The global science community is arguably facing one of its greatest challenges yet in the current global healthcare crisis.
Article after article demonstrates that the global pandemic is causing the breakdown of societal norms.
Scientists across the globe are working tirelessly to understand the virus at a molecular level; how it survives, mutates, spreads and infects humans. Collectively, their efforts will enhance our ability to develop both preventive and therapeutic strategies against this crisis.
According to Clinical Trials Arena, stated: “Vaccine development to fight Covid-19 is picking up pace, as more and more companies are starting clinical trials and forming collaborations to ensure rapid development and sufficient production capacity.
The number of vaccine candidates and techniques in development raises optimism, but the history of vaccine development shows that setbacks and roadblocks are almost certain and a finished product is unlikely to be widely available in 2020.
Although Gilead released positive but inconclusive data from its trial of the antiviral remdesivir, a vaccine is still the ultimate goal to prevent future Covid-19 outbreaks.”
The article continued: “On Monday, May 3, a global coalition led by EU member states, Canada, Japan, Saudi Arabia, the UK, and Norway pledged $8B for the development of Covid-19 vaccines and to ensure universal global access.
The World Bank, the Bill and Melinda Gates Foundation, and other wealthy donors contributed. Meanwhile, the US created its own project, “Operation Warp Speed”, which aims to spend several billion dollars to produce enough doses of a potential vaccine to protect the US population.”
The FDA in the U.S. is also doing its part to help accelerate the process.
On its site it said: “FDA has created a special emergency program for possible therapies, the Coronavirus Treatment Acceleration Program (CTAP).
It uses every available method to move new treatments to patients as quickly as possible, while at the same time finding out whether they are helpful or harmful.
We continue to support clinical trials that are testing new treatments for COVID so that we gain valuable knowledge about their safety and effectiveness.
BioSig Technologies, Inc. BREAKING NEWS – FDA Clears the Investigational New Drug Application to Enable the Phase II Trial of ViralClear’s Merimepodib, Oral Solution to Treat Adult Patients with Advanced COVID-19, to Proceed – BioSig Technologies and its majority owned subsidiary, ViralClear Pharmaceuticals, Inc. (ViralClear), this week announced that the U.S. Food and Drug Administration (FDA) has completed its review of ViralClear’s Investigational New Drug (IND) application.
The FDA informed ViralClear that it may proceed with a proposed phase II study of merimepodib oral solution in adults with COVID-19 who are hospitalized and either require supplemental oxygen or are on non-invasive ventilation or high flow oxygen devices.
This study will be a randomized, double blind, placebo-controlled trial to evaluate the efficacy and safety of merimepodib as an orally administered treatment.
The trial will occur in hospitalized patients who have confirmed infection with SARS-CoV-2 and require supplemental oxygen.
“I’m very pleased to be involved in this planned Phase II study of merimepodib for the treatment of patients with COVID-19 disease,” said Andrew D. Badley, M.D., Professor and Chair of Department of Molecular Medicine and the Enterprise Chair of COVID-19 Task Force. “We are grateful to the FDA for their prompt response in helping accelerate opportunities to find treatments for the novel coronavirus. We plan to begin enrollment of this trial as soon as practicable given the importance of finding solutions to this pandemic.”
“FDA clearance for our proposed phase II trial to proceed is an important step for the development of merimepodib,” commented Jerome B. Zeldis, M.D., Ph.D, Executive Chair, co-founder and acting Chief Medical Officer of ViralClear Pharmaceuticals, Inc. “We intend to conduct Phase II evaluations of our drug both in the hospital and outpatient settings as part of our clinical development plan.”
“We thank the Mayo Clinic for collaborating with us to conduct the trials under the leadership of Professor Badley,” said Nick Spring, Chief Executive Officer of ViralClear Pharmaceuticals, Inc. “Of the therapies that are currently being evaluated as treatments and can be available in the short term, we believe that a broad-spectrum antiviral that is orally administered and widely available could be very helpful in addressing the COVID-19 pandemic. We further believe it can play a pivotal role in helping manage this type of public health crisis.”
