by Charlotte Kilpatrick | Jul 10, 2024 | Technology |
An article in Scientific reports in July 2024 describes the “pressing need” for novel and safe vaccines that provide “robust immune defence and have various applications” against tuberculosis. The authors apply an immunoinformatic strategy to generate an adequate multi-epitope immunisation against Mycobacterium tuberculosis (Mtb). Their analysis suggests that the vaccine could induce specific immune responses, indicating potential against Mtb, but they recognise the need for validation through in-vivo research.
A persistent threat and an old vaccine
Tuberculosis (TB) is “one of the most ancient diseases” but is still considered a global threat to human morbidity. Although identification and treatment solutions are evolving, TB remains the second-highest fatal infectious disease. Therapeutic options are “limited” and only one approved vaccine exists: BCG. The BCG vaccine has existed for over 80 years and is “one of the most widely used of all current vaccines”. However, it does not prevent primary infection or reactivation of latent pulmonary infection, the “principal source of bacillary spread in the community”.
There are “several” TB vaccines at various stages of clinical trials, but safety issues “remain a concern”, with nearly 50% of the candidates using a live, attenuated Mtb strain. Contrasting with “most of the past research”, which relies on exosome vesicles or known antigenic proteins to identify epitopes, the authors of this study integrate highly antigenic, non-allergenic, and non-toxic epitopes from novel immunogenic proteins for an in silico multi-epitope vaccine.
The study
In a literature study the authors identified five antigenic proteins that could serve as vaccine targets: probable transcriptional regulatory protein, possible exported protein, PPE family protein PPE41, conserved threonine-rich protein, and Phospholipase C A. These proteins were found to be antigenic and could induce an immune response in the host but have not been explored in the context of vaccine development against Mtb, providing a “novel avenue for investigation”.
The selection is also grounded in a “comprehensive antigenicity, non-allergenicity, and non-homology analysis”. The proteins were targeted to develop a potential vaccine against Mtb, and specific epitopes that can bind with Toll-Like Receptors (TLRs) were selected.
“The evolution of sequencing and immunoinformatics has revolutionised drug and vaccine design, replacing traditional, time-consuming approaches with efficient, epitope-based strategies utilising in silico tools.”
The study framework is centred on the development of a subunit vaccine through the analysis of five antigenic proteins derived from Mtb. This resulted in a chimeric vaccine, comprising 15 cytotoxic T lymphocytes (CTL), 5 interferon-gamma (IFN- γ) inducing helper T lymphocytes (HTL), and 5 B-cell epitopes. By linking these epitopes, the authors intended to “optimise protein folding and enhance flexibility”.
“This multiepitope vaccine, grounded in immunogenic antigens, has been conceived in response to the global tuberculosis pandemic, addressing the imperative for effective TB treatment. The envisaged assessment profile of the vaccine design provides insights into its immunogenicity, laying the foundation for subsequent experimental evaluation.”
The vaccine design elicited “robust” primary and secondary immune responses. A primary response was characterised by an elevation in IgM antibodies, manifesting after a “lag time” of five to seven days after antigen exposure. Following this, the secondary immune response was marked by elevated expression of IgM, IgG1, and IgM-IgG antibodies as well as increased B-cell proliferation. Furthermore, the population of cytotoxic (Tc) and helper (Th) cells demonstrated a “clear increase” post-immunisation and the enhanced production of IFN- γ and IL-2 observed after immunisation “underscores the activation of essential immune effectors”.
An assessment of clonal specificity with the Simpson index, D, indicates a “potentially diverse” immunological response. Earlier research has highlighted the role of innate immune cells like NK cells and DCs in “combatting” Mtb. Analysis revealed a “potent” activation of these cells, notably a “rapid and sustained increase” in NK cell production. Resting DC cells influenced the total counts of DCs, increasing from 150 to approximately 200 cells/mm 3 while inducing “limited” proliferation of presenting-1 and presenting-2 DCs.
“These results collectively signify a substantial and comprehensive immune response against Mtb, validating the efficacy of our vaccine design.”
The authors conclude that “more attention” should be directed to the development of innovative vaccine targets to control TB at all phases of infection with the goal of improving TB care. They also call for research on novel pharmacological targets to shorten the drug regimen, addressing the issue of treatment resistance. Their work, using immunoinformatic methods to extract immunodominant and non-allergic peptides from antigenic proteins, promises to produce an “adequate immune response”. However, an animal model will be “essential” to validate immunogenicity.
We look forward to considering TB vaccine progress at the Congress in Barcelona this October, welcoming experts from IAVI and BioNTech among others – you can get your tickets to join us here! Don’t forget to subscribe for more vaccine development updates.
by Charlotte Kilpatrick | Jul 9, 2024 | Technology |
WHO announced in July 2024 that its online open access clearing house, MeDevIS (Medical Devices Information System), is being publicly released following a consultation period with WHO Member States. The platform is designed to support governments, regulators, and users in decision-making on the selection, procurement, and use of medical devices for diagnostics, testing, and treatment of diseases and health conditions.
MeDevIS
MeDevIS is an electronic database of Medical Devices that was established in response to a 2007 WHA resolution demanding an “evidence web-based health technologies database” to provide guidance on appropriate medical devices according to the levels of care, setting, and intended health intervention. Member States, governmental institutions, public health bodies, and funding agencies can access priority medical devices lists and use them as a reference for national lists for procurement, reimbursement, and facility planning needs.
The platform includes 2301 types of medical devices across a “broad ranging” spectrum of health issues, including reproductive, maternal, newborn and child health, noncommunicable diseases, and infectious diseases. WHO states that there are over 10,000 different medical devices in use for protection, prevention, diagnostics, treatment, or rehabilitation of health issues. However, the many different sources of information about these can make it hard to “discern and utilise the most reliable data”. With MeDevIS, users can explore devices by type, level of health care systems to support the device, scope, and infrastructure required, among other categories. It replaces paper-based literature search and aims to make the naming of medical devices simpler.
The platform draws on two international naming systems for medical devices: the European Medical Device Nomenclature (EMDN) and the Global Medical Device Nomenclature (GMDN).
Navigating the technology landscape
Dr Yukiko Nakatan, WHO Assistant Director-General for Access to Medicines and Health Products, commented that the number of medical technologies used in health care is “growing, as is their complexity”. This makes it “challenging” to navigate.
