by Charlotte Kilpatrick | Feb 16, 2024 | Technology |
In February 2024 Ginkgo Bioworks announced that it has been awarded a 5-year contract with SaponiQx from the US Defence Threat Reduction Agency’s (DTRA) Joint Science and Technology (JSTO) for the Chemical and Biological Defence (CBD) Programme. The award is worth $31 million and will go towards the discovery and development of next-generation vaccine adjuvants. The companies have partnered in discovery and development since 2021 and plan to use a combination of “high throughput empirical and artificial intelligence/machine learning approaches”, which will include Generative Molecular Design (GMD) to develop “superior novel saponin-based adjuvants”.
A need for adjuvants
Gingko identifies a need for adjuvants to increase the “handful” that are available for human use in licensed vaccines.
“Novel adjuvants with enhanced properties, including tailored humoral and cellular immune responses, could pave the way for a new wave of innovative vaccines against existing and emerging pathogens.”
Gingko is to develop a first-generation Adjuvant Development Candidate (ADC) production method through a heterologous production strain like brewers’ yeast, Saccharomyces cerevisiae.
“Our platform powers iterative Design-Build-Test-Learn-driven cell engineering to enable the rapid prototyping, optimisation, and development of proteins, enzymes, metabolic pathways, and whole organisms under commercial-scale manufacturing conditions.”
Jennifer Wipf, SVP, Head of Commercial Cell Engineering at Gingko, commented on the need for “safe, effective, and accessible” vaccines that was emphasised during the COVID-19 pandemic.
“Imagine a future where vaccines are not only more affordable but also provide consistent protection in fewer doses, without causing discomfort or requiring refrigeration. We’re very excited by this opportunity to strengthen and expand the SaponiQx-Gingko partnership and to work with DTRA to make that future a reality.”
STIMULON QS-21
SaponiQx’s STIMULON QS-21 is a “key adjuvant component” in “market-leading” vaccines for threats such as shingles, malaria, and RSV. SaponiQx states that it uses a method that “doesn’t rely on trees”.
“This innovation is designed to ensure a stable supply chain, uniform quality, scalable manufacturing, and reduced cost of goods.”
SaponiQx’s Head of Operations is Rebecca Kurnat, who hopes that the project will enable the team to “demonstrate in the laboratory and in animal studies the ability of these novel adjuvants to protect against challenges from biothreat agents” and to “provide lower cost, sustainable, and scalable manufacturing processes”.
By “harnessing a first-of-its-kind ‘data lake’ for adjuvants”, the partnership plans to use iterative GMD to “propose and optimise adjuvant structures” against eight functional parameters.
“Building on our achievements with STIMULON QS-21, SaponiQx is excited to realise our company’s founding vision of harnessing the potential of Generative Molecular Design to dramatically increase access to lifesaving vaccines around the world.”
We have a workshop dedicated to Vaccine Technologies at the Congress in Washington this April, during which the importance of adjuvants and ways to exploit them will be discussed; do join us there by getting your tickets here or subscribe for more vaccine technology insights!
by Charlotte Kilpatrick | Feb 15, 2024 | Technology |
In February 2024 the University of Birmingham announced that a project to use “powerful digital tracking and accountability technology” to determine the “precise burden of open- and closed-vaccine vial losses”, understanding how and where these losses occur. The project started in December 2023 in collaboration with the Africa Centre of Excellence for Sustainable Cooling and Cold-Chain (ACES), Rwanda Biomedical Centre, Circulor, and Crown Agents. The study takes place in the Rwamagana District in the District Hospital and 16 Health Centres in the network.
Cold-chain interruptions
A statement from the university reflects that vaccines must be “carefully stored and transported” within a controlled temperature range, often between 2°C and 8°C. This cold chain is “uninterrupted from vaccine manufacture and throughout the country-wide distribution networks” to keep vaccines “effective up to the point of use”.
The new project will explore the burden and occurrence of vaccine vial losses:
- Open-vial losses – when there are not enough individuals to vaccinate after giving the first dose from a vial, so the leftover unused doses need to be discarded
- Closed-vial losses – the loss of a whole vaccine vial before being opened, usually due to physical damage, vaccine expiry, or loss of temperature control at some stage of the chain (can cost up to 6-10 doses at a time)
Professor Toby Peters from the University of Birmingham, Co-Director of the Centre for Sustainable Cooling, stated that “an estimated 25% or more” vaccine doses are “compromised by failures in cold chain custody”. With the VaccMap project he hopes to “get a better understanding of where these losses occur in the Rwandan cold chain”. This would allow prevention and design of better cold chain systems in the future.
