by Charlotte Kilpatrick | Oct 24, 2024 | Technology |
The University of Connecticut (UConn) announced in October 2024 that associate Professor Thanh Nguyen’s research has received “significant” backing from The Bill and Melinda Gates Foundation. The Gates Foundation has awarded a series of grants totalling $6.6 million, following support from the National Institutes of Health (NIH) and the US Department of Agriculture (USDA). The funding will contribute to research and innovation for a microneedle array patch that can deliver multiple human vaccines at once. The Foundation initially awarded $2 million, which has increased after early success.
Microneedle array patch technology
Dr Thanh Nguyen works in the College of Engineering’s School of Mechanical, Aerospace, and Manufacturing Engineering. His microneedle method is “far less painful” than traditional syringe delivery and offers access and uptake benefits.
“What if we were able to mail people vaccines that don’t need refrigeration, and they could apply to their own skin like a bandage?”
The technology delivers highly concentrated vaccines in powder from over months, through a “nearly painless” 1-centimetre-square biodegradable patch.
“The primary argument is that getting vaccines and boosters is a pain. You have to go back two or three times to get these shots. With the microneedle platform, you put it on once, and it’s done.”
Funding increases
After the initial award of $2 million, the project made good progress and received additional funding to support the development of a scale-up manufacturing technology to produce patches on an industrial scale. In late September, the Gates Foundation awarded $4 million to take the patch “a step farther” as a pentavalent and Polio vaccine targeting diphtheria, tetanus, pertussis, HIV, Hepatitis B, and Polio. With this funding, the team can “build up productivity”. They are partnering with LTS to scale up production and are expanding the size of laboratory.
The award also marks a fundraising milestone for Dr Nguyen, who has earned more than $25 million in research awards, which he reflects “doesn’t come naturally”.
“It comes from the recognition of the high impact of the research and the lab’s success in publishing articles. It is a testament to the importance of what we are doing.”
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by Charlotte Kilpatrick | Aug 27, 2024 | Technology |
Immorna Biotherapeutics announced in August 2024 that it has received a grant, worth $3,800,000, from the Bill & Melinda Gates Foundation in support of the clinical development of JCXH-108. JCXH-108 is a Respiratory Syncytial Virus (RSV) vaccine based on Immorna’s proprietary mRNA and ‘ready-to-use’ lipid nanoparticle (RTU-LNP) technologies. The grant will provide staged financial support to expedite clinical trials in the US, the process and clinical development of multi-dose vial vaccine (MDV), a marketing application in the US, and WHO Pre-Qualification (PQ). If the vaccine is approved for marketing, Immorna has committed to supplying it to LMICs at a pre-negotiated price.
JCXH-108
JCXH-108 is a monovalent RSV vaccine that uses Immorna’s mRNA and RTU-LNP technologies, which have “gained successful clinical proof-of-concept” in other infectious disease vaccines. This vaccine encodes an engineered RSV Fusion protein with stabilised pre-fusion configuration (pre-F). The pre-F antigen demonstrated “high” in vitro and in vivo expression from the mRNA in preclinical studies, and low doses of JCXH-108 elicited high titres of neutralising antibodies against both RSV A and RSV B strains.
The vaccine “features a mild storage and transportation condition” with a shelf life of around 18 months at between 2°C and 8°C. Enhanced stability should “significantly reduce the logistics complexity” associated with mRNA vaccine storage, transportation, and distribution.
Reducing the burden of RSV
Dr Zihao Wang, Co-Founder and CEO of Immorna, appreciates the “trust and support” shown by the foundation as the company strives to introduce a “safe and effective” RSV vaccine to reduce RSV related hospitalisations and deaths.
“We look forward to working closely with the foundation to expedite the clinical development and marketing of JCXH-108. As a biotech company developing mRNA-based vaccines and therapeutic drugs, Immorna closely follows the global needs for prevention of infectious diseases and strives to help provide more treatment options to patients.”
Dr Wang emphasises the focus on contributing to the creation of a “disease-free, better future”.
“I believe that, if successfully approved for marketing, JCXH-108 may help protect millions of susceptible individuals and their families from the deadly diseases associated with RSV infection, which is particularly meaningful in the LMICs where RSV infection is prevalent.”
Immorna is “on track” to enrol the first subject in a clinical trial by the end of August 2024.
