Palm Beach, FL – May 12, 2020 – The latest strategic attack on the coronavirus resembles a war time scenario. When generals find a weaknesses in the enemy’s lines, it will need plenty of ammunition to win the battle. In this case, even before a vaccine or vaccines are proven effective in controlling or killing the virus, in order to save time, companies are manufacturing at the same time the studies are ongoing… trying to save months if not years to have the “ammunition” to will the battle and end the war. Anthony Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases, said that it would take about a year and a half to complete trials of experimental coronavirus vaccines, scale up production and make a licensed product widely available. A team at the University of Oxford (and others) has set an ambitious aim of producing efficacy results for its vaccine candidate in September and aims to shorten the path to delivering the initial doses of a proven product by beginning manufacturing now. It is a bold move. Mentioned in today’s commentary include: NanoViricides, Inc. (NYSE: NNVC), Moderna, Inc. (NASDAQ: MRNA), Gilead Sciences, Inc. (NASDAQ: GILD), Inovio Pharmaceuticals, Inc. (NASDAQ: INO), Dynavax Technologies Corporation (NASDAQ: DVAX).
A recent article in the Washington Post discussed this novel approach. It said: “Because the coronavirus responsible for the Covid-19 pandemic is new to humans, doctors had no specific medicines to treat it at the start of the crisis. A scramble to fill that void is beginning to pay off, with the first medication backed by early clinical data authorized to fight the virus. Efforts will continue to ensure it works, find better treatments, and develop a vaccine that would prevent coronavirus infection to start with. In normal times, the process of approving new drugs and vaccines is slow and painstaking. It can be accelerated in times of crisis such as these. It continued: “More than 100 different programs have been launched to develop and test treatments. These include everything from antiviral drugs and antibody-containing plasma from recovered patients, to traditional Chinese herbal medicine. A number of studies are looking at whether drugs for rheumatoid arthritis, cancer and autoimmune disorders can halt dangerous inflammation, sometimes called “cytokine storm,” which can be lethal…
NanoViricides, Inc. (NYSE American: NNVC) Breaking News: NanoViricides Develops Highly Effective Broad-Spectrum Drug Candidates Against Coronaviruses – NanoViricides (the “Company”), a leader in the development of highly effective antiviral therapies based on a novel nanomedicines platform, announced today that it has developed drug candidates that have demonstrated very high anti-viral effectiveness in cell culture studies against multiple coronaviruses.
Two of the tested nanoviricides drug candidates were highly effective in cell culture assays against multiple coronaviruses that infect humans. In particular, they were several-fold more effective than favipravir (aka T-705), against the tested viruses. Favirpravir is a broad-spectrum nucleoside-like analog drug that is in clinical testing against SARS-CoV-2, originally developed by Fujifilm.
The Company has tested its drug candidates for anti-viral effectiveness against two distinctly different, unrelated coronaviruses that cause human disease, namely hCoV-NL63, and hCoV-229E. The assays evaluated the reduction caused by the drug candidate in cell death upon viral infection, formally known as cytopathic effects (CPE) assays.
Human coronavirus NL63 (hCoV-NL63) uses the same ACE2 receptor as the SARS-CoV-2 that causes CoVID-19. Both in terms of its clinical pathology, and its receptor usage, it is known to be very similar to SARS-CoV-2, except much milder. Therefore the Company believes hCoV-NL63 is a good surrogate model for therapeutics development against SARS-CoV-2. H-CoV-Nl63 can be studied in a BSL2 lab whereas SARS-CoV-2 currently requires a BSL3 or BSL4 facility.
The Company also found that the same two nanoviricides drug candidates were highly effective against another coronavirus, namely hCoV-229E, that causes seasonal common colds in humans. These nanoviricides drug candidates were several-fold more effective than favipravir in this human common colds coronavirus as well. HCoV-229E uses the APN (Aminopeptidase-N) membrane protein on human cells as its receptor to enter cells, different from hCoV-NL63 and SARS-CoV-2.
The fact that these nanoviricides anti-coronavirus drug candidates are highly effective against two distinctly different coronaviruses that use different cellular receptors is very significant, the Company believes. Specifically, it provides confidence to the Company and rational basis to scientists that even if the SARS-CoV-2 coronavirus mutates, the nanoviricides can be expected to continue to remain effective.
