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Findings announced at World Vaccine and Immunotherapy Congress West Coast may help overcome technical, economic and political hurdles to global COVID-19 vaccine distribution
SAN DIEGO--Verndari, Inc., a California-based developer of room-temperature-stable mRNA vaccines, therapeutics and delivery technologies, today announced the discovery of novel formulations that allow cost-effective, room-temperature drying, storage and reconstitution of mRNA with 100% retention of mRNA activity after one month. These patent-pending formulations have the potential for use with all mRNA vaccines, therapeutics and delivery methods.
“We believe this discovery may prove instrumental in helping healthcare leaders overcome the technical, economic and political hurdles that have impeded universal access to COVID-19 vaccines and other life-saving mRNA vaccines and therapeutics.”
“Using a formulation analogous to those of the current, FDA-approved mRNA COVID-19 vaccines, we have been able to dry, store at room temperature, and reconstitute 100% of the activity of the vaccine in vitro,” said Daniel Henderson, CEO and chief scientific officer, Verndari. “We believe this discovery may prove instrumental in helping healthcare leaders overcome the technical, economic and political hurdles that have impeded universal access to COVID-19 vaccines and other life-saving mRNA vaccines and therapeutics.”
Using proprietary formulations, Verndari scientists found that when encapsulated in lipid nanoparticles, dried, stored at room temperature, reconstituted, extracted and analyzed by gel electrophoresis, replicon hemagglutinin mRNA was physically intact after seven days at 25°C. Moreover, when printed on the thermostable Verndari VaxiPatch microarray patch, they found the same formulations to be stable after 28 days at 25°C.
“The ability to stabilize mRNA formulations at room temperature is just the latest in a series of historic scientific advances that are giving hope to people at a time when hope seems most precious,” said Dr. Henderson. “We’re actively engaging in discussions with a range of companies about applying this new technology to dramatically lower distribution costs and open up access to life-saving mRNA vaccines and therapeutics for all people around the world.”
Verndari is a California-based life science company founded in 2015 with the goal of developing and commercializing room-temperature-stable mRNA vaccines, therapeutics and delivery technologies for the protection of all human lives. The company’s patented and patent-pending discoveries are now poised to help healthcare leaders overcome the technical, economic and political hurdles that have impeded universal access to life-saving mRNA vaccines and therapeutics – enabling large-scale, low-cost, global mRNA manufacturing, distribution and administration. More information is available at www.verndariinc.com.
By Peter Fimrite
Scientists at Bay Area universities, laboratories, biotechnology companies and drug manufacturers are fashioning drug concoctions out of blood plasma, chimpanzee viruses and cells taken from bone marrow in the race to rid the world of COVID-19.
The microbial treasure hunt is not just to find a cure — which may not be possible — but to control the debilitating health problems caused by the coronavirus.
Major progress has been made this year. The antiviral drug remdesivir, produced in Foster City, has improved recovery times, and the steroid dexamethasone has cut the number of deaths in severely ill patients.
What follows is a list of some of the most promising medications and vaccines with ties to the Bay Area...
VaxiPatch / Verndari (Napa and UC Davis Medical Center):
A Napa company, Verndari, is studying vaccines for COVID-19 that can be delivered using an adhesive patch. Researchers at UC Davis Medical Center in Sacramento said the patch caused an immune response in preclinical tests.
An October report in the online journal ScienceDirect touted the system, saying it “could serve as a ‘shelter in place’ vaccination strategy, in which vulnerable populations receive delivery at home without needing to engage an already-overtaxed health care infrastructure.”
If the vaccine is proven effective and safe, patients could receive it through the mail, according to Dr. Daniel Henderson, Verndari’s chief executive officer.
The US federal government said Wednesday it’s investing nearly $2.5 million in efforts to create a needle-free coronavirus vaccine.
The Biomedical Advanced Research and Development Authority (BARDA) announced four small grants to groups trying to make either oral vaccines against coronavirus, or patches that could painlessly deliver a vaccine.
“The novel routes of administration they are developing could reduce the dependence on needles and syringes that are used to deliver vaccine via intramuscular injection. Instead, a wearable skin patch or oral option for vaccines may support rapid, large-scale immunization while reducing the strain on the manufacturing supply chain,” BARDA said in a statement.
