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Verndari Announces Breakthrough mRNA Stabilization Discovery

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.”

About Verndari

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.

Contacts

Elisabeth Hershman
ehershman@iq360inc.com
+1 917.385.6057


Pharma Company With UC Davis Connection Receives Patent For Painless Vaccine Technology

Sacramento Business Journal

Verndari Inc., a pharmaceutical company with laboratories at the UC Davis Medical Center, has received a patent for vaccines administered through adhesive skin patches. 

The technology, known as VaxiPatch, can be self-applied and is painless to the user, unlike typical vaccines that require a needle and syringe. The patent was issued to the company on July 17 and describes a method to manufacture the vaccine patches.

While the pharmaceutical industry has continued to develop vaccines for the prevention of a wider range of diseases, innovations in actual vaccine administration have remained somewhat stagnant over the last 70 years, said Dr. D.R. Henderson, CEO of Verndari.

In addition to skin patches, syringe-free inventions for vaccines include jet injectors, which use high pressure to push a stream of liquid into the skin, and nasal sprays. The Centers for Disease Control and Prevention advised against a nasal-spray-administered flu vaccine in 2016, citing data showing that it was ineffective.

The VaxiPatch contains “microneedles” which rest on the skin for 10 minutes and are too small to cause pain for the vaccine recipient. Additionally, the vaccine patches are stable at room temperature, so they don’t require refrigeration.

Verndari’s goal with the design is to “substantially lower the cost of vaccines by eliminating the need for a hypodermic needle, eliminating the need for highly paid medical professionals to administer a vaccine and by eliminating dependence on the cold chain,” according to the company's website.

The skin patch technology currently works with the hepatitis B vaccine and three types of influenza vaccines, Henderson said via email. Verndari is focusing on developing vaccines for the flu vaccine development and is meeting with the Food and Drug Administration next month about clinical development, he said.

Eliminating the need for a needle and syringe could increase the number of people who choose to get vaccinated. A 2012 study in Toronto found that 24 percent of adults and 63 percent of children reported a fear of needles. The skin patch could make getting vaccinated less daunting for these populations.

Now that the patent has been issued, the company’s next step is to “raise money and start clinical trials,” Henderson said.
Verndari has raised about $2.7 million through a bridge loan and has started efforts to raise $15 million through a series A venture capital round with Young & Partners LLC, a life sciences and chemical investment bank based in New York, Henderson said.
Verndari is headquartered in Napa, but its research and development and lab work are conducted in at UC Davis Medical Center.


AACC Honors 2015 Award Winners for Advancing Laboratory Medicine and Patient Care

AACC

Daniel Henderson PhD receives the Ullman Prize

WASHINGTON – AACC and its academy, the National Academy of Clinical Biochemistry (NACB), are pleased to announce the recipients of the 2015 AACC and NACB Awards, which honor laboratory medicine professionals worldwide for advancing the field of clinical laboratory testing. Through these annual awards programs, AACC strives to support laboratory medicine practitioners in all stages of their careers and to build awareness of the essential contribution made by all laboratorians in today’s complex, changing healthcare environment.


Verndari, Inc. Begins Preclinical Testing of COVID-19 Vaccine at University of California, Davis

  • Vaccine will be delivered via a dermal patch applied to skin
  • Verndari’s VaxiPatch™ microneedle patch technology enables mass production of vaccination kits

Sacramento, CA, April 29, 2020 -- Verndari, Inc., a biopharmaceutical company in Napa, California, announced today it will begin preclinical testing this week of a potential COVID-19 coronavirus vaccine, which will be administered using its patented VaxiPatch™, a microneedle array dermal patch. The testing will be conducted in laboratories at the University of California, Davis.

We are excited to work with Verndari, Inc. to move its vaccine candidate through preclinical, and potentially clinical, studies

Verndari, Inc. founded in 2015 by recognized leaders in the biotechnology industry, developed the potential COVID-19 vaccine using single, purified protein antigens produced by genetic engineering in a process that has proven to be extremely reliable. The vaccine candidate uses the COVID-19 “spike” protein that enables the virus to infect human cells.