“We aim to provide a one stop shop of international information, which can be invaluable for those making decisions on life-saving medical technologies, especially in resource-limited settings, and to improve access.”
Dr Deus Mubangizi, WHO Director for Health Products Policy and Standards in the Access to Medicines and Health Products Division, hopes the platform will be useful for national policymakers to “develop or update” national lists for procurement, contributing to “progress towards universal health coverage”.
“It can also help agencies in health insurance and reimbursement policies for patients.”
For more on how vaccine device technology is evolving at the Congress in Barcelona, get your tickets here, and don’t forget to subscribe for weekly newsletters here.
by Charlotte Kilpatrick | Jul 9, 2024 | Technology |
Moderna and Mitsubishi Tanabe Pharma Corporation announced in July 2024 that they have entered a joint agreement regarding the co-promotion of Moderna’s mRNA respiratory vaccine portfolio in Japan. This includes Moderna’s COVID-19 vaccines, Spikevax. Through the agreement, Moderna will handle the manufacturing, sales, medical education, and distribution of its mRNA respiratory vaccines. The two companies will engage in activities to “enable broad access” to Moderna’s mRNA respiratory portfolio to ensure that it has the “maximum impact on public health” in Japan. The agreement has an initial term until 31st March 2029.
Mitsubishi Tanabe Pharma Corporation is the pharma arm of Mitsubishi Chemical Group and is “one of the oldest” pharmaceutical companies in the world. Founded in 1678, it focuses on ethical pharmaceuticals. Moderna, a “leader in the creation of the field of mRNA medicine” is “reimagining how medicines are made” and “transforming” disease prevention and treatment.
Kazumasa Nagayama, President and Representative Director of Moderna Japan, is “pleased” to partner with Mitsubishi Tanabe Pharma to “enable the commercialisation of our COVID-19 vaccine and future mRNA respiratory vaccine portfolio to the people of Japan”.
“Mitsubishi Tanabe Pharma has a significant heritage in Japan and has long contributed to public health through numerous vaccines and possesses extensive experience and deep knowledge in this area.”
Moderna looks forward to “working together to provide our COVID-19 vaccine in Japan” as the virus “continues to pose a significant threat to public health”. Akihiro Tsujimura, Representative Director of Mitsubishi Tanabe Pharma, stated that Moderna has delivered COVID-19 vaccines to “many people worldwide” since the beginning of the COVID-19 pandemic.
“We are delighted to collaborate with Moderna and engage in commercial activities for the COVID-19 vaccine and other mRNA respiratory vaccines in Japan. We will continue to contribute to public health in Japan through our vaccine business.”
For more vaccine partnerships and efforts to bring innovative technology to all who need it, why not join us at the Congress in Barcelona this October? Don’t forget to subscribe to our weekly newsletters here.
by Charlotte Kilpatrick | Jul 8, 2024 | Technology |
In July 2024 CEPI announced an award of US $1.1 million to support Apriori Bio in advancing its biology-informed artificial intelligence platform Octavia. Octavia is intended to protect humanity against rapidly evolving viruses through the design of variant-resilient vaccines. The seed funding will focus on pandemic influenza strain H3N2, which has already affected pigs, birds, and humans. This work comes from within CEPI’s biosecurity department, established to reduce biosafety and biosecurity risks associated with CEPI research investments and accelerate responsible AI for vaccine development.
The Octavia platform
Apriori introduces Octavia as a biology-enabled AI platform that creates landscape maps of existing and potential variants of a virus based on their ability to bind human cells and evade antibodies. These maps enable the creation of an “antibody repertoire” to “fill gaps in our defences with new vaccines”. The platform is designed “from the bottom-up” to “seamlessly integrate experimental insights and artificial intelligence”. Octavia uses several enabling technologies, such as protein display systems, deep mutational scanning, single-cell sorting, and deep sequencing.
The goal of the platform is to make the “vision” of a vaccine to protect against variants that will emerge in the future a reality. This would inform a public health policy based on an “accurate understanding” of how medical countermeasures and natural immunity interact with existing, emerging, and potential variants of concern.
Precision and speed for preparedness
Dr In-Kyu Yoon, Acting Executive Director of Vaccine R&D at CEPI, reflected that the world was “brought to its knees” by the “devastating” COVID-19 pandemic, in which “fast-emerging variants like Omicron outsmarted our medical defences, so we had to constantly play catch-up”.
“To avoid being in this vulnerable position again, we need to shift our global mindset to one of preparedness. By focusing on the range of potential deadly viral variants that could emerge from deadly pathogens ahead of time, we could seriously speed up our response to a future outbreak.”
Dr Lovisa Afzelius, Co-founder and CEO of Apriori, is “honoured to be recognised by a global leader in pandemic preparedness”. The two organisations share a “commitment to better protecting humanity from rapidly-evolving viruses”.
“With CEPI’s support we will continue advancing our Octavia platform, focusing on viruses beyond coronavirus, to ensure the global community is better prepared to effectively address future outbreaks with precision and speed.”
For more insights into technology for global pandemic preparedness, why not join us at the Congress in Barcelona this October? Don’t forget to subscribe to our weekly newsletters here.
by Charlotte Kilpatrick | Jul 8, 2024 | Technology |
HilleVax announced in July 2024 that topline data results from NEXT-IN1, a Phase IIb trial of HIL-214, reveal a failure to meet primary and secondary efficacy endpoints. This trial in infants around 5 months old at time of initial vaccination was conducted after a Phase IIb study in adults demonstrated “statistically significant efficacy” against moderate or severe acute gastroenteritis (AGE) caused by norovirus. The company plans to discontinue further development of HIL-214 in infants but will explore the potential for continued development of HIL-214 and HIL-216, a Phase I-ready candidate, in adults.
HIL-214 fails to meet endpoints
HIL-214 is a norovirus bivalent GI.1/GII.4 virus-like particle (VLP) vaccine intended for active immunisation to prevent AGE caused by norovirus. The latest trial was a Phase IIb, randomised, double-blind, placebo-controlled clinical trial to evaluate the efficacy, safety, and immunogenicity of HIL-214 in infants at sites in the US and Latin America. HilleVax states that in the study there were 51 primary endpoint events: 25 in the vaccine arm and 26 in the placebo arm. This resulted in vaccine efficacy of 5%.