The four new technologies are also "shelf-stable" -- unlike current coronavirus vaccine candidates, they don’t have to be kept under special conditions or temperatures, making them easier to store and deliver.
The four groups:
- Michigan-based Esperovax is working on vaccines people could take in capsules. They received $600,000 from BARDA.
- The University of Connecticut already has a microneedle patch that can deliver pneumonia vaccines. They are now testing a coronavirus vaccine in animals. BARDA gave them $430,000.
- Vaxess Technologies spun out of research done at Tufts University and MIT. Its patch releases a vaccine over time. BARDA gave them $749,000.
- California-based biotech startup Verndari is creating a fast-production, sugar- based microneedle patch. BARDA awarded them $700,000.
- VaxiPatchTM microneedle dermal patch is part of a novel vaccination system comprised of subunit antigens and adjuvants
- Preclinical data showed use of VaxiPatch™ microneedle dermal patch with proprietary vaccine showed significantly higher immune response at much smaller dose compared with an existing influenza vaccine,
- Verndari VaxiPatchTM system is being developed for application across multiple diseases
Napa, CA, August 19, 2020 - Verndari, Inc., a biopharmaceutical company transforming vaccines with next generation vaccine science and delivery technology, announced today publication of preclinical data in Vaccine on its novel vaccination system using a microneedle dermal patch. The early study examined Verndari’s proprietary influenza vaccine administered with its patented VaxiPatch™ technology. Results showed a significantly increased immune response compared with an existing influenza vaccine. The study is available online here.
“The Verndari VaxiPatch™ system holds the promise of enabling faster development of vaccines for new threats such as COVID-19 as well as more effective vaccines for existing viruses, such as influenza,” Dr. Daniel R. Henderson, CEO of Verndari said. “VaxiPatch™ eliminates the need for refrigeration, a major cost factor and barrier to access throughout developing countries. By using microarray technologies that carry a temperature-stable vaccine, we can enable mass manufacturing, which is both cost effective and increases global access to these life-saving treatments.”
For the preclinical study, Verndari used novel formulations of genetically engineered, single, purified protein antigens or “subunits,” along with novel formulations of adjuvants and its patented VaxiPatch™ microneedle array dermal patch. Verndari has created a single monovalent component of a quadrivalent seasonal flu vaccine that uses recombinant influenza hemagglutinin (rHA) as an antigen active ingredient for influenza
virus B/Colorado/06/2017. The rHA functions in the FDA-approved single radial immunodiffusion (SRID) potency test. Verndari’s influenza vaccine configuration also allows the use of FDA-approved surrogate marker of influenza vaccine efficacy, the testing of the patient vaccine response by the hemagglutination inhibition test (HAI). This shortens clinical trial times to six weeks. Results showed that when compared with an existing influenza vaccine, Verndari obtained as much as a 15-fold higher immune response with 1/15 of the dose for the B/Colorado/06/2017 influenza strain.
The Verndari VaxiPatchTM Vaccination System
Verndari’s unique VaxiPatch™ is a complete single-dose vaccination kit that uses a painless dermal patch with a microneedle array to deliver vaccines to the arm and can potentially be self-administered. Vaccine delivery to the skin rather than an intramuscular injection has advantages including production of a stronger immune response. It also holds the promise of allowing the use of a significantly smaller dose of vaccine as compared to the traditional injection. The novel system eliminates the need for refrigeration, facilitating a high-volume, automated manufacturing of vaccines. The technology can be used for both existing vaccines and new vaccines developed to meet emerging threats.
In addition to the preclinical study of its influenza vaccine, Verndari has developed a SARS-CoV-2 Recombinant Spike Receptor Binding Domain (RBD) Skin Patch Vaccine candidate that is currently undergoing preclinical testing in laboratories at the University of California, Davis, where Verndari is a member of the university’s Venture Catalyst Program.
The vaccine uses the COVID-19 “spike” protein that enables the virus to infect human cells and contains Verndari’s proprietary VAS 1.0 adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. Early preclinical trials demonstrate an indication of antibodies that block the binding of the spike domain to receptors targeted by the virus. Preliminary preclinical results are expected in the third quarter of 2020. Subject to safety and efficacy success, as well as discussions with regulatory bodies, a Phase 1 clinical study would commence.