Importantly, nanoviricides are designed to act by a novel mechanism of action, trapping the virus particle like the “Venus-fly-trap” flower does for insects. Antibodies, in contrast, only label the virus for other components of the immune system to take care of. It is well known that the immune system is not functioning properly at least in severe COVID-19 patients. Read the full press release by going to: http://www.nanoviricides.com/companynews.html
In other biotech news in the markets this week:
Inovio Pharmaceuticals, Inc. (NASDAQ: INO) recently announced it has entered into an agreement to expand its manufacturing partnership with the German contract manufacturer Richter-Helm BioLogics GmbH & Co. KG, to support large-scale manufacturing of INOVIO’s investigational DNA vaccine INO-4800, which currently is in Phase 1 clinical testing in the U.S. for COVID-19 and could potentially advance to Phase 2/3 efficacy trials this summer. The agreement is being partly funded by an initial grant of $1.3 million from the Coalition for Epidemic Preparedness Innovations (CEPI), which brings CEPI’s total support to date for the development of INO-4800 to $17.2 million.
“We are grateful to CEPI for its continued generous funding and pleased to expand our work with Richter-Helm BioLogics to support large-scale manufacturing capacity for INO-4800,” said INOVIO’s President & CEO, Dr. J. Joseph Kim. “Richter-Helm has deep experience working with our optimized DNA plasmids, which are the building blocks of our DNA vaccines, and have consistently produced DNA medicines of the highest quality under stringent GMP standards.”
INOVIO has been working with Richter-Helm BioLogics, which manufactures INOVIO’s DNA medicine candidate VGX-3100, since 2014. Currently, VGX-3100 is in Phase 3 clinical trials for the treatment of precancerous cervical dysplasia caused by high-risk human papillomavirus (HPV). INOVIO has established commercial-scale plasmid production at Richter-Helm BioLogics for its DNA medicines platform, with successful technology transfer already demonstrated for VGX-3100 and an Advanced Therapy Medicinal Product (ATMP) certification granted by the European Medicines Agency (EMA) in May 2019.
Moderna, Inc. (NASDAQ: MRNA) a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, and Lonza Ltd. (SIX: LONN) recently announced a 10-year strategic collaboration agreement to enable larger scale manufacture of Moderna’s mRNA vaccine (mRNA-1273) against the novel coronavirus (SARS-CoV-2) and additional Moderna products in the future.
Under the terms of the agreement, the companies plan to establish manufacturing suites at Lonza’s facilities in the United States and Switzerland for the manufacture of mRNA-1273 at both sites. Technology transfer is expected to begin in June 2020, and the companies intend to manufacture the first batches of mRNA-1273 at Lonza U.S. in July 2020. Over time, the parties intend to establish additional production suites across Lonza’s worldwide facilities, ultimately allowing for the manufacture of material equivalent to up to 1 billion doses of mRNA-1273 per year for use worldwide assuming the currently expected dose of 50 µg. The manufacturing facilities at Lonza complement Moderna’s ongoing U.S. manufacturing efforts, which continue to ramp up to prepare for the further clinical development and commercialization of mRNA-1273.
Gilead Sciences, Inc. (NASDAQ: GILD) recently announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has granted regulatory approval of Veklury®(remdesivir) as a treatment for SARS-CoV-2 infection, the virus that causes COVID-19, under an exceptional approval pathway. The exceptional approval was granted due to the COVID-19 pandemic and references the Emergency Use Authorization of remdesivir in the United States.
The approval is based on clinical data from the U.S. National Institute of Allergy and Infectious Diseases’ global Phase 3 trial, Gilead’s Phase 3 SIMPLE trial in patients with severe manifestations of COVID-19, and available data from Gilead’s compassionate use program, including patients in Japan.
“The Japanese approval of remdesivir is in recognition of the urgent need to treat critically ill patients in Japan. It is a reflection of the exceptional circumstances of this pandemic,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “We thank the Japanese Ministry of Health, Labour and Welfare for their leadership and collaboration, as we together work to respond to this public health emergency.”
Novavax, Inc. (NASDAQ: NVAX) a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, 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.
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