“The study did not meet its primary endpoint of efficacy against moderate or severe acute gastroenteritis (AGE) events due to GI.1 or GII.4 norovirus genotypes. No clinical benefit was observed across secondary endpoints.”
HIL-214 exhibited a safety and immunogenicity profile that was “consistent” with observations in the prespecified analysis of the first 200 subjects in this trial and in previously reported studies. Dr Rob Hershberg, Chair and Chief Executive Officer of HilleVax, is “disappointed” that the study did not meet its primary efficacy endpoint
“While HIL-214 previously showed clinical benefit in adults, NEST-IN1 was the first efficacy study conducted in infants for a norovirus vaccine candidate.”
Dr Hershberg suggested that the efficacy in the infant setting “may have been impacted by the appearance of multiple emerging GII.4 strains in this trial”.
“We sincerely thank the trial investigators, clinical sites, and the HilleVax team for conducting a highly rigorous study, and we are deeply appreciative to the infants and families that participated in this trial.”
For more vaccine trial updates, don’t forget to subscribe to our weekly newsletters here.
by Charlotte Kilpatrick | Jul 4, 2024 | Technology |
Merck’s Life Science business sector and Afrigen Biologics announced in July 2024 that they have entered a non-binding Memorandum of Understanding (MoU) to support the development of an mRNA vaccine technology platform. The collaboration will seek to advance manufacturing capabilities, scale up production, optimise processes, and provide troubleshooting expertise. Within the MoU, Merck will support Afrigen’s Centre of Excellence and training initiatives, intended to build mRNA production capacity in LMICs.
Technology transfer
Co-led by WHO and Medicines Patent Pool (MPP), the mRNA technology transfer programme will provide knowledge transfer to allow 15 recipient manufacturers to produce and release mRNA vaccines at scale to support clinical development, national/regional marketing authorisation and WHO prequalification, and sustainable supply to meet local and regional demand.
Merck describes itself as “one of the key players” driving mRNA technology forward. It brings a comprehensive approach involving mRNA expertise, tech-transfer proficiency, regulatory knowledge, and product portfolios streamline manufacturing and testing.
Combining expertise
Head of Commercial EMEA Process Solutions, Life Science business sector of Merck, Bert de Vet, hopes that by “leveraging our comprehensive chemical portfolio and custom production capabilities”, Merck will be able to “offer cutting-edge experience” to ensure a “seamless journey from research to production”.
“Our alliance with Afrigen for mRNA technology platform development echoes our commitment to fostering equitable access to life-saving therapies for global health.”
Professor Petro Terblanche, CEO of Afrigen, stated that the mRNA vaccine technology transfer hub is “well on its way to create a sustainable mRNA product innovation platform for public health benefit and pandemic preparedness”.
“The platform at Afrigen provides access to mRNA technology for 15 partners in LMICs and straddles the entire vaccine value chain from R&D to Good Manufacturing Practices (GMP) manufacturing. Following the launch of the programme in 2021, we have successfully developed mRNA vaccine technology R&D and production capabilities. Our progress has been accelerated by Merck’s technical expertise.”
Dr Ike James, Head of Technology Transfer at Medicines Patent Pool, commented that the mRNA technology transfer programme distinguishes itself through “exceptional collaboration among numerous partners, all dedicated to empowering LMICs to develop and manufacture the mRNA vaccines of the future”.
“Today’s MoU signing between Afrigen and Merck is a clear testament to this shared commitment and a significant step in this journey.”
For more from Professor Terblanche at the Congress in Barcelona this October, get your tickets here. Don’t forget to subscribe to our weekly newsletters here.
by Charlotte Kilpatrick | Jul 3, 2024 | Technology |
In July 2024, GSK and CureVac announced that they have “restructured” an existing collaboration into a new licensing agreement to allow both companies to “prioritise investment and focus their respective mRNA development activities”. The two companies have been working together on mRNA vaccines for infectious diseases since 2020. This collaboration has led to the development of vaccine candidates for seasonal influenza and COVID-19 (Phase II) and avian influenza (Phase I).
CureVac’s mRNA
The candidates are based on CureVac’s proprietary second-generation mRNA backbone. CureVac states that mRNA has “unparalleled potential as a drug”, which is driving an “exciting mission” into “unexplored territory”. The team analysed millions of naturally occurring sequences to gain insights into the endogenous RNA language, which enabled them to develop an in-house nucleotide sequence library to “optimally assemble the various pieces of the mRNA puzzle”.
The agreement
Under the terms of the new agreement, GSK will assume control of developing and manufacturing the vaccine candidates, with worldwide rights for commercialisation. This is the “latest step in GSK’s ongoing investment in vaccine platform technologies”, through which the company matches the best platform to specific pathogens to create best-in-class vaccines.
CureVac will receive upfront payment of €400 million and up to €1.05 billion more in development, regulatory and sales milestones, and tiered royalties. This agreement replaces all previous financial considerations from the prior collaboration agreement. CureVac will also retain exclusive rights to the additional undisclosed and preclinically validated infectious disease targets from this collaboration, with the opportunity to independently develop and partner mRNA vaccines in any other infectious disease or other indication.
Vaccines at pace
Dr Tony Wood, GSK’s Chief Scientific Officer, is “excited” about the flu/COVID-19 programmes and the “opportunity to develop best-in-class mRNA vaccines to change the standard of care”.
“With this new agreement, we will apply GSK’s capabilities, partnerships, and intellectual property to CureVac’s technology, to deliver these promising vaccines at pace.”
Dr Alexander Zehnder, Chief Executive Officer, CureVac, states that the new agreement “puts us in a strong financial position and enables us to focus on efforts in building a strong R&D pipeline”.
“The collaboration with GSK has been instrumental in developing promising, late clinical-stage vaccine candidates, leveraging our proprietary mRNA platform.”
