Helix Nanotechnologies on the development of a Covid vaccine resistant to mutations

In March 2020, Hannu Rajaniemi pivoted his biotech company Helix Nanotechnologies from cancer therapies to Covid-19 vaccines.

Rajaniemi’s then six-person start-up was not going to be able to compete with Pfizer and AstraZeneca, but HelixNano, as it’s called, had a different goal: to create a better, second-generation vaccine against new coronavirus.

“We need to go on and develop more countermeasures – more effective vaccines, therapies and second wave tests. … The virus is very good at generating surprises,” says Rajaniemi.

Today, HelixNano has nine employees and Rajaniemi says its new vaccine will go into clinical trials in 2021, with potential for approval by early 2022, depending on “many factors”.

Rajaniemi initially co-founded Helix Nanotechnologies in Cambridge, Massachusetts in 2013 to develop cancer therapies, which was a personal mission: his mother fell ill and eventually died from metastatic breast cancer.

When the company started working on Covid-19 vaccines, he knew his start-up would not be one of the first vaccines to come out.

“It would have required billions in [Operation] Funding from Warp Speed, “says Rajaniemi. (HelixNano received $ 6.4 million in total funding in May, according to Crunchbase, from investors such as Y Combinator, and received grants from Google billionaire Eric Schmidt’s Schmidt Futures.)

“In this crisis, the role of a start-up is to pursue more technically complex second-generation approaches and find solutions that the large less agile players might miss,” he says.

As the first wave of Covid vaccines distributed in the United States by Pfizer / BioNTech, Moderna and Johnson & Johnson must adapt their vaccines to new strains, HelixNano’s booster vaccine is designed to “provide much broader immunity” , he said.

“The reason we got into this situation … was because we were concerned about the mutated strains of SARS-CoV-2 capable of evading vaccine immunity,” says Rajaniemi. “This is exactly the scenario currently playing out with the South African, Brazilian and other emerging variants.”

Developing a vaccine resistant to viral mutations is “a technically extremely difficult problem,” says Rajaniemi.

But with the advantage of being able to draw on all the knowledge scientists now have about the virus, HelixNano has invented “two completely new vaccine technologies” for which they have filed patents, according to Rajaniemi.

“Basically we have a ‘zoom’ function and an ‘amplify’ function for mRNA vaccines,” he says. (The Pfizer-BioNTech and Moderna vaccines are both mRNA technology, as is the Helix Nanotechnologies booster.)

“We can make vaccines both more targeted and more potent than ever before,” says Rajaniemi.

The first technology developed by Helix Nanotechnologies makes vaccines more precise.

“Traditional vaccines are blunt instruments. You show the immune system a bit of the virus – like the spike protein that SARS-CoV-2 uses to infect cells – and [the body] generates antibodies against it, ”says Rajaniemi. And “these antibodies are essentially random”.

However, HelixNano’s new technology directs the antibodies to a very specific part of the virus spike protein that “matters most in preventing infection,” according to Rajaniemi.

“To use a cheesy analogy, imagine the virus is the Death Star [space station from Star Wars]. To detonate it you have to hit a very small target – the thermal exhaust port, ”says Rajaniemi (who is also a published sci-fi author).

“Your X-Wings [starfighters] could just randomly shoot the entire Death Star, but it would take a lot of luck to destroy it, ”he said.

“But if you focus all of your fire on the exhaust port, you have a much better chance – even if your shots become less precise as the virus mutates.”

The second vaccine technology developed by HelixNano is a way to boost the body’s immune system response to a specific vaccine target by a factor of 100.

Taken together, these two technological advancements are what HelixNano used to build its Covid-19 anti-mutation booster vaccine.

Beyond its own vaccine, HelixNano is also working with Louis Falo’s lab at the University of Pittsburgh to make a vaccine called PittCoVacc that can be applied to the skin, rather than by injection, which can therefore be self-administered.

“We envision an mRNA vaccine that is stable at room temperature and can therefore be easily deployed in global immunization campaigns in the same way as one would distribute and apply dressings,” said Falo, president of the department of dermatology at the University. from Pittsburgh and a professor of bioengineering.

PittCoVacc has submitted preclinical data to the Food and Drug Administration as part of a New Drug Pre-Investigation (pre-IND) request. “I dare not venture to guess when the IND will be approved because their evaluation could reveal anything more than a lot of preclinical studies to be done,” Falo told CNBC Make It. “Obviously, we hope for the best.”

So largely protective and easily administered vaccines could play a role in immunizing more than 7.7 billion people worldwide. Even as U.S. vaccination efforts progress – as of March 29, 143 million doses of the vaccine had been administered, according to the Center for Disease Control and Prevention – many other countries are lagging behind by orders of magnitude.

But the work being done by HelixNano will also have implications beyond Covid-19. The technology created by the start-up can be used to develop other vaccines beyond Covid, says Rajaniemi.

“Just as we’ve taken some of the technologies we’ve developed in a cancer setting – like rapid mRNA manufacturing – and applied them to Covid, Covid’s work has taught us how to develop a whole new class of cancer vaccines. personalized, ”says Rajaniemi.

“We are still 95% on Covid, but we are starting to restart work on cancer.

“For us as a company and for biotechnology as a whole, the pandemic has engulfed an entire decade of development in 12 months,” says Rajaniemi.

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