Several Potential Coronavirus Vaccines and Treatments Progressing Towards Human Trials

PALM BEACH, Florida, April 13, 2020 /PRNewswire/ -- The search for a vaccine for the global health crisis is being conducted by companies and countries around the world. Some are taking a cue from older antivirals. Some are tapping tried-and-true technologies, and others are pressing forward with futuristic approaches to human medicine. A recent article in the NY Times pointed out that just three months after the start of the coronavirus pandemic, several biotech companies are beginning trials of promising vaccines and treatments. As the coronavirus pandemic spreads at unprecedented rates, invading the lungs of people of all ages, ethnicities and medical histories, companies are ratcheting up their efforts to fight the disease with accelerated schedules for creating new vaccines, and beginning clinical trials for potential treatments. In normal circumstances, development of new vaccines and treatments would take years. But the pharmaceutical industry is racing to compress this timeline with the support of nonprofit organizations, government agencies and regulatory authorities.  The article  said that: ""We're all trying to do something which we have almost no precedents for, which is accelerating a vaccine in the middle of a pandemic," said Dr. Peter Hotez, who is a co-director of the Texas Children's Hospital Center for Vaccine Development at Baylor College of Medicine.   Active biotech and pharma companies in the markets this week include CNS Pharmaceuticals, Inc. (NASDAQ: CNSP), Pluristem Therapeutics Inc. (NASDAQ: PSTI), MediciNova, Inc. (NASDAQ: MNOV), Novavax, Inc. (NASDAQ: NVAX), Co-Diagnostics, Inc. (NASDAQ: CODX).

There is no approved treatment for Covid-19, the illness caused by the coronavirus, and researchers and doctors are testing a host of therapies in a desperate bid to save the lives of people who have few other options. President Trump has aggressively promoted two old malaria drugs, which have shown only limited evidence of working as treatments for the coronavirus. He has pushed for the drugs' broader use in patients without the more rigorous clinical trials typically used to evaluate treatments… Still, a vaccine would be the best way to stop further spread of the coronavirus because it enhances the immune system's natural defenses. Of course, many companies are also struggling with ways to partner with manufacturing ventures to produce enough vaccine so that it will be widely available.  "If you could only have a vaccine, just imagine you could walk out your door confident that you were not going to get sick," said Dr. Gregory Glenn, the president for research and development at Novavax. "Because of that, everyone is very motivated and working to move things quickly."

CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) BREAKING NEWS:  CNS Pharmaceuticals Announces Independent University Research Confirms Active Compound in WP1122 Completely Prevents Coronavirus Replication In Vitro; WP1122 is Subject to Development Agreement with WPD Pharmaceuticals  - CNS Pharmaceuticals, a biotechnology company specializing in the development of novel treatments for brain tumors, announced that independent research by the University of Frankfurt found 2-deoxy-D-glucose ("2-DG") to reduce replication of SARS-CoV-2, the virus that causes COVID-19, by 100% in in vitro testing.

Researchers at the University of Frankfurt disclosed the findings in their article submitted to NatureResearch on March 11, 2020 (Bojkova, D et al; DOI: 10.21203/rs.3.rs-17218/v1) (https://www.researchsquare.com/article/rs-17218/v1). The authors reported that inhibiting glycolysis with non-toxic concentrations of 2-DG completely prevented SARS-CoV–2 replication in Caco–2 cells.  Glycolysis is a process by which cells convert glucose into energy and infected (host) cells are induced by viruses to dramatically increase their dependence on glycolysis. 2-DG inhibits glycolysis because, although it appears to cells to be glucose, it is in fact a decoy that cannot be converted into energy.

As previously announced, CNS entered into an agreement with WPD Pharmaceuticals Inc. (CSE: WBIO), for the development of several preclinical drug candidates including WP1122. WP1122, which is being tested on a range of viruses including the coronavirus SARS-CoV-2, is a prodrug of the glucose decoy called 2-deoxy-D-glucose, or 2-DG. While the free form of 2-DG is rapidly metabolized and ineffective within minutes of entering the body, WP1122 has a much longer half-life, potentially enabling it to deliver quantities adequate for a therapeutic effect. WPD Pharmaceuticals previously licensed rights to a portfolio of drug candidates, including WP1122, from Moleculin Biotech, Inc. for certain territories.

