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Los Angeles, CA – January 29, 2020 – USA News Group– Several well-known drugmakers are hurrying to come up with a vaccine to deal with the rapidly spreading coronavirus that has infected at least 2,700 people in China and now four individuals in the United States. Officials with the National Institute of Allergy and Infectious Diseases report that there are reasons why the drugmakers may have an advantage to quickly develop a vaccine for this infection.
A broad group of biotech companies are hot on the trail of therapies that could be applied to the treatment of coronavirus. Some have been requested to move on the development at the request of agencies, while others are independently looking at how to apply new strategies. Participants in this space expect increased support for new technologies and a serious push to forward viral treatments and diagnostics including Moderna, Inc. (NASDAQ: MRNA), Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), and Fate Therapeutics, Inc. (NASDAQ: FATE).
A lesser known company making strides is Aethlon Medical, Inc., (NASDAQ:AEMD) a medical technology company that focuses on addressing unmet needs in health and biodefense worldwide. Aethlon Medical Inc. is known for its Aethlon Hemopurifier, a clinical-stage immunotherapeutic device that removes exosomes and life-threatening viruses from the human circulatory system. At the same time, Aethlon is developing TauSome, an exosomal biomarker candidate to diagnose chronic traumatic encephalopathy in living individuals. The Aethlon Hemopurifier® has secured the FDA’s “Breakthrough Device” designation for treating life-threatening viruses, as well as for the treatment of individuals with advanced or metastatic cancer.
Officials Expect to Be in Phase One in Three Months
While public health officials are working furiously to contain the spread of the coronavirus and deliver medical aid to hard-hit regions, scientists, governments and drugmakers are moving rapidly to develop new vaccines and other drugs that can stop the deadly virus.
The NIAID has reported that they believe there could be a vaccine in Phase One trials in as little as three months. The main reason for their confidence is confirmation by Chinese scientists that they have rapidly sequenced the virus’s genome. This is vital to getting a head start on the development of a vaccine.
Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases says that the agency has both the funding and technology to get the job done.
“Barring any bureaucratic or regulatory holdups, which I don’t think will happen, we can almost certainly get into phase one in three months.”, Fauci is quoted as saying.
According to a spokesman, scientists need to secure samples of the coronavirus from China so they can begin testing. They expect that Chinese authorities will very soon allow release of the crucial samples to the appropriate testing authorities. They note that the samples could be used to develop other drugs with different applications.
Once samples are obtained, scientists can test the vaccine in animals, and then move to trials in humans. A typical “phase one” study consists of about 20 patients to evaluate whether the vaccine is safe, often known as “do no harm”. Only then can officials decide whether to expand a larger study to test the vaccine’s effectiveness.
The reality is that even if the vaccine gets into rapid testing, it might not come fast enough to be able to slow the outbreak. Officials say that public health efforts to control the spread of the virus and delivering more immediate treatment for those who are infected should have a more positive effect.
Existing Therapies May Prove Effective
Researchers exploring new ways to attack the coronavirus and other deadly viruses believe there may also be other approaches that already exist. One example is Aethlon Medical Inc. and its Hemopurifier® –one of the most fascinating, patent-protected therapeutic devices available. Aethlon’s Hemopurifier® therapy works through a unique blood purification process. The device is a first-in-class therapeutic technology receiving two FDA Breakthrough designations, through multiple therapeutic targets: viral disease and cancer.
Hemopurifier® therapy has been administered to individuals infected with deadly viruses including Hepatitis C virus (HCV), the Human Immunodeficiency virus (HIV) and most dramatically, Ebola virus. The device was named as one of Time Magazine’s Top 25 Inventions and 11 Remarkable Health Advances in 2014. It is now also recognized by the National Cancer Institute.
Aethlon recently announced the closing of its latest $5 Million Public Offering, which will provide the company a solid position to advance its application of the Hemopurifier® in the treatment of deadly viruses and in treating cancer.
Many Paths to Success but Timing is Critical
The researchers dealing with coronavirus know the similarities shared by the family of viruses, but they say that the parts that are different from virus to virus are the critical parts – the ones that are important for protection.
The current plan calls for development of the vaccine using a technology called messenger RNA platform. This newer method instructs cells to make proteins and allows for more speedy development. For instance, the SARS outbreak of 2002-2003 took about 20 months to prepare a vaccine for clinical trial. That vaccine has not been needed because the virus did not return.
Another possibility is to develop a universal vaccine to attack all types of coronaviruses. This could apply to a broad range of viruses and safeguard when one is transmitted from an animal to a human.
Not surprisingly, many companies and agencies are focused on the development of a universal flu vaccine, since the flu is more common and far more lethal than the coronavirus. The CDC estimates that the flu has infected at least 15 million and caused 8,200 deaths this season. Undoubtedly, leading biotech companies that can use new technologies or approaches and capitalize on the growth in this space stand to make the greatest gains. Spotlight companies at the forefront of this space include:
Moderna, Inc. (NASDAQ: MRNA) is a clinical stage biotechnology company that develops therapeutics and vaccines based on messenger RNA for the treatment of infectious diseases, immuno-oncology, rare diseases, and cardiovascular diseases. The company had 11 programs in clinical trials and a total of 20 development candidates in six modalities in February 2019. Moderna just announced a new collaboration to develop an mRNA vaccine against the novel coronavirus (2019-nCoV). Moderna will manufacture an mRNA vaccine against 2019-nCoV, which will be funded by CEPI.
Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) is a development stage biotech company focused on an immuno-oncology virus (called pelareorep) currently being studied for potential combination with lead treatments Opdivo® from Bristol-Myers Squibb Company, Roche’s Tecentriq, Pfizer’s & Merck KGaA’s Bavencio. Oncolytics Biotech(R) most recently announced it abstract outlining a potential new biomarker to be presented at the 2020 Gastrointestinal Cancers Symposium.
Fate Therapeutics, Inc. (NASDAQ: FATE) is a clinical-stage biopharmaceutical company that develops programmed cellular immunotherapies for cancer and immune disorders worldwide. Its immuno-oncology product candidates include FATE-NK100, FT500, FT516, among others. The Company recently announced that the U.S. Food and Drug Administration (FDA) has allowed its second Investigational New Drug (IND) application for FT516, the Company’s off-the-shelf natural killer (NK) cell product candidate derived from a clonal master induced pluripotent stem cell (iPSC) line engineered to express a novel CD16 Fc receptor.
To learn more about biotech solutions and defense against viral diseases, see the report at USA News Group: https://usanewsgroup.com/2020/01/03/could-this-fda-designated-breakthrough-device-literally-save-the-world-from-a-threat-that-could-wipe-out-millions-of-people-in-hours/
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USA News Group
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