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Human Trials Forge Ahead For Development of COVID-19 Vaccine For Global Immunization

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PALM BEACH, Florida, April 22, 2020 /PRNewswire/ -- The question heard around the world is "When will a coronavirus vaccine be ready?". Its not an "if" but a "when" and that "when" from all accounts will most likely be much faster than all previous models. The Guardian spoke to this point in a recent article adding another aspect to the question, saying: "Human trials (have begun)…  but even if they go well and a cure is found, there are many barriers before global immunisation is feasible." They continued: "Though we can slow the spread of COVID-19, through confinement and other social distancing measures, and scientists are developing drugs to treat its symptoms, the only way to actually prevent people from catching COVID-19 is with a vaccine – and we don't yet have one of those.  It continued: "Nearly 80 companies and academic institutions are racing to produce one, and of those, five are already testing their vaccine candidates in people. The first of these to enter human trials – one produced by Boston-based biotech company Moderna – did so on 16 March. This unprecedented speed is thanks in large part to early Chinese efforts to sequence the genetic material of Sars-CoV-2, the virus that causes COVID-19. China shared that sequence in early January, allowing research groups around the world to grow the live virus and study how it invades human cells and makes people sick.   Active biotech and pharma companies in the markets this week include:  Q BioMed Inc. (OTCQB:QBIO), Novartis AG (NYSE:NVS), Vir Biotechnology, Inc. (NASDAQ:VIR), Gilead Sciences, Inc. (NASDAQ:GILD), Inovio Pharmaceuticals, Inc. (NASDAQ:INO).

But there is another reason for the head start. Though nobody could have predicted that the next infectious disease to threaten the globe would be caused by a coronavirus – flu is generally considered to pose the greatest pandemic risk – vaccinologists had hedged their bets by working on "prototype" pathogens. "The speed with which we have [produced these candidates] builds very much on the investment in understanding how to develop vaccines for other coronaviruses," says Richard Hatchett, CEO of the Oslo-based nonprofit the Coalition for Epidemic Preparedness Innovations (Cepi), which is leading efforts to finance and coordinate Covid-19 vaccine development.

Q BioMed Inc. (OTCQB:QBIO) BREAKING NEWS:  Q BioMed Initiates Rapid Development of Novel COVID-19 Therapeutics - Q BioMed, a commercial stage biotech company, today announced that together with its technology partner, Mannin Research, they are accelerating the rapid development of novel drugs for the treatment of life-threatening complications caused by COVID-19 and other viral infections. This novel drug program is being evaluated by government programs for funding and accelerated development under various COVID-19 response initiatives. Q BioMed and Mannin hope to have at least one treatment in human trials this year.

The accelerated development is the result of a joint venture (JV) between Mannin, with its Tie2 based small molecule platform that addresses vascular leakage, and Cyclica, a Toronto-based biotechnology company that has a proprietary AI-augmented drug discovery platform, Ligand Design and Ligand Express. The JV agreement will deploy Cyclica's unique AI platform to accelerate the development of new treatments based on Mannin's Tie2 based platform.

Several diseases increase the risk of vascular leakage through blood vessels, including acute respiratory distress syndrome (ARDS), sepsis, malaria, and viral infections. Viral infections do so by causing damage to the cells that make up the inner wall of blood vessels, called the endothelium. This leakage allows a virus to move systemically while also increasing secondary bacterial infections. Independent research has demonstrated that reducing vascular leakage helps prevent organ failure and ameliorate acute infections. By activating the Angiopoietin-Tie2 signaling pathway it is possible to treat the vascular leakage associated with pulmonary edema, addressing the respiratory infection caused by viruses such as COVID-19.

Mannin CEO George Nikopoulos said, "Therapeutics based on the Tie2 platform have the potential to offer clinicians an intervention to rapidly stabilize the patient's vascular endothelium in hospital settings, such as the intensive care unit (ICU) or emergency room (ER), when pulmonary edema is diagnosed. Such an intervention could improve outcomes without waiting for a definitive diagnosis, which has been a bottleneck in the current COVID-19 pandemic in the US and around the world. By targeting Tie2, our therapeutic may also be effective in the treatment of a number of conditions including pulmonary edema, ARDS and severe acute respiratory syndrome (SARS) associated with COVID-19 and the seasonal flu."

