BOULDER, COLORADO – July 19, 2023 – VitriVax, Inc., a formulation technology company, has been awarded a $29M five-year contract by the Defense Threat Reduction Agency (DTRA), an agency within the U.S. Department of Defense.

The overall objective of the research proposal titled “Optimization and Production of Single-Shot Vaccines for Melioidosis and Glanders” is to apply VitriVax’s single-shot and thermostabilization technology (ALTA™) to the lead B. pseudomallei (Bp) vaccine candidate, which is currently a three-dose regimen, with the goal of developing a single injection, thermostable vaccine formulation to protect against melioidosis and glanders. The project will focus on preclinical studies and development of Good Manufacturing Practice protocols, working toward an Investigational New Drug Application submission.

“We are excited about the opportunity to partner with DTRA and researchers at the University of Nevada, Reno, to bring our technology to a class of vaccines that will benefit both military personnel and the general population in regions where the disease is endemic,” said Kimberly D. Erickson, Ph.D., VitriVax’s Vice President of Operations and Principal Investigator. 

VitriVax has built a strong research team consisting of formulation and analytical scientists, as well as particle engineers and manufacturing experts. They have strategically partnered with the University of Nevada, Reno, and the Latham BioPharm Group, Inc., to compile a support team of industry veterans with years of Bp vaccine development, government program management experience, and government contract compliance knowledge.

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About VitriVax:  VitriVax, headquartered in Boulder, CO, has engineered its proprietary Atomic Layering Thermostable Antigen and Adjuvant (ALTA™) technology platform to enable thermostable, single-shot vaccines across a broad range of indications, while maintaining or potentially even enhancing the immune response of vaccines. ALTA™ can be applied to a wide variety of vaccine antigens and adjuvants to protect against thermal and chemical degradation and enable controlled release, incorporating prime doses + additional booster doses in a single-shot administration. These technologies may also facilitate co-formulation of multiple, otherwise incompatible, antigens in a single injection.

Contact:  Anne King, anne.king@kingpr.net, 860 415 3290

VitriVax was selected out of more than 300 competing submissions to present a “Lightning Talk” at this year’s BARDA Industry Day. 

BARDA (the Biomedical Advanced Research and Development Authority) hosts an annual Industry Day to increase potential partner’s awareness of U.S. Government medical countermeasure priorities, interact with BARDA and ASPR staff, and network with public and private sector colleagues working in the Health Security space.

Lightning Talks are designed to be brief, energetic, and full of information to pique the curiosity of industry and government colleagues and prospective partners. 

To view presentations from the event click here: https://medicalcountermeasures.gov/barda/barda-industry-day-2020/

VitriVax is pleased to announce the publication of the paper “Single-Administration, Thermostable Human Papillomavirus Vaccines Prepared With Atomic Layer Deposition Technology” in the Nature journal npj Vaccines.

The study was funded in part by the NIH and the Bill & Melinda Gates Foundation, and was conducted in the University of Colorado laboratories of our co-founders, Bob Garcea and Ted Randolph.   The data demonstrate the effectiveness in mice of a single-shot human papillomavirus (HPV) vaccine using VitriVax’s groundbreaking vaccine formulation platform.

Traditional HPV vaccines require strict refrigeration to maintain their efficacy, and 2-3 doses must be administered over the course of months for full immunization.  The VitriVax formulated HPV vaccine demonstrated in this study is thermostable at over 50°C (122°F) for months without loss of efficacy.  Further, because the VitriVax combined dose technology provides timed release of a booster dose weeks after injection, only a single injection the VitriVax HPV vaccine formulation is required for full immunization.

“We’re thrilled to share the results of this exciting study.  The VitriVax platform’s ability to eliminate vaccine cold chain requirements, and to deliver multi-dose vaccines in a single injection can make an enormous impact for common public health vaccines like HPV, and it can also provide huge benefits in the fight against COVID-19 and other future pandemics” said VitriVax CEO, Matt Raider.