“Verndari, Inc. was founded to enable a rapid response to new viral threats as well as to produce more effective vaccinations for existing viruses, such as seasonal flu, while sharply reducing costs and making vaccine administration much simpler,” said Daniel R. Henderson, Ph.D., CEO, and chief scientific officer of Verndari, Inc. “Our new approach and previous vaccine work have enabled us to quickly develop a potential vaccine for COVID-19. UC Davis provides a world-class forum for testing with leading researchers and a full spectrum of supporting capabilities.”

Preclinical testing of immune response begins this week at UC Davis’ Mouse Biology Program. Verndari, Inc. is also in discussions with the California National Primate Research Center at UC Davis to conduct further testing in nonhuman primates. If the preclinical testing meets safety and efficacy goals, Phase 1 human clinical trials would begin. Verndari estimates that testing from inception through Phase 1 human clinical trials will take approximately six months. The company is in consultation with the U.S. Food and Drug Administration (FDA) on its Investigational New Drug (IND)  submission.

“We are excited to work with Verndari, Inc. to move its vaccine candidate through preclinical, and potentially clinical, studies,” said Prasant Mohapatra, vice chancellor for research at UC Davis. “This collaboration illustrates one of many ways that UC Davis is leveraging our unique expertise and established platform built on previous research for HIV, Zika and human cytomegalovirus in order to advance knowledge and solutions specific to COVID-19.”

“When we founded Verndari, Inc. we set about to transform the entire vaccination process, from development through vaccination,” said John H. Brown, president, and co-founder of Verndari, Inc. “Our goal is to enable more rapid development of more effective vaccines for both existing and emerging diseases that can be delivered at lower cost to populations around the world.”

Verndari’s unique VaxiPatch™ is a complete single-dose vaccination kit that uses a dermal patch with a microneedle array to deliver vaccines to the arm. The technology eliminates the need for refrigeration, a major cost factor in vaccination, and facilitates high-volume, automated manufacturing of vaccines. The vaccine technology can be used for both existing vaccines and new vaccines developed to meet emerging threats.

The VaxiPatch™ kit reduces or eliminates the reliance on healthcare professionals to administer vaccines and the need for sterile use of a needle and syringe. The vaccination is accomplished with a painless microneedle patch applied to the arm, which 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 has the promise of requiring the use of a significantly smaller dose of vaccine as compared to the traditional injection.

About Verndari, Inc.

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, including pandemic threats such as COVID19, with a rapid response vaccination kit. The single-dose vaccination kit has the potential to be shipped around the world to enable simple shelter-in-place inoculation using a microneedle patch placed on the back of the arm. 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

Press and Investor Relations Inquiries:

Amy Van Prooyen, Esq. 
Corporate Communications and Legal Affairs, Verndari, Inc.
Contact:  avanprooyen@verndariinc.com, Tel: +1 (917) 626-6004

McDougall Communications on behalf of Verndari, Inc.
Contact: Elizabeth Harness, elizabeth@mcdougallpr.com, Tel: +1 (585) 435-7379


COVID-19 Vaccine With Patch Delivery Technology Enters Preclinical Testing at UC Davis

UC Davis

Verndari Inc., a stage biopharmaceutical company, announced today that it will begin preclinical testing this week at UC Davis’ Mouse Biology Program to evaluate a potential vaccine and delivery system for COVID-19.

Verndari’s VaxiPatch is a single-dose vaccination kit that uses a dermal patch with a metal microneedle array to deliver vaccines. The company states that the technology eliminates the need for refrigeration, facilitates high-volume, automated manufacturing of vaccines and can potentially be self-administered on the subject’s arm.

“Verndari was founded to enable a rapid response to new viral threats as well as to produce more effective vaccinations for existing viruses, such as seasonal flu, while sharply reducing costs and making vaccine administration much simpler,” said Verndari’s Chief Executive Officer Daniel R. Henderson in a release. “Our new approach and previous work enabled us to quickly bring a potential vaccine against COVID-19 to preclinical testing. UC Davis provides a world-class forum for testing, with leading researchers and a full spectrum of supporting capabilities.”

