The quest for coronavirus treatments

Yaky Yanay, CEO and president of Pluristem Therapeutics. (Pluristem Therapeutics)

Medical history has involved more than a few quests for a sort of scientific holy grail. The eradication of smallpox was a major milestone, as was the advent of penicillin and the polio vaccine. Until recently, developing a cure for cancer would likely have been viewed as the ultimate accomplishment for a medical researcher, but then the coronavirus set up shop.

Now, with most of the planet stuck in neutral, the medical field is rushing to find something better equipped to protect us than face masks and hand sanitizer, and allow the world to start spinning again.

On May 5, the Maryland/Israel Development Center organized an online conference on the work being done in the medical research community to combat COVID-19, featuring representatives from three different Israeli medical companies. The speakers included Yaky Yanay, CEO and president of Pluristem Therapeutics; Vered Caplan, CEO of Orgenesis Inc., and Dr. Mark L. Levitt, the medical director of RedHill Biopharma Ltd. Over the course of the hour-long conference, the speakers outlined the different technologies and strategies their respective companies have been developing.

The American medical community is also hard at work on finding new treatments for it, according to Matthew Frieman, an associate professor at the University of Maryland School of Medicine, Department of Microbiology and Immunology. His team has been testing the effectiveness of different drugs on the virus.

Pluristem and placenta cells

One of the treatments highlighted at the conference comes from placenta cells, which Pluristem is exploring.

Drugs manufactured with these placenta cells and injected into patients hold tremendous therapeutic potential, Yanay said. “So think of our drug as a tiny manufacturing, as a tiny factory that, based on the signals received from the patient’s body, responds by secreting therapeutic proteins,” he said.

Yanay explained that placenta cells are well suited to this purpose because the human body does not view them as a hostile foreign entity. “The new system do not see the placenta cells as an intruder, as an enemy,” he said. “So, it doesn’t trigger any immune response against our cells. So once we inject them to their patients, these are young, fresh, potent cells in high quantities and high quality, and the immune system will let the cells to stay for a few weeks in the patient’s body. They can stop and interact, secrete, push the body towards regeneration.”

Pluristem’s new drug, PLX-PAD, which is created from placenta cells, shows promise as a potential treatment for the complications of COVID-19, Yanay said. PLX-PAD can secrete therapeutic proteins and reduce inflammation, he said.

Recently, Pluristem, which has a hub of their logistics supply chain in Rockville, received FDA approval to conduct a double-blind, placebo controlled study on the effectiveness of PLX-PAD, Yanay said. The European Investment Bank had expressed confidence in the new treatment to the tune of 50 million euros, to expedite the development of Pluristem’s COVID-19-related medication. Pluristem is looking to begin its studies in the U.S. and Europe in a matter of weeks, Yanay said. They are currently focused on enrollment, and are hoping to have the studies concluded, and the accumulated data released, before the end of 2020.

However, Pluristem believes that many people simply cannot wait that long. “So we are taking the dual approach here,” Yanay said. “COVID is here and now, and people are dying here and now.”

Under the FDA’s Expanded Access program, a limited number of patients in the New York and New Jersey area are currently being treated with PLX-PAD, Yanay said.

“I don’t think that the patients, the hospitals, nor the health care system has the luxury and the time to wait the for the completion of the development,” Yanay said. “I really hope so that we’re going to find a funding partner on either the government or state level. That will enable us to bring this product to Americans to be treated now.”

Orgenesis and gene therapy

Also at the conference, Caplan presented the work her company, Orgenesis, has been doing on the ongoing pandemic. Describing her company as a provider of gene therapies, she said that Orgenesis has three programs in the works related to COVID-19.

The first of these Caplan described as a bio-defense program involving special mice able to generate human blood cells, initially intended to protect a nation’s military from an engineered virus. “It’s a very interesting model where you have a humanized mouse,” Caplan said, which “makes human blood cells, white blood cells, red blood cells, and also hormones quickly, any kind of antibody kind of based cells.”

