Palm Beach, FL – September 16, 2020 – The National Institute for Health (NIH) is at the heart of the emerging and rapidly evolving war against the global pandemic. They constantly update the public on the latest information on research for a vaccine and therapies to fight the virus. A recent report from them shone the light on a specific promising therapeutic approach… nanomedicine. The NIH said that nanomedicine is a promising approach for diagnosis, treatment and prophylaxis against COVID-19. They said that: “The COVID-19 pandemic caused by the newly emerged severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) puts the world in an unprecedented crisis, leaving behind huge human losses and deep socioeconomic damages. Due to the lack of specific treatment against SARS-CoV-2, effective vaccines and antiviral agents are urgently needed to properly restrain the COVID-19 pandemic. Repositioned drugs such as remdesivir have revealed a promising clinical efficacy against COVID-19. Interestingly, nanomedicine as a promising therapeutic approach could effectively help win the battle between coronaviruses and host cells.” Mentioned in today’s commentary include: NanoViricides, Inc. (NYSE: NNVC), Immunomedics (NASDAQ: IMMU), Gilead Sciences, Inc. (NASDAQ: GILD), Inovio Pharmaceuticals, Inc. (NASDAQ: INO), Novavax, Inc. (NASDAQ: NVAX).
Due to a lack of approved vaccines and specific treatments only preventive measures can currently be applied. Currently, development of an effective vaccine and specific treatment is the main concern for researchers worldwide to fight the current COVID-19 and any future mutations. Understanding the coronaviral genome and the processes of viral replication and pathogenesis will enable researchers to develop specific drugs and vaccines. So researchers are turning to nanomedicine, one of the most important and emerging fields of modern science.
NanoViricides, Inc. (NYSE American: NNVC) Breaking News: NanoViricides Nominates a Novel Candidate for Advancing Into Clinical Trials for Treatment of COVID-19 – NanoViricides, a global leader in the development of highly effective antiviral therapies based on a novel nanomedicines platform, today announced that it has nominated a clinical drug candidate for the treatment of COVID-19, thus further advancing its COVID-19 program closer to human clinical trials.
The Company has accelerated its drug development program for COVID-19 with the goal of creating the most effective medicine to obtain regulatory approval for emergency use in the COVID-19 pandemic in the shortest timeline feasible, after achieving proof of concept of broad-spectrum anti-coronavirus effectiveness of test candidates. The Company therefore aggressively worked to harness the full power of the nanoviricides® nanomedicine platform to achieve these objectives.
A curative treatment for a virus such as SARS-CoV-2 coronavirus would require a multi-faceted attack that shuts down (i) ability of the virus to infect host cells and simultaneously, (ii) ability of the virus to multiply inside the host cells. The nanoviricide® platform enables direct multi-point attack on the virus that is designed to disable the virus and its ability to infect new cells. At the same time, a nanoviricide is also capable of carrying payload in its “belly” (inside the micelle) that can be chosen to affect the ability of the virus to replicate. The nanoviricide is designed to protect the payload from metabolism in circulation. Thus, the nanoviricide platform provides an important opportunity to develop a curative treatment against SARS-CoV-2, the cause of COVID-19 spectrum of pathologies.
The clinical candidate the Company has chosen is identified as NV-CoV-1-R. It is made up of a nanoviricide that we have found to possess broad-spectrum anti-coronavirus activity, now identified as NV-CoV-1, and remdesivir encapsulated inside the core of NV-CoV-1. NV-CoV-1 itself is designed to attack the virus particles themselves, and possibly would also attack infected cells that display the virus antigen S-protein, while sparing normal (uninfected) cells that do not display the S-protein. Additionally, remdesivir is widely understood to attack the replication cycle of the virus inside cells. Thus the combined attack enabled by NV-CoV-1-R on the virus could prove to be a cure for the infection and the disease, provided that the necessary dosage level can be attained without undue adverse effects. Human clinical trials will be required to determine the safety and effectiveness of NV-CoV-1-R.
