In March 2020, Hannu Rajaniemi pivoted his biotech company Helix Nanotechnologies' focus from cancer therapies to Covid-19 vaccines.
Rajaniemi's then-six-person start-up wasn't going to be able to compete with the likes of Pfizer and AstraZeneca, but HelixNano, as it's known, had a different goal: Create a better, second-generation vaccine against the novel coronavirus.
"We need to keep going and develop more countermeasures — more broadly effective second-wave vaccines, therapeutics and tests. ... The virus is very good at generating surprises," Rajaniemi says.
Today, HelixNano has nine employees and Rajaniemi says its new vaccine will go to clinical trials in 2021, with the potential for approval by early 2022, depending "on a lot of factors."
Rajaniemi originally co-founded Helix Nanotechnologies in Cambridge, Massachusetts in 2013 to develop cancer therapeutics, which was a personal mission: His mother got sick with and eventually passed due to metastatic breast cancer.
When the company pivoted to working on Covid-19 vaccines, he knew his start-up wouldn't be one of the first vaccines out of the gate.
"That would have required billions in [Operation] Warp Speed funding," Rajaniemi says. (HelixNano has received $6.4 million in total funding as of May, according to Crunchbase, from investors including Y Combinator, and has received grant money from Google billionaire Eric Schmidt's Schmidt Futures.)
"In this crisis, the role of a start-up is to pursue more technically challenging, second-generation approaches and find solutions that the less agile bigger players might miss," he says.
While the first wave of Covid vaccines distributed in the United states from Pfizer/BioNTech, Moderna and Johnson & Johnson have to adapt their vaccines to new strains, HelixNano's booster vaccine is designed to "provide much broader immunity," he says.
"The reason we got into this ... was that we were worried about mutated SARS-CoV-2 strains able to evade vaccine immunity," Rajaniemi says. "That is exactly the scenario that is now playing out with the South African, Brazilian and other emerging variants."
Developing a vaccine that is resistant to virus mutations is "an extremely challenging problem technically," Rajaniemi says.
But with the advantage of being able to build on all the knowledge scientists now have about the virus, HelixNano invented "two completely new vaccine technologies" for which they've filed for patents, according to Rajaniemi.
"Essentially, we have a 'zoom' function and an 'amplify' function for mRNA vaccines," he says. (Both the Pfizer-BioNTech and Moderna vaccines are mRNA technology, as is Helix Nanotechnologies' booster.)
"We can make vaccines both more targeted and more powerful than was previously possible," says Rajaniemi.
The first technology Helix Nanotechnologies developed makes vaccines more accurate.
"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," Rajaniemi says. And "those antibodies are essentially random."
However, HelixNano's new technology directs antibodies at a very specific part of the virus' spike protein that "matters the most for preventing infection," according to Rajaniemi.
"To use a nerdy analogy, imagine the virus is the Death Star [space station from Star Wars]. To blow it up you need to hit a very small target — the thermal exhaust port," says Rajaniemi (who is also a published science fiction author).
"Your X-Wings [starfighters] could just randomly fire at the whole Death Star, but you would have to get very, very lucky to destroy it," he says.
"But if you concentrate all your fire on the exhaust port, you have a much better chance — even if your shots get less accurate as the virus mutates."
The second vaccine technology HelixNano developed is a way to multiply the body's immune response to a specific vaccine target by a factor of 100.
Taken together, these two technological advances are what HelixNano has used to build their Covid-19 mutation-resistant booster vaccine.
Beyond its own vaccine technology innovations, HelixNano is also collaborating with Louis Falo's lab at University of Pittsburgh to make a vaccine technology that can be applied to the skin, rather than by a shot, which therefore can be self-administered.
"The mRNA platform has proven to be effective for vaccination, but does have limitations including the requirement for very low temperatures (cold-chain) across the storage, delivery, and deployment process," says Falo, who is chairman of the dermatology department at the University of Pittsburgh and a bioengineering professor.
"We imagine an mRNA vaccine that is stable at room temperature and can therefore be readily deployed in global vaccination campaigns the same way that one would distribute and apply Band-Aids."
(Separately, Falo's lab has its own skin application vaccine called PittCoVacc, which has submitted preclinical data to the Food and Drug Administration as a Pre-Investigational New Drug Application application.)
Such broadly protective and easily administrable vaccines could play a roll in getting more of the more than 7.7 billion people people in the world immunized. Even as the U.S. vaccination efforts move along — as of March 29, 143 million vaccine doses have been administered, according to the Center for Disease Control and Prevention — many other countries efforts are lagging by orders of magnitude.
But the work HelixNano is doing will have implications beyond Covid-19, too. The technology the start-up has created can be used to develop other vaccines beyond Covid, Rajaniemi says.
"Just like we took some of the technologies we developed in a cancer context — like rapid mRNA manufacturing — and applied them to Covid, the Covid work has taught us how to develop an entirely new class of personalized cancer vaccines," Rajaniemi says.
"We're still 95% on Covid, but are starting to spin the cancer work back up."
"For us as a company and for the biotech as a whole, the pandemic has squeezed an entire decade of development into 12 months," Rajaniemi says.
Correction: This story has been corrected to reflect the collaboration between Helix Nanotechnologies and Louis Falo's lab concerns an mRNA vaccine that can be applied to the skin rather than injected.