Palm Beach, FL – May 4, 2020 – Public and Private companies and governments around the globe are forming alliances to rapidly find treatments and vaccines to overcome this world health crisis. Every day there are new updated reports and articles describing new efforts and collaborations to find the solutions. They show that scientists around the world are working on potential treatments and vaccines for the new coronavirus disease. Several companies are working on antiviral drugs, some of which are already in use against other illnesses, to treat people who already have COVID-19. Other companies are working on vaccines that could be used as a preventive measure against the disease. With confirmed COVID-19 cases continuing to grow, scientists are pushing forward with efforts to develop vaccines and treatments to slow the pandemic and lessen the disease’s damage. Some of the earliest treatments will likely be drugs that are already approved for other conditions, or have been tested on other viruses. Mentioned in today’s commentary include: NanoViricides, Inc. (NYSE: NNVC), Moderna, Inc. (NASDAQ: MRNA), Inovio Pharmaceuticals, Inc. (NASDAQ: INO), Dynavax Technologies Corporation (NASDAQ: DVAX), Vaxart, Inc. (NASDAQ: VXRT).
A report from Healthline said: ““People are looking into whether existing antivirals might work or whether new drugs could be developed to try to tackle the virus,” Dr. Bruce Y. Lee, a professor at the CUNY Graduate School of Public Health & Health Policy, said in March. FDA officials have stated it could still be a year before any drugs are available to the general public for COVID-19 treatment, because the agency needs to make sure the medications are safe for this particular use and what the proper dosage should be.” It continued: “Several companies are developing or testing antivirals against SARS-CoV-2, the virus that causes COVID-19. Antivirals target the virus in people who already have an infection. They work in different ways, sometimes preventing the virus from replicating, other times blocking it from infecting cells. Lee says antivirals work better if you administer them sooner, “before the virus has a chance to multiply significantly. Dr. Robert Amler, dean of the School of Health Sciences and Practice at New York Medical College and a former chief medical officer at the Centers for Disease Control and Prevention (CDC) Agency for Toxic Substances and Disease Registry (ATSDR), says both antivirals and vaccines will be valuable tools in combating COVID-19. However, he (said) that “antivirals are likely to be developed and approved before a vaccine, which typically takes longer… and are centered around existing drugs.”
NanoViricides, Inc. (NYSE American: NNVC) Breaking News: NanoViricides Signs a Confidential Disclosure Agreement with an International Pharmaceutical Company to Explore Collaborating on its COVID-19 Program – NanoViricides, a leader in the development of highly effective antiviral therapies based on a novel nanomedicines platform, announced that it has signed a Confidential Disclosure Agreement (CDA) with a leading pharmaceutical company in the Asian region to explore collaborating on the Company’s COVID-19 Program.
The Company previously disclosed that it has already found certain drug candidates that are active against multiple coronaviruses in cell culture studies. The Company intends to perform testing against SARS-CoV-2 (the virus that causes COVID-19 disease) and is in advanced discussions with at least two sites that have such capability. This testing is expected to enable the Company to declare a clinical drug candidate for COVID-19 based on viral load reduction.
The potential pharma collaborator with whom the CDA was executed has experience in drug development of novel technology platform-based drug candidates. It has both marketing and R&D presence in multiple countries in the Asian region. It has several collaborative drug development programs, both in-licensed from smaller biopharma companies and out-licensed to global Big Pharma companies, in a range of disease indications.
The Company is developing what currently may be one of the very few novel antiviral drug candidates specifically targeting the coronavirus SARS-CoV-2, with broad-spectrum activity against other coronaviruses. We believe the broad-spectrum activity of our drug candidates substantiates that the drugs may continue to work even as the virus mutates in the field. Such viral mutations are already demonstrated with SARS-CoV-2 and it is widely thought that vaccines and antibodies could be rendered ineffective in the next iteration of the virus’s outbreak due to such mutations.
The Company’s approach goes beyond antibodies. An antibody binds the virus at only two points of attack, and tens of antibodies would be needed to disable a single virus. In contrast, our nanoviricides bind with copious numbers of binding points, all designed to occlude the receptor-binding-domain of the S-protein of the coronavirus, thus disabling the virus’s ability to infect human cells. In addition, the attack of a nanoviricide micelle on the virus particle is expected to result in encapsulation of the virus particle, with potential uprooting of the S-protein tail from the virus lipid membrane, thereby neutralizing the virus particle. The Company has previously demonstrated that such effects, driven by the well-known biophysical mechanism of lipid-lipid-fusion, can occur with at least some viruses.
Thus, in the current pandemic scenario, the Company’s drug development is a highly promising approach. At the same time, as a novel drug candidate, it is necessary to come up with an accelerated path into humans without compromising safety. Our platform has been shown to be safe as injectable in preliminary, non-GLP animal studies directed at other diseases. We intend to perform similar animal studies for the clinical SARS-CoV-2 nanoviricide drug candidate, towards developing information for entering into first-in-human studies under the US FDA or other regulatory agencies.
The CDA allows the two companies to discuss publicly undisclosed information about NanoViricides’ drug development against SARS-CoV-2 to treat COVID-19 that is currently a worldwide pandemic. Further discussions may lead to additional collaborative development agreements. As with any such exploratory discussions, there is no guarantee of such additional agreements at this time.
“We are pleased with the global interest in our drug development programs,” said Anil R. Diwan, PhD, President and Executive Chairman of the Company, adding, “We believe a collaboration with a pharma company with expertise in rapid drug development of novel technologies would help us accelerate the time to human clinical trials for our SARS-CoV-2 drug candidate in development.” Read the full press release by going to: http://www.nanoviricides.com/companynews.html
In other biotech news in the markets this week:
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.
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.”
Moderna, Inc. (NASDAQ: MRNA) 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.
“We are very pleased to partner with Lonza, which shares our commitment to rapidly addressing this pandemic which has created a global health crisis,” said Stéphane Bancel, Moderna’s Chief Executive Officer. “This long-term strategic collaboration agreement will enable Moderna to accelerate, by 10-times, our manufacturing capacity for mRNA-1273 and additional products in Moderna’s large clinical portfolio. Lonza’s global presence and expertise are critical as we scale at unprecedented speed. Our common goal is to potentially enable manufacturing of up to 1 billion doses of mRNA-1273.”
Vaxart, Inc. (NASDAQ: VXRT) recently announced that it has obtained positive pre-clinical results for its COVID-19 vaccine candidates, with several of the vaccine candidates generating immune responses in all tested animals after a single dose.
“These pre-clinical results confirm that all constructs are immunogenic as measured by IgG antibodies in serum, and we observed a robust boosting effect after the second dose.” said Sean Tucker, Ph.D., chief scientific officer of Vaxart. “This latest data set will help to select the lead candidate for manufacturing, and we remain on track to start a first phase 1 study in the second half of this year.”
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