-- Feasibility Arrangement to test GreenLight Bioscience Inc's
COVID-19 messenger RNA vaccine candidate as a shelf-stable dry
powder formulation using TFF Pharmaceuticals' Thin-Film
Freezing technology.
-- An easily reconstituted and shelf-stable dry powder
formulation of messenger RNA COVID-19 vaccine could overcome the
extreme low temperature cold chain requirements for current RNA
vaccines.
-- Eliminating extreme cold from the supply chain simplifies
global distribution and opens vaccine availability to the large
populations in regions and countries with limited refrigeration
infrastructure.
-- Should the study prove successful, the next phase may include
non-needle administration of mRNA vaccines, including nasal spray
and lung inhalation form.
MEDFORD, Mass. and AUSTIN, Texas, March 9,
2021 /PRNewswire/ -- Two biotech companies have
partnered for feasibility studies aimed at opening broader global
vaccine distribution through production of a shelf-stable powder
form of messenger RNA Covid-19 vaccine that would be easily
reconstituted prior to injection and not require the extreme cold
chain of current RNA vaccines.
While messenger RNA Covid-19 vaccines have proved among the
fastest to develop, produce and adapt to new variants of concern,
maintaining stability has required supply chain temperatures for
some vaccines as low as -80°C (-112°F).
This requirement for extreme cold increases distribution
complexity, cost and also constrains vaccine distribution to
regions and countries with limited cold chain infrastructure.
To address this challenge, GreenLight Biosciences Inc, a
privately-held RNA vaccine developer and manufacturer, and TFF
Pharmaceuticals, Inc. (NASDAQ: TFFP), have entered into a
feasibility and material transfer agreement to evaluate a
shelf-stable dry powder formulation of GreenLight's COVID-19
messenger RNA vaccine candidate.
"We are excited to partner with GreenLight Biosciences on their
unique RNA production platform," said Glenn
Mattes, President & CEO of TFF Pharmaceuticals. "Their
messenger RNA production platform represents a breakthrough in
efficient production of messenger RNA vaccines, and by combining
both of our technologies, this collaboration could be a real game
changer for people around the world suffering through this
pandemic."
Should the feasibility study prove successful, a further stage
of work will include non-needle administration methods for the
GreenLight mRNA vaccine candidate in a dry powder form that
could be administered via nasal spray or lung inhalation.
Under the Feasibility Agreement, GreenLight Biosciences is
delivering its COVID-19 messenger RNA product candidate materials
to TFF in order to perform feasibility formulation work and
testing.
The goal of this feasibility work is to formulate and identify
an optimal formulation of the GreenLight Biosciences messenger RNA
product candidate in a dry powder form, which has superior
stability, maintains particle size of the
encapsulated messenger RNA as well as high encapsulation
efficiency and has rapid reconstitution characteristics for
injection.
If successful, this should make messenger RNA vaccines available
to the whole world simplifying cold chain supply challenges. Thin
film technology potentially allows vaccines to be transported at
fridge, or even room, temperatures as a powder. It can then be
reconstituted by a health care worker at the point of use.
This agreement is part of GreenLight Biosciences goal of using
its unique manufacturing platform to produce vaccines in volumes
that can serve the world's need for billions of doses. This
partnership offers the hope of speeding these doses into use.
"Overcoming the COVID-19 pandemic requires a large volume of
second generation vaccines that adapt rapidly and can be delivered
to all parts of the world, regardless of local cold chain
infrastructure," said Andrey J.
Zarur, Ph.D, CEO of GreenLight Biosciences. "Thin Film
Freezing has the potential to deliver on this promise by
reformulating the complex messenger RNA molecules of our vaccine
candidate into a shelf-stable powder readily reconstituted by a
healthcare worker just prior to injection."
TFF has two candidates in phase one clinical trials,
Voriconazole Inhalation Powder and Tac-Lac Inhalation Powder. TFF
requires about six weeks from receipt of materials to prepare an
initial dry powder form of GreenLight's vaccine candidate to test
for reconstitutability and viability.