“The vaccine cold chain underpins vaccine policy and is part of any country’s critical national infrastructure. This cold chain is vital for every birth in every country in the world. However, 20% of African children do not receive a complete immunisation schedule and more than 30 million children under five years old suffer from vaccine-preventable diseases every year, 68% of which are in Africa.”
Preparing to implement new technology
Associate Clinical Professor Christopher Green, Principal Investigator for the study, is excited by the new vaccine technologies that were “accelerated” during the pandemic and are being “re-designed to target many major outstanding global health priorities”.
‘This study is very important in our wider work to prepare African healthcare systems for the deployment needs of these technologies and manage the concurrent challenges caused by climate change. We have excellent collaborations from our project partners for this difficult problem.”
The software that the team is using was developed by Circulor and was originally designed to track components for car batteries through supply chains. The Circulor team modified their technology for use in vaccine supply chains, recording the life of every vaccine vial to “build an accurate real-world picture” of how to “strengthen vaccine security and efficiency”.
If you’re interested in vaccine supply chains and logistics, do join us for our dedicated track at the Congress in Washington this April by getting your tickets here, or subscribe for more vaccine insights.
by Charlotte Kilpatrick | Feb 14, 2024 | Technology |
In February 2024 Replicate Bioscience announced “positive” results from a Phase I trial of the comapny’s self-replicating RNA (srRNA)-based rabies vaccine, RBI-4000. The trial evaluated the safety and immunogenicity of the vaccine with participants receiving one or two low doses. Replicate reports that “at all assessed doses” (0.1 mcg, 1mcg, or 10 mcg), the vaccine achieved a “strong immune response” with protective virus-neutralising antibody titers above the WHO-defined immune surrogate level of protection against the virus. Furthermore, the RBI-4000 was “well tolerated” at all dose levels.
RBI-4000
“A next-generation rabies vaccine with improved immunogenicity and simpler manufacturing represents an opportunity to broaden access to rabies prevention worldwide.”
The first vaccine candidate from Replicate is RBI-4000, an srRNA vaccine developed to “stimulate virus-neutralising immune responses to rabies for prophylactic use”. The srRNA platform amplifies protein expression with self-limited replication unlocking “new opportunities” for more patients across a broad range of disease.
What do the data show?
Replicate states that the data indicate:
- The surrogate metric of protection was achieved in most subjects in the ultra-low 0.1 mcg cohort – the lowest dose of any RNA technology reported to achieve surrogate of protection in humans
- Single administration met the surrogate metric of protection for most subjects in multiple cohorts
- Favourable tolerability across all dose levels tested, with no severe adverse events
- Superior therapeutic index with clinical bioactivity and tolerability at all doses tested
Exceptional results
Dr Nathaniel Wang, CEO of Replicate, commented that the results “have exceeded our expectations” and show the “power and potential” of the technology, de-risking the platform, process, and pipeline.
“Achieving a broad therapeutic window is an important step-up from other existing mRNA and srRNA approaches, which allows us to expand applications of our self-replicating RNA to complex infectious diseases, off-the-shelf cancer vaccines, and as a platform for protein production.”
Dr Michael Ehlers, co-Founder and Board Chair of Replicate suggested that “when we founded Replicate, we envisioned a class of RNA therapeutics capable of treating many more diseases and reaching many more patients”.
“These data represent exciting progress towards realising that vision.”
We look forward to hearing more from Replicate at the Congress in Washington during our RNA workshop. Do join us by getting your tickets here and don’t forget to subscribe to our weekly newsletters!
by Charlotte Kilpatrick | Feb 8, 2024 | Technology |
CEPI announced in February 2024 that it is providing LenioBio with funding of up to US$2 million to provide preclinical proof-of-concept that a commercially available, plant-based, and cell-free technology can produce proteins to be used in vaccine trials for epidemic and pandemic threats in 20-40 days. Using LenioBio’s ALiCE technology, the ambition is to reduce the time required to manufacture vaccine proteins with “more traditional methods” like cell cultures.
