Dallas-Based Vaxxinity Prepares for $100M IPO; Aims to Turn Immune Systems Into ‘Antibody Factories’ » Dallas Innovates

Dallas-based company Vaxxinity, which uses synthetic peptides to develop a “safe and mild” COVID-19 vaccine along with vaccine therapies for several chronic diseases, plans to go public this Thursday under the NASDAQ symbol VAXX. The biotech aims to raise $ 100 million by offering 6.7 million shares between $ 14 and $ 16. In the middle of that price range, the company would be valued at just over $ 2 billion.

Vaxxinity aims to “democratize” health by pioneering what it calls the “third biological revolution”: developing vaccines to treat chronic diseases. The company is developing a new class of therapeutics to treat diseases such as Alzheimer’s, Parkinson’s, migraines, hypercholesterolemia, and others.

It also developed what is known as the first multitop protein / peptide-based vaccine candidate for COVID-19.

Use synthetic peptides to transform the body into its own “antibody drug factory”

Vaxxinity’s multitop tech platform creates synthetic peptides to activate the immune system and overcome “immune tolerance” – the body’s tendency not to attack molecules in the body even when they are harmful.

“By turning the body into its own antibody“ drug factory ”, we are developing drugs that are easier to manufacture, easier to take, and significantly cheaper than [monoclonal antibodies]“Says Vaxxinity on its website.

“The key to the platform is the proprietary library of UBITh peptides, which are immunosilent, prevent inflammation and, in conjunction with tailor-made target antigens, can elicit highly specific antibodies,” says the company.

Vaxxinity’s proprietary platform “addresses diseases with validated and novel targets”. [Image: Vaxxinity]

Based on a technology that led to the foot and mouth sensory substance

The technology behind the company’s vaccines has been used for decades to make vaccines for farm animals against foot and mouth disease. Vaxxinity says its platform has been “scientifically validated, with billions of doses marketed in animal health and six successful human clinical trials”.

“Super Safe and Mild” COVID-19 vaccine candidate

Vaxxinity’s COVID-19 vaccine candidate UB-612 is “super safe and mild and won’t bring down recipients with flu-like symptoms for a few days,” the startup’s co-founder and CEO Mei Mei Hu told Clinical Trials Arena at im Mai, describing it as “the not-so-scary vaccine you would give your kids”.

Unlike Moderna and Pfizer’s mRNA COVID-19 vaccines, Vaxxinity’s COVID-19 vaccine is based on protein peptides. His platform “works like a sheep in wolf’s skin, using a synthetic piece of a noxious self-protein that your body normally considers a ‘sheep’, combined with a synthetic peptide that acts as ‘wolf’s clothing’ and signals to the immune system that it does ‘Sheep’ is actually harmful, ”explains the company on its website.

“It has been commercialized in several animal health applications and these are large farm animals,” Hu told Clinical Trials Arena. “You learn a lot about your technology when you have that much attention. We have learned how to scale in terms of manufacturing technology, and we know how to do it efficiently. We know how to achieve low cost of goods in order to be competitive and we understand the safety and efficacy platform of previous indications, both of which are very strong. Because of this, we have great self-confidence and feel very well placed to tackle the rest of the world. “

Increasing “choice” in COVID-19 vaccines

CEO Hu told Fortune magazine that limited vaccine options could be a reason many Americans are not fully vaccinated against COVID-19.

“There’s an anti-Vax population in general, but it’s actually very small in the US,” Hu told Fortune. “But for COVID vaccines we have about 40 percent of those who are not fully vaccinated. I think where there is a gap, to be honest, the choice is the one. “

“We need to have a respectful conversation that understands people’s concerns, so we hope to make that conversation easier,” she added, “and offer more choice of more products and vaccines. There are some people who are afraid of certain technologies, so it is important to offer a choice. “

Another benefit of Vaxxinity’s COVID-19 vaccine: it only requires the standard refrigeration temperatures to remain stable. This could make it particularly useful for sales in developing countries.

