Italian biotech firm Takis has claimed that their vaccine candidate has become one of the first to successfully neutralize the SARS-CoV2 virus in animal models.
“This is the most advanced stage of testing of a candidate vaccine created in Italy. As far as we know, we are among the first in the world to have demonstrated the neutralization of the coronavirus by a vaccine. We believe this will also happen in humans,” said Luigi Aurisicchio, chief executive officer (CEO), Takis.
The company aims to start human trials after this summer. It had shortlisted five vaccine candidates for experimental validation at the popular Spallanzani National Institute for Infectious Diseases in Rome on the basis of “extremely positive” results in animal trials.
“After a single dose, our five candidate DNA-based vaccines were able to induce a strong antibody response against the covid-19 spike protein in just 14 days in mice. Two of them, in particular, induced the strongest antibody production against the spike protein on SARS-CoV2,” it said on 10 April. The firm, which is part of World Health Organization’s international collaboration to help speed up the availability of vaccine against covid-19, has now finalized one candidate that showed strong antibody response in mice.
It is now looking for funding and collaborations to move to the three phases of human clinical trials, which will be held by Pascale Institute in Naples.
The company has partnered with New York-based Applied DNA Sciences Inc. for manufacturing the DNA-based vaccine for both pre-clinical and clinical trials. The partners begin dose-response trials this week.
“The candidate vaccine lends itself to rapid manufacturing, and the potential for low-dose vaccination means it would require less manufacturing to vaccinate a given population size. We are especially aware of the irony of collaborating from New York and Rome, two locations so badly struck by COVID-19,” said Dr. James Hayward, CEO of Applied DNA Sciences, terming the technology ‘highly scalable’.
However, the team also cautions that positive results in animals may not be predictive of human outcomes after DNA vaccination.
The vaccine developed by the team is a DNA-based vaccine. Unlike other vaccines which use weak/inactivated/live virus to train our immune system to fight an actual virus attack, it uses fragments of the virus DNA to induce an immune response against the virus.
So, when a person is attacked by the actual virus, the body recognizes its DNA and directs the immune system to immediately block it by releasing antibodies. The approach is faster, but is still experimental.
Since it is a DNA-based vaccine, it is injected intra-muscularly and followed by a brief electrical impulse, which strengthens the vaccine uptake in a technique called DNA-electroporation. One of the first such genetic vaccine candidates to enter human trials was an RNA vaccine developed by Moderna.
Usually it takes two years to design and conduct multiple animal studies to assess safety, efficacy, toxicity and immunogenicity of the vaccines, however, the unprecedented health crisis has led researchers to speed up the process as fast as they can.
As of Wednesday, there are at least 391 candidates in various stages of development for vaccines and therapies for COVID-19, some of which have shown promising results including the one by Moderna and Oxford University.