Palm Beach, FL – July 8, 2020 – The entire global medical community has focused on finding treatments and vaccines to defeat the current global health crisis. Some treatments are showing signs of helping patients survive but a vaccine is the “Holy Grail” that all researchers are looking to find. A recent article on Biopharma from Technology Networks reported that: “Vaccine development can often take many years. To accelerate the process, a team of scientists including Dr. Larry Corey of the Fred Hutchinson Cancer Research Center and experts at the National Institutes of Health have come together to create a plan – a coordinated and efficient approach to creating vaccines against COVID-19. In a perspective published online by the journal Science, Corey and coauthors Dr. Anthony Fauci, Dr. John Mascola, and Dr. Francis Collins, share their vision for bringing together industry, government and academia to meet this urgent need. Dr. Fauci is the director of the National Institute of Allergy and Infectious diseases, part of NIH. Dr. Mascola is the director of the NIAID Vaccine Research Center, and Dr. Collins is the NIH director. Unprecedented collaboration and resources will be required to research and develop safe and effective vaccines for COVID-19 that can be manufactured and delivered in the scale of billions of doses to people globally.” Mentioned in today’s commentary include: NanoViricides, Inc. (NYSE: NNVC), Novavax, Inc. (NASDAQ: NVAX), Vaxart, Inc. (NASDAQ: VXRT), Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), Sorrento Therapeutics, Inc. (NASDAQ: SRNE).
The article continued: “We’re experiencing a series of unprecedented events with a disease that has spread globally and infected more people in a shorter time than any other infection in modern times,” said Corey, past president and director of Fred Hutch and a professor in its Vaccine and Infectious Disease Division. “In order to overcome the challenges in front of us, we each need to bring nothing short of our absolute best. The research and development of COVID-19 vaccines will require creativity, cooperation and commitment to save as many lives as possible as soon as we can. Throughout his career in developing vaccines, therapeutics and immunotherapies, Corey has led the successful integration of academic institutions, biotechnology and pharmaceutical companies in collaboration with public funding from NIH. Besides scientists and health experts, we need the help of industry and affected communities throughout the country to participate in large-scale trials of potential COVID vaccines,” he said.
NanoViricides, Inc. (NYSE American: NNVC) Breaking News: Safety and Tolerability of Anti-Coronavirus Drug Candidates Observed in an Animal Model Further Advances NanoViricides’ SARS-CoV-2 Therapeutics Program – NanoViricides (the “Company”), a leader in the development of highly effective antiviral therapies based on a novel nanomedicines platform, announced today that excellent safety and tolerability of the drug candidates it is developing against SARS-CoV-2 to treat COVID-19 spectrum of diseases was observed in an animal model. The nanoviricides drug candidates tested in this safety/tolerability study have previously shown strong effectiveness against lung infection by a SARS-CoV-2 like coronavirus, namely, hCoV-NL63, in an animal study as previously reported by the Company.
Three different drug candidates at three different dosage levels (low, medium, and high) and vehicle control were administered to separate groups of mice intravenously in the Safety-Tolerability study reported here. Clinical observations and gross post-mortem studies have been completed. The tested drug candidates were safe and well tolerated, thereby clearing the path for further development towards a treatment for SARS-CoV-2 infection that has caused the current COVID-19 pandemic.
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.
Additionally, it is well known that viruses escape antibody-drugs via mutations. The Company’s “nanoviricide” drug candidates, in contrast, are designed to be broad-spectrum, and therefore virus escape by mutations is expected to be unlikely.
In this Safety/Tolerability Study, there were no clinical signs of immune or allergic reactions such as itching, biting, twitching, rough coat, etc. Further, there were no observable changes in any organs including large intestine or colon on post mortem in gross histology. The only reportable changes observed were, in the high dosage groups of two of the three drug candidates tested, associated with the non-absorption of water, in the colon. This is consistent with the clinical observation of very loosened stools in the same groups. In clinical usage, the drug candidates are not anticipated to be administered in such high levels. The objective of this study was to discover the dosage level at which such an effect may occur.
Sixteen mice in each group (8 males, 8 females), were administered one of the three drug candidates at one of the three dose levels, and additionally, one group was administered vehicle control, for seven days by daily tail-vein intravenous infusion in this blinded study with additional evaluations on 8th day. This non-GLP safety/tolerability study was conducted under GLP-like conditions by AR BioSystems, Inc., Odessa, Tampa, FL.