VitriVax is actively engaging in trials with multiple partners to demonstrate thermostability and combined doses for a variety of different antigens and disease targets, in both human and animal health.  Please reach out to us at info@vitrivaxbio.com if you have an antigen or vaccine candidate you’d like to discuss.

Link to the full paper at Nature.com

The State of Colorado’s Office of Economic Development and International Trade (OEDIT) announced that VitriVax is a recipient of one of its Advanced Industry Accelerator grants. The grants fund companies commercializing innovative technologies to create viable products that meet a market need and can be created or manufactured in Colorado and exported globally.

VitriVax will apply the grant funding to accelerate the development of its “Vaccine Formulation Foundry” in Colorado, partnering with vaccine developers around the globe to make their vaccines thermostable and single-shot. The benefits of the VitriVax platform to Colorado resonate even more today given its unique ability to help with the COVID-19 fight.

“The Advanced Industry grants expand Colorado’s vital innovation ecosystem where this very innovation drives economic growth,” said Katie Woslager, senior manager – Advanced Industries. “These cutting-edge companies create jobs and leverage additional investment into the state, proving to be true economic engines contributing to Colorado’s economy.”

See the press release here:
https://choosecolorado.com/7-3-million-advanced-industries-awards-fuel-27-colorado-start-ups/

The Boettcher Foundation announced today that VitriVax will be one of the recipients of a series of grants totaling $1 million for biomedical research to fight COVID-19 and potential future pandemics.

“Colorado has long been home to incredible innovation, so it’s no surprise that we’re seeing an effort like this to support research around our state that could help us address this pandemic,” said Gov. Jared Polis.

As vaccine developers across the globe make great strides in getting a working vaccine against COVID-19 across the regulatory finish line, the challenge that now also needs to be addressed is actually getting those vaccines to the billions of people around the world that will need them. Most vaccines require strict temperature controls to maintain their effectiveness, and often require a follow-on “boost” dose to achieve full immunization.

VitriVax’s vaccine formulation platform addresses both of these challenges by enabling vaccines to be made thermostable up to 70°C (158°F), and the combination of prime and boost doses into a single injection with timed release, eliminating the need for a follow up injection. The platform uses a technology called atomic layer deposition (ALD) to coat the active ingredient in the vaccine with a protective layer of adjuvant (commonly used in vaccines to stimulate immune response). That coating then slowly dissolves to release the dose inside. The current generation of ALD system in use by VitriVax operates at the scale of around 1000 doses per run.

The Boettcher grant, to be shared between VitriVax and the academic lab of VitriVax Co-Founder Ted Randolph at The University of Colorado in Boulder, will be used to build the next generation of pilot-scale ALD system capable of producing 10,000-100,000 doses of vaccines per run, to be ready for use as COVID-19 candidate vaccines begin to emerge over the next 6 to 12 months. The new system will be ready to manufacture thermally stable, single-dose formulations of novel COVID-19 vaccines at the scale required for large human clinical trials.

“Would you rather have to vaccinate billions of people once, or twice? And would you rather have to store those billions of doses at room temperature, or in refrigerators? The VitriVax platform can play a huge role in the success of the global COVID-19 vaccination effort, and this grant will help us prepare for that role,” said VitriVax CEO Matt Raider.

See the full announcement here: https://boettcherfoundation.org/innovationfund/

“Ted’s research has provided the biotechnology industry a fundamental understanding of biopharmaceutical formulation, protein lyophilization, protein-solvent interactions in aqueous and nonaqueous environments, protein folding, colloidal and conformational stability of macromolecules, from small to large molecular assembly states up to and including visible particles and vaccine complexes.”

https://www.jpharmsci.org/article/S0022-3549(19)30720-8/fulltext

Soligenix, Inc., a licensee of VitriVax’s thermostability technology, announced that it has opened the study titled “A Phase 1C, Double-Blind, Placebo-Controlled, Randomized Study to Evaluate the Safety of RiVax^®, a Lyophilized Ricin Toxin A-Chain Subunit Vaccine with Alum-Adjuvant, in Healthy, Normal Adults.” Preliminary safety results from the trial are expected in the second quarter of 2020 with longer-term safety and immunogenicity results from throughout the 6-month follow-up period expected in the fourth quarter of 2020.

