Covid-19 Global Race for Testing and Vaccines Sees Biotechnology Innovation (TSXV: LXG.V) (OTCQB: $LXXGF) (NASDAQ: $MRNA) (NASDAQ: $NVAX) (NASDAQ: $GILD)
Point Roberts, WA and Delta, BC - June 3, 2020 (Investorideas.com Newswire) Investor Ideas, a global investor news source covering biotech and pharma stocks releases a Covid-19 sector snapshot. According to Bio.org, COVID-19 (Coronavirus) has ignited the sector, noting "Biotech Companies are responding faster than ever to emerging health threats." Investor ideas looks at some of the leading innovators and what is in the pipeline.
LexaGene Holdings, Inc. (TSX-V: LXG) ( OTCQB: LXXGF), a TSX Venture Top 50 Company, developing a fully automated pathogen detection platform just announced they have "PLACED A PRE-COMMERCIAL INSTRUMENT FOR COVID-19 TESTING IN A MAJOR HOSPITAL LABORATORY."
From the news: Lexagene Holdings Inc. has placed a precommercial instrument that tests for COVID-19 and other respiratory pathogens at the Dartmouth-Hitchcock Medical Center (DHMC), in its laboratory for clinical genomics and advanced technology (CGAT) in Hanover, N.H.
Continued: Dr. Gregory J. Tsongalis, PhD., HCLD, CC, Professor and Vice Chair for Research Director at CGAT, comments "Our standard test for SARS-CoV-2, the pathogen that causes COVID-19, takes about 7.5 hours. Given the highly contagious nature of this virus, this is a long time to wait. We want the ability to get results much faster and to be able to screen for more pathogens at once since respiratory symptoms can be caused by numerous other viruses."
Continued: Dr. Jack Regan, Lexagene's Founder and CEO, states "We are excited to be able to contribute to the fight against COVID-19 and illustrate our applications in the human clinical space. Unlike many of the near-patient testing solutions used today that only look for COVID-19 and have a significant false negative rate, the instrument we have placed at Dartmouth-Hitchcock screens for many pathogens at once, namely COVID-19, influenza, RSV, adenovirus, metapneumovirus, and seasonal coronavirus, and it performs gold-standard chemistry for exceptional data quality. Our breadth of detection allows users of our technology to generate informative data for the vast majority of people with respiratory symptoms. This is particularly important as healthcare providers are increasingly questioning negative results from COVID-19 only tests, wondering if the test result is a false negative or the person is sick from another pathogen."
Continued: The Company is also pleased to report that we have submitted our plan to the FDA for Emergency Use Authorization (EUA) for COVID-19 testing and anticipates completing the described studies in the near future. Until these studies are completed and the FDA grants Lexagene's instrument EUA for COVID-19 testing, all work using Lexagene instruments is classified as Research Use Only and cannot be used for human clinical diagnostics.
Continued: The Company is not making any express or implied claims that its product has the ability to eliminate, cure or contain the COVID-19 (or SARS-2 Coronavirus) at this time.
The Company has a proven and credible background in dealing with pathogens. LexaGene's patented microfluidic system was invented by company founder and CEO, Dr. Jack Regan who was a lead scientist in developing a predecessor instrument designed for bio-warfare surveillance that was adopted by the Department of Homeland Security for the BioWatch Program and a second R&D instrument that was designed for detecting respiratory pathogens from nasal swab samples.
On May 18th, Moderna, Inc., (Nasdaq: MRNA) 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).
From the news: "These interim Phase 1 data, while early, demonstrate that vaccination with mRNA-1273 elicits an immune response of the magnitude caused by natural infection starting with a dose as low as 25 µg," said Tal Zaks, M.D., Ph.D., Chief Medical Officer at Moderna. "When combined with the success in preventing viral replication in the lungs of a pre-clinical challenge model at a dose that elicited similar levels of neutralizing antibodies, these data substantiate our belief that mRNA-1273 has the potential to prevent COVID-19 disease and advance our ability to select a dose for pivotal trials."
"With today's positive interim Phase 1 data and the positive data in the mouse challenge model, the Moderna team continues to focus on moving as fast as safely possible to start our pivotal Phase 3 study in July and, if successful, file a BLA," said Stéphane Bancel, Chief Executive Officer at Moderna. "We are investing to scale up manufacturing so we can maximize the number of doses we can produce to help protect as many people as we can from SARS-CoV-2."