In other healthcare news of note:
Sorrento Therapeutics, Inc. recently announced that its anti-SARS-CoV-2 antibody, STI-1499, demonstrated 100% inhibition of SARS-CoV-2 virus infection in an in vitro virus infection experiment at a very low antibody concentration.
As recently announced, Sorrento aims to generate an antibody cocktail product that would act as a “protective shield” against SARS-CoV-2 coronavirus infection and remain effective even if virus mutations render a single antibody therapy less effective over time.
Sorrento has been diligently screening billions of antibodies in its proprietary G-MAB™fully human antibody library and has so far identified hundreds of antibody candidates that bind the S1 subunit of the SARS-CoV-2 Spike protein.
Approximately one dozen of these antibodies have demonstrated the ability to block the S1 protein’s interaction with human angiotensin-converting enzyme 2 (ACE2), the receptor used for viral entrance into human cells.
These blocking antibodies were further tested for their ability to inhibit SARS-CoV-2 virus infection in an in vitro SARS-CoV-2 virus infection model pursuant to a preclinical testing agreement for COVID-19 therapeutic candidates that was previously announced on March 31, 2020 (Sorrento Therapeutics).
Gilead Sciences, Inc. 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.”
Moderna, Inc. a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, announced positive interim clinical data of mRNA-1273, its vaccine candidate against novel coronavirus (SARS-CoV-2), from the Phase 1 study led by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).
Immunogenicity data are currently available for the 25 µg and 100 µg dose level (ages 18-55) after two doses (day 43) and at the 250 µg level (ages 18-55) after one dose (day 29).
Dose dependent increases in immunogenicity were seen across the three dose levels, and between prime and boost within the 25 µg and 100 µg dose levels. All participants ages 18-55 (n=15 per cohort) across all three dose levels seroconverted by day 15 after a single dose.
At day 43, two weeks following the second dose, at the 25 µg dose level (n=15), levels of binding antibodies were at the levels seen in convalescent sera (blood samples from people who have recovered from COVID-19) tested in the same assay. At day 43, at the 100 µg dose level (n=10), levels of binding antibodies significantly exceeded the levels seen in convalescent sera.
Samples are not yet available for remaining participants.
Novavax, Inc. a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, recently announced that the Coalition for Epidemic Preparedness Innovations (CEPI) will invest up to $384 million of additional funding, on top of $4 million it invested in March, to advance clinical development of NVX-CoV2373, Novavax’ coronavirus vaccine candidate against SARS-CoV-2.
The additional funding from CEPI will also support rapid scale-up of the NVX-CoV2373 vaccine antigen, as well as Novavax’ proprietary Matrix-M™ adjuvant, which is expected to enhance immune responses by stimulating high levels of neutralizing antibodies.
In addition, the CEPI funding will allow Novavax to dramatically increase its large-scale manufacturing capacity for both antigen and adjuvant in multiple locations.
“CEPI plays a vital role in advancing innovative technologies against the COVID-19 pandemic. Their partnership and support allows Novavax to leverage its innovative vaccine platform and expertise in this global crisis,” said Stanley C. Erck, President and Chief Executive Officer of Novavax. “For the last few months, the entire Novavax team has been working nonstop in an ongoing effort to make our vaccine a reality, and we appreciate CEPI’s confidence in our technology platform and our progress.”
“The expansion of our partnership with Novavax represents CEPI’s single biggest investment to date”, said Richard Hatchett, Chief Executive Officer of CEPI. “Our vaccine R&D programmes are starting to show progress, so it is vital that we invest now to boost manufacturing capacity, so that our partners have the ability to produce vaccines at a global scale. We still have a long way to go, but we’re making important steps forward to deliver a safe, effective, and globally accessible vaccine as quickly as possible.”
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