Read more here: http://ir.soligenix.com/2019-12-12-Soligenix-Initiates-Clinical-Trial-Heat-Stable-Ricin-Toxin-Vaccine

The human papillomavirus (HPV) vaccine was a landmark first in cancer prevention, protecting women against the virus that causes cervical cancers. Yet this life-saving vaccine and many others remain inaccessible to a large part of the developing world due to their high cost and need for refrigeration. Many have tried to overcome these barriers to universal vaccination, but thus far, all have fallen short.

Now BioFrontiers scientist Bob Garcea and collaborator, Ted Randolph, promise to finally break down these barriers with a fresh, cross-disciplinary approach. Blending their expertise in virology and chemical engineering, with a dash of ingenuity, they are redesigning low-cost, heat-stable vaccines with unprecedented success. Starting with HPV, their revolutionary vaccine designs could transform vaccine programs worldwide to serve regions that need them most.

VIROLOGY GURU

Bob Garcea

Bob Garcea has been a transformative force in vaccine development since the 1980s. By studying viral structures, he has discovered new ways to simplify vaccines that drastically reduce their cost and increase their reach. His discovery of virus-like particles (VLPs) led to next-generation vaccines that are more affordable and safer than traditional live attenuated or heat-killed virus vaccines, and have since become the new gold standard in vaccine design.

Now, Bob promises to revolutionize vaccines once again with his discovery of viral capsomeres. “You don’t need the whole VLP to elicit an immune response,” says Bob. “Building blocks of the viral shell, termed capsomeres, are just as good at sensitizing the immune system against HPV.” These capsomeres are so simple they can be churned out en masse by bacteria, whereas VLPs require more complex biological production systems that are four times as costly. In addition, complex VLP vaccines are unstable, requiring liquid suspension and refrigeration for preservation. Meanwhile, simple capsomeres are much more stable, lending themselves to a new heat-tolerant formulation.

While Bob had no experience with vaccine formulations himself, he knew someone in a neighboring lab who did. “Our BioFrontiers lab happened to be next to chemical engineers. They come at problems in a very different way than we do. For them, it’s about practicality,” says Bob. “In particular, Ted Randolph had developed a technique for thermo-stabilizing proteins in powder form.”

CHEMICALLY ENGINEERING DRUG FORMULATIONS

Ted Randolph

Ted Randolph specializes in the practical matters of converting molecular discoveries into viable treatments. Biological proteins are notoriously unstable, particularly when exposed to heat. Ted’s job is to prevent them from degrading throughout the manufacture, storage, and distribution processes. The stakes are high—any failures can compromise drug safety or efficacy, putting patients’ lives at risk.

“Meeting the stringent requirements for chemical and conformational stability during shelf life is a daunting task,” says Ted. Exploring how and why proteins go bad, he stabilizes them with chemical engineering solutions. His cutting-edge technique to freeze-dry proteins into powder form has achieved unprecedented heat-stability, enduring temperatures as high as 120 degrees Fahrenheit for 3 to 4 months.

“We brought our capsomeres over to Ted’s lab, and his team quickly made thermostable capsomere powders that equaled the ability of the current HPV vaccine to sensitize the immune system,” Bob says.

FROM DISCOVERY TO THE REAL-WORLD

Recognizing the revolutionary nature of their breakthrough, and its potential to finally overcome barriers to universal vaccination, the duo teamed up with Al Weimer of the Department of Chemical and Biological Engineering in a unique collaboration that secured a $1.1 million grant from the Bill & Melinda Gates Foundation in 2016. The three investigators work in the Jennie Smoly Caruthers Biotechnology Building (JSCBB) at CU Boulder, but their research areas have very different emphases, and the grant has helped them work together and collaborate to translate their discovery into real-world vaccines. “It’s really merging three different people with three different sets of expertise into one project,” Garcea says. Ted adds, “This formulation represents a breakthrough technology previously unattainable for vaccines, allowing for safe and effective distribution wherever needed.”

