Feasibility Arrangement for shelf-stable powder form of messenger RNA COVID-19 Vaccine Candidate announced by GreenLight Biosciences and TFF Pharmaceuticals
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 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
About TFF Pharmaceuticals
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SOURCE GreenLight Biosciences, Inc.
Company Codes: NASDAQ-NMS:TFFP