Clinical Research and Development Efforts Booming in Midst of COVID-19 Health Crisis
Palm Beach, FL – May 19, 2020 – Fighting the new global pandemic is a top priority in medical research and pharmaceutical development. Hundreds of organizations are working on innovations to reduce the impact of the disease and prevent further infection. An article from Johns Hopkins pointed out that the treatment for COVID-19 depends on if the case is mild or more severe. For milder cases, resting at home and taking medicine to reduce fever is often sufficient. The most severe cases require hospitalization, with treatment that might include supplemental oxygen, assisted ventilation and other measures. The article acknowledged that: “There is currently no vaccine to prevent infection with the new coronavirus. Vaccine development takes time. Several organizations… are working on a vaccine… investigators plan to work with a company to begin testing version in humans by the end of 2020. Still, it could be many months of testing and refining before a COVID-19 vaccine is deemed safe, effective and ready to be administered to the general public.” So the focus is on two targets at once… treatments to control the growth in the meantime and a vaccine to kill it. The article concluded: “In the midst of the COVID-19 pandemic, people everywhere are concerned about what kind of treatment might be available if they or their loved ones get the illness. Researchers and doctors around the world are working hard to develop ways to fight the new coronavirus and reduce the impact of COVID-19.” Mentioned in today’s commentary include: NanoViricides, Inc. (NYSE: NNVC), Co-Diagnostics, Inc. (NASDAQ: CODX), Vir Biotechnology, Inc. (NASDAQ: VIR), Inovio Pharmaceuticals, Inc. (NASDAQ: INO), Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN).
An article in the Washington Post added: “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.
NanoViricides, Inc. (NYSE American: NNVC) Breaking News: Strong Effectiveness of NanoViricides Drug Candidates Observed in an Animal Model of Infection by an ACE2-using Human Coronavirus – NanoViricides (the “Company) announced today that strong effectiveness against infection by an ACE2-utilizing coronavirus in an animal model has been observed for the drug candidates it is developing against SARS-CoV-2 to treat COVID-19 spectrum of diseases.
NanoViricides is developing an animal model for coronavirus infection using hCoV-NL63 as a surrogate for SARS-CoV-2, the virus that causes COVID-19 disease. HCoV-NL63 is a circulating human coronavirus that causes a disease that is similar to SARS-CoV-2, but much milder. Both viruses utilize the same cell receptor, namely ACE2, to gain entry into the cell. Because it causes a mild disease, hCoV-NL63 can be used in BSL2 environments, and the Company believes it is a useful surrogate for development of therapeutics against SARS-CoV-2 infection.
In this lethal direct-lung-infection model, animals in all groups developed lung disease which later led to multi-organ failures, a clinical pathology resembling that of the SARS-CoV-2. Reduction in loss of body weight at day 7 was used as the primary indicator of drug effectiveness. Rats were infected directly into lungs with lethal amounts of hCoV-NL63 virus particles and then different groups were treated separately with five different nanoviricides drug candidates, remdesivir as a positive control, and the vehicle as a negative control. The treatment was intravenous by tail-vein injection once daily for five days, except in the case of remdesivir wherein it was by tail-vein injection twice daily.
Animals treated with the five different nanoviricides showed significantly reduced body weight loss. The body weight loss was only 3.9% for the best nanoviricide candidate, ranging to 11.2% for the potentially least effective one, as compared to 20% in the vehicle-treated control group, in female animals (n=5 in each group). Male animals treated with the same nanoviricides also showed significantly reduced body weight loss. The body weight loss in male animals was 8.0% for the best nanoviricide candidate and ranged up to 10.9% for the potentially least effective one, as compared to 25% in the vehicle-treated control group (n=5 in each group). In comparison, remdesivir treatment led to a body weight loss of 15.2% in females and 18.6% in males in this study (see below). Smaller numbers mean less loss in body weight compared to starting body weight in the group, and indicate greater drug effectiveness.
The strong effectiveness of nanoviricide drug candidates in this model is consistent with the effectiveness observed in cell culture studies against infection of both hCoV-NL63, which was used in this study, and hCoV-229E, another circulating coronavirus that uses a distinctly different receptor, namely APN.
Thus this study corroborates the previous cell-culture effectiveness reported by the Company and provides confidence to the Company that these nanoviricides drug candidates may be expected to result in a clinical candidate to be pursued in human clinical trials.
The Company believes 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. Specifically, it provides a rational basis to scientists indicating 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.
The Company believes that these nanoviricides drug candidates are potentially superior to favipravir, based on cell culture studies and may be superior to remdesivir based on the results of this study, however, a definite conclusion to that effect cannot be drawn. Oral favipravir and infusion of remdesivir are two anti-viral drugs in clinical trials for the treatment of COVID-19.
Prior to filing for human clinical trials, NanoViricides plans on conducting studies to further determine the effectiveness against SARS-CoV-2, perform drug development studies for safety/toxicology, and request a pre-IND Meeting with the US FDA for regulatory guidance.
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. HCoV-NL63 can be studied in a BSL2 lab whereas SARS-CoV-2 currently requires a BSL3 or BSL4 facility.
The striking difference in weight loss between the two sexes in this animal model was remarkable. It has been widely reported that men are more likely to suffer severe infection and fatalities from SARS-CoV-2 than women in the current pandemic. This feature was replicated in our animal model study indicating that biological sex differences are the driver of the differences in the severity of infection by the coronaviruses that utilize the ACE2 receptor.