The basic strategy, according to Caplan, is to take blood cells that have been affected by a viral infection and pass them on to the special mice. This quickly leads to the manufacturing of these types of cells, which can then be harvested for the production of antibodies. Caplan considered this strategy to be a “quick first line of defense” that could be deployed in a matter of months.

Orgenesis’ second program involves a type of enzyme derived from frogs called ranpirnase, which functions as a broad spectrum antiviral, according to Caplan.

“First of all, because it breaks down RNA very quickly, it actually works on the virus directly, just breaks up the RNA of the virus,” Caplan said. Afterward, the enzyme is able to induce apoptosis, or cell death, in the cells affected by a virus, comprising a process that, as Caplan viewed it, could constitute an efficient defense against the coronavirus.

The third program, referred to as “whole cell vaccination,” allows for the rapid development of an immune reaction upon a viral infection like the coronavirus, Caplan said. These cells are designed to “actually take in the virus, and then they actually act as a triggering mechanism for the immune system.” Testing on animals is currently underway, she said, to see how effective whole cell vaccination can be on the novel coronavirus.

RedHill Biopharma and oncology medicine

Last to speak at the conference was Levitt of RedHill Biopharma Ltd., on the subject of his company’s drug opaganib. While originally intended as an oncology medication, opaganib has demonstrated both anti-inflammatory and antiviral effects, Levitt said. Recently, six COVID-19 patients were treated with opaganib at a leading Israeli hospital, he said. For some patients who were suffering from moderate to severe acute respiratory symptoms, “the doctors were considering intubating within the next day or two, and decided to give opaganib a chance first,” Levitt said.

All six patients showed significant improvement after taking opaganib, Levitt said. “All of the patients showed objective, significant, measurable, clinical improvement within days of treatment initiation. These included decreased primary and supplemental oxygen, a rise in lymphocyte counts … and significantly decreased CRP levels.” Higher CRP levels correlate with inflammation, Levitt explained, as well as with pneumonia, which is induced by COVID-19.

“All six patients have been weaned from oxygen, and all six have been discharged from the hospital,” Levitt said.

RedHill has submitted an Investigational New Drug (IND) application to the FDA, Levitt said. If approved, it will clear their way to begin a study of opaganib’s effects on American COVID-19 patients who have also been diagnosed with pneumonia and hypoxia.

University of Maryland and testing drugs

With the outbreak in full sway, Frieman and his team have been hard at work testing the effectiveness of FDA-approved drugs on warding off COVID-19, he said.

“Basically my lab is a coronavirus lab,” Frieman said. “I’ve been here for 10 years, and we’ve worked on SARS coronavirus 1, Sars-CoV-1, and MERS coronavirus since I got here. And now we’re using all of the same principles that we knew and learned about those coronaviruses for this new virus, Sars-CoV-2.”

In an important first step, his team has “identified several drugs that work, that inhibit this virus in cells in a lab,“ he said.

Frieman stressed, however, that a medication that protects cells in a laboratory will not necessarily be effective in animal or human test subjects.

He said that the drug Remdesivir has shown promise. “Remdesivir is one of the first ones being pushed into clinical trials really around the world, especially the U.S.,” he said.

“That’s the one that Gilead [Sciences] made. And it’s been shown to be effective against multiple coronaviruses in animals, and now it’s being tested in controlled clinical trials, by humans at many sites in the country.“

Trials are also soon expected for a possible COVID-19 vaccine, Frieman said.

“Vaccines, which we’re working on with a company called Novavax, which is in Gaithersburg, they’re going to be starting a trial soon,” Frieman said. He stated he has worked with Novavax in the past on the vaccine for the MERS coronavirus, which emerged in 2012, and that they are utilizing the same technology to develop a vaccine for COVID-19.

“That data looks very promising in the lab so far, very antigenic, so making good antibodies,” Frieman said. “And then that will be there in production right now to scale up the number of doses so they can do a clinical trial in humans.”

Jesse Berman is a reporter for the Baltimore Jewish Times, an affiliated publication of Washington Jewish Week.

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