#Covid19 Global Race for Testing and Vaccines Sees #Biotechnology
Innovation (TSXV: $LXG.V) (OTCQB: $LXXGF) (NASDAQ: $MRNA) (NASDAQ: $NVAX)
(NASDAQ: $GILD) @lexa_gene @moderna_tx @Novavax @GileadSciences
Point Roberts WA,
Delta BC, June 3, 2020 - 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.
Read this news featuring LexaGene in full at https://www.investorideas.com/news/2020/biotech/06031Covid19-GlobalRace-Vaccines.asp
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.”
Visit Investorideas.com biotech and
coronavirus stocks directory https://www.investorideas.com/BIS/stock_list.asp
About Investorideas.com - News that
Inspires Big Investing Ideas Investorideas.com is a recognized news source publishing
third party news, research and original financial content. Learn about investing
in stocks and sector trends with our news alerts, articles, podcasts and videos, looking at cannabis,
crypto, AI and IoT, mining, sports biotech, water, renewable energy and more.
Investor Idea’s original branded content includes the following podcasts and
columns : Crypto Corner , Play by Play sports
and stock news column, Investor Ideas Potcasts Cannabis
News and Stocks on the Move podcast and column,
Cleantech and Climate Change , Exploring Mining the AI Eye .
Disclaimer/Disclosure: Investorideas.com is a
digital publisher of third party sourced news, articles and equity research as
well as creates original content, including video, interviews and articles.
Original content created by investorideas is protected by copyright laws other
than syndication rights. Our site does not make recommendations for purchases
or sale of stocks, services or products. Nothing on our sites should be
construed as an offer or solicitation to buy or sell products or securities.
All investing involves risk and possible losses. This site is currently
compensated for news publication and distribution, social media and marketing,
content creation and more. Disclosure is posted for each compensated news
release, content published /created if required but otherwise the news was not
compensated for and was published for the sole interest of our readers and
followers. Contact management and IR of each company directly regarding
specific questions. This stock bites news release publication is available as a paid for service on Investorideas.com https://www.investorideas.com/News-Upload/ Disclosure:
This article featuring LexaGene Holdings is a paid for service by a third party (
two thousand five hundred) More disclaimer
info: https://www.investorideas.com/About/Disclaimer.asp Learn
more about publishing your news release and our other news services on the
Investorideas.com newswire https://www.investorideas.com/News-Upload/ and
tickertagstocknews.com Global investors must adhere to regulations of each
country. Please read Investorideas.com privacy policy: https://www.investorideas.com/About/Private_Policy.asp
Get free investor news alerts
Contact Investorideas.com
800 665
0411
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.