ALiCE
LenioBio’s Almost Living Cell-Free Expression (ALiCE) uses the protein production machinery of plant cells to rapidly express proteins in a “cell-free” reaction. It is a lysate derived from Nicotiana. Tabacum c.v. BY-2 root cells, prepared through removal of the cell wall and other unnecessary components to leave the machinery and mitochondria.
ALiCE has a “proven” track-record of producing various types of proteins used in the development of vaccines and other medicines, but the latest funding will enable further testing of to see if it can support “rapid manufacture of vaccine clinical trial material”.
Speedy processes and easy access
CEPI states that the speed potential offered by LenioBio’s technology could facilitate the 100 Days Mission. Ingrid Kromann, Acting Director, Manufacturing and Supply Chain described this potential as a “game-changer”.
“This study will explore whether ALiCE can support the rapid and scalable development of viable protein-based vaccine candidates and move these promising candidates more quickly into clinical trials, pushing forward our goal to achieve the 100 Days Mission.”
Furthermore, ALiCE is easy to use, which means that it could be enabled in remote or low-resource settings to ensure that vaccines reach the people who need them most. The technology could also reduce carbon emission levels due to a “small operational footprint”.
André Goerke, CEO at LenioBio, looks forward to the study, a “great opportunity to demonstrate the significant potential” of the platform.
“This project supports our goals of enabling accelerated discovery and development of essential medicines and brings us a step closer to our long-term vision of creating fast access of essential medicines for patients.”
Could this be the way forward in vaccine testing? If vaccine technologies and investment in innovation are of interest to you do join us at the Congress in Washington this April or subscribe to our newsletters.
by Charlotte Kilpatrick | Jan 23, 2024 | Technology |
In January 2024 EnsiliTech announced that it has been awarded a “highly competitive” research contract from the UK’s Small Business Research Initiative to develop the “world’s first thermally stable mRNA vaccine”. The project will be carried out in partnership with Afrigen Biologics in South Africa and EmerVax in the US. EnsiliTech will also work with S-cubed Ltd, who will offer Regulatory Affairs Consultancy support. The research is funded as a UK Aid programme by the Department of Health and Social Care within the UK Vaccine Network.
With a value of around £1.7 million the project will involve work on the development of a world first vaccine against Hantaan Virus (HTNV), which is an orthohantavirus responsible for Haemorrhagic Fever with Renal Syndrome (HFRS), a serious illness with a morality rate of around 15%. Incidence is growing, concentrated in Asia and South America. The project will both prevent thousands of cases each year of HFRS and associated deaths and develop a heat tolerant mRNA vaccine platform with EnsiliTech’s proprietary technology.
Ensilication technology
Despite their “huge potential” for prevention of infectious diseases and other conditions, mRNA vaccines demand ultracold storage. To fix this challenge, EnsiliTech’s ensilicated mRNA platform “removes the need for cold storage” with the potential to “revolutionise vaccine distribution”. This will be of greatest benefit in “remote or resource-limited regions”.
Democratising access
Dr Asel Sartbaeva is co-founder and CEO of EnsiliTech, identifying the team’s “mission” as “to democratise access to vaccines across the globe”. They hope to do this by “developing the first fully thermally stable mRNA vaccine”.
“We are grateful to the SBRI and Innovate UK for being awarded this funding, which will help in bringing vaccines where they are needed.”
Professor Petro Terblanche, CEO of Afrigen, is “excited to be part of this initiative”.
“One of Afrigen’s priorities is to make the latest biological products, such as mRNA vaccines, accessible and affordable to low- and middle-income countries and the potential to eliminate or reduce the need for cold chain logistics through ensilication technology will significantly contribute towards this goal.”
Dr Peter D. Weinstein, Emervax’s CEO, is “enthusiastic” about the opportunity to “participate in this important effort”.
“Emervax will apply its novel mRNA vaccine platform technology to develop a first of its kind HTNV mRNA vaccine that will be used to help protect people throughout the world, regardless of their income, who could be exposed and suffer from this terrible and debilitating disease.”
For more vaccine innovation updates, do join us at the Congress in Washington this April, or subscribe to our newsletters here!
