The deadly coronavirus worsened quickly this month, roiling the financial markets as investors fled risk assets amid concerns the outbreak would disrupt the global economy. Meanwhile, a number of biotech companies have ramped up vaccine or drug programs to battle the disease, causing investors to bid up their shares amid the market rout.
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The Race for Coronavirus Vaccine
Antiretrovirals drugs can reduce the viral load of the disease. A recent announcement by the World Health Organization (WHO) indicated that Gilead is the front runner in Coronavirus vaccine development with Remdesivir but experts have raised concerns whether Gilead’s Remdesivir can treat Coronavirus?
Monoclonal antibodies represent another approach and Regeneron has indicated they are weeks away from announcing their target antibodies identified by using their VelocImmune mice used to screen for the viruses antibodies.
However, the most novel way to treat the disease comes from CytoDyn’s researchers, who in a cancer trial have demonstrated how to control the trafficking of suppressor cells that instigate an inflammatory cycle that in some cases is more destructive than the initial viral infection.
CytoDyn’s lead candidate leronlimab, filed for Breakthrough Therapy Designation (BTD) in metastatic breast cancer (MBC) and anticipates an FDA decision by March 10th. The interim results of the trial showed a stoppage of metastasis and the tumor shrinkage was linked to a halt of the CD4 suppressor cells to the tumor.
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Strong evidence from leading virologists suggests that controlling the cytokine storm which is a result of the trafficking immune cells could make a profound difference in the treatment of the disease. If these theories pan out in soon to start clinical trials, a potent COVID-19 treatment could emerge.
Biotechs working on Coronavirus Vaccine
The $35 billion vaccine market is dominated by GlaxoSmithKline, Sanofi Adventis, Merck and Pfizer. These 4 players represent 85% of the vaccine market. These are the primary players but are by no means alone because there is a global rush out there. Here are some companies making news in COVID-19.
Moderna made news news recently when it announced that Moderna’s experimental vaccine was ready for human testing with mRNA COVID-19 vaccine and mRNA-1273 been shipped to U.S. governmental researchers at the National Institute of Allergy and Infectious Diseases. The company anticipates the vaccine’s first clinical trial could start in April. Assuming the April start early-stage trial results could be available in August. The company has approximately 10 indications in phase 1/2 clinical trials.
Inovio Pharmaceuticals Inc
Inovio Pharmaceuticals Inc partnered with Beijing Advaccine Biotechnology Co. to advance the development of INO-4800 which is their version of the vaccine to target COVID-19. Through their partner they hope to quickly advance the vaccine through Chinese clinical trials. They are also developing a vaccine to treat the MERS strain of coronavirus. The company is also developing a phase 3 candidate for cervical HSIL using its compound VGX-3100.
Vaxart Inc has a core competency in oral recombinant protein vaccines but is expanding indications to work on a possible vaccine against Covid-19. Since the vaccine is in the form of a tablet it lends itself to much wider adoption should it be approved. Studies have shown that it is just as effective as the seasonal vaccine Fluzone manufactured by Sanofi Adventis. The market cap is only $80 million so any positive approval news could vault the stock price.
Novavax Inc has a proprietary nanoparticle technology that uses different antigens to give the patient better immune response. This broader response could result in a superior vaccine that a level of adaptability built into the vaccine. The company quickly developed a COVID-19 vaccine candidate and has a track record of success in vaccine development especially for the MERS and SARS strains.
Standard approaches to stopping Viral Infections
In an online interview Dr Mark Denison, a virologist at Vanderbilt University School of Medicine said “there are two basic approaches to stopping viral infections. One is to block an enzyme the virus needs to survive…so protease, polymerase, exonuclease, endonuclease, cap inhibitors, you name it, right? So we want to find things that target every function. A second approach is to give people drugs made from antibodies know to stop a particular virus.”
Many of these approaches were used during the HIV epidemic that resulted in Highly Active Antiretroviral Therapy (HAART). The legacy of HAART resulted in a basketful of drugs to treat the disease. Many may not realize but there are 5 classes of drugs and over 40 drugs or combinations approved for HIV today. Many of the HIV drugs target these viral enzymes and are probably worthy of research and like HIV the therapy may be a combination of therapies designed to the virus on multiple fronts.
Denison concluded the interview by saying “if we understood ways the coronavirus has caused lung disease, we might be able to block that damage while we’re treating the virus.” The recent Washington Post article, How the coronavirus can kill people, echoed Denison’s sentiment and addressed in detail the factors that cause the lung damage. This represents a third possible approach.
The WHO has openly endorsed Gilead for its remdesivir drug. Earlier in the outbreak China’s Health Commission recommended use of HIV drug Kaletra manufactured by AbbVie (ABBV).
NanoViricides has been very actively traded since it announced it was working on a treatment for COVID-19. The company has a platform technology that is designed to bind to the virus and then eventually encapsulates the virus which ultimately leads to its destruction.
Crocrystal is another stock moving which announced a licensing agreement with Kansas State University for COVID-19 using their technology to identify target enzymes needed for viral replication. The company is in their preclinical phase.
During the Ebola outbreak Regeneron was able to demonstrate a superior standard of care with their REGN-EB3 drug. They demonstrated a 90% survival rate on Ebola patients that receive treatment early. They used a technique that utilized its VelociSuite technologies to figure out a combination of 3 monoclonal antibodies. Regeneron’s plan is to use the same technique to develop a coronavirus drug candidate.
As part of the VelociSuite technology the company “humanized” their mice. When these mice are exposed to a disease like COVID-19 their immune system ends up making human antibodies to fight the disease. These antibodies can be captured and tested as therapeutics.