For more from senior representatives of GSK at the Congress in Barcelona this October, get your tickets here. Don’t forget to subscribe for weekly vaccine updates here.
by Charlotte Kilpatrick | Jul 2, 2024 | Technology |
The US Department of Health and Human Services (HHS) announced that through BARDA, part of the Administration for Strategic Preparedness and Response (ASPR), it will provide around $176 million to Moderna to support the development of an mRNA-based pandemic influenza vaccine. The award will allow Moderna to establish additional pandemic influenza vaccine response capability, leveraging existing US domestic large-scale commercial mRNA-based manufacturing platforms and ongoing seasonal influenza vaccine development. Furthermore, ASPR has secured a fair pricing agreement to ensure “enduring equitable access” to vaccines.
Learning from COVID-19
HHS Secretary Xavier Becerra stated that the team has “successfully taken lessons learnt during the COVID-19 pandemic” to “better prepare for future public health crises”. This includes the continued development of vaccines and “other tools” to “help address influenza and bolster our pandemic response capabilities”.
“Importantly, we are doing this work in partnership with some of the nation’s leading scientists and clinicians. The Biden-Harris Administration won’t stop until we have everything we need to prepare for pandemics and other public health emergencies that impact the American public.”
Moderna’s technology
Moderna’s influenza vaccine candidate uses the mRNA technology that was “leveraged successfully” during the COVID-19 response.
“mRNA vaccines have the potential to complement traditional vaccine technologies during a pandemic influenza emergency response.”
Moderna will prepare materials and conduct clinical trials to collect data for FDA licensure and potential scale-up. HHS believes that a successful mRNA-based licensed pandemic influenza vaccine could “further improve response timelines” if a new virus strain emerged and caused a pandemic.
Technology in the toolkit
Assistant Secretary for Preparedness and Response, Dawn O’Connell, stated that the award is part of a “longstanding commitment to strengthen our preparedness for pandemic influenza”.
“Adding this technology to our pandemic flu toolkit enhances our ability to be nimble and quick against the circulating strains and their potential variants.”
Moderna’s CEO Stéphane Bancel is “pleased to continue our collaboration with BARDA” as his organisation seeks to “expedite our development efforts for mRNA-based pandemic influenza vaccines”.
“mRNA vaccine technology offers advantages in efficacy, speed of development, and production scalability and reliability in addressing infectious disease outbreaks, as demonstrated during the COVID-19 pandemic.”
Bancel hopes to “support the global public health community in preparedness against potential outbreaks”.
To join important discussions about influenza and pandemic preparedness, why not get your tickets to the Congress in Barcelona this October? Don’t forget to subscribe for more insights here.
by Charlotte Kilpatrick | Jul 2, 2024 | Technology |
In July 2024, the US National Institutes of Health (NIH) announced the beginning of a Phase I trial to test the safety of a nasal vaccine candidate against emerging variants of SARS-CoV-2. Enrolment of healthy adults has started at three sites in across the US for the first-in-human trial of the vaccine, designed and tested in pre-clinical studies by scientists at the National Institute of Allergy and Infectious Diseases (NIAID) Laboratory of Infectious Diseases.
The vaccine enters study
The investigational vaccine, MPC/S-2P, uses murine pneumonia virus (MPV) as the vector to deliver a version of the SARS-CoV-2 spike protein (S-2P), stabilised in its prefusion conformation. MPV doesn’t cause disease in humans or non-human primates but has an “affinity for epithelial cells” along the respiratory tract, which means it could be effective in taking the vaccine to the site of natural coronavirus infection.
In pre-clinical non-human primate studies, MPV/S-2P was “safe and well tolerated”, and produced robust systemic immune responses, including SARS-CoV-2-directed antibodies, and local immunity in cells in the mucosal tissues that line the nose and respiratory tract. NIH states that studies indicate that “mucosal immunity is more effective than systemic immunity in controlling replication of respiratory viruses”.
The study is intended to enrol 60 adult participants between the ages of 18 and 64, who have previously received at least three prior doses of an FDA-approved or –authorised mRNA COVID-19 vaccine. The sites are Baylor College of Medicine, Houston, The Hope Clinic of Emory University, Decatur, Georgia, and New York University, Long Island.
Volunteers will be divided into three cohorts with participants in the first cohort receiving a dose delivered in a nasal spray at the lowest dosage. Participants in the next two cohorts will receive progressively higher doses. They will attend seven follow-up visits over a year, during which scientists will measure how well the vaccine candidate is tolerated and look for immune responses in the blood and nose.
A next-gen need
Dr Jeanne M. Marrazzo, Director of NIAID, recognised that the “rapid development of safe and effective COVID-19 vaccines was a triumph of science” and they “greatly mitigated the toll of the pandemic”.
“While first-generation COVID-19 vaccines continue to be effective at preventing severe illness, hospitalisations, and death, they are less successful at preventing infection and milder forms of disease. With the continual emergence of new virus variants, there is a critical need to develop next-generation COVID-19 vaccines, including nasal vaccines, that could reduce SARS-CoV-2 infections and transmission.”
For more on efforts to bring a new generation of more effective COVID-19 vaccines to market, why not join us at the Congress in Barcelona this October? Don’t forget to subscribe to our weekly newsletters here for vaccine insights.
by Charlotte Kilpatrick | Jul 1, 2024 | Technology |
In June 2024 it was announced that CTIBIOTECH has launched the SAFESKIN3D project to produce flexible 3D bioprinted human skin models for use in the evaluation of vaccines, particularly next generation mRNA vaccines. CTIBIOTECH has secured a strategic partnership with Sanofi, who will act as “beta tester”, providing “expert feedback” to validate and refine the models.
SAFESKIN3D
The project is described as a “significant technological breakthrough” for vaccine development. It leverages CTIBIOTECH’s expertise in 3D printing and human tissue engineering to create advanced models that mimic subcutaneous and intramuscular injection sites. This will provide pharmaceutical companies with the opportunity to predict the effects of mRNA vaccines, reducing reliance on animal testing.
The SAFESKIN3D project seeks to:
- Develop sophisticated 3D human skin models including epidermis, dermis, hypodermis, and muscle layers
- Integrate immune cells, sensory neurons, and vascular components to provide a comprehensive vaccine safety testing model
- Reduce vaccine development cost and time
- Minimise the need for animal experimentation
CTIBIOTECH is investing €1 million in the project, supported by €500,000 from:
- Sanofi iDEA-TECH Award
- Transforming SMEs through innovation | France 2030 award
- Important Project of Common European Interest (IPCEI Med4Cure award)
Professor Colin McGuckin, President and Chief Innovation Officer at CTIBIOTECH, described the project as a “testament to our commitment to innovation and excellence in making human tissues”.
