While much of the pharma industry has fixed its gaze on personalized medicines for smaller patient populations, Vaxxinity has instead kept its eyes on bigger horizons. With experimental drug candidates for major diseases and a novel platform aimed at providing key advantages over existing tech, the company is shooting for nothing short of leading pharma toward its next frontier.
“The industry is being driven into smaller indications with a higher cost per patient, and this is fundamentally wrong,” Lou Reese, co-founder and executive chairman of Dallas-based Vaxxinity, says. “[Pharma] is an industry that has become less visionary, less bold, less moonshot-oriented and less population-focused.”
Behind the company’s vision is a novel class of clinical-stage immunotherapeutic vaccines being developed to treat and prevent massive indication areas including COVID-19, Alzheimer’s, Parkinson’s and more. They are the kinds of high-reward but high-risk products that could keep some execs up at night. But Reese isn’t the kind of guy to break a sweat over the pressure. With steadfast clarity, he calls Vaxxinity’s products and platform “revolutionary” and says his goal is to do his part to “save humanity.”
And it’s these kinds of bold proclamations, which are often reserved for business leaders in Silicon Valley, that make it feel like Reese is putting the “tech” in biotech.
“In tech, you can say, ‘We are going to Mars in 10 years.’ But in biotech, you have to say, ‘We’re going to shrink the population we’re going after so that the risks can be calculated, we’re not going to help a lot of people, and we‘re going to charge a fortune,’” he wryly notes. “That system…is in desperate need of additional vision.”
The secret sauce
At a young age, Reese says he identified three industries where he thought he could have the largest impact on the world: healthcare, energy and housing. After becoming an investment banker, Reese later transformed into an entrepreneurial investor and then set out to do his life’s work.
First he tackled housing, creating the first U.S Green Building Council LEED certified multifamily community project for the U.S. Green Building Council. Next, he moved on to energy, setting up a solar power company in Hawaii. Finally, the opportunity came to complete the trifecta and head into healthcare. Thanks to a bit of serendipity, the family of Reese’s wife, Mei Mei Hu, was already there.
As the chief scientific officer of United Biomedical (UBI), Hu’s mother, Chang Yi Wang, was the brainchild behind a number of drugs — including a foot-and-mouth disease vaccine that proved to be highly effective in pigs. With Wang’s blessing, Hu and Reese set out to see if the same vaccine tech could work in humans. Last April, their company, COVAXX, merged with United Neurosciences (a subsidiary of UBI) and Vaxxinity was born. Hu, a Harvard-trained lawyer, took the helm as CEO.
The platform behind the duo’s company has a familiar ring in this new age of vaccines. Like mRNA vaccines, the idea is to turn the body into its own “drug factory.” But Vaxxinity’s platform uses synthetic peptides to activate the immune system to produce antibodies for a specific target. According to Reese, its “secret sauce” is a T-helper epitope component that allows “virtually every person” to safely break immune tolerance.
The other benefits of this approach, Vaxxinity says, are numerous. Unlike monoclonal antibodies (mAbs), which have become dominant in pharma development, Vaxxinity’s products would not need to be administered through frequent injections.
Production for the technology is also easily scalable, and because the therapies harness the body’s own immune system, the cost for manufacturing materials would be smaller than mAbs.
By targeting specific antigens, the company says that the products also help avoid off-target effects, have a low reactogenicity profile and are safer than traditional vaccines.
And crucially, the platform can be utilized for both infectious and chronic diseases.
“The limitations of the platform have yet to be reached,” Reese says.
Drugs for the masses
In animal health, Vaxxinity has commercialized six billions of doses made with its technology. Reese adds that trials of its products have shown high rates of efficacy among large livestock. Time will tell just how well the platform translates into human use.
Vaxxinity’s most advanced candidate, UB-311, targets the sticky plaques — called beta-amyloid — that can build up in the brains of patients with Alzheimer’s. A Phase 2a trial of the treatment showed that it was well tolerated, elicited a high response rate and that it was generally safe.
Safety, in particular, has become a growing concern now that Biogen’s controversial drug Aduhelm, a mAb, has been FDA approved and is being used in a real-world setting. So far, at least one patient death has been potentially linked to a brain-swelling side effect of Aduhelm called ARIA.
“If I said that you could have an Alzheimer’s drug with a clean safety profile — meaning zero brain swelling — better efficacy on all of your cognitive and functional endpoints, a cost of less than a 10th of [Aduhelm’s price] and instead of going into an infusion center for three hours at a time, you get an injection at your doctor’s office a few times a year…tell me if that would be less controversial,” Reese muses.
Although the trial results showed that UB-311 trended in the right direction with its secondary endpoints that measured clinical cognitive improvements, the results were not statistically significant. But in a press release, Hu said that the outcome of the trial will help provide “directional information” about the drug, which is slated to start a Phase 2b study this year.
The clinical results of its other leading candidate, a COVID-19 vaccine called UB-612, have generally been positive. A Phase 1 trial of the vaccine showed that it was well-tolerated — very few solicited and unsolicited adverse events were observed — and that it produced virus-neutralizing antibodies in 100% of the study’s volunteers after two doses. The company has now launched Phase 2 trials in Taiwan.
It has also already secured supply agreements with several countries for the shot, pending a regulatory approval. However, those contracts hit a roadblock in August when Taiwan rejected the company’s Emergency Use Authorization application for the vaccine, saying that the antibodies it triggered were not more robust than the AstraZeneca shot.
When faced with the setback, Reese says that he rallied the company’s employees by emphasizing transparency and accountability as they move forward.
“That’s the time to respect the quality of the team you built so that you can have clear, transparent communication, and so that people feel like they know what the path forward is,” he says.
Vaxxinity is appealing Taiwan’s decision and Reese says that the company is unwavering in its resolve.
“Just because there are things that happen that could be perceived as scary, you have to remain grounded in your mission and you have to continue to champion that from the tallest hill you can,” he says.
Among the other products in its pipeline are vaccine treatments for migraines and hypercholesterolemia, which are all in earlier phases of development. Last week, Vaxxinity also launched a Phase 1b study of its vaccine for Parkinson's. On the heels of positive data from its Phase 1a study, the new trial, which will include up to 20 participants, will help measure the safety and immunogenicity of the drug, UB-312.
The company is also trialing a candidate that targets tau — instead of amyloid — in Alzheimer’s patients.
If successful, the company hopes that the treatments will provide the kind of safe, low-cost and effective therapies that each indication area needs. With operations around the world — including the U.S., Asia, Latin America and Europe — the company has a strong global perspective and hopes to ultimately deliver vaccines that are easily accessible to everyone.
For Reese, it all goes back to the same objective he’s had in every industry he’s entered — shake up the status quo with a “revolution” that will have a lasting and large impact.
“My goal is not to affect millions of people — but billions. I don’t want to save billions of dollars, I want to save trillions. I want to have a truly global impact on the elimination of suffering,” he says. “I’m exhilarated to do this.”