Verndari remains in ongoing discussions FDA for pre-IND submission for the VaxiPatchTM Vaccine System.
New vaccine delivery technologies could provide individuals with a broader range of options for immunization, including ones that are easier to use and potentially more effective than traditional vaccination with needle and syringe. With the potential for self-administration, these technologies could also expand the range of available care settings, allowing for wider coverage and ultimately improving the capability to reach herd immunity for many diseases.
BARDA will explore the feasibility of two innovative approaches with four new partners: Esperovax, Inc., the University of Connecticut, Vaxess Technologies, and Verndari, Inc. The novel routes of administration they are developing could reduce the dependence on needles and syringes that are used to deliver vaccine via intramuscular injection. Instead, a wearable skin patch or oral option for vaccines may support rapid, large-scale immunization while reducing the strain on the manufacturing supply chain.
The Egress RDTM mRMA oral cellular delivery technology from Esperovax, Inc. is a technology aiming to provide a cost-effective immunization that improves uptake with the potential for self-administration.
The other vaccine technologies – from the University of Connecticut, Vaxess and Verndari – collectively known as Micro Array Patches (MAP), would deliver vaccine using a microneedle patch worn on the skin as an alternative to standard inoculation.
With support from BARDA, the four partners will each advance the development of their respective products, formulate and optimize materials, and demonstrate their ability to effectively administer vaccine. If successful, these technologies could have a profound impact on the potential to offer better options to improve vaccine coverage.
These awards are part of BARDA’s rapidly expanding COVID-19 medical countermeasure portfolio; visit BARDA’s COVID-19 Portfolio to learn more.
About the companies:
The following information is provided by company and does not indicate endorsement by the federal government of the company or its products.
Esperovax looks to become the global leader in oral tablet/capsule vaccinations for some of the world's deadliest treatable diseases by leveraging its new oral vaccine platform. Their delivery system holds the potential to provide billions of doses annually that could be delivered by mail and consumed directly by the consumer without the need to visit a healthcare setting. The oral platform holds a potential for significant expansion of vaccination to the most vulnerable and in need, at a fraction of traditional cost.
The University of Connecticut (UConn):
Dr. Nguyen and his lab at UConn have developed a process to manufacture a vaccine microneedle (MN) skin patch that only requires single-time administration to automatically deliver vaccine antigens repeatedly, similar to the use of multiple bolus injections, over a long period. They have shown that the MNs can deliver a clinical vaccine of Prevnar-13 against the pneumococcal infection (which causes pneumonia like COVID-19). They have started the study on the S-protein from a small urgent funding from UConn, School of Engineering to test/stabilize the S-protein (as a COVID-19 vaccine) in their MNs, and evaluate the antigenicity of the vaccine MNs (with only single administration) for a long-term immune-protection in an animal model.
Vaxess Technologies, Inc.:
Vaxess is developing next-generation vaccines that are not only more protective but also more accessible for people at home and around the world. Vaxess is developing its proprietary MIMIX™ therapies based on technology originally developed at Tufts University and MIT. With just minutes of wear-time, the shelf-stable, self-applied MIMIX™ patch enables sustained release of treatments in the skin over weeks to months. Vaxess is a venture-funded company that is also supported by the NIH, NSF, and DARPA.
Verndari, Inc. was founded in 2015 with the goal of transforming global health through next generation vaccine development and delivery. The privately held company based in Napa, California, aims to treat existing and emerging diseases, with rapid response to new viral threats such as COVID-19 as well as to produce more effective vaccinations for existing viruses, such as influenza, enabling delivery at lower cost to populations around the world. Verndari’s unique VaxiPatch™, a single-dose vaccination kit using a microneedle dermal technology, offers advantages that include dose sparing, improved efficacy, and pain-free delivery - while making vaccine administration much simpler. The technology eliminates the need for refrigeration and facilitates high-volume automated manufacturing of vaccines. Through innovation in vaccine science, Verndari aims to address many different diseases and to save countless lives. For more information on Verndari, please visit https://verndariinc.com.