Vaxxinity is taking vaccine technology beyond infectious disease, setting its sights on Alzheimer’s, Parkinson’s and heart disease.
Immunotherapeutic vaccine developer Vaxxinity is developing a new class of synthetic, peptide-based vaccines for chronic diseases. The company has a pipeline of vaccines under development, targeting chronic diseases like Alzheimer’s, Parkinson’s and hypercholesterolemia, as well as infectious diseases, including COVID-19. Vaxxinity’s anti-amyloid beta immunotherapeutic vaccine (UB-311) was recently granted Fast Track designation by the US FDA for the treatment of Alzheimer’s disease. The company is now seeking a partner for a Phase 2b clinical trial of UB-311.
Longevity.Technology: They may not be the first technology that you think of when it comes to longevity science, but vaccines have already contributed considerably to healthy human longevity. Since the first vaccine for smallpox was invented in 1796, vaccines have been developed for 29 preventable infectious diseases. However, chronic diseases are now killing us more than infectious diseases, and Vaxxinity believes prevention is better than a cure. To learn more, we spoke with Dr Ulo Palm, Vaxxinity’s Chief Medical Officer.
Vaxxinity (Nasdaq: VAXX) is aiming to disrupt the traditional approach to treating chronic disease, a field increasingly dominated by monoclonal antibodies, which the company says “suffer from prohibitive costs and cumbersome administration.”
“We need to change our mindset – it’s a paradigm shift from treatment to prevention,” says Palm, a pharmaceutical R&D veteran, with more than 30 successful new drug applications under his belt. “We must think very early on about prevention and going after the underlying root causes of these diseases that turn aging into a nightmare for millions and millions of people.”
Vaccines vs monoclonal antibodies
When he was approached to become CMO at Vaxxinity, Palm recalls his excitement at what he felt could be the disruptive innovation he had been waiting 30 years in the industry for. He analogises the technology to recent changes in the automotive sector.
“Everybody thought that an internal combustion engine would be around forever – but it’s highly complex, with thousands of moving parts,” explains Palm. “The electric engine has 12 moving parts, and no one questions today that the future is electric.”
“At Vaxxinity, we are replacing an entire factory that cost billions of dollars producing monoclonal antibodies with your own body – using established peptide vaccine technology that has been around for a long time. The cost of goods of our vaccines is less than a hundredth of monoclonal antibodies, so they are cost-effective to produce and everyone should be able to access them.”
One of the other issues with monoclonal antibodies, says Palm, is that they are not your own antibodies, and so the body produces anti-drug antibodies to combat them.
“Despite the fact that they are humanised, monoclonal antibodies are still not your own, so after a while, your body recognises them and develops antibodies against them, which leads to a significant decline in efficacy.”
A vaccine for Alzheimer’s?
Using the company’s lead Alzheimer’s vaccine as an example, Palm explains how Vaxxinity’s approach differs.
“UB-311 is a vaccine that we have shown in patients produces internal antibodies in the brain at a similar concentration to monoclonal antibodies,” he says. “Our Phase 2a study, while not statistically significant, showed that almost all the cognitive endpoints indicated a reduction in cognitive decline. We were able to show that our internally produced antibodies reached the amyloid target in the brain. And, very importantly, that they bind specifically to the toxic amyloid.”
Vaxxinity is currently seeking partners for its Phase 2b trial.
“These are huge studies to run, so we’re looking for partners and, as soon as we have one, we want to move into further development,” says Palm. “There’s a lot of excitement in the field right now, and we want to get a vaccine out there, first for patients who are already having mild cognitive impairment. And then looking ahead, the Holy Grail, of course, is to move into earlier, asymptomatic stages, and one day to have a preventive vaccine.”
Palm’s enthusiasm for the approach is infectious as he paints a picture of the potential future of Alzheimer’s treatment.
“Imagine going to your doctor in your late 30s and they say that, based on your family history, they recommend you start getting a shot twice a year to potentially prevent Alzheimer’s,” he says. “I think, as long as they know it’s safe and has limited side-effects, a lot of people would seriously consider it. Why not? I would do it.”
Behind Vaxxinity’s approach
Vaxxinity’s technology is based on research and development licensed from Taiwan-based biotech UBI. One of UBI’s key breakthroughs was in animal health, when it produced a vaccine that helped stop the 2001 foot and mouth outbreak in the UK. In 2014 the company decided to expand its focus to chronic diseases in humans, and so Vaxxinity was born.
“There has to be lots of research behind this kind of approach because using the immune system to do something different in a targeted fashion in your body is a very critical and complex process,” says Palm.
Vaxxinity’s secret lies in its patent-protected peptides, which means its vaccines are well-tolerated by our bodies.
“We have proprietary peptides that are linked with a sequence of our target protein,” says Palm. “They are essentially sheep in wolf’s clothing, because the sequence is your own and isn’t recognised by your immune system. But then we link them together, and all of a sudden, this raises a red flag for the immune system. This is what makes it highly targeted, because the response only happens when the sequence is connected to our peptide.”
Palm acknowledges that others are also trying to use vaccines in this way, but they don’t have the benefit of the decades of R&D that Vaxxinity is built on.
“The challenge other companies have is that their vaccines trigger an unwanted inflammatory immune response and, if they mitigate that, then the effect goes down,” he says. “So they don’t have the necessary immunogenicity to target beta amyloid, for example, in substantial quantities. Of course, they can get there but they’ll need to put in the 20 years research!”
In addition to its clinical trials in Alzheimer’s, Vaxxinity has also commenced a Phase 1 trial in Parkinson’s and expects to enter a Phase 1 trial for hypercholesterolemia next year, following favourable preclinical results.