Bob and Ted also founded the spin-off company VitraVax Inc., turning to CU’s Technology Transfer Office in conjunction with the Innovation Center of the Rockies to get up and running. Offering essential guidance in identifying business drivers, finding equity support and licensing intellectual property, among other new challenges, these resources were instrumental in successfully launching the new venture.

IMPACTING GLOBAL HEALTH

With low-cost, heat-stable vaccines in a single dose, this BioFrontiers inspired team is aiming for the holy grail of vaccination. Their revolution in vaccine design would overcome the barriers to universal vaccination and save millions of lives, particularly in developing nations.

Current disparities in access to HPV vaccination deprive millions of women and men worldwide of this life-saving breakthrough in cancer prevention. “In cancer, an ounce of prevention is worth a pound of cure,” says Bob, explaining that HPV vaccination offers a more realistic strategy to save lives in areas without the resources for cervical cancer screening or treatments.

In addition, the team’s new technique could lead to new, more protective HPV vaccines by lowering R&D costs. “Although a majority of HPV-related cancers result from HPV16 and 18 infections, another 15 different strains can be oncogenic,” Bob says, “Our ability to fight this disease is currently limited by manufacturing and distribution costs as well as the breadth of coverage.”

Beyond HPV, the team is laying the foundation for an entirely new paradigm in vaccinology that could impact all vaccines. “Our decades of work aimed at better HPV vaccines may become more about a process than a product—a way of making many types of vaccines rather than a single vaccine itself,” Bob explains. With their elegant combination of virology and chemical engineering, Bob and Ted’s next-generation vaccines have the potential to rewrite the book on disease prevention worldwide. Their admirable work exemplifies the BioFrontiers mission to drive medical advances through innovative cross-disciplinary science.

Read the original article here.

Vaccines are crucial to the health of millions in developing countries, but timely delivery of these lifesaving immunizations has always been hindered by the need for refrigeration.  Now, a unique interdisciplinary collaboration at CU Boulder’s BioFrontiers Institute aims to change that.

Professors Robert Garcea, Theodore Randolph and Al Weimer specialize in different areas of biochemistry; but recently, the trio banded together on a multiyear effort to develop shelf-stable, nonperishable vaccines that can be stored at high temperatures for months rather than days.

If successful, such an advancement would radically ease the difficult task of distributing immunizations to rural hospitals and population centers.

The magnitude of the challenge requires a wide range of skill sets and ideas, something that the researchers were all too happy to take on.  “It’s really merging three different people with three different sets of expertise into one project,” Garcea said.

In Garcea’s lab, investigators work on new vaccines such as those for human papillomavirus (HPV), a leading cause of cervical cancer that is particularly devastating to women in developing countries.

One corridor away, Randolph’s team, which focuses on creating stable dosage forms for therapeutic proteins and vaccines, developed a process for making vaccines thermostable, or resistant to damage from heat or cold. In its final form, this vaccine resembles a glassy powder.

The two began collaborating about two years ago and even formed a spinoff company, Vitravax Inc., which has seen encouraging results in mice thus far.

Weimer contributed the final piece of the puzzle.  His lab coats the vaccine microparticles with protective layers of aluminum oxide, a process known as atomic layer deposition.  This nanometer-thick barrier shields the vaccine particles while helping trigger the body’s immune response.

The trio are now forming extended-release vaccine dosage forms.  When the formulation is injected, the outer layer provides an initial vaccine dose.  Next, the aluminum oxide layer slowly dissolves, eventually releasing the inner core, which acts as a second dose of vaccine.  Patients receive their second or third “dose” without ever knowing it and without a return trip to the doctor.

Individual results have been promising, but scaling from test batches in the lab to manufacturing millions of vaccines for public use is a challenging process that might not succeed quickly—or at all.  “We’ve done many of the individual parts of this project,” Randolph said.  “Now we’ve got to put those pieces together and have it work.”

