Happy New Year from all of us at MVMD! Our team is very excited about what’s in store in 2022 as we continue to advance our pursuit of “More Life”. We continue to be united and driven in our belief that every human, husbandry and companion animal, no matter who they are or where they live, deserves to live their best life, free from the tragedies of disease.
Our team had a very strong finish to 2021 on both the science advancement and our business development efforts. In December, I traveled extensively with key members from our management team to Peru, Colombia, and the United States. With previous COVID restrictions impacting our normal travel patterns, it was a great window to advance some of our strategic initiatives before returning to Canada late on December 23rd in time for the Christmas holiday with my family.
We had very successful meetings in South America with key partners to discuss pharmaceutical husbandry sciences, as well as the application of our technology to nutraceutical and cannabinoid products in these markets. In the United States, we were able to meet with our final short list of manufacturing partners for our licensee production requirements, and we are currently finalizing a master manufacturing agreement that will enable us to formally commence GMP production with our partners Circadian Wellness and Red White and Bloom Brands. Securing this key manufacturing partner is also important for our broader nutraceutical business development push in 2022. Critical to these meetings was ensuring the protection of our patents and trade secrets so we can have one master manufacturer for our North American licensee products.
Kicking off 2022, our Chief Medical Officer, Dr. Rana, is currently with key members of our team in Bangladesh to finalize elements of our Soluvec™ 1% husbandry animal science development, pharmaceutical production and commercialization strategies. The team is also overseeing the conduct and planning of our farmed fish trials in person with The People's Republic of Bangladesh’s Ministry of Fisheries & Livestock. Updates from the team have been very encouraging and we continue to look forward to positive outcomes in Bangladesh that we believe will have a material impact on our business in 2022.
Every quarter since we have been publicly traded, I work on the Management Discussion and Analysis (MD&A) with our management team for filing with the securities commission. The MD&A is a document where executives analyze the company's performance, discuss compliance, risks, and any future plans. For those that have not had a chance to review our most recent filing, I have summarized some key updates from the MD&A covering oncology, cold chain, farmed fish, dose sparing adjuvant, insulin and our COVID-19 research, and development. All of that information is included below my signature in this email for those that wish to review in greater detail.
As you can see, we have a lot of amazing projects and science advancements and we remain squarely focused on solving the most significant human and husbandry animal health problems facing our global population. I thank our team members at MVMD for pushing new boundaries every single day, our extensive research partner network, our key science advisors and our shareholders for all of the ongoing support.
We couldn’t be more honoured to drive forward this important work.
President & CEO, MVMD
As outlined late last year, MVMD’s initial oncology studies presented some noteworthy exploratory findings that have resulted in the expansion of our oncology work to explore human cell line tumors with further investigational research studies currently being executed. We have focused on expanding our relationships with experts in clinical and research focused oncology to pursue advanced understanding of how our Quicksol™ technology applications could be applied across a broad array of cancer types. Additionally, MVMD is looking at modeling impact of new molecules that could positively impact innovation in cancer treatments. Given the devastating impact of cancer globally, this entire area of our research and development is so important against our mission of “More Life”.
We remain very excited about our work in cold chain and our vision of impacting the current limitations and wastage incurred across a temperature-controlled supply chain for transport, storage, and handling of vaccines and drugs. Last year we made some very strong advancements in our preservation attempts to test if we could apply a thin Quicksome™ desiccated liposome layer of Trivalent Inactivated Poliovirus Vaccine (tIPV) inside a vial for five days of exposure at 40 degrees Celsius and then reconstituted for injection at the point of administration. This proprietary approach yielded extremely positive results and we have commenced additional characterization studies to optimize both the technology application in the current Trivalent Inactivated Poliovirus Vaccine (tIPV) work, as well as expansion to additional vaccines and proteins. MVMD believes the technology would allow for long term stability and ease of global distribution, appropriate for pandemic preparedness, and other administration and distribution advantages, including potential sublingual applications that would eliminate the use of needles where desired.
As outlined above, MVMD is working with the Ministry of Fisheries in Bangladesh, which engaged MVMD to evaluate whether a combined application of both our Quicksol™ and Quicksome™ technologies to a novel fish food application would be able to reduce the effect of parasitic infections across a variety of farmed fish species. Preliminary toxicity studies in different fish species are currently being completed with our team in Bangladesh, and the next phase of trials are being planned, aiming to complete in the first quarter of 2022.