“By developing advanced 3D bioprinted skin models, we not only enhance the safety and efficacy of new vaccines but also pave the way for more ethical and sustainable research practices. This project will significantly reduce the reliance on animal testing and accelerate the development of next-generation vaccines, ultimately benefitting public health at a global scale.”
Professor McGuckin is “thrilled” to work with Sanofi and “leverage their expertise to bring this transformative technology to market”. Dr Nicolas Forraz, Chief Executive Officer of CTIBIOTECH, believes the launch is a “pivotal moment” for the organisation and the “broader field of vaccine development”.
“Our innovative 3D bioprinted skin models will provide a more accurate and ethical method for assessing vaccine safety, ultimately leading to faster and more cost-effective development of new vaccines.”
The project demonstrates Dr Forraz’s team’s “commitment to scientific excellence” and “dedication to transforming public health”.
For more on innovative vaccine technologies, don’t forget to get your tickets to the Congress in Barcelona here and subscribe to our weekly updates here.
by Charlotte Kilpatrick | Jul 1, 2024 | Technology |
In June 2024, PharmaJet announced that the Tropis Intradermal (ID) Needle-free System will be used for a house-to-house polio immunisation in Somalia. The campaign, a collaboration of the African Field Epidemiology Network (AFENET), WHO, UNICEF, BMGF, Gavi, and CDC, will target over 170,000 children across 4 districts in Banadir. It will be conducted in two rounds, offering children between 4 and 59 months the needle-free polio vaccine and novel oral polio vaccine to reach 95% coverage.
Fighting an ongoing outbreak
PharmaJet states that an ongoing variant poliovirus outbreak, which is the longest running of its kind, has paralysed 38 children in Somalia. In April, Somalia’s Minister for Health and Human services, His Excellency Dr Ali Haji Adam, met high-level representatives of the Global Polio Eradication Initiative (GPEI) to review progress and accelerate efforts to end the 7-year outbreak. The Somalia Emergency Action Plan (SEAP) 3, presented at the meeting, “builds on measures taken so far and will fill existing gaps in polio eradication efforts”.
“The plan prioritises robust, high-quality polio vaccination campaigns and better poliovirus surveillance. Efforts will also be targeted at high-risk populations in hard-to-reach areas and where variant poliovirus is circulating, as well as underserved, displaced, and nomadic communities.”
PharmaJet’s involvement in the campaign
The campaign in Somalia comes after “positive results” from a WHO-lead pilot in Nigeria. This demonstrated that administering an injectable vaccine with Tropis facilitated high coverage rates and that most parents (94%) and health staff members (93%) preferred needle-free injections. In this campaign 87% of target group children received immunisation. The Tropis System was also deployed for polio vaccinations in the Berbera Region of Somaliland, supporting high immunisation coverage thanks to preference for the use of intradermal needle-free delivery and parental enthusiasm for less invasive administration.
Paul LaBarre, Vice President, Global Business Development, PharmaJet, is “very pleased” with the collaboration on “this important campaign”. With the experience of delivering “over 10 million polio immunisations” with needle-free technology in Nigeria, Pakistan, and Somalia”, the team is “very committed” to the GPEI.
“In Somalia, we are eager to build on previous house-to-house campaign experience that demonstrates how needle-free enables vaccination teams to move quickly and achieve high coverage without the burden of sharps waste management and with reduced vaccine volume and cold chain logistics.”
We look forward to hearing more from PharmaJet about their technology and its applications at the Congress in Barcelona this October. Get your tickets here to join us and don’t forget to subscribe to our weekly newsletters here.
by Charlotte Kilpatrick | Jun 28, 2024 | Technology |
Researchers at La Jolla Institute for Immunology (LJI) Centre for Vaccine Innovation are exploring ways to prevent the fusion of measles “machinery” with host cell membranes. Using an imaging technique called cryo-electron microscopy, they have shown “in unprecedented detail” how an antibody can neutralise the measles virus before it completes fusion. Their work in Science (not open access) seeks to explain the mechanism of action of monoclonal antibody (mAb) 77, and could have implications beyond measles, such as for other members of the paramyxovirus family.
Measles concerns
Despite “extensive” vaccine efforts, measles remains a “major health threat”, particularly to children. Dr Erica Ollmann Saphire, LJI professor, states that the virus “causes more childhood deaths than any other vaccine-preventable disease” and is “one of the most infectious viruses known”. The study first author and LJI postdoctoral researcher Dr Dawid Zyla highlights that the risk is not just for young children.
“The current vaccine works well, but it cannot be taken by pregnant people or people with compromised immune systems.”
Furthermore, there is currently no specific treatment for measles.
mAb 77
An antibody called mAb 77 targets the measles fusion glycoprotein, which is the “piece of viral machinery” that enables the virus to enter human cells by fusion. Working with a team at Columbia University, the LJI team sought to engineer a version of the measles fusion glycoprotein that was stable enough for cryo-electron imaging. Dr Matteo Porotto, Professor of Viral Molecular Pathogenesis (in Paediatrics), had been exploring “strange mutations” in a measles variant that had targeted the central nervous system. This variant had weak points in the fusion glycoprotein structure that “forced” the virus to evolve.
“The virus has to mutate to go into the brain, but then it needs these stabilising mutations to compensate.”
Using this research, Dr Zyla could engineer a fusion glycoprotein with the same mutations; it could be mass produced and was “sturdy” enough for structural investigations. With the LJI Cryoelectron Microscopy Core, the researchers started to capture images that showed the fusion glycoprotein “in complex” with mAb 77. This revealed that mAb 77 “arrests the virus in the middle of the fusion process”, interrupting the “folding” towards fusion.
“It was striking to see what this intermediate step in the fusion process actually looks like.”
Dr Saphire agrees that it was “exciting” to capture “snapshots of the fusion process in action”.
“The series of images is like a flip book where we see snapshots along the way of the fusion protein unfolding, but then we see the antibody locking it together before it can complete the last stage in the fusion process. We think other antibodies against other viruses will do the same thing but have not been imaged like this before.”
