The decision to approve human trials for a COVID-19 vaccine in Cayman puts the islands in the midst of one of the greatest medical arms races of all time. It has also raised questions and concerns in the community.
The Cayman Compass spoke with Dr. Thomas Wagner, the lead scientist and founder of Orbis Medical Solutions and its Cayman subsidiary Perseus Cayman Limited, and president Riley Polk, about their work in Cayman and to try to answer some of the key questions about the vaccine.
Who is Perseus Cayman Ltd?
Perseus Cayman Ltd was set up by Dr. Thomas Wagner in Cayman, in partnership with Dr. Sook Yin, as a cancer clinic in 2012.
It pioneered a new therapy to treat patients with malignant tumours with a customised vaccine that would trigger their immune system.
What do they know about COVID-19?
Wagner, whose wife is from the Chinese city of Wuhan where the outbreak began, said he was quickly aware of the virus and by November 2019 was already turning his attention to how the technology his company has developed to fight cancer could be adapted to deal with the threat posed by the pandemic.
“We are experts in stimulating and modulating the human immune system,” Polk added. “We were able to transition a lot of the research we had already done towards this COVID vaccine.”
How does it work?
In the simplest possible terms, Perseus’s methodology involves displaying the ‘foreign body’ or antigen to the immune system so that it can recognise and fight that invader.
In the case of the cancer therapy, the DNA of the patients’ own tumours is directly injected into ‘antigen displaying cells’ under the skin. These cells ingest the foreign body, analyse it and train the body’s immune system to recognise and repel it.
The technique has been used in cancer therapy in Cayman for the last eight years.
How does that help with COVID-19?
The same technique has been adapted for the pandemic. Using the DNA sequence of COVID-19, the scientists have created a synthetic replica of part of the virus’s genetic code. This is what is ‘displayed’ to the immune system to teach it to fight the virus.
The method does not replicate the entire virus but instead focusses on the ‘spike proteins’ – the ‘Velcro’ that allows it to attach to human cells.
Does it work?
That is what they are trying to find out. Pre-clinical trials in mice had a 100% success rate in triggering an antibody response, according to data that was shared with the Health Practice Commission in Cayman.
The next step involves testing to see if the same antibody response is seen in humans.
How will the human trials work?
Perseus is looking for 20 volunteers to take part in the trial. They will first be tested to confirm they have not previously had COVID-19. Once that is established, they will receive an ‘intradermal injection’ under the skin.
This will inject the DNA that encodes those spike proteins directly into the body’s ‘antigen presenting cells’ and, in theory, should create a response that allows the immune system to recognise and repel those viral proteins.
Half of the volunteers will receive a second inoculation one week later to help determine if one or two injections are required.
How will they know if it works without exposing the volunteers to COVID-19?
The first phase of the trial is based on blood work. Volunteers will have blood draws after one, two, four and eight weeks to test for the presence of antibodies which target the spike proteins. If the antibodies are present, that would suggest the vaccine has been successful in creating the required immune response.
A larger phase three trial, if it reaches that stage, would need to involve communities where there is exposure to the virus and would test if fewer people who received the vaccine become sick compared to those who received a placebo.
What happens next?
If the trial is successful with the first 20 volunteers, Perseus will seek permission from the Health Practice Commission to expand it in a second phase to up to 1,000 volunteers, Polk told the Compass.
Further phases would involve patients in the US as well as in Cayman, if there was interest.
Why do this in Cayman and not the US?
Wagner and Polk say their methodology for the immunotherapy treatment of certain cancers – which has been adapted to create their COVID-19 vaccine – was established in Cayman. They have a treatment clinic and FDA-approved phase one testing centre in Cayman, and their process throughout that research has been to conduct phase one trials in Cayman.
Wagner said this had worked well in the past and the results of their work in Cayman were accepted by the US Food and Drug Administration.
“This is our process for the last eight years,” he said. “We are familiar with it and it is a highly effective way to do it.”
Polk added that the decision to seek approval for the trial in Cayman was taken along with the company’s partners on the island.
Are they trying to skirt the stricter regulatory controls of the FDA?