About GreenLight Biosciences, Inc.
GreenLight
Biosciences has several messenger RNA Covid vaccine candidates in
development, are built off of GreenLight's manufacturing
platform, which delivers high-quality RNA at a lower cost and
higher speed than comparable processes.
GreenLight is a bio-performance company with a unique, cell-free
production platform that delivers high-performing RNA solutions to
human, plant and animal challenges. GreenLight develops RNA
products for plant and life science applications, and collaborates
with industry leaders to advance vaccine development, pandemic
preparation, crop management, and plant protection. The GreenLight
team is committed to social justice, diversity, inclusion, and
equality, and promises to use collaboration to remain
scientifically imaginative and passionately focused on making a
difference in the world. For more information, visit
https://www.greenlightbiosciences.com/.
About TFF Pharmaceuticals' Thin Film Freezing technology
platform
TFF Pharmaceuticals' Thin Film Freezing (TFF)
platform was designed to improve the solubility and absorption of
poorly water-soluble drugs and is particularly suited to generate
dry powder particles with properties targeted for inhalation
delivery, especially to the deep lung, an area of extreme interest
in respiratory medicine. The TFF process results in a "Brittle
Matrix Particle," which possesses low bulk density, high surface
area, and typically an amorphous morphology, allowing the particles
to supersaturate when contacting the target site, such as lung
tissue. Based upon laboratory experiments the aerodynamic
properties of the particles are such that the portion of a drug
deposited to the deep lung has the potential to reach as high as 75
percent.
About TFF Pharmaceuticals
TFF Pharmaceuticals,
Inc. is a clinical-stage biopharmaceutical company focused on
developing and commercializing innovative drug products based on
its patented Thin Film Freezing, or TFF, technology platform. Early
testing confirms that the TFF platform can significantly improve
the solubility and absorption of poorly water-soluble drugs, a
class of drugs that comprises approximately one-third of the major
pharmaceuticals worldwide, thereby improving their
pharmacokinetics. TFF Pharmaceuticals has two lead drug
candidates: Voriconazole Inhalation Powder and Tac-Lac Inhalation
Powder. The Company plans to add to this pipeline by collaborating
with large pharmaceutical partners. The TFF Platform is protected
by 42 patents issued or pending in the US and internationally. To
learn more about TFF Pharmaceuticals and its product
candidates, visit the Company's website
at https://tffpharma.com.
Safe Harbor
This press release contains
forward-looking statements regarding TFF Pharmaceuticals,
Inc., including the benefits of the Company's TFF platform and its
dry powder versions of GreenLight Bioscience Inc's COVID-19
messenger RNA vaccine candidate. Those forward-looking statements
involve known and unknown risks, uncertainties and other factors
that could cause actual results to differ materially. Among those
factors are: (i) the risk that GreenLight Bioscience may not be
able to successfully conclude clinical testing or obtain pre-market
approval of its COVID-19 messenger RNA vaccine candidate,
(ii) the risk that GreenLight Bioscience and the Company may
not be able to produce a dry powder version GreenLight Bioscience
Inc's COVID-19 messenger RNA vaccine candidate, (iii) the risk that
GreenLight Bioscience and the Company may not be able to
successfully conclude clinical testing or obtain pre-market
approval of a dry powder version GreenLight Bioscience Inc's
COVID-19 messenger RNA vaccine candidate, (iv) no drug product
incorporating the TFF platform has received FDA pre-market approval
or otherwise been incorporated into a commercial drug product, and
(iv) those other risks disclosed in the section "Risk Factors"
included in the Company's prospectus supplement filed with
the SEC on December 8, 2020. TFF
Pharmaceuticals cautions readers not to place undue reliance
on any forward-looking statements. TFF
Pharmaceuticals does not undertake, and specifically
disclaims, any obligation to update or revise such statements to
reflect new circumstances or unanticipated events as they occur,
except as required by law.