To hear from experts on different approaches to RSV prevention and mitigation, why not get your tickets to join us in Barcelona for the Congress this October? Don’t forget to subscribe to our weekly newsletters here.
by Charlotte Kilpatrick | Jul 31, 2024 | Technology |
Biological E announced in July 2024 that WHO has granted prequalification status to the company’s Novel Oral Polio Vaccine type 2 (nOPV2). Biological E describes this as a “monumental stride” towards global polio eradication, celebrating the 10th Biological E vaccine to receive this status. nOPV2 is a next-generation live, attenuated oral vaccine that “significantly reduces” the risk of circulating vaccine-derived poliovirus type 2 (cVDPV2) outbreaks and is intended for use in countries affected by these outbreaks in a “crucial moment in the fight against polio”.
A strong candidate
Biological E states that nOPV2 can tackle the “persistent threat” of circulating cVDPV2; the vaccine boasts “improved genetic stability” with a “significantly” lower risk of “seeding new outbreaks” in low-immunity environments, compared to the Sabin poliovirus type 2 (mOPV2) vaccine. Through “extensive” clinical trials the safety and immunogenicity of nOPV2 have been “rigorously” evaluated. Furthermore, use in outbreak regions has shown that nOPV2 can “significantly” decrease the incidence of cVDPV2 outbreaks.
Mahima Datla, Managing Director of Biological E, is “pleased to be a part of the global effort to eradicate polio”.
“Our collective quest to eradicate polio marks a significant milestone with the WHO prequalification of nOPV2. This vaccine has been specifically designed to address concerns about vaccine-associated paralytic polio (VAPP), which has occurred in approximately 2 to 4 cases per million births with the traditional OPV due to the vaccine virus reverting to a virulent form.”
Ms Datla also recognised the role of key collaborator PT Bio Farma (PTB) in Indonesia and supporter, the Bill and Melinda Gates Foundation. The Gates Foundation provided a grant to support efforts to meet the global demand. She described the PTB collaboration as a “privilege” and extended “heartfelt gratitude” to the Gates Foundation for “entrusting us with the responsibility of manufacturing nOPV2”.
“Together we are committed to advancing the cause of global health equity and guaranteeing that no child is affected by the devastating effects of polio. The significance of this milestone extends beyond scientific achievement; it represents a beacon a hope for millions of children and families around the globe.”
Ms Datla states that administering more than 1 billion doses of nOPV2 in outbreak regions is “crucial to realising the dream of a polio-free world”.
We look forward to welcoming Dr Ajoy Chakrabarti, Portfolio and Platform Lead, Polio, Global Health Programme, Gates Foundation to the Congress in Barcelona this October; get your tickets to join us here and don’t forget to subscribe to our weekly newsletters here.
by Charlotte Kilpatrick | Mar 20, 2024 | Global Health |
In March 2024 The Bill & Melinda Gates Medical Research Institute (Gates MRI) announced the commencement of a Phase III clinical trial to assess the efficacy of the M72/AS01E tuberculosis (TB) vaccine candidate. The first doses will be administered in South Africa, where the disease “takes a heavy toll”. Gates MRI states that, if the vaccine is well-tolerated and effective it could potentially become the first vaccine to help prevent pulmonary TB in adolescents and adults and the first new TB vaccine in over a century.
The burden of TB
WHO estimates that 10.6 million people became ill with TB in 2022, with 1.3 million deaths: over 3,500 people died each day. The disease “primarily affects people in low- and middle-income countries”, with the people at highest risk “often living in poverty”. Gates MRI states that, in South Africa alone, around 280,000 people are diagnosed with TB each year. TB is “one of the world’s deadliest infectious diseases” and the “leading cause of death amongst people living with HIV”. However, the only available vaccine, BCG, was developed in 1921 and offers “inadequate protection” to adolescents and adults against the pulmonary form of the disease.
Dr Emilio A. Emini, CEO of Gates MRI, commented that the launch of the trial “demonstrates our commitment to harnessing the power of medical innovation to fight diseases like TB”. These diseases are “particularly devastating for low- and middle-income countries”.
“Clinical study of the vaccine will still require years, but our incredible partners in South Africa and elsewhere who have come together for the Phase III study share our hope in the vaccine’s potential.”
Dr Lee Fairlie, Director of Maternal and Child Health at Wits RHI at University of the Witwatersrand in South Africa, and national principal investigator for South Africa, emphasises that this trial is an “important moment for South Africans” that demonstrates “a strong local and global commitment to fight a disease that remains distressingly common in our communities”.
“South Africa also has considerable experience with TB- and vaccine-related clinical trials and a strong track record for protecting patient safety and generating high quality data essential for regulatory approvals.”