Translating the research into treatment
With this newfound understanding of mAb 77, the researchers hope it could be used in a “treatment cocktail” for prevention or treatment of active measles infection. They found that mAb 77 offered “significant” protection against measles in cotton rat models, which were pretreated before virus exposure. The rats showed either no infection or “reduced signs of infection” in lung tissue.
However, the investigations will continue into different antibodies against measles. Dr Zyla states that “we’d like to stop fusion at different points in the process and investigate other therapeutic opportunities”. This can be done in collaboration with the team at Columbia University.
“The combination of structural biology expertise from LJI and cell biology and virology expertise from Columbia was key to pushing this project forward.”
Furthermore, this work could have implications for other viruses, such as Nipah, parainfluenza viruses, and Hendra viruses.
“These are all viruses with pandemic potential.”
We will explore the returning threat of measles at the Congress in Barcelona this October, so do get your tickets to join us there and don’t forget to subscribe to our weekly newsletters for more research updates.
by Charlotte Kilpatrick | Jun 27, 2024 | Technology |
IDT Biologika and SK bioscience announced a strategic partnership in June 2024, with SK bioscience to acquire 60% of IDT Biologika’s shares from the Klocke Group, which will remain the second largest stakeholder. The partnership, described as a “leap forward into global markets”, seeks to build a close relationship between the companies “based on trust in each other’s business capabilities and growth potential”. The companies hope to “stabilise and expand” their market position to meet global standards and “build an integrated infrastructure that connects multiple nations”.
Combining strengths
IDT Biologika brings access to long-standing partnerships with leading pharma companies and institutions, cGMP-level manufacturing, and R&D infrastructure, a global supply chain, global talent, and immediate entry into the new bio business. The partnership will enable IDT Biologika to strengthen its position in the vaccine market and expand its cell and gene therapy portfolio.
“Both companies expect to create synergies.”
SK bioscience is committed to promoting human health “from prevention to cure” and demonstrated superior CMO and CDMO capabilities during the COVID-19 pandemic.
Carsten Klocke of Klocke group, shared that “we have invested significantly in the future of IDT Biologika in recent years”.
“In addition to the development of highly qualified personnel along the entire value chain, the expansion of our manufacturing capacities, including in the production of drug substance and large-volume filling, was a key focus.”
Klocke is “delighted” with SK bioscience’s decision to “enter the future together”.
“This shows that they value and trust our know-how, our scientific expertise, and our strong partnership with customers. I am convinced that SK bioscience is the right partner for IDT Biologika; we share a solid foundation and the same vision. We are combining our expertise and commercial capabilities to contribute to the health of people worldwide.”
IDT Biologika’s CEO, Dr Ulrich Valley, looks forward to working with SK bioscience. Dr Valley stated that IDT Biologika has “built up an excellent reputation in the field of viral vaccines in recent years” and has a “reliable business” internationally. SK bioscience “is also pursuing this strategy” with “extensive expertise in the development and production of vaccines” that enables both companies to expand their market position.
“It is equally important that SK bioscience is focusing on the cell and gene therapy segment, just like IDT, and would like to strategically accompany customers in this business area into the future together with IDT Biologika.”
Jaeyong Ahn, CEO and President of SK bioscience, believes that the “main purpose” of the partnership is to “establish a new growth base and to further expand our core businesses into global markets, including developed countries”.
“Since it represents a high business value for the investment by securing immediate revenue, a global production base, and efficient production facilities, we will continue to make an effort to enhance the company’s corporate value.”
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by Charlotte Kilpatrick | Jun 26, 2024 | Technology |
ILiAD Biotechnologies announced in June 2024 that Emmes Group has been chosen to conduct Phase III studies of its lead pertussis vaccine candidate, BPZE1. The organisations are finalising the definitive agreement, but ILiAD stated that Emmes Group was selected “for their expertise in vaccine development, agility in managing complex clinical trials, strong local market presence, and their integrated technology capabilities”. The VaxTrials unit previously demonstrated “proficiency and clinical trial excellence” in supporting ILiAD’s Phase II IB-201P BPZE1 study.
BPZE1
ILiAD states that “there is a critical need for a new and more effective pertussis vaccine”. Although there are antibiotics, the window of effectiveness after infection is limited. ILiAD’s lead product candidate is BPZE1, a live attenuated pertussis vaccine based on a strain developed at the Institut Pasteur de Lille and Inserm. It is a “technologically advanced” pertusiss vaccine containing genetic modifications to “eliminate, attenuate, or inactivate” three B. pertussis toxins.
A carefully considered decision
Dr Keith Rubin, Chief Executive Officer of ILiAD Biotechnologies, commented that the selection of Emmes Group for the upcoming trials was a “carefully considered strategic decision to ensure the highest standards of clinical research”.
“VaxTrials’ specialisation in vaccines and Veridix AI’s advanced technological capabilities will be instrumental in executing our BPZE1 vaccine clinical development plan.”
Sastry Chilukuri, Chief Executive Officer of Emmes Group, is “honoured and pleased” that ILiAD has selected Emmes Group as partner in the continued clinical development of BPZE1.
“We look forward to working closely with ILiAD’s clinical development team on this promising new vaccine, which could significantly reduce the transmissibility and incidence of B. pertussis, particularly in vulnerable populations.”
To join us at the Congress in Barcelona this October, get your tickets here, and don’t forget to subscribe for weekly vaccine updates.
by Charlotte Kilpatrick | Jun 25, 2024 | Technology |
Osivax announced in June 2024 that it has completed enrolment for its Phase I trial of OVX033, a broad-spectrum vaccine candidate against sarbecoviruses. The study will evaluate the safety and immunogenicity of OVX033 with three dose levels (100µg, 250µg and 500µg). No safety concerns or signals have been observed at any dose level to date. The study is a single-centre, randomised, double-blind, placebo-controlled trial conducted at the Clinical Investigation Centre in Vaccinology Cochin Pasteur (CIC) in Paris.
OVX033
OVX033 is a first-in-class coronavirus vaccine candidate that targets the nucleocapsid (N), which is a “highly conserved internal antigen”. Compared to the Spike (S) surface antigen, N is “much less likely to mutate”, which offers a “broader and more universal immune response”. The goal is to induce broad-spectrum protection against all current and future variants of SARS-CoV-2 as well as future pandemic coronavirus strains.
