All Eyes on #Biotech #Stocks -Sector Snapshot; (TSXV: $LXG.V)
(OTCQB: $LXXGF) (NASDAQ: $MRNA) (NASDAQ: $NVAX) (NASDAQ: $GILD)
Point Roberts WA,
Delta BC, June 4, 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.
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.