"We are extremely encouraged by this breakthrough discovery of WP1122's potential efficacy in fighting COVID-19," commented John M. Climaco, CEO of CNS Pharmaceuticals. "We believe these findings represent a significant catalyst and incentive to expedite the development of WP1122. We look forward to working closely with WPD Pharmaceuticals to continue the advancement of the WP1122 program toward a potential life-saving treatment for this deadly disease, the death toll from which is nearly 100,000 lives worldwide this year and climbing every hour."     Read this full release and more news for CNSP at:  https://www.financialnewsmedia.com/news-cnsp/ 

Other recent developments in the biotech industry include:

Pluristem Therapeutics Inc. (NASDAQ: PSTI) a leading regenerative medicine company developing a platform of novel biological therapeutic products, recently announced preliminary data from its compassionate use program, treating seven patients suffering from acute respiratory failure and inflammatory complications associated with COVID-19 with Pluristem's PLX cells, in three medical centers in Israel. All seven patients approved for treatment under compassionate use program with PLX cells exhibited, prior to treatment, respiratory failure due to ARDS, which is a major cause of mortality and required mechanical ventilation in an ICU. Four of the patients also demonstrated failure of other organ systems, including cardiovascular and kidney failure, indicating critical disease and poor prognosis.  

MediciNova, Inc. (NASDAQ: MNOV) recently announced that it will initiate a clinical trial of MN-166 (ibudilast) for acute respiratory distress syndrome (ARDS) caused by COVID-19 (Coronavirus Disease 2019).  The study will be conducted by Yale's Advanced Therapies Group, which is co-directed by Richard Bucala, M.D., Ph.D., Chief, Rheumatology, Allergy & Immunology at Yale School of Medicine and Rheumatologist-in-Chief at Yale New Haven Health.  Dr. Bucala, is credited with the cloning of MIF (macrophage migration inhibitory factor) and its receptor and led prior efforts targeting MIF in autoimmunity and in cancer.

Novavax, Inc. (NASDAQ: NVAX)  recently announced it has identified a coronavirus vaccine candidate, NVX-CoV2373, a stable, prefusion protein made using Novavax' proprietary nanoparticle technology, and will initiate a first-in-human trial in mid-May. Novavax' proprietary Matrix-M™ adjuvant will be incorporated with NVX-CoV2373 in order to enhance immune responses and stimulate high levels of neutralizing antibodies.

NVX-CoV2373 was shown to be highly immunogenic in animal models measuring spike protein-specific antibodies, antibodies that block the binding of the spike protein to the receptor and wild-type virus neutralizing antibodies. High levels of spike protein-specific antibodies with ACE-2 human receptor binding domain blocking activity and SARS-CoV-2 wild-type virus neutralizing antibodies were observed after a single immunization. In addition, the already high microneutralization titers seen after one dose increased eight fold with a second dose. High titer microneutralizing antibodies are generally accepted evidence that a vaccine is likely to be protective in humans.

Co-Diagnostics, Inc. (NASDAQ: CODX) recently announced  that its Logix Smart™ Coronavirus COVID-19 Test has obtained Emergency Use Authorization (EUA) by the Food and Drug Administration (FDA) to be used for the diagnosis of SARS-CoV-2. The Company's test can be used by clinical laboratories certified under Clinical Laboratory Improvement Amendments (CLIA) to detect the presence of the virus that causes COVID-19, and is available for purchase from the Company's Utah-based ISO-13485:2016 certified facility.

Co-Diagnostics began offering its COVID-19 test to some U.S. CLIA labs in March 2020as a result of the FDA's policy for diagnostic tests for COVID-19 during the current public health emergency. Previously, the Company had initiated sales of its CE-IVD test to the European Community, and to other global markets that accept a CE marking as valid regulatory approval following routine local product registration.

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