Good morning. I am very pleased to share some very exciting progress related to one of our key technology initiatives – Cold Chain. This morning we have distributed a media release announcing the results of our recent controlled cold chain evaluation of our Quicksome™ desiccated liposome technology.
OUR UNIQUE APPROACH TO COLD CHAIN
MVMD’s recent approach to cold chain is very unique. We “lay down” a thin Quicksome™ desiccated liposome film of Trivalent Inactivated Poliovirus Vaccine (tIPV) inside a vaccine vial, transporting the vial outside of cold chain and then reconstituting the contents with distilled water for injection at the point of administration. Trivalent IPV is composed of three unique serotypes of inactivated polioviruses. Each of the serotypes needs to be preserved outside of cold chain to constitute tIPV and thus each is evaluated in our process. We were asked to look at this approach in business development conversations with a pharmaceutical partner and this was MVMD’s first attempt at advancing this approach.
COLD CHAIN EVALUATION RESULTS
The recent trivalent IPV stability evaluation was conducted to assess the preservation efficacy of our technique and involved subjecting tIPV to 40 degrees Celsius over a five day period. With IPV serotype two we achieved 100% preservation and stability. With IPV serotypes one and three, we achieved 50% preservation and stability. Simply put, we have a bit of work to do on serotypes one and three and we successfully accomplished the objective on serotype two.
The 100% preservation and stability of IPV serotype two exceeds the World Health Organization’s guideline temperature requirements for all three defined vaccine management categories including traditional cold chain between +2°C and +8°C, Extended Controlled Temperature Conditions (ECTC) above +8°C for a specified number of days to support vaccine distribution, and Controlled Temperature Chain (CTC) where the vaccine must be able to tolerate ambient temperatures of at least +40°C for a minimum of 3 days.
Previously MVMD has achieved 100% preservation of all three serotypes in a thin film format up to 30°C so this advancement is pursuing the extreme CTC requirements that we believe necessary to transform the category.
IPVserotypes one and three will be the focus of the next phase of evaluation the company will conduct by focusing on lowering residual moisture content, achieving more robust liposomal protection, and faster drying of the mixture within the vial. Our objective is to achieve full CTC compliance at 40°C for tIPV polio vaccines in a vial format that can be reconstituted at the point of administration for injection, and we are immediately commencing this work with the Food and Drug Administration (FDA) Polio Lab under our recently signed collaborative research agreement.
Our initial preservation achievement of IPV serotype two we believe is a proxy that we can apply to other vaccines in our future work as well.
WHAT ARE WE LOOKING TO SOLVE WITH OUR COLD CHAIN WORK?
Cold chain is a temperature-controlled supply chain that prescribes necessary conditions during the transport, storage, and handling of vaccines to preserve a temperature range between +2°C and +8°C from the time the vaccine is produced until it is administered. Current estimates place cold chain biopharma logistics spending for 2020 at USD $17.2 billion annually, with costs due to failures in temperature-controlled logistics estimated at approximately USD $35 billion per year, and in most cases representing over half of a vaccine’s cost. The WHO estimates that more than 50% of vaccines are wasted globally every year due to temperature control, logistics and shipment-related issues.
You can access the full media release on our website:
Our Quicksome™ technology has taken an important step forward in our pursuit to change the global vaccination landscape and provide more certainty of vaccine distribution to the most disadvantaged communities in the world. With the planned work in the coming months on our tIPV project, we feel our Quicksome™ technology is progressing positively towards our vision of reducing the complexity, wastage and significant costs associated with cold chain distribution.
There are so many exciting projects that we are advancing at an unprecedented pace and I could not be prouder of our team and our key partners. Today’s news is another significant validation of our science and our ability to progress quickly towards solving real health and wellness problems.
Thank you to all of you for your ongoing support of our transformational work!
President & CEO, Mountain Valley MD