Still, the professors say they are optimistic about the collaboration, which might never have happened if not for their proximity on CU Boulder’s East Campus and the interdisciplinary mission of the BioFrontiers Institute, which drives innovation by combining researchers from different fields.

“One of the hopes of the BioFrontiers Institute is that investigators will, by their proximity, do new and interesting things,” Garcea said.  “In a sense, we’ve fulfilled the mission. If the technology works, we’ve really fulfilled the mission.”

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Read the original article here.

The University of Colorado Boulder has received a $1.1 million grant from the Bill & Melinda Gates Foundation to develop next-generation vaccines that require no refrigeration and defend against infectious diseases with just one shot.

If successful, those advancements could radically transform the difficult task of dispensing life-saving immunizations in developing countries — and improve convenience in every part of the world.

Professor Bob Garcea of the Department of Molecular, Cellular and Developmental Biology and the BioFrontiers Institute has teamed up with Professors Ted Randolph and Al Weimer of the Department of Chemical and Biological Engineering in a unique collaboration that applies a wide range of skillsets and ideas to the pressing challenge of delivering vaccines to patients in developing countries.  All three investigators work in the Jennie Smoly Caruthers Biotechnology Building (JSCBB) at CU Boulder, but their research areas have very different emphases.

“It’s really merging three different people with three different sets of expertise into one project,” Garcea said.

In Garcea’s lab, located in the Jean and Jack Thompson Vaccine Research Laboratories of the JSCBB, investigators work on new vaccines such as those for human papillomavirus, a leading cause of cervical cancer that is particularly devastating to women in developing countries.

One corridor away, Randolph’s team, which focuses on creating stable dosage forms for therapeutic proteins and vaccines, developed a process for making vaccines thermostable, or resistant to damage from heat or cold.  In this glassy powder state, the vaccine can be stored at temperatures as high as 120 degrees Fahrenheit for three to four months without losing efficacy, Randolph said.

The two began collaborating about two years ago and even formed a spinoff company, Vitravax Inc., which is seeing successful results in vaccine studies conducted in mice.

The Gates Foundation grant will take these innovations a step further by combining the thermostable vaccine powders with techniques developed in the Weimer lab that allow uniform nanoscopic protective layers of aluminum oxide to be applied to vaccine microparticles.  This coating process, called atomic layer deposition, not only provides a nanometer-thick protective barrier for the vaccine particles but also helps trigger the body’s immune response.

The trio is now forming extended release, multilayer microparticulate vaccine dosage forms, composed of an inner core of stabilized vaccine coated with aluminum oxide layers and an outer layer of vaccine, all embedded in a glassy powder. When the formulation is injected, the outer layer provides an initial vaccine dose.  Next, the aluminum oxide layer slowly dissolves, eventually releasing the inner core which acts as a second dose of vaccine.  Patients receive their second or third “dose” without ever knowing it and without a return trip to the doctor.

Although each step of the process has worked independently, researchers cautioned that moving from small test batches in the lab to manufacturing millions of vaccines for public use is a challenging process that may not succeed quickly – or at all.

“We’ve done many of the individual parts of this project,” Randolph said.  “Now we’ve got to put those pieces together, and have it work.”

Still, investigators say they’re optimistic about the collaboration, which might never have happened if not for their proximity on CU-Boulder’s East Campus and the interdisciplinary mission of the BioFrontiers Institute, which seeks to drive innovation by combining researchers from different fields.

“One of the hopes (of the BioFrontiers Institute) is that investigators will, by their proximity, do new and interesting things,” said Garcea, who is a member of the Institute.  “In a sense, we’ve fulfilled the mission. If the technology works, we’ve really fulfilled the mission.”

The Randolph and Weimer Labs are part of the Department of Chemical and Biological Engineering.  The Garcea lab is part of the Department of Molecular, Cellular and Developmental Biology at CU Boulder and the BioFrontiers Institute.  At the University of Colorado BioFrontiers Institute, researchers from the life sciences, physical sciences, computer science and engineering are working together to uncover new knowledge at the frontiers of science and partnering with industry to make their discoveries relevant.

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