Regeneron’s Christos Kyratsous, Vice president of research for infectious diseases and viral vector technologies said, “They are basically making fully human antibodies. We’ve created a mini-human immune response in a mouse. And the mice are mounting an immune response against these components as we speak. So within the next few weeks, we should be able to start harvesting antibodies out of these mice and testing them in vitro assets (ph).” It appears that Regeneron is still in the race and should be closely watch for developments in the near future.
Vir Biotechnology is moving rapidly in the fight against COVID-19. They recently identified 2 antibodies that bind to the spike protein using the same process that they used to isolate mAb114 during the Ebola outbreak. VIR has a library of 20 human antibodies that neutralize related coronaviruses. They just announced a collaboration with WuXi Biologics to develop the cell-line and work on regulatory approval in China. It’s important to point out that finding a target doesn’t always result a therapeutic that works.
Stopping Lung Damage
The Washington Post article really highlighted a novel approach. To many that have been infected with COVID-19 it is tantamount to a bad cold, but to others it becomes a fight for their life. The key to the severity of the disease is based on the individual’s immune response. In the article Matthew Friedman, a virologist at the University of Maryland School of Medicine said “What you get is the initial damage and rush of inflammatory cells, but the damage is so extensive that the body’s immune response is completely overwhelmed — which causes even more immune response, more immune cells and more damage.” He is referring to the trafficking of suppressor cells to the lungs.
Acute Respiratory Distress Syndrome (ARDS) is a consequence of the damage the virus inflicts on the patients lungs. A ventilator is the primary treatment option that forces the body to absorb some of the fluid in the lungs so that there is a better oxygen transfer. The leader in this field of therapy is CytoSorbents which just recently announced an agreement with China Medical System Holdings Limited to bring CytoSorb to China to treat the critically-ill COVID-19 patients.
The cooperative agreement hopes to achieve regulatory approval under China’s “fast track” program established by the National Medical Products Administration of the People’s Republic of China (NMPA). CtyoSorb is essentially a specialized filter used in conjunction with extracorporeal membrane oxygenation (ECMO). ECMO procedures use a heart lung machine that takes blood out of a vein and then oxygenates and removes CO2 only to return it to the artery. This procedure is a last resort that not only provides oxygen to the oxygen deprived organs in the body, but also filters the virus and inflammatory cytokines from the blood. This procedure worked on the SARS and MERS outbreaks and is destined to work on COVID-19.
CtyoSorb is a great concept however in mass casualty situations that currently exist in Wuhan China, this may not be a realistic treatment for the masses.
Just recently Bioxytran Inc announced it was seeking to partner with a drug company to treat COVID-19 using its lead compound BXT-25. Bioxytran is developing an oxygen transport molecule that is 5000 times smaller than a red blood cell. It’s molecule is based off of Hemopure which is an FDA approved blood substitute for veterinary use. The drug is thought to be safe and is designed to get rid of the Nitric Oxygen scavenging which effected the approval trajectory of Hemopure. The drug is a product of over 30 years and $500 million of drug development.
As an oxygen carrier it can treat literally any disease including ARDS and stroke. In ARDS the theoretical mechanism is that BXT-25 would be part of the blood plasma that leaks out into the lungs getting much closer to the air so that it is able to capture the oxygen and recirculate it. Unless they are able to get a quick approval and funding this preclinical asset may be too late to join the fight regardless of the vastness of their platform technology to deliver oxygen without a hypobaric chamber.
Fusion inhibitors would be the ideal way to treat the disease because it would simply keep the virus outside the target cells. This is exactly what CytoDyn’s drug leronlimab does in HIV. It blocks the CCR5 Co-receptor. After the SARS outbreak there was a lot of research that found viable targets but then became ignored because the virus disappeared. The fact remains that one of those targets is cell surface vimentim. In a 2016 journal article titled Surface vimentin is critical for the cell entry of SARS-CoV the mechanism is elucidated.
Nascent Biotech Inc
The only company with a target for vimentim is Nascent Biotech Inc. Their lead candidate is pritumumab which was a phase 2 brain cancer asset in Japan. They have redone their cell line for study and on the cusp of starting their phase 1 cancer trial.
The Cytokine Storm
In COVID-19 viral loads are ultimately not the killing factor. In reality the human immune system does a great job of controlling the virus but once the adaptive immune system kicks this is the tipping point where intervention could be the key in treating the disease.
CytoDyn’s diagnostic partner Bruce Patterson said in a press release “Leronlimab has both the potential to enhance the cellular immune response by suppressing Treg cells that, in turn, inhibit the anti-viral T-cell responses and the potential to repolarize macrophage activity. Lung (alveolar) macrophages in coronavirus infections have been implicated as a contributing factor to significant morbidity and mortality of the infectious disease. Leronlimab could potentially synergize with other retroviral therapies that are currently being used for the potential treatment of 2019-nCoV.”
The bottom line of the scientific jargon is that leronlimab has the potential to stop the trafficking of cells. This will prevent the immune system from spinning out of control which ultimately results in the downfall of the patient.
Vaccines take time to develop and require extensive testing to ensure their safety and effectiveness. Companies which have tailored therapies to end stage patients have a limited patient population, but have the ability to charge a lot if their efficacy comes through as expected. Understanding the underlying mechanism of action is the key to predicting this outcome. Doctors know that a shot of lidocaine in the hand will also work in the toe because of the underlying mechanism of action of the drug. The science fits and throttling the suppressive response of the immune system seems to be the best theory to fight the disease. There is no magic bullet to treat COVID-19 yet even though some ideal targets have been identified like cell surface vimentim.
Chris Sandburg for Insider Financial
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