Osivax’s oligoDOM technology “enables the design and production of a recombinant version of nucleocapsid”, which “self-assembles into a nanoparticle”. It has been “uniquely designed” to increase the T-cell immune response through a specific signal sequence targeting and activating cells from the immune system. It also triggers a strong B-cell response. OVX033 has demonstrated a preclinical proof-of-concept for cross-protective efficacy in a hamster challenge model.
Dr Nicola Groth, CMO of Osivax, suggested that “sarbecoviruses remain a threat” as we saw during the COVID-19 pandemic, which “continues to have long-term consequences for global health”.
“By completing enrolment for our Phase I trial with OVX033, we are taking a significant step forward in addressing the need for a broad-spectrum vaccine to provide protection against these rapidly mutating viruses.”
Professor Odile Launay from Paris University is the Principal Investigator of the trial and looks forward to sharing the data readout “later this year”.
“The data gathered from the Phase I trial with OVX033 will be critical to its further development as an effective and safe protective measure against various strains of sarbecoviruses.”
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by Charlotte Kilpatrick | Jun 24, 2024 | Technology |
AstriVax announced in June 2024 that the first participants have been dosed in a Phase I clinical study to investigate the safety and efficacy of their prophylactic vaccines for yellow fever and rabies in healthy adults. The first-in-human clinical study is called SAFYR and will be conducted at two Belgium-based, world-class vaccine clinical trial sites, enrolling around 100 adults between the ages of 18 and 40.
An innovative platform
AstriVax’s PLLAV (Plasmid-Launched Live Attenuated Virus) technology is “easy to produce” with “limited cold chain requirements” and is “expected to trigger a strong and lasting immune response”. The company has a “rich” pipeline targeting viral infections. Dr Mathieu Peeters, Chief Development Officer at AstriVax, looks forward to the opportunity to evaluate the “cutting-edge technology in a clinical proof-of-concept study”.
“We use plasmids that deliver live-attenuated virus vectors along with the target viral antigen. This self-amplifying mechanism is designed to elicit strong and long-lasting immune responses with only microdoses.”
Dr Hanne Callewaert, CEO and co-founder of AstriVax, reflected on the “journey” that began “less than two years ago” with “solid, academically developed technology and a €30 million seed round”.
“In May 2023, we were awarded a grant from Flanders Innovation & Entrepreneurship (VLAIO) to further advance our technology. I am deeply grateful to my exceptional team for shaping the company into what it is today, and I look forward to continuing our journey towards better global health together. We anticipate our chronic hepatitis B immunotherapeutic will enter the clinical phase in 2025, marking yet another significant milestone for AstriVax.”
To hear the latest in vaccine design and development at The World Vaccine Congress in Barcelona this October, get your tickets to join us here. Don’t forget to subscribe for weekly vaccine updates and insights here.
by Charlotte Kilpatrick | Jun 18, 2024 | Technology |
GeoVax announced in June 2024 that it has received an award to advance development of GEO-CM04S1 in a Phase IIb clinical trial. GEO-CM04S1 is GeoVax’s dual-antigen, next-generation COVID-19 vaccine and the trial will compare its efficacy, safety, and immunogenicity with an FDA-approved mRNA COVID-19 vaccine. The trial is expected to enrol 10,000 participants and will be a randomised, double-blinded study within BARDA’s Clinical Studies Network.
GEO-CM04S1
GEO-CM04S1 is based on GeoVax’s MVA viral vector platform, which supports the presentation of “multiple” vaccine antigens in a single dose. The vaccine encodes for both the spike (S) and nucleocapsid (N) antigens of SARS-CoV-2. It is designed to induce both antibody and T-cell responses to the parts of the virus that are “less likely to mutate over time”.
“The more broadly functional engagement of the immune system is designed to protect against severe disease caused by continually emerging variants of COVID-19. Vaccines of this format should not require frequent and repeated modification or updating.”
In trial
The funding of $24.3 million could increase to as much as $45 million to fund the manufacturing of clinical materials and support for the trial, including regulatory activities. David Dodd, Chair and CEO of GeoVax, is “honoured and proud” to receive the award from BARDA to advance the vaccine. He suggests that the contract “not only provides the vital resources for advancing the development of GEO-CM04S1, but it also advances our MVA platform in infectious diseases”.
“First-generation COVID-19 vaccines were beneficial during the peak of the pandemic but are limited in breadth and durability of clinical protection, requiring frequent updates. Now that COVID-19 is in an endemic stage, many people continue to have their everyday lives impacted in meaningful ways.”
Mr Dodd reflected that there are an “estimated 23 million adults in the US with immunocompromised conditions”. They are “less likely to have an adequate response to current vaccines”, which puts them at risk of severe COVID-19 symptoms, hospitalisation, and death.
“GEO-CM04S1 was designed to address these limitations by inducing durable neutralising antibody and T-cell-based immunity against current and future SARS-CoV-2 variants. Our vaccine has continued to demonstrate induction of potent immune responses with potential to drive broad and durable clinical protection, and we eagerly anticipate commencing the Phase IIb study to further demonstrate the value and advantages of our technology.”
For more on COVID-19 vaccine development and improvement, why not join us at the Congress in Barcelona this October or subscribe to our weekly newsletters?
by Charlotte Kilpatrick | Jun 18, 2024 | Technology |
In a throwback to the Barcelona Congress in October 2023 we are sharing a conversation with RAY CRO’s Ahmed Hamouda, who joined us to share his vision for growth and the importance of his team’s work. RAY CRO joined us as exhibitors on the packed exhibition floor; did you meet them there? It was a pleasure to meet Ahmed and we hope that you enjoy the interview!
Introducing Ahmed and RAY CRO
Ahmed kindly introduces himself as clinical research director at RAY, a “full-service” CRO that covers the Middle East and Africa. Based in Egypt, Ahmed also travels overseas to the US and other sites across the region, which are expanding!
Services
So, what exactly does “full service” mean? Ahmed outlines the range of services that he and his team offer. He is personally responsible for clinical operations, but they also offer regulatory, pharmacovigilance, and safety services among others. On top of these, they have recently launched the offsite research nursing service, which facilitates easier and more convenient participation in trials for patients.