The public-private collaboration between Verndari and the University of California, Davis, provides the ideal platform to rapidly move such crucial research process forward.

“This is exactly the type of combined business and academic effort our university excels at delivering,” said David Lubarsky, vice chancellor for Human Health Sciences and CEO of UC Davis Health. “UC Davis is uniquely positioned to enable companies like Verndari to accelerate their work. By working together with us at UC Davis, we can potentially help to address this global pandemic sooner rather than later.”

Evaluation with UC Davis’ research pipeline for viral pathogens

Preclinical testing of the immune response to the vaccine begins May 1 at UC Davis’ Mouse Biology Program, where researchers amended an existing protocol for influenza to test a COVID-19 vaccine in rats. Using the established rodent model can quickly provide data related to vaccine efficacy and immune response before moving into larger species, such as nonhuman primates, and human clinical trials.

“We are comparing administration of the VaxiPatch to an injectable vaccine in rodents and monitoring them closing for any adverse reactions as well as collecting blood samples to evaluate immune responses,” said Kristin Grimsrud, veterinarian and lead scientist at the Mouse Biology Program. “Due to the impressive campuswide effort to accelerate essential COVID-19 research, we were able to get approval on the amended protocol in less than 72 hours, allowing us to focus on SARS-CoV-2 vaccines.”

Verndari is also in discussions with the California National Primate Research Center at UC Davis to conduct further testing in rhesus macaques, a powerful animal model for COVID-19.

If the preclinical testing meets safety and efficacy goals, Phase 1 human clinical trials could begin. In preparation for human trials, the company is working on an agreement with UC Davis’ Good Manufacturing Practice, or GMP, facility to manufacture the clinical version of the vaccine kit. This would include manufacturing the vaccine, loading it onto the delivery device and packaging it within the clean room’s sterile environment.

“While we are seeing hopeful evidence that physical distancing has slowed the rate of transmission in California and the Sacramento area, the world's best hope is for a vaccine to prevent new viral infection,” said Alison Brashear, dean of the UC Davis School of Medicine. “If the skin patch technology proves viable in the preclinical models, we’ve got the facilities and expertise ready to immediately launch the necessary human clinical trials that will then test the safety and efficacy of this innovative technology.”

Leveraging scientific and entrepreneurial resources at UC Davis

The collaboration between Verndari and UC Davis exemplifies the value of industry/academic partnerships and how they can advance innovative solutions.

“We are excited to work with Verndari to move its vaccine candidate through preclinical, and potentially clinical, studies,” said Prasant Mohapatra, vice chancellor for research at UC Davis. “This collaboration illustrates one of many ways that UC Davis is leveraging our unique expertise and established platform built on previous research for HIV, Zika and human cytomegalovirus to advance knowledge and solutions specific to COVID-19.”

The company joined the university’s START program led by Venture Catalyst in March of 2016. The START program provides UC Davis-affiliated innovators and entrepreneurs the resources, training, tools and connections to develop successful startups.

Verndari is part of a network of industry partners who lease state-of-the-art life science laboratory space managed by the School of Medicine on the UC Davis Medical Center campus. This allows industry experts to work alongside top academic and clinical scientists at UC Davis, nurturing a new wave of innovation — the impetus for the creation of UC Davis Aggie Square, a 1.3 million square-foot innovation district currently in development.

The company began initial testing of an influenza vaccine at the Mouse Biology Program in 2017 using Venture Catalyst’s DART program that provides startups with access to the university’s state-of-the-art research services and equipment at competitive rates. These collaborative relationships provide not only the services to conduct animal research, but also the scientific expertise in translational animal models, study design and device development.

Verndari’s scientific advisory panel includes Peter Barry, professor emeritus and former director of UC Davis’ Center for Comparative Medicine, and John Crowe, professor emeritus of the Department of Molecular and Cellular Biology at UC Davis.