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 | Sep 18, 2024 | Technology |
PharmaJet announced in September 2024 that it has entered a long-term license and supply agreement with Scancell Holdings to use PharmaJet’s Stratis Intramuscular (IM) Needle-free System for the delivery of its advanced melanoma DNA vaccine. Through the agreement, Scancell will use Stratis for the clinical development and commercialisation of ImmunoBody, the advanced melanoma DNA vaccine. PharmaJet will receive development and regulatory milestone payments and royalties on net sales upon commercialisation.
Stratis
PharmaJet’s Stratis technology is a needle-free system for 0.5 ml intramuscular and subcutaneous injections that enhances the performance of nucleic acid vaccines and therapeutics. Stratis delivery has demonstrated the ability to enable “effective uptake” of the Scancell DNA melanoma vaccine; 60 patients across 15 clinical trial sites have received a total of 171 doses of SCIB1/iSCIB1+ through Stratis. This approach offers the “convenience of an off-the-shelf therapeutic cancer vaccine with the speed and enhanced patient experience of needle-free delivery”.
ImmunoBody vaccines
Scancell’s ImmuoBody vaccines are designed to generate “potent” T cell responses that provide a broad anti-tumour effect. They are DNA vaccines that encode a protein in antibody form, with the elements of the antibody that would normally bind to the target protein replaced with cancer antigen epitopes. ImmunoBody vaccine design features include:
- Epitopes that bind to MHC class I and MHC class II
- Retention of the Fc region of the protein, which targets activated dendritic cells via its specific receptor
However, Scancell highlights the “most important aspect” of the technology as the ability to initiate both direct and cross-presentation of epitopes to T cells. The “highest avidity T cell responses” are generated if different pathways are used to present the same epitope. In ImmunoBody, the DNA form is taken up and processed directly by dendritic cells and the protein form binds to the high affinity Fc receptor on dendritic cells, leading to cross-presentation.
Advancing innovation
Professor Lindy Durrant, Chief Executive Officer of Scancell, is pleased that PharmaJet delivery “works effectively” with the SCIB1/iSCIB1+ vaccines and offers a “well-received immunisation for patients”.
“Securing long term supply for the PharmaJet Stratis Needle-free Injection System is important to allow clinical and commercial development of iSCIB1+…Our ultimate goal for Scancell has been to deliver an off-the-shelf, safe, tolerable, effective therapy that can provide potent and durable anti-tumour responses for unresectable stage IV melanoma, which currently has a 5-year survival of 35%.”
PharmaJet’s Chief Scientific Officer, Nathalie Landry, looks forward to working with Scancell to “advance their innovation further in clinical development and commercialisation” with benefits for melanoma patients.
“The Scancell strategic partnership further solidifies PharmaJet’s commercial delivery platform as a leader in the delivery of nucleic acid vaccines and immunotherapies.”
For more on PharmaJet’s needle-free delivery technology, join us at the Congress in Barcelona next month. Don’t forget to subscribe to our weekly newsletters for regular vaccine updates.
by Charlotte Kilpatrick | Jul 11, 2024 | Technology |
Seattle-based biotech Orlance announced in July 2024 that it has been awarded a Phase I Small Business Innovation Research (SBIR) grant from the US NIH to develop and optimise RNA vaccine formulations with its needle-free MACH-1 platform. The technology is intended to enhance the safety, stability, and efficacy of RNA vaccines for infectious diseases and cancer immunotherapy applications. MACH-1 is described as a “potentially significant advancement” in RNA vaccine delivery.
Meet MACH-1
MACH-1 is a needle-free vaccine platform that provides a “rapidly deployable, ambient stable, dose sparing, and easy to use product”. Orlance hopes it will increase immunisation in underserved regions by overcoming logistics or personnel difficulties and needlestick hesitancy. With pressurised gas, MACH-1 accelerates microparticles of DNA vaccines, RNA vaccines, or a combination. Vaccine microparticles penetrate the outer layer of skin to reach the epidermal layer, achieving intracellular delivery and transfection in local antigen presenting cells within the epidermis. This results in “robust” induction of systemic and mucosal antibody and cytotoxic T cell responses.
Compared to traditional lipid nanoparticle (LNP) RNA formulations, the MACH-1 platform uses dry, stable RNA-coated gold microparticles. It is needle-free and painless and ensures better stability at ambient temperatures with “significant supply chain advantages”.
Gene Gun project
The SBIR-funded project, “Gene Gun-delivered RNA vaccines”, is to be led by Orlance Principal Investigators Dr Hannah Frizzell and Dr Kenneth Bagley. They will aim to optimise RNA formulations for MACH-1 gene gun delivery to “maximise loading, maintain functional integrity, and ensure stability and immunogenicity”. The researchers will compare the effectiveness of MACH-1 delivered RNA vaccines against traditional LNP/RNA vaccines.
The 2-year grant provides $300,000 a year to enable Orlance to conduct preclinical studies, expected to “pave the way” for subsequent phases of development. Orlance has already received $13 million in SBIR funding, advancing MACH-1 towards readiness for initial regulatory filings in 2024. The company plans to initiate Phase I clinical trials for its lead infectious disease asset in 2025.
Kristyn Aalto, co-founder and CEO of Orlance, stated that the “breakthrough” of mRNA vaccines in recent years has “established the enormous potential of genetic (RNA and DNA vaccines”. However, there is still “significant work to do to improve utility and overall global health impact”.
“We are very grateful for NIH’s continued support and are rapidly accomplishing MACH-1 platform goals that could truly enhance the clinical research and impact of genetic vaccines.”
With a “well-developed” candidate portfolio and offerings across both DNA and RNA, Aalto hopes to “leverage the attributes of both platforms to provide ideal solutions tuned to the immunogenicity, protection, and durability profiles sought for specific indications”.
To hear the latest on innovative vaccine delivery approaches, why not join us in Barcelona for the Congress this October, or subscribe to our weekly newsletters 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 | 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.
