Clinical Trials for COVID-19 Treatments or Vaccines Reaching Unprecedented Levels

The world is now racing to find ways to slow the spread of the novel coronavirus and to find effective treatments.

According to the U.S. National Institutes of Health (NIH) as of April 6, more than 200 clinical trials of COVID-19 treatments or vaccines are either ongoing or recruiting patients. New ones are being added every day, as the case count in the U.S. and globally skyrockets.

The drugs being tested range from repurposed flu treatments to failed ebola drugs, to malaria treatments that were first developed decades ago. A recent article from Reuters reported that the reasons for hope is growing daily as there are more drug tests and tactics every day that are designed to conquer the global health crisis. The article continued: “While a safe, effective vaccine is still more than a year away, researchers are rushing to repurpose existing drugs and non-drug therapies as well as testing promising experimental drugs that were already in clinical trials. Active biotech and pharma companies in the markets this week include AIkido Pharma Inc. (NASDAQ: AIKI), Moderna, Inc. (NASDAQ: MRNA), Inovio Pharmaceuticals, Inc. (NASDAQ: INO), Novavax, Inc. (NASDAQ: NVAX), VBI Vaccines Inc. (NASDAQ: VBIV).

Even moderately effective therapies or combinations could dramatically reduce the crushing demand on hospitals and intensive care units, changing the nature of the risk the new pathogen represents to populations and healthcare systems. New drugs, together with new diagnostics, antibody tests, patient- and contact-tracing technologies, disease surveillance and other early-warning tools, mean the anticipated next “wave” of the global pandemic does not have to be nearly as bad as the first. More than 70 vaccine candidates are also in development around the world, with at least five in preliminary testing in people. Below are some of the drugs, vaccines and other therapies in development.”

AIkido Pharma Inc. (NASDAQ: AIKI) BREAKING NEWS:  AIkido Pharma Executes Licensing Agreement with University of Maryland for Antiviral Compounds, Including COVID-19  – AIkido Pharma (“AIkido” or the “Company”) today announced that on April 13, 2020, the Company executed a Master License Agreement (the “License Agreement”) with the University of Maryland, Baltimore (“UMB”). The License Agreement covers specific antiviral compounds discovered by UMB. The compounds seek to inhibit replication of multiple viruses, including Influenza virus, SARS-CoV, MERS-CoV, Ebolavirus and Marburg virus.

The technology is covered by two patent applications already on file with the United States Patent and Trademark Office. The UMB inventors are Drs. Matthew Frieman, Alexander MacKerell and Stuart Watson. The Company has also executed a Sponsored Research Agreement with UMB to support the development of the technology.

Mr. Anthony Hayes, CEO of AIkido, stated, “We are excited to move forward with this new antiviral platform. The pedigree of the inventors and the institution is first rate. We believe the doctors and UMB are both leaders in the field and are frequently cited in major publications discussing viruses generally, as well as COVID-19.  We are proud to partner with them in this critical undertaking.

Hayes continued, “We have also added significant depth to our board of directors. Our recent capital raise has positioned the Company to comfortably fund current opporations and acquire new assets. Management believes that our new board members bring significant capital market and M&A experience, which we plan to leverage. While the world works to overcome the difficult challenges as a result of the pandemic, we at AIkido are excited to look to the future.” Read this full release and more news for AIKI at:  https://www.financialnewsmedia.com/news-aiki

Other recent developments in the biotech industry include:

Moderna, Inc. (NASDAQ: MRNA) recently announced an agreement for a commitment of up to $483 million from the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services (HHS), to accelerate development of the Company’s mRNA vaccine candidate (mRNA-1273) against the novel coronavirus (SARS-CoV-2).

“We are thankful for BARDA’s support to fund the accelerated development of mRNA-1273, our vaccine candidate against SARS-CoV-2,” said Stéphane Bancel, Moderna’s Chief Executive Officer. “Time is of the essence to provide a vaccine against this pandemic virus. By investing now in our manufacturing process scale-up to enable large scale production for pandemic response, we believe that we would be able to supply millions of doses per month in 2020 and with further investments, tens of millions per month in 2021, if the vaccine candidate is successful in the clinic.”

Inovio Pharmaceuticals, Inc. (NASDAQ: INO)  – The International Vaccine Institute (IVI) recently announced that the Coalition for Epidemic Preparedness Innovations (CEPI) has granted $6.9 million funding to INOVIO to work with IVI and the Korea National Institute of Health (KNIH) for a Phase 1/2 clinical trial of INOVIO’s COVID-19 vaccine candidate (INO-4800) in South Korea. IVI will conduct the trial in parallel to INOVIO’s Phase 1 INO-4800 study currently underway in the US since April 6, 2020 with 40 healthy adults receiving the vaccine candidate and eventually expanding to older adults.

Dr. Jerome H. Kim, Director General of IVI, said, “Vaccines are the long-term solution to controlling the COVID-19 pandemic. The rapid global response to developing vaccine candidates has been a profound demonstration of governments, industry, and the scientific community coming together to confront a common crisis, and we’re looking forward to accelerating one of those candidates through clinical testing. IVI has achieved promising trial results with INOVIO’s DNA vaccine platform in the past, and we’re pleased to partner again to test the safety and immunogenicity of an urgently needed COVID-19 vaccine.”

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.

VBI Vaccines Inc. (NASDAQ: VBIV)  recently announced a collaboration with the National Research Council of Canada (NRC), Canada’s largest federal research and development organization, to develop a pan-coronavirus vaccine candidate, targeting COVID-19, severe acute respiratory syndrome (SARS), and Middle East respiratory syndrome (MERS).

“COVID-19 is now the third, and to-date the most widespread, coronavirus outbreak in the 21^st century, and while it is clearly a priority at this time, there remains an unmet medical need for broader protection against emerging coronaviruses,” said Francisco Diaz-Mitoma, M.D., Ph.D., VBI’s Chief Medical Officer. “Coronaviruses are enveloped viruses by nature, which we believe makes them a prime target for VBI’s flexible enveloped virus-like particle (eVLP) platform technology, ongoing development of which is led and conducted at our research facility in Ottawa, Canada. Based on past clinical experience with the eVLP platform, we expect that a multivalent eVLP vaccine candidate, co-expressing SARS-CoV-2, SARS-CoV, and MERS-CoV spike proteins on the same particle, will be possible to develop.

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