Thermogenesis Holdings Inc (THMO)

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THMO - Rancho Cordova scientists hope to market coronavirus treatment to hospitals in 2 months
April 22, 2020 05:00 AM, Updated April 22, 2020 10:20 AM

https://www.sacbee.com/news/coronavirus/article242173766.html#storylink=cpy

Scientists in the Sacramento area believe they have developed a way to keep the new coronavirus from finding the doorknob that it typically turns to enter human lung cells.

Chris Xu, the CEO of Rancho Cordova-based ThermoGenesis, said the biopharmaceutical treatment could go to market within two months.

“We are so advanced at this because we leveraged our unique global resources,” Xu said. “When this epidemic started to surface in Asia, we have several top universities in China where we collaborate and developed the science behind this and did the screening. So now we are probably at least four to six months ahead of any other comparable research institution here (in the US).”

In addition, the company is now marketing a diagnostic kit that will allow health care professionals to tell patients whether they’ve already had COVID-19, the illness caused by the coronavirus, and have developed antibodies that can help fight the disease, Xu said. The company also is requesting federal approval to market this kit directly to consumers.

Even as the company developed this antibody assay, Xu said, Thermogenesis was using test results to identify people who recently recovered from COVID-19 to identify those who had the strongest antibody response.

The coronavirus gets into the human body by attaching itself to an enzyme that helps to regulate blood pressure. Nicknamed ACE2 by researchers, the angiotensin-converting enzyme-2 has regions where the new coronavirus can easily latch onto its surface.

Once the new coronavirus, formally known as SARS-CoV-2, gets inside cells, it starts replicating itself and hijacking control of the body’s system. While this takeover won’t be virulent for most people, it can result in severe symptoms of fever, coughing and shortness of breath for some.

The viral invasion can compromise the body’s ability to stave off fever and process oxygen to the point that as many as 20 percent of those infected require hospitalization.

In the last few weeks, Xu said, MD Anderson Cancer Center, the Mayo Clinic and other major institutions have launched programs using convalescent plasma, blood plasma from people who have recovered from the disease, to treat other COVID-19 patients.

HOW IT WORKS

The biological therapy developed at ThermoGenesis and its affiliate, ImmuneCyte, takes the science behind convalescent plasma to a new level.

When people survive a virus, their blood plasma often develops antibodies that can neutralize the marauding virus, Xu said, but scientists have long known that some people have a much stronger antibody response than others. Xu and his team began using their kit to screen for those individuals months ago, long before COVID-19 began to infect a low number of U.S. citizens.

Then ThermoGenesis and ImmuneCyte scientists got whole blood plasma from recently recovered individuals and began identifying and isolating white blood cells, known as B cells. These tiny lymphocytes produce neutralizing antibodies that can recognize unique molecules on the invading virus where they can bind and mount a sabotage.

Working inside a highly secure lab, the scientists then isolated copies of the cells.

“They make a huge (DNA expression) library,” said Xu, an immunologist who trained at Washington University School of Medicine in St. Louis. “They’re looking for which B cells or which DNA from B cells can recognize the virus. So we screened millions of those candidates in the library.”

Slowly and painstakingly, they picked over 1,700 clones before finding 456 that seemed particularly effective at recognizing SARS-CoV-2. Then, they sequenced each of them, identifying 50 unique DNA sequences. All had a variable region encoded that seemed to bind to a surface protein known as Spike-1 on the coronavirus. They then made 50 unique full-length human antibodies, each of which could be a single product.

“We’re looking at whether there’s an antibody that can block the virus from not only recognizing the cell, but also from entering the cell,” Xu said. “So out of that 50 we sequenced, 16 neutralizing antibodies were identified.”

ThermoGenesis and ImmuneCyte researchers and their collaborators produced four antibodies – all clones of a unique parent cell – that showed the highest affinity to bind with the new coronavirus and block its entry into human cells, Xu said. The two companies hope to get the first monoclonal antibody treatment into the market.

Separately, ThermoGenesis joins Davis-based Gold Standard Diagnostics and other companies in releasing diagnostic tests that can determine whether people have developed antibodies after having a bout of COVID-19, but Xu said the ThermoGenesis test stands out from those offered by Gold Standard and others because it does not require sophisticated laboratory instruments to evaluate test results.

“Our assay is more like a home pregnancy test,” Xu said. “I did it on myself and it took only two minutes. It’s very fast and it doesn’t require any sophisticated instrument. ... Our intention is to one day have this used by every household.”

While other tests can cost $500, Xu said, his company will sell its diagnostic kit for less than $30. Ideally, individuals will be tested twice a year in order to determine whether they still have antibodies to the disease, Xu said.

“If we want to re-open the country, we want to know who we can bring back first ... so the ideal scenario is to bring back people who have developed protective immunity,” Xu said. “And if you have antibodies, the likelihood is that you’re protected.”