“We’re proud of this service, which has been really successful so far!”
Overcoming access obstacles
During the COVID-19 pandemic we became acutely aware that the distribution and deployment of vaccines is unequal. A focus at the Congress was how we can encourage greater manufacturing on the African continent in particular, to foster resilience and independence. Therefore, we asked Ahmed about his team’s contribution to empowering the region. Ahmed reflects on his COVID-19 experience, supporting clinical trials that brought the vaccine to the continent.
“Let’s face it – we had an access challenge.”
Alongside this trial, RAY CRO assisted regulatory efforts, registering the vaccine for emergency use; Ahmed is “proud” of this contribution to maintaining the vaccine portfolio for the region.
Awareness and engagement
Acknowledging the inequality highlighted in the pandemic, focus is shifting to what can be done to prevent future barriers to access. For Ahmed, a key element of this is public engagement.
“We’re trying to increase awareness, and to highlight the importance of focusing on clinical trials, research, which is an unending process for African nations, by increasing investments, enhancing clinical trial and research.”
This applies to “all” vaccines, not just COVID-19. However, a “rare benefit” of the pandemic was the “increased awareness” of the vaccines to the public and to regulatory authorities.
“Infrastructure has been significantly introduced.”
Thus, the event offers an opportunity to connect with other stakeholders. For example, Ahmed met with Africa CDC in Barcelona to discuss complementary activities.
“One event after another, will be definitely helping us towards the right direction.”
Why WVC?
Ahmed has already touched on some of his hopes for the event, but no one escapes our final question about their reasons for joining us.
“What I’m hoping to gain is to maintain contacts. I’ve met really nice people, very professional organisations, with visions.”
Furthermore, the opportunity to learn about new innovations and organisations was welcome! We hope that the event was productive for RAY CRO.
It was fantastic to meet Ahmed to learn more about his work, and we hope that if you weren’t able to meet him in Barcelona you contact his team here. For more interviews and insights, don’t forget to subscribe to our newsletters here! To get your tickets to this year’s event in Barcelona click here.
by Charlotte Kilpatrick | Jun 18, 2024 | Technology |
In June 2024 Merck (known as MSD outside the US and Canada) announced that the FDA has approved CAPVAXIVE for the prevention of invasive disease and pneumonia caused by specific Streptococcus pneumoniae serotypes that cause most invasive pneumococcal disease (IPD) cases. The vaccine has been approved for use in adults and targets serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F and 35B. The CDC’s Advisory Committee on Immunisation Practices is expected to meet this month to discuss recommendations for the use of CAPVAXIVE in adults.
Targeting new serotypes
Merck used CDC data to inform serotype selection. In adults aged 50 and older, CAPVAXIVE covers the serotypes responsible for around 84% of IPD cases, which compares to approximately the 52% covered by PCV20 (pneumococcal 20-valent conjugate vaccine). In adults aged 65 and older, CAPVAXIVE covers the serotypes responsible for approximately 85% of IPD cases, compared to around 51% covered by PCV20.
CAPVAXIVE incorporates eight unique serotypes that are not covered by other currently approved pneumococcal vaccines: 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B. Dr Walter Orenstein, professor emeritus of medicine, epidemiology, global health, and paediatrics at Emory University and member of Merck’s Scientific Advisory Committee, suggested that “complications from invasive pneumococcal disease can lead to hospitalisation, organ damage, and even death”.
“CAPVAXIVE is designed to include the serotypes that cause the majority of invasive pneumococcal disease in adults, helping to protect adults against invasive pneumococcal disease and pneumococcal pneumonia.”
Dr Dean Y. Li, president, Merck Research Laboratories, stated that the approval is a “testament to our population-specific strategy behind CAPVAXIVE, which demonstrated robust immunogenicity in a range of adult populations” and is “driven by a deep understanding of pneumococcal disease”.
“We are proud to provide CAPVAXIVE as a new option specifically designed to help protect against the majority of invasive pneumococcal disease-causing serotypes in adults.”
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by Charlotte Kilpatrick | Jun 17, 2024 | Technology |
In June 2024 Vaxart announced that it has received a project award valued at up to $453 million to conduct a Phase IIb comparative study to evaluate Vaxart’s oral pill COVID-19 vaccine candidate against an FDA-approved mRNA vaccine comparator. The funding will be provided in two parts, with approximately $65.7 million available immediately; this will be followed by $387.2 million when Vaxart and BARDA have established that the study can proceed.
The vaccine and the trial
Vaxart’s oral pill vaccine “holds the promise of longer protection from infection, broader protection against virus variants, and a greater reduction in virus transmission than the first-generation injectable vaccines”. The vaccine triggers “strong” IgA and T-cell responses. It is designed to be room temperature-stable to facilitate global distribution with “wide public acceptance, minimal cost, and maximum speed”.
The Phase IIb trial is a double-blind, multi-centre, randomised, comparator-controlled study to determine the relative efficacy, safety, and immunogenicity of the oral pill candidate against an approved mRNA injectable vaccine in adults who have previously been immunised against COVID-19 infection. The study will enrol around 10,000 healthy adults.
A next-generation approach
Dr James F. Cummings, Vaxart’s Chief Medical Officer, is “grateful to BARDA for this funding”, which will enable Vaxart’s pursuit of a Phase IIb trial for the COVID-19 oral pill vaccine candidate.
“This trial will evaluate whether our oral pill vaccine candidate compares favourably against an approved mRNA injectable vaccine. We are excited to explore the results of this head-to-head comparison. Previous research showed that our earlier COVID-19 vaccine constructs triggered long-lasting immune responses and induced a cross-reactive immunogenic response against all tested SARS-CoV-2 variants.”
Vaxart’s Chief Executive Officer, Steven Lo, commented that “vaccine delivery has relied primarily on injection for more than 150 years”.
“This funding from BARDA will assist us in determining whether we can bring a transformational, next-generation approach to global vaccination. We believe our oral pill vaccine platform can better meet societal needs not just for COVID-19, which now in the endemic phase, but for other infectious diseases that present significant endemic and pandemic threats.”
We look forward to hearing more about this oral vaccination strategy from Vaxart at the Congress in Barcelona this October; get your tickets to join us here and don’t forget to subscribe for more updates.
