Biological Drugs in the Aftermath of the Pandemic

July 18, 2020
Sarfaraz K. Niazi, PhD

Sarfaraz K. Niazi, PhD, is an adjunct professor of biopharmaceutical sciences at the University of Illinois and the University of Houston, and founder of biosimilars companies Karyo Biologics and Adello Biologics. He also founded the biosimilar advisory company PharmSci.

Although devastating in its toll on human life, the coronavirus disease 2019 will likely bring new understanding and technology and leave us better prepared to manage the next health threat of this scope.

The bubonic plague (1347-1351) originated in rats and spread through fleas to wipe out half of Europe’s human population; smallpox has killed 56 million since 1520 and devastated Native American populations; the Spanish flu (1918-1919) killed 40 million to 50 million; and the coronavirus disease 2019 (COVID-19) has, so far, killed over half a million and is still going strong.

In terms of mortality, COVID-19 will compare to Spanish flu if left to spread. The actual numbers will be significantly higher, given that today a virus can travel across the globe within hours. But like every other pandemic, COVID-19 will taper off; we still have people dying of yellow fever, Ebola, and SARS coronavirus. Although COVID-19 will take a heavy toll, it will leave us with a few bright spots as well, mostly relating to the new drugs and treatment modalities that we will see arising shortly.

First, I am confident, after reviewing the current status of vaccine development, that the FDA will approve its first mRNA vaccine. As of today, there is only 1 vaccine approved, Ad5, from the Chinese company CanSino. Based on unique need, this has jumped from phase 2 trials to regulatory acceptance. Such an approval is not likely to happen elsewhere; however, it is almost sure that several of the over 150 vaccines under development will be approved. However, there are 15 vaccines in phase 1, 11 in phase 2, and 4 in phase 3 as of July 16, 2020.

The First mRNA Vaccine

It is highly likely that the FDA will approve the first mRNA vaccine, which will open the door to many new opportunities for treating infectious diseases. This in turn will create opportunities for smaller companies to jump into the business of vaccines that are synthetic and do not require a large investment. We will certainly be able to handle the next pandemic (and I can assure you it will happen) much better by developing a vaccine faster than we have ever been able to do.

Second, the therapeutic management of COVID-19 has introduced repurposing or purported repurposing of a variety of drugs, including the antimalarial hydroxychloroquine; steroid dexamethasone; remdesivir; a chemical drug developed to treat Ebola, without success, and currently not approved for any indication; antibodies, including itolizumab, sarilumab, bevacizumab; and other repurposed drugs, such as lopinavir, ritonavir, nafamostat, camostat, famotidine, umifenovir, ivermectin, nitazoxanide, and fluvoxamine. Only remdesivir, dexamethose, and enoxaparin have shown a definitive role in therapy. There are many anecdotal treatments and nutrition supports suggested as well. It is doubtful that the FDA will approve any of these treatments, over and above the temporary emergency use allowance. Still, the science of repurposing the drugs will create a race that brings approved drugs for new indications.

Third, we will have a renewed awareness of the importance of our immune system and new knowledge about how the body responds to antigens. More particularly, the cytokine rush will trigger discoveries that may not have been in the pipeline. The perennial search for universal multidomain antibodies will be reinvigorated to produce antibodies that may function by having a flexible structure to bind to specific receptors, yet having sufficient structural control to not bind to other receptors. I foresee a giant leap in the science of antibody design and manufacturing, all of which will lead to a larger portfolio of biological drugs and many new biosimilar alternatives.

Fourth, a better understanding of the nature of viruses will develop from our growing knowledge of the unique nature of COVID-9, which is less infective to children, has fewer mutations, penetrates deeply into vital organs besides the lungs, and passes from person to person efficiently.

Fifth, investigation leading to DNA/RNA vaccines will create new technology of synthesizing DNA, and it will not be a surprise if we become able to synthesize human genes that will replicate and can be inserted into animal species to produce human organs—even, new species—while potentially opening a Pandora’s box.

Sixth, we would have learned the hard way the importance of speedy development of new drugs. If this learning leads to changes in the pace of new drug discovery, we will have acquired a high-value advance in our technological and medical capability.

Although we are still struggling with getting out of this pandemic, I am confident, as an optimist, that we will come out with more tools to improve health care, a better understanding of infectious diseases, and perhaps a revolutionary technology that was lurking beneath the spiked protein of an enveloped virus.


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