Q BioMed CEO Denis Corin stated, "Simply put, drugs from Mannin's Tie2 based platform help to stabilize 'leaky vessels' that play a critical part in organ injury, a major determinant of negative outcomes in patients affected by several infectious diseases, including influenza and the current COVID-19 pandemic. While the COVID-19 pandemic has created an urgent need for life saving therapeutics, the Tie2 based platform addresses life threatening complications from a number of infectious diseases including inevitable future novel viral threats. We hope these treatments will be in testing in the clinic by the end of the year." Mr. Corin continued, "We're also excited about the potential synergy between virus directed treatments such as remdesivir and Mannin's host-directed therapeutics. Mannin's therapy targets the common physiological pathways that become compromised during any viral infection. Consequently, co-administering an antiviral drug with Mannin's therapeutic is likely to have a positive synergistic effect on the infected patient. In addition, because it is not limited to acting on a specific virus, Mannin's therapeutic wouldn't be affected by any viral mutation that makes the virus resistant to anti-viral."   Read this entire release and more news for QBIO athttps://www.financialnewsmedia.com/news-qbio/   

Other recent developments in the biotech industry include:

Novartis AG (NYSE:NVS) recently announced its commitment to donate up to 130 million doses of generic hydroxychloroquine to support the global COVID-19 pandemic response. Hydroxychloroquine and a related drug, chloroquine, are currently under evaluation in clinical trials for the treatment of COVID-19. Novartis is supporting ongoing clinical trial efforts, and will evaluate needs for additional clinical trials.

When supported for use in COVID-19 infected patients by regulatory authorities, Novartis intends to donate up to 130 million 200 mg doses by the end of May, including its current stock of 50 million 200 mg doses. The company is also exploring further scaling of capacity to increase supply and is committed to working with manufacturers around the world to meet global demand.

Novartis Sandoz division currently only holds a registration for hydroxychloroquine in the U.S., and will pursue appropriate regulatory authorizations from the U.S. FDA and the European Medicines Agency. Novartis will work with stakeholders including the World Health Organization to determine the best distribution of the medicine to ensure broad access to patients most in need of this medicine globally. The company aims to ensure that patients currently depending on this medicine are not impacted by the donation.

Vir Biotechnology, Inc. (NASDAQ:VIR) announced additional interim data from the ongoing Phase 2 trial in patients and results from the Phase 1 trial in healthy volunteers of VIR-2218, an investigational small interfering ribonucleic acid (siRNA) that mediates RNA interference (RNAi) for the treatment of chronic hepatitis B virus (HBV) infection.

Interim results from the ongoing Phase 2 trial demonstrate that VIR-2218 results in a significant dose-dependent and durable reduction in hepatitis B surface antigen (HBsAg) through Week 24 in patients with chronic HBV who received two doses of VIR-2218, ranging from 20 mg to 200 mg. Similar HBsAg reductions were observed in both HBeAg- and HBeAg+ patients. In addition, VIR-2218 was generally well tolerated, with the majority of treatment emergent adverse events (AEs) reported as mild in severity, and no clinically significant alanine transaminase (ALT) elevations observed.

Gilead Sciences, Inc. (NASDAQ:GILD) recently announced results from a cohort analysis of 53 patients hospitalized with severe complications of COVID-19 who were treated with the investigational antiviral remdesivir on an individual compassionate use basis. The majority of patients in this international cohort demonstrated clinical improvement and no new safety signals were identified with remdesivir treatment. Compassionate use data have limitations and multiple Phase 3 studies are ongoing to determine the safety and efficacy of remdesivir for the treatment of COVID-19. The detailed results of this analysis were published today in The New England Journal of Medicine.

Remdesivir is not yet licensed or approved anywhere globally and has not been demonstrated to be safe or effective for the treatment of COVID-19.

Inovio Pharmaceuticals, Inc. (NASDAQ:INO) News: 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."

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