Getting the vaccine to trial
The M72/AS01E vaccine candidate has been in development “since the early 2000s”, originally designed and clinically evaluated by GSK in partnership with Aeras and IAVI. In 2020, GSK announced a partnership with Gates MRI to further develop the vaccine. GSK “continues to provide technical assistance” and supplies the adjuvant component of the vaccine. GSK will provide the adjuvant post licensure if the trial is successful. The trial is sponsored by Gates MRI, with funding from the Gates Foundation and Wellcome.
Gates MRI, GSK, Wellcome, and the Gates Foundation are working together to understand the potential demand for the vaccine and develop an end-to-end plan that ensures long-term sustainable access if the trial is successful. This involves supporting research and building an evidence-base for the potential effect of the vaccine and community requirements for uptake as well as collaborating with multilateral, regional, and country partners to introduce the vaccine. The trial funders also intend to form an international advisory group comprising representatives of these groups to provide input on the programme.
The trial is expected to include up to 20,000 participants, including people living with HIV, across up to 60 trial sites in seven countries: South Africa, Zambia, Malawi, Mozambique, Kenya, Indonesia, and Vietnam. Participants will either receive the investigational M72/AS01E vaccine or placebo in the double-blind trial. The trial is anticipated to last up to 5 years before data analysis and preparation for submission to regulatory authorities.
Deborah Waterhouse, CEO, ViiV Healthcare, and President, Global Health, GSK, is “delighted” that the trial is underway after GSK has dedicated “over 20 years to developing this essential candidate vaccine”.
“Developing and ensuring access to global health products is complex but our collaboration with the Gates MRI, Wellcome, and the Gates Foundation exemplifies the transformative power of leveraging disease partners’ expertise to change the trajectory of challenging diseases, like TB, which place a huge burden on communities around the world.”
Dr Alemnew Dagnew leads the development of the vaccine at Gates MRI and is “particularly excited to see this trial get underway” after experience working as a physician in Ethiopia, which revealed the effect of pulmonary TB on communities.
“If effective M72/AS01E could reinvigorate a global fight against TB that has been weakened by the COVID-19 pandemic.”
Dr Dagnew commented that TB represents both a health and a socioeconomic problem, with the disease primarily affecting people in their “prime” working years, leaving families without income and children without parents. Almost half of TB-affected households face costs higher than 20% of their household income. Dr Trevor Mundel, President, Global Health, Gates Foundation, echoed that the start of the trial is a “pivotal moment” in the fight to “end TB, which devastatingly afflicts the world’s most vulnerable communities”.
“We think this trial marks the beginning of a series of opportunities that will usher in the most promising pipeline ever of new TB tools.”
Dr Mundel stated that the Gates Foundation “remains committed to supporting local and global partners to accelerate the solutions needed to save lives and reduce suffering”. Dr Alex Pym, Wellcome’s Director of Infectious Disease, recognised that there is a “long journey to results”. However, the start of the trial “brings us a critical step closer to having an effective vaccine to protect those most at risk of TB”.
“Global collaboration with regulators, in-country decision makers, and communities affected is crucial if those who need it most are to benefit from this vaccine, should the trial be successful.”
To connect with representatives from some of the organisations behind this trial, such as Gates MRI, Wellcome, and GSK, join us in Washington for the Congress this April. Don’t forget to subscribe for further insights into vaccine trials and development.
by Charlotte Kilpatrick | Mar 7, 2024 | Infection |
In March 2024 the Gates Foundation announced a collection of “major new policy, programmatic, and financial commitments” to contribute to efforts to eliminate cervical cancer. These commitments include almost $600 million in funding and were made at the first Global Cervical Cancer Elimination Forum: Advancing the Call to Action in Cartagena de Indias, Colombia. The Foundation states that a woman dies from cervical cancer every two minutes, despite the knowledge and tools to “prevent and even eliminate” the disease. Vaccination against human papillomavirus (HPV), which is the leading cause of cervical cancer, can prevent most cases.
The Gates Foundation statement acknowledges “many challenges on the path to elimination”. A combination of “supply constraints, delivery challenges, and the COVID-19 pandemic” meant that only 1 in 5 eligible adolescent girls were vaccinated in 2022. Furthermore, while cost-effective and evidence-based tools for screening and treatment exist, under 5% of women in many LMICs are screened for cervical cancer. These barriers cause “deep inequity”; over 90% of cervical cancer deaths in 2022 happened in LMICs.