Further microscopic histology and blood work analyses are in progress. Read the full press release by going to: http://www.nanoviricides.com/companynews.html
In other biotech news in the markets this week:
Novavax, Inc. (NASDAQ: NVAX) recently announced that it has been selected to participate in Operation Warp Speed (OWS), a U.S. government program that aims to begin delivering millions of doses of a safe, effective vaccine for COVID-19 in 2021. Novavax has been awarded $1.6 billion by the federal government to complete late-stage clinical development, including a pivotal Phase 3 clinical trial; establish large-scale manufacturing; and deliver 100 million doses of NVX‑CoV2373, Novavax’ COVID-19 vaccine candidate, as early as late 2020. NVX‑CoV2373 consists of a stable, prefusion protein made using its proprietary nanoparticle technology and includes Novavax’ proprietary Matrix‑M adjuvant.
“The pandemic has caused an unprecedented public health crisis, making it more important than ever that industry, government and funding entities join forces to defeat the novel coronavirus together. We are honored to partner with Operation Warp Speed to move our vaccine candidate forward with extraordinary urgency in the quest to provide vital protection to our nation’s population,” said Stanley C. Erck, President and Chief Executive Officer of Novavax. “We are grateful to the U.S. government for its confidence in our technology platform, and are working tirelessly to develop and produce a vaccine for this global health crisis.”
Vaxart, Inc. (NASDAQ: VXRT) recently announced that its oral COVID-19 vaccine has been selected to participate in a non-human primate (NHP) challenge study, organized and funded by Operation Warp Speed, a new national program aiming to provide substantial quantities of safe, effective vaccine for Americans by January 2021.
The study is designed to demonstrate the efficacy of Vaxart’s oral COVID-19 vaccine candidate. “We are very pleased to be one of the few companies selected by Operation Warp Speed, and that ours is the only oral vaccine being evaluated. SARS-CoV-2, the coronavirus that causes COVID-19, is primarily transmitted by viral particles that enter through the mucosa – nose, mouth or eyes – strongly suggesting that mucosal immunity could serve as the first line of defense,” said Andrei Floroiu, Chief Executive Officer of Vaxart Inc. “In addition, our vaccine is a room temperature-stable tablet, an enormous logistical advantage in large vaccination campaigns.”
Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS) recently announced that it has initiated a Phase 1 study to investigate a novel immunotherapy approach for patients with COVID-19. The first cohort of five patients enrolled in the study was treated at Temple University Hospital in Philadelphia, PA. The study is expected to enroll up to 30 patients at several sites in the United States. This follows the U.S. Food and Drug Administration’s (FDA) review and acceptance of the Company’s investigational new drug (IND) application for the COVID-19 study.
Corvus is studying an agonistic (immunostimulatory) humanized monoclonal antibody, designated as CPI-006, which has demonstrated a potential new approach to immunotherapy of infectious diseases and cancer. In both in vitro and in vivo studies in cancer patients, CPI-006 has demonstrated binding to various immune cells and the inducement of a humoral adaptive immune response – B cell activation and lymphocyte trafficking leading to the production of antigen-specific immunoglobulin (IgM and IgG) antibodies. Administration of CPI-006 has also led to increased levels of memory B cells, which are the cells responsible for long-term immunity. The similar production of antibodies and memory cells to pathogens such as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19, may provide immediate and long-term clinical benefits for patients including shortened recovery time and improved long-term protective immunity.
Sorrento Therapeutics, Inc. (NASDAQ: SRNE) recently announced that it has published a pre-print publication describing initial pre-clinical results from its COVID-19 vaccination program, which introduced a novel targeted protein vaccine against COVID-19, referred to as T-VIVA-19. T-VIVA-19 is a recombinant fusion protein of the spike protein S1-domain and the Fc portion of the human IgG1 antibody (rS1-Fc). The rS1-Fc was injected into either the vein or the thigh muscle of a mouse. The mice were given a booster shot three weeks later (by the same route as the initial injection) and immune responses to SARS-CoV-2 were examined.
Immunization with the rS1-Fc protein via intramuscular and intravenous injections induced antibodies against the SARS-CoV-2 protein in all mice within the first week of administration. Antibodies were observed to be enhanced upon the administration of a booster. Approximately 80% of the mice’s sera possessed neutralizing antibodies and completely prevented virus infection in in vitro cell cultures using 100 TCID50 viruses and VERO cells.
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