On May 25th, Novavax, Inc. (NASDAQ: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases announced enrollment of the first participants in a Phase 1/2 clinical trial of its coronavirus vaccine candidate, NVX‑CoV2373, a stable, prefusion protein made using its proprietary nanoparticle technology. NVX‑CoV2373 includes Novavax' proprietary Matrix‑M™ adjuvant to enhance immune responses and stimulate high levels of neutralizing antibodies. Preliminary immunogenicity and safety results from the Phase 1 portion of the trial are expected in July 2020.
"Administering our vaccine in the first participants of this clinical trial is a significant achievement, bringing us one step closer toward addressing the fundamental need for a vaccine in the fight against the global COVID‑19 pandemic," said Stanley C. Erck, President and Chief Executive Officer of Novavax. "We look forward to sharing the clinical results in July and, if promising, quickly initiating the Phase 2 portion of the trial."
Continued: The Phase 1/2 clinical trial is being conducted in two parts. The Phase 1 portion is a randomized, observer-blinded, placebo-controlled trial designed to evaluate the immunogenicity and safety of NVX‑CoV2373, both adjuvanted with Matrix‑M and unadjuvanted. The trial is enrolling approximately 130 healthy participants 18 to 59 years of age at two sites in Australia. The protocol's two-dose trial regimen assesses two dose sizes (5 and 25 micrograms) with Matrix‑M and without.
Continued: The Phase 2 portion is expected to be conducted in multiple countries, including the United States, and would assess immunity, safety and COVID‑19 disease reduction in a broader age range. This Phase 1/2 approach allows for rapid advancement of NVX‑CoV2373 during the pandemic. The trial is being supported by the recently announced funding arrangement with the Coalition for Epidemic Preparedness Innovations (CEPI).
Continued: Novavax identified NVX‑CoV2373 as its lead SARS-CoV-2 candidate following pre-clinical testing that demonstrated high immunogenicity and high levels of neutralizing antibodies. These results provide strong evidence that the vaccine candidate will be highly immunogenic in humans, potentially leading to protection from COVID‑19 and thus helping to control the spread of this disease.
Gilead Sciences, Inc. (NASDAQ:GILD), looked at as the hopeful leader with remdesivir, issued an open letter from the CEO at the end of April noting, "Over the past two months we all have been waiting in hopeful anticipation for the science to speak on remdesivir. While there were clues along the way, we knew that only clinical trials could provide the answers on whether it is a safe and effective treatment for COVID-19. Today we have some initial answers."
"The results from the global, placebo-controlled trial run by the National Institute of Allergy and Infectious Diseases (NIAID) are positive. They show that patients with COVID-19 who received remdesivir recovered faster than similar patients who received placebo."
"There is still more work to do and remdesivir has not been approved, but all of us at Gilead are humbled by what these promising results might mean for patients. After years of research and hard work on remdesivir, there is relief and gratitude among our teams today that their efforts have been so worthwhile."
"This work started long before we knew about the outbreak of COVID-19. Remdesivir is the result of more than a decade of research, experimentation and iteration by Gilead scientists. In recent years, we have been studying its impact in hemorrhagic fever viruses such as Ebola, Marburg and Nipah viruses as well as other coronaviruses such as SARS and MERS. We had built up sufficient knowledge so that when the novel coronavirus emerged, we could move very quickly into clinical trials."
From testing to vaccines-the race is on, inciting innovation and opportunities for investors like never before. As Zacks Research noted, "All eyes are on pharma/biotech sector to find a treatment/vaccine for COVID-19 as they are being considered the key to bring stalled global economies back on track."
And as GlobalCitizen reported, "As the world awaits the development of treatments and vaccines for COVID-19, diagnostic testing remains the first line of defense against the virus."
LexaGene Holdings notes on its investor presentation, "Many different viral infections present with similar symptoms to COVID-19. This makes multiplex molecular diagnosis essential."
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The information set forth above contains forward-looking information, which involves known and unknown risks, uncertainties and other factors that may cause actual events to differ materially from current expectation. Important factors - including the availability of funds, the results of financing efforts, the success of technology development efforts, the cost to procure critical parts, performance of the instrument, market acceptance of the technology, regulatory acceptance, licensing issues, ability for its product to detect SARS-CoV-2 N gene RNA and obtaining FDA approval of its products - that could cause actual results to differ materially from the Company's expectations as disclosed in the Company's documents filed from time to time on SEDAR (see www.sedar.com). Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date herein.
Readers are cautioned that the information contained is not making any express or implied claims that LexaGene or technology has the ability to eliminate the SARS-CoV-2 virus at this time. We further caution that LexaGene's technology has yet to receive FDA authorization, as the company is currently pursuing this distinction.