The various receptors used by different coronaviruses appear to fall in the broad family of membrane-associated serine proteases. As a family, they share several structural features. Their substrate specificities are dictated by specific amino acid residues and their positions. However, the coronaviruses do not appear to insert into the specific substrate sites on their receptors as can be broadly deduced from limited, available knowledge of these interactions. NanoViricides believes that this has made it possible for the Company to develop receptor-mimetic virus-binding ligands that have broad-spectrum effectiveness against multiple coronaviruses that use different receptors.
HCoV-NL63 is known to cause severe lower respiratory tract infections in young children leading to hospitalization. The symptoms are generally less severe than SARS-CoV-2 but are similar. In most cases, hCoV-NL63 causes relatively mild disease, often associated with croup, bronchiolitis, and lower respiratory tract disease in children, and is considered to cause some of the common colds in adults. Thus, the clinical manifestation of hCoV-NL63 infection in pediatric patients is similar to that of SARS-CoV-2, although much less severe. SARS-CoV-2 causes clinically similar milder forms of disease in most patients, but moderate to severe disease requiring hospitalizations in about 15-20% of infected persons. These similarities imply that hCoV-NL63 should be a reasonable model virus for antiviral cell culture and animal studies in BSL2 environment in the course of antiviral drug development for SARS-CoV-2. 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 that 85 percent (44 out of 52) of patients newly diagnosed with the deadly brain cancer glioblastoma multiforme (GBM) who received the company’s DNA medicine INO-5401, in combination with INO-9012 and PD-1 inhibitor Libtayo® (cemiplimab), were alive for at least 12 months or more (overall survival at 12 months: OS12) following treatment. These data will be featured at an oral poster presentation at the ASCO 2020 Virtual Scientific Program, May 29-31, 2020.
GBM is the most common and aggressive type of brain cancer. Currently, the median overall survival with standard of care therapy, which includes radiation and chemotherapy (temozolomide: TMZ), is approximately 15 to 22 months.
Vir Biotechnology, Inc. (NASDAQ: VIR) recently announced the publication of research findings from the company’s efforts to develop therapeutics for COVID-19 in the May 18, 2020 issue of the journal Nature. The paper, entitled “Cross-neutralization of SARS-CoV and SARS-CoV2 by a human monoclonal antibody” (Pinto, et al., Nature), details the identification and characterization of S309, an antibody isolated from a patient who recovered from severe acute respiratory syndrome (SARS) in 2003, which has been shown to prevent SARS-CoV-2 live virus infection of cells. Vir is advancing two clinical development candidates based on the S309 antibody as potential therapeutics for COVID-19, VIR-7831 and VIR-7832, in collaboration with GlaxoSmithKline plc (LSE/NYSE: GSK).
“Remarkably, we believe S309 likely covers the entire family of related coronaviruses, which suggests that, even as SARS-CoV-2 continues to evolve, it may be quite challenging for it to become resistant to the neutralizing activity of S309,” said Herbert “Skip” Virgin, M.D., Ph.D., Chief Scientific Officer, Vir. “In addition, S309 exhibits potent effector function in vitro, potentially allowing the antibody to engage and recruit the rest of the immune system to kill off already infected cells. We have seen in animal models of other respiratory infections, such as influenza, that effector function significantly enhances the activity of antibodies that are already potently neutralizing.”
Co-Diagnostics, Inc. (NASDAQ: CODX) a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, recently announced that its Logix Smart™ Coronavirus COVID-19 Test has been approved for sale in Mexico by the Mexican Department of Epidemiology (“InDRE”) after InDRE successfully concluded an evaluation of the test’s sensitivity and specificity and its non-reactivity with other respiratory viruses. InDRE, which is analogous to the U.S. Centers for Disease Control and Prevention (CDC), is required to evaluate any test to detect the disease before the test may gain clearance to be sold into the Mexican healthcare market.
Co-Diagnostics also announced that CoSara, the Company’s joint venture for manufacturing in India, expects to now begin filling orders following the successful evaluation of CoSara’s Saragene™ COVID-19 RT-PCR test kit by the Indian Council of Medical Research. The evaluation showed 100% sensitivity and 100% specificity without any cross reactivity with other respiratory viruses, and it has been cleared for sale to the Indian market.
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and the Colorado Center for Personalized Medicine (CCPM) at the University of Colorado Anschutz Medical Campus announced a large-scale research collaboration designed to advance the field of human genetics and precision medicine through the sharing of 450,000 DNA samples and corresponding health records from de-identified, consented patient participants in the expansive UCHealth system. The Regeneron Genetics Center (RGC), a wholly owned subsidiary of Regeneron, has entered into the collaboration with CCPM and will sequence these samples, producing genomic data that can be used to facilitate translational medical research and ultimately enable physicians to make better decisions for their patients.
The CCPM is one of the largest health data warehouses in the United States and a pioneer in the use of a secure cloud platform with more than 8.7 million de-identified patient records. The five-year old research enterprise is also one of the first and largest programs in the country to integrate personalized genomic information with clinical data via a research biobank. CCPM physicians will validate any genetic findings from the RGC data in their CLIA-certified lab, enabling the return of clinically-actionable results to patients.
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