The first global forum
In 2022, WHO’s global recommendation for one-dose HPV vaccine schedules “significantly reduced barriers” to scaling up vaccination programmes, a move that was reinforced by the America’s Region in 2023 and the Regional Office for Africa in 2024. However, the latest commitments “mark a watershed moment” to accelerate progress to eliminate cervical cancer.
Dr Tedros Adhanom Ghebreyesus, WHO Director-General, commented that “vaccination, screening, and treatment programmes are still not reaching the scale required”, even though we “have the knowledge and tools to make cervical cancer history”.
“This first global forum is an important opportunity for governments and partners to invest in the global elimination strategy and address the inequities that deny women and girls access to the life-saving tools they need.”
Country level commitments
Indonesia made a “re-commitment” to its National Action Plan 2023. Further commitments include:
- Democratic Republic of Congo commits to start introducing the HPV vaccine as early as possible with the WHO-recommended single-dose schedule and to do everything to get to the cervical cancer elimination strategy immunisation coverage target for girls aged 9 to 14 years as soon as possible.
- Ethiopia commits to implement a robust vaccine delivery strategy across the country, targeting at least 95% coverage in 2024 for all 14-year-old girls, regardless of their socioeconomic and education status, and to screen 1 million eligible women every year and to treat 90% of those who present with positive precancerous lesions. HPV single dose has been approved for introduction this year and scale up within the country’s Expanded Programme on Immunisation plans.
- Nigeria launched its HPV vaccine national programme this year, adopting the single-dose schedule for girls aged 9 to 14 and now commits to achieving at least 80% vaccine coverage of girls and continuing to increase coverage through a robust delivery strategy that will meet girls where they are, whether in school or not.
Experts weigh in
Quoted are several public health and development leaders, including Dr Chris Elias, President, Global Development at the Gates Foundation, who described HPV vaccines as a “miracle of modern medicine”. However, “too many” in LMICs do not have access to them.
“There is no reason why women should die from cervical cancer when a vaccine to prevent it exists…cervical cancer elimination is within reach. Now is the time for governments and partners around the world to increase HPV vaccine access and protect future generations from cervical cancer.”
Aurélia Nguyen, Gavi’s Chief Programme Officer, believes the HPV vaccine is “one of the most impactful vaccines on the planet” and has “already helped save thousands of lives”. Gavi is committed to supporting efforts to vaccinate 86 million adolescent girls by 2025.
“With bold commitment and decisive action, we can look forward to a future where cervical cancer has been eliminated for good.”
Juan Pablo Uribe, Director of the Global Financing Facility for Women, Children, and Adolescents (GFF) and Global Director for Health Nutrition and Population at the World Bank, emphasises the World Bank and the GFF are “doubling down efforts for cervical cancer elimination”.
“Every woman and every girl should have access to cervical cancer prevention, screening, and treatment as part of regular health care services. Much more work is ahead of all of us with a shared goal: eliminate cervical cancer. We need to build on today’s momentum and support countries’ leadership to accelerate progress.”
Director of PAHO, Dr Jarbas Barbosa, identifies an “urgent need” to scale up access and coverage for vaccination, screening, and treatment”
“I express PAHO’s profound commitment to elevate the political will and prioritise cervical cancer elimination in the public health agenda of countries in the Americas.”
Helga Fogstad, UNICEF Director of Health, sees the “end of an entire category of cancer” in sight for the first time.
“With the necessary tools at our disposal, commitment and political will are the next critical steps to a future free of cervical cancer for generations to come.”
UNITAID’s Executive Board Chair, Marisol Touraine, “cannot accept that women die from cervical cancer, when we know how to prevent and treat this disease”.
“At this pivotal moment, we must ensure the efficient tools we have are both affordable and available to every woman and girl in need…Together with our partners, we will continue to lay the groundwork for a future where all women have equitable access to the care they deserve, regardless of their socio-economic status or geographic location.”
Dr Atul Gawande, Assistant Administrator for Global Health at the US Agency for International Development, reflected that the “powerful shield” of the vaccine, regular screening, and early treatment will enable us to “safeguard a generation from the devastating effects of cervical cancer”.
“Every shot is a bold stride towards a future where cervical cancer is eliminated…Together we’re forging a path towards a future where cervical cancer is no longer a threat to the health and wellbeing of women worldwide.”
We’re looking forward to exploring some of the key challenges and opportunities in the WHO Cervical Cancer Elimination Goal during the HPV workshop at the Congress in Washington, so do get tickets to join us there at this link, and don’t forget to subscribe for more insights here.