DOSE SPARING ADJUVANT
Adjuvants are well known pharmacological or immunological agents that improve the immune response of a vaccine, which are added to a vaccine to boost the immune response to produce more antibodies and longer-lasting immunity, thus minimizing the dose of antigen needed. The purpose of MVMD’s PANA process is to produce stable nano-particulate adjuvant with the intention of overcoming certain limitations of traditional aluminum-based adjuvants and allowing for the use of smaller doses of vaccine without a reduced immune response and the delivery of vaccines to a greater population, including those that may have limited to no access.
In partnership with the Tulane University School of Medicine in New Orleans, Louisiana, we executed a study comparing an existing Alhydrogel adjuvant to the Company’s invented stable nano- particulate adjuvant by both intramuscular injection and intradermal injection immunization. The study evaluated the antibody responses following vaccination with fractional doses of IPV and compared delivery types with IPV alone or adjuvanted. The evaluation of MVMD’s novel aluminum nanoparticle adjuvant from this study demonstrated no toxicity or adverse reactions when combined with tIPV in intramuscular or intradermal injection. However, the initial results were not satisfactory in terms of producing a robust response or desired elevation in the immune response over IPV alone.
MVMD continues to work with its key advisors and Tulane University to explore if changes in the adjuvant development and administration may support a positive research outcome. We will continue this work through the first half of 2022 to evaluate the impact of these key changes, with respect to IPV and other vaccines, in several models of interest from both a scientific and commercialization standpoint.
We believe that despite significant innovation in recent years in relation to diabetes, insulin remains a cornerstone of treatment and that there is an unmet need in the insulin space, resulting from challenges such as costs, the use of needles, hypoglycemia, and fear of injection. We are advancing our exploration of the application of our key Quicksome™ technology to the needleless administration of insulin. MVMD is currently planning the execution of formulation experiments, to optimize the potential delivery of rapid-acting human insulin in a sublingual format. In addition to the experimental work, we are actively engaging clinical experts in insulin science to support planning of necessary trials. This is advanced and very important work and we expect to have further information on formulation developments in the second half of 2022.
MVMD has shared our exploration work for the application of a solubilized form of ivermectin in the potential treatment of COVID-19. Early in the year, we announced the results from our third-party Bio Safety Level 4 (“BSL-4”) COVID-19 viral clearance study conducted with its solubilized Ivermectin technology, Soluvec™. It is MVMD’s view based on an internal review of publicly available literature, that the positive indicators from the BSL-4 trials are consistent in general with other global trials and contribute to evidence for the effect of ivermectin on inhibition of viral replication and the potential application as a treatment for COVID- 19. We have previously shared that MVMD was evaluating joining a human trial in Brazil to test the effectiveness of our solubilized ivermectin, but made the decision to pause this work due to challenges with the design of the study. Due to the complexity and cost of human ivermectin trials, as well as the global political landscape for approval of treatments for COVID-19, we are currently working to evaluate the business case for further studies in humans, with academic and non-academic partnerships, in those jurisdictions which may have less access to vaccines and other treatments. This is a complicated pathway but we anticipate clarity on the business direction, including necessary budgets, partnerships and a pathway for data generation, in the first half of 2022.
Earlier in 2021, MVMD publicly confirmed our ability to create a solubilized Selamectin product using our patented Quicksol™ technology applied to the macrocyclic lactone drug class. MVMD believes that Selamectin, a highly insoluble molecule, has tremendous potential in treating mycobacterium-based infections in humans and animals.
As a result of the solubilization achievement, which we believe to be a critical achievement to allow formulation of different applications, MVMD confirmed that it was finalizing a study framework to apply its novel Selactosol™ 1.5% for preclinical evaluation trials targeting mycobacterium-based infections, namely Tuberculosis. Tuberculosis affects roughly 25% of the world’s population and is the leading infectious disease killer in the world, claiming approximately 1.5 million lives each year. An initial trial design has been developed and MVMD is in ongoing discussions with CRO partners on approach, cost and timing of the study. We anticipate that we will make a final decision to proceed or delay early this year.
President & CEO, Mountain Valley MD