Remdesivir is a well-known antiviral drug (developed by Gilead) that has been approved for emergency use treatment of SARS-CoV-2 infection or COVID-19 in several countries. NV-CoV-1 is a novel agent that is being used as an adjuvant to remdesivir in creating NV-CoV-1-R, to improve the overall effectiveness. It is well known that remdesivir suffers from rapid metabolism in circulation that breaks down the prodrug to its nucleoside form which is not readily phosphorylated. The Company anticipates that encapsulation in NV-CoV-1 may protect remdesivir from this rapid metabolism. If this happens, the effective level and stability of remdesivir in the body would increase. This increase may lead to increased effectiveness if there are no adverse effects. Such increased effectiveness, if found, may also allow reduction in the required dosage of remdesivir in the encapsulated form, i.e. as NV-CoV-1-R. In this sense, NV-CoV-1 can be viewed to act as an adjuvant that enhances the effect of remdesivir, a known antiviral against SARS-CoV-2.
“This is an extremely important milestone for the Company,” said Anil R. Diwan, PhD, President and Executive Chairman of the Company, adding, “We look forward to rapid development of the IND enabling core safety pharmacology studies and, thereafter, human clinical development on an accelerated timeline in these trying times of the pandemic.” Read the full press release by going to: http://www.nanoviricides.com/companynews.html
In other biotech news in the markets this week:
Immunomedics (NASDAQ: IMMU) and Gilead Sciences, Inc. (NASDAQ: GILD) recently announced that the companies have entered into a definitive agreement pursuant to which Gilead will acquire Immunomedics for $88.00 per share in cash. The transaction, which values Immunomedics at approximately $21 billion, was unanimously approved by both the Gilead and Immunomedics Boards of Directors and is anticipated to close during the fourth quarter of 2020.
The agreement will provide Gilead with TrodelvyTM (sacituzumab govitecan-hziy), a first-in-class Trop-2 directed antibody-drug conjugate (ADC) that was granted accelerated approval by the U.S. Food and Drug Administration (FDA) in April for the treatment of adult patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease. Immunomedics plans to submit a supplemental Biologics License Application (BLA) to support full approval of Trodelvy in the United States in the fourth quarter of 2020. Immunomedics is also on track to file for regulatory approval in Europe in the first half of 2021.
“This acquisition represents significant progress in Gilead’s work to build a strong and diverse oncology portfolio. Trodelvy is an approved, transformational medicine for a form of cancer that is particularly challenging to treat. We will now continue to explore its potential to treat many other types of cancer, both as a monotherapy and in combination with other treatments,” said Daniel O’Day, Chairman and Chief Executive Officer, Gilead Sciences. “We look forward to welcoming the talented Immunomedics team to Gilead so we can continue to advance this important new medicine for the benefit of patients with cancer worldwide.”
INOVIO (NASDAQ: INO), a biotechnology company focused on bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases and cancer, recently announced that Thermo Fisher Scientific, the world leader in serving science, has signed a letter of intent to manufacture INOVIO’s DNA COVID-19 vaccine candidate INO-4800.
Thermo Fisher joins other contract development and manufacturing organizations in INOVIO’s global manufacturing consortium, enabling INOVIO to potentially scale commercial production of INO-4800. With its consortium of third-party manufacturers, INOVIO plans to have 1001 million doses of INO-4800 manufactured in 2021, subject to FDA approval of INO-4800 for use as a COVID-19 vaccine. Thermo Fisher plans to manufacture INO-4800 drug substance as well as perform fill and finish of INO-4800 drug product at its commercial facilities in the US. At peak capacity, Thermo Fisherprojects that it could produce at least 100 million doses of INO-4800 annually.
Novavax, Inc. (NASDAQ: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, recently announced an amendment to its existing agreement with Serum Institute of India Private Limited (SIIPL) under which SIIPL will also manufacture the antigen component of NVX‑CoV2373, Novavax’ COVID‑19 vaccine candidate. With this agreement, Novavax increases its manufacturing capacity of NVX-CoV2373 to over two billion doses annually, when all planned capacity has been brought online by mid-2021. NVX‑CoV2373 is a stable, prefusion protein made using Novavax’ recombinant protein nanoparticle technology and includes Novavax’ proprietary Matrix‑M adjuvant.
“Today’s agreement with Serum Institute enhances Novavax’ commitment to equitable global delivery of our COVID-19 vaccine. With this arrangement, we have now put in place a global supply chain that includes the recently acquired Praha Vaccines and partnerships with leading biologics manufacturers, enabling production on three continents,” said Stanley C. Erck, President and Chief Executive Officer of Novavax. “We continue to work with extraordinary urgency to develop our vaccine, now in Phase 2 clinical trials, and for which we anticipate starting Phase 3 efficacy trials around the world in the coming weeks.”
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