A team of Israeli researchers says that they are days away from completing the production of the active component of a coronavirus vaccine that could be tested on humans as early as June 1.
“We are in the final stages and within a few days we will hold the proteins – the active component of the vaccine,” Dr. Chen Katz, group leader of MIGAL’s biotechnology group, told The Jerusalem Post.
In late February, MIGAL [The Galilee Research Institute] committed to completing production of its vaccine within three weeks and having it on the market in 90 days. Katz said they were slightly delayed because it took longer than expected to receive the genetic construct that they ordered from China due to the airways being closed and it having to be rerouted.
As a reminder, for the past four years, researchers at MIGAL scientists have been developing a vaccine against infectious bronchitis virus (IBV), which causes a bronchial disease affecting poultry. The effectiveness of the vaccine has been proven in preclinical trials carried out at the Veterinary Institute.
“Our basic concept was to develop the technology and not specifically a vaccine for this kind or that kind of virus,” said Katz. “The scientific framework for the vaccine is based on a new protein expression vector, which forms and secretes a chimeric soluble protein that delivers the viral antigen into mucosal tissues by self-activated endocytosis, causing the body to form antibodies against the virus.”
Endocytosis is a cellular process in which substances are brought into a cell by surrounding the material with cell membrane, forming a vesicle containing the ingested material.
In preclinical trials, the team demonstrated that the oral vaccination induces high levels of specific anti-IBV antibodies, Katz said.
“Let’s call it pure luck,” he said. “We decided to choose coronavirus as a model for our system just as a proof of concept for our technology.”
But after scientists sequenced the DNA of the novel coronavirus causing the current worldwide outbreak, the MIGAL researchers examined it and found that the poultry coronavirus has high genetic similarity to the human one, and that it uses the same infection mechanism, which increased the likelihood of achieving an effective human vaccine in a very short period of time, Katz said.
To ensure they come close to the deadline they set for themselves, MIGAL is concurrently working with the relevant regulators to ensure the product will be considered safe for human trials. He explained that because it will be an oral vaccine, “the quality of this kind of vaccine should be closer to food regulations than pharma regulations or somewhere in between. We hope that we will not need to go through the complete purification process like in the drug industry, because that could delay us.”
The group also started trials on mice to support their previous trials on chickens.
Katz said phase I human trials would be conducted on “young, healthy individuals” and then would likely expand to the general population. The group, which is funded in part by an NIS 30 million grant from the Science and Technology Ministry, is in touch with the Health Ministry, he said, and noted that “technology wise, people wise we have all we need in Israel.” He believes the vaccine will first be available in the Jewish state
In February, Science and Technology Minister Ofer Akunis said he had instructed his ministry’s director-general to fast-track all approval processes with the goal of bringing the human vaccine to market as quickly as possible. On Wednesday, a representative from his ministry said it would not be directly involved in the regulatory process.
According to Katz, close to 100 research teams around the world are currently focused on developing a vaccine or treatment for the novel virus, including several in Israel.
In fact, on Tuesday, another company, the Israel Institute for Biological Research (IIBR), told Reuters that it had begun testing a COVID-19 vaccine prototype on rodents at its biochemical defense laboratory.
Prime Minister Benjamin Netanyahu ordered the IIBR, in rural Ness Ziona, to join the fight against the coronavirus pandemic on February 1, prompting an easing of its secrecy as it cooperates with civilian scientists and private firms.
In a statement, Netanyahu's office said IIBR director Shmuel Shapira had informed him of "significant progress" in designing a vaccine prototype and that the institute "is now preparing a model for commencing an animal trial."
A source familiar with IIBR activities told Reuters that trials were already under way on rodents. The source declined to identify the kind of rodent.
In rare public comments, IIBR chief innovation officer Eran Zahavy said last week that the institute had shifted its entire focus to the new coronavirus, with three groups trying to develop a vaccine against the COVID-19 disease it causes, and others researching potential treatments.
"We are trying as much as we can to collaborate and have other ideas of other people," he said at last week's English-language online conference hosted by Jerusalem Venture Partners.
"But the facility of the lab is very crowded and very busy and very dangerous, so it has to be very slow and very cautious."
Zahavy described arranging an animal test subject as "a very big challenge" because "this disease is not affecting animals."
Shapiro added that many experiments that are successful in animals are not always successful when tested on human test subjects.
"It's not enough only to detect neutralizing antibodies in the animal. You really want to see them getting sick and getting better by this vaccine," he said.
Wednesday, April 1, 2020
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