The vaccine order was placed on June 16 in Asunción by Dr. Julio Borba, Paraguayan Minister of Health and Social Affairs (center) and Jon Harrison, Chief Strategy Officer of Vaxxinity (right), signed. Ambassador José Han, Taiwan’s Ambassador to Paraguay, was also present (left). [Photo: Vaxxinity]

Targeting underserved populations in developing countries

Vaxxinity’s path to IPO this week has not been entirely smooth. In June, Vaxxinity signed an order with the Paraguayan government for one million doses of the company’s UB-612 COVID-19 vaccine. However, the deal was contingent on Vaxxinity approving the vaccine for emergency approval from the Taiwanese Food and Drug Administration.

Fortune said the application was denied, but Vaxxinity had “submitted new data to the Taiwanese FDA and has just received approval to conduct a study in the US.”

“You don’t give up on drug development,” Hu told Fortune. “As in life, you persevere.”

Paraguay has suffered one of the worst COVID outbreaks per capita in the world. In June, Lou Reese, co-founder and CEO of Vaxxinity (and Hu’s husband) spoke about the company’s direction.

“Vaxxinity has focused on UB-612 while continuing to develop the other vaccines in its pipeline to rapidly develop, manufacture and distribute vaccines to fight the global COVID-19 pandemic in countries most in need,” Reese said in a statement last spring.

Vaxxinity is targeting emerging markets for UB-612, with a focus on India and Latin America.

“I think less than 1 percent of vaccines have been used in developing countries, and that is our goal. Our mission is to truly serve the underserved, ”Hu told the Clinical Trials Arena in May.

Vaxxinity was founded in April 2021 through the merger of two companies

Vaxxinity was known as COVAXX until April last year when it consolidated its vaccine development efforts with United Neuroscience, based in Dublin, Ireland and Dallas.

“Bringing our pipelines together and using the same platform in one company will strengthen our ability to advance these much-needed vaccines around the world,” Hu said in a statement at the time.

“It’s a vision that has been a long time coming,” Clinical Trials Arena said last May. “The two companies share the same vaccine platform, have many overlapping team members, and the same mission of democratizing health.”

COVAXX was founded in early 2020 as a spin-out from Taiwan-based United Biomedical, a manufacturer of diagnostic tests and veterinary vaccines led by Hu’s mother, scientist Chang Yi Wang. United Neuroscience was also a United Biomedical spin-off.

“COVAXX was only outsourced for Covid-19, at a time when nobody really knew what it was and if it would last,” Hu added last May. “Now it’s clear it won’t go away, so it made sense to bring the company together so that we have a single, unified, aligned entity that houses the entire vaccine platform under one roof.”

Phases of the Vaxxinity clinical trial [Image: Vaxxinity]

Phases of Vaxxinity’s clinical trial and “expansive disruption”

The graphic above shows the current clinical study stages of Vaxxinity’s synthetic peptide vaccines on the company’s website.

The company says innovation of complex biologics made in bioreactors – especially monoclonal antibodies – have been very effective against certain chronic diseases. However, these drugs present manufacturing challenges, are difficult to administer, and are extremely expensive – which is why less than 1 percent of the world’s population is currently receiving the medical benefits of monoclonal antibodies.

Vaxxinity says it will not steal market share from monoclonal antibodies by bringing its cheaper, more convenient, and more accessible vaccines to the market. Instead, it will expand the addressable overall market and create what is known as “expansive disruption”.

Manufacturing facilities in Taiwan, India, Europe and the USA

Vaxxinity has its own manufacturing facilities in Taiwan, where the COVID-19 vaccine UB-612 can be manufactured. However, the company has gained additional manufacturers in the US, India and Europe to meet its goal of over 500 million doses per year, reports Clinical Trials Arena.

Last April, Vaxxinity announced a global logistics partnership with Maersk, the world’s largest shipping and logistics service provider. The partnership created a framework for all transportation and supply chain services required for the global delivery of UB-612.

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