our start-up zone at the Congress last year, and we’re glad to see the team go from strength to strength in vaccine development. If you’re interested in joining the start-up zone this year in Washington, head to this link to register interest. To get your tickets to attend the Congress click here, and don’t forget to subscribe to our weekly newsletters for more updates.
by Charlotte Kilpatrick | Feb 20, 2024 | Technology |
In February 2024 Evaxion announced the “successful completion” of initial phases of a vaccine collaboration with MSD to combine “both organisations’ unique capabilities and know-how”. This update follows a statement last year that indicated that a novel pipeline programme, EVX-B3, had been initiated in partnership with an “undisclosed leading pharmaceutical company”. EVX-B3 is a vaccine candidate designed using novel targets against a bacterial pathogen that were identified with Evaxion’s proprietary platform, AI-Immunology.
EVX-B3 and AI-Immunology
EVX-B3 is a bacterial vaccine development project, executed in collaboration with MSD, to address a “pressing global medical issue” presented by an “undisclosed bacterial pathogen”, which currently has “no preventive or curative options”.
AI-Immunology is a “scalable and adaptable artificial intelligence technology platform” that is “at the forefront of vaccine discovery for infectious diseases and cancers”. It integrates the “collective power” of other proprietary models to model the complexity of the patient’s immune system.
“AI-Immunology advanced computational modelling swiftly and uniquely identifies, predicts, and designs vaccine candidates, revolutionising the landscape of immunotherapy by offering a holistic and personalised approach.”
Evaxion’s Chief Executive Officer, Christian Kanstrup, is “proud” to reveal that the “leading pharma company” that joined the collaboration is MSD.
“We are excited about the successful conclusion of the vaccine target discovery and design phases of the collaboration and are eagerly awaiting the next phase. We strongly believe that this collaboration will further validate the power of our AI-Immunology platform and contribute to improving lives by designing unique vaccines addressing serious medical conditions.”
Dr Tarit Mukhopadhyay, Vice President, Head of Infectious Diseases and Vaccine Discovery at MSD Research Laboratories is “excited” to “further advance” the collaboration with the Evaxion team.
“At MSD, we are exploring new ways to apply AI technologies across the discovery-development continuum.”
We’re looking forward to hearing more from representatives of both organisations at the Congress, including a showcase on the AI-Immunology platform – don’t forget to get your tickets to join us there and subscribe for more insights here.