Polk insists this is not the case. He said the company was required to file exactly the same paperwork as it would have in the US.
“Your regulatory body is approved by the FDA so there is no shortcut there,” he said.
He praised the HPC as efficient and thorough in processing the application. The globalisation of clinical trials, particularly in the early phases, has been an industry trend over the past decade.
According to a 2017 analysis by Scientific American, 90% of new drugs approved that year were tested, at least in part, outside the US and Canada.
Polk said the goal was not to avoid FDA standards, because the data will ultimately be submitted to the administration as the research advances.
“The goal is to provide a new therapy with the best chances for success, and in the case of COVID, timing is critical,” he said. “Conducting smaller proof-of-concept studies outside of the US reduces regulatory timelines and allows for a more efficient and expeditious research and development process.”
Why would anyone volunteer for a trial like this?
The development of any vaccine requires human trials, so the short answer is that someone, somewhere, has to do it. Thousands of people all over the world are currently involved in clinical trials for various vaccines.
“Every day there are people willing to take part in COVID-19 vaccine tests because it is for the greater good,” said Polk. “It is a personal decision for everyone if they are prepared to take it. Even once a vaccine is approved, it will be a personal decision.”
Wagner believes the Cayman trial is particularly low risk because it involves technology that is already in use.
“Our vaccine delivers only the DNA that encodes the spike protein of the virus,” he said. “That is injected directly into the antigen-presenting cells in order to generate an immune response. It is not free flowing in the body and, even if it was, it wouldn’t be dangerous.”
The intricacies of the technology are complicated and Polk does not expect everyone to understand it and acknowledges that many will be fearful.
“We might not convince the man on the street but I believe there are 20 people down there that can read about it and understand the technology we are involved in and think that this is a big problem and we can help mankind,” he said.
Is there any payment involved for volunteers?
There is no financial compensation for participants in the trial.
How is the trial funded?
The trial is funded by Orbis Health Solutions, the parent company of Perseus Cayman. It is a privately held biotech company, founded by Wagner, which has raised millions of dollars in private equity to develop its vaccine technology. This trial as well as the cancer vaccine trials are covered as research and development expenses.
A company spokesperson said trial costs can vary based on type, size, complexity of the research and the need accommodate any changes in protocol or developments as the trial advances.
What’s in it for Cayman?
Being involved in the development of a vaccine for COVID-19 would be huge for a place the size of Cayman, said Yin, the principal investigator in the trial.
“This puts the Cayman Islands on the global stage and provides its residents with an opportunity to take part in a trial that may offer a life-saving solution to this unprecedented global public health crisis,” she said in a statement to the Compass.
If a vaccine is ultimately developed, Cayman will get priority access. It is also possible, says Polk, that a large percentage of Cayman could be inoculated in the trial phase.
If the initial trials are successful, the company will look for a larger number of volunteers for a second trial. Theoretically, the whole island could receive the vaccine during trials.
How soon do they think they can create a fully approved vaccine?
Perseus Cayman does not expect to win the global race to find a vaccine. The US has pumped around US$9 billion into sponsoring companies that can research and produce a COVID-19 vaccine on a large scale. Other major economies have also invested heavily, and six vaccines are already approved for limited use.
“It is a race,” says Polk. “The whole world wants an answer to this pandemic and everyone believes a vaccine is the answer. Our aim is not to be first to market – we believe we can make a better COVID vaccine.”
What makes it better?
Perseus believes it has created a process that can be adapted for almost any disease. It is essentially a DNA-based vaccine.
If it proves successful for COVID-19, says Wagner, there is no reason it wouldn’t be similarly effective in a future pandemic.
Once the process itself is tested and accepted, he said, it could be adapted to fight any virus.
The DNA sequence of COVID-19 was known within weeks of the outbreak. The same would likely be true in a future pandemic. What Perseus is developing, says Wagner, is a delivery system that ‘shows’ the DNA structure of a foreign body to the immune system and stimulates the natural defence system to attack it.
Anyone interested in volunteering to take part can contact Dr. Sook Yin by email at [email protected].