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Tuesday, August 06, 2019 4:45:33 AM
Mymetics $MYMX FULL DD & Potential Catalyst
MYMETICS CORPORATION
Founded in 1990.
Mymetics Corporation is US registered biotechnology company with its main offices in Switzerland and the Netherlands. Focused on developing next generation vaccines for infectious and life threatening diseases. Mymetics core technology and expertise are in the use of virosomes, lipid-based carriers containing functional fusion viral proteins in combination with rationally designed antigens and membrane proteins. Mymetics currently has the following vaccines in its pipeline: HIV/AIDS. intranasal Influenza, RSV, Malaria and Chikungunya and collaboration projects in the allergy and cancer immunotherapy field.
Objective: "Build small / medium size innovative R&D virosome vaccine company with strong
partnerships, Phase II – III clinical vaccine pipeline and have optionality for M&A or sale."
PIPELINE:
1. RSV Prophylactic. Back in 2013/2014 Mymetics was engaged with Astellas Pharmaceuticals (Japanese) to collaborate and develop a Virosome RSV Vaccine. Mymetics received a $5,000,000.00 upfront payment. Mymetics stood to receive up to $82 million in upfront and milestone payments for its technology for RSV through a licensing deal. I also read in the filings that is was to be "Double-Digit Royalties upon commercialization."
This deal was terminated in 2016:
“Due to fast evolving market dynamics in the RSV vaccine market and in particular the development by several major pharma companies of promising candidates already at clinical stage, we have decided to focus our priorities on other areas and therapeutic needs,” said George Siber, MD Chief Scientific Officer of RSVC. “We’re very appreciative of the efforts by the Mymetics team to advance the project.”
“While being terminated, this partnership has nevertheless allowed Mymetics to further strengthen its know-how and expertise in the RSV field and enveloped viruses. We will build on this to create additional value for virosome based vaccines for infectious diseases,” said Ronald Kempers, CEO of Mymetics
And Strengthen their expertise they did. In 2018 Mymetics announced the...
"Development of a Virosomal RSV Vaccine Containing 3D-PHAD® Adjuvant: Formulation, Composition, and Long-Term Stability." https://www.ncbi.nlm.nih.gov/pubmed/29971500
https://www.mymetics.com/media-center/development-virosomal-rsv-vaccine-containing-3d-phad-adjuvant-formulation-composition-and-long-term-stability/
RSV TARGET POPULATION AND MARKET SIZE
Mymetics RSV vaccine candidate is targeting the elderly population, representing a target population in the Western world of about 150 million. The potential RSV vaccine sales is estimated between USD 1. 2 and USD 1.5 billion USD a year and is thereby one of the few remaining vaccines with block-buster potential.
No vaccine is currently approved for respiratory syncytial virus, or RSV
ENCOURAGING RESULTS
In pre-clinical studies Mymetics’ vaccine has shown strong safety and immunogenicity and the vaccine did not induce enhanced disease, while mice and cotton rats were completely protected against a live virus challenge.
If you would like to read about the competition and how far along they currently are with RSV vaccine development you can read about it here:
https://www.healio.com/pediatrics/vaccine-preventable-diseases/news/print/infectious-diseases-in-children/%7B8c78b63a-2b98-47d5-b353-e7a83c64dfcd%7D/rsv-vaccine-development-about-to-enter-golden-age?page=6
POTENTIAL FOR GROWTH
New research indicates that the respiratory syncytial virus (RSV) market is expected to grow from $418.6 million in 2018 to $5.39 billion by 2028 across the seven major markets (7MM: USA, France, Germany, Italy, Spain, UK and Japan) at a compound annual growth rate (CAGR) of 29.1%.
I believe there is potential here to strike a new licensing and collaboration agreement with another Big Pharma sponsor in the near term to initiate a new partnership. The niche market for the elderly should give us relevance if the vaccine makes it to clinical trials. Near term we could see an upfront payment, then milestone payments (phase 1,2,3), and eventually royalties on potential sales in the billions-- should MYMX make a new partnership with their RSV vaccine.
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2. HSV Virus: On hold for now. Not much is known about the status of this Pre-clinical Vaccine.
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3. Influenza Intra-Nasal Application Prophylactic. Mymetics originally licensed their Influenza vaccine to Solvay Pharmaceuticals. The Product being developed was called: Influvac TC (the cell-cultured version of Influvac) Solvay had made plans to spend 50 million euros in order to ramp up production of this particular "TC" version of influvac. Solvay was suddenly bought by Abbott and Abbott apparently did not want to invest their money into this. You can read more about it here in my previous post:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=141909826
Some 10 years ago, Solvay was the clear leader in the development of a cell-based seasonal influenza vaccine. Its cell-based version of Influvac, named Influvac TC, was approved in the Netherlands in 2001 as the first vaccine to be manufactured in MDCK cells. However, despite benefiting from a $298m US grant which it received in 2006 for the development of Influvac TC, Solvay failed to capitalize on this competitive advantage in the following years.
https://www.biospace.com/article/around-the-web/datamonitor-report-abbott-laboratories-s-flu-vaccine-business-may-represent-a-good-deal-for-acquisitive-drug-makers-/
Influvac (Which is now owned by Mylan because a deal they made with Abbott) was making sales as of recent and it is of my opinion that if Abbott did not buyout Solvay at the time they did, Mymetics would have made multiple millions of dollars on their "TC" version of the vaccine and still be collecting royalties today.
In December 2016 Shares of Mymetics spiked to .085 on a few million shares traded due to news that Sanofi announcing they would be collaborating with Mymetics on "Evaluating Mymetics Intra-nasal Influenza Vaccine."
Ultimately in late 2018/ early 2019 Sanofi decided to no longer purse this with Mymetics. However Mymetics had this to say in the most recent Annual Report:
"The results were positive for most of Mymetics virosome formulations, some virosomes generated significantly higher HA inhibition (HAI) titers and good antibody titers. Although this study was successful and the Company has discussed the results with Sanofi, Mymetics for the time being will not be continuing its collaboration with Sanofi due to other priorities of Sanofi. We are evaluating the possible publication of the results."
Then shortly after, this statement appeared on the Mymetics website:
During 2017 and 2018 Mymetics partnered with Sanofi to test different influenza virosome formulations with different HA And NA concentrations in pre-clinical mice models. Although the first study did not trigger the results that were expected, a second study corrected this and showed good and improved HAI titers. Due to changes in strategy at Sanofi this project is currently not advancing with Sanofi and Mymetics is taking this further by itself.
What I believe happened, is that Sanofi was "interviewing" Mymetics and at the same time as "Protein Sciences" for potential buyout or license... they ended up going with Protein sciences and their "Flu-Bok" vaccine instead of Mymetics and just flat out bought Protein Sciences. (Sanofi completes acquisition of Protein Sciences http://www.news.sanofi.us/press-releases?item=137157";)
Nevertheless. Mymetics claims it will take this further by itself. We are unaware of the current plans for this path forward. It remains a mystery as to whether or not they will attempt a new partnership for this application. The filing states: "influenza for elderly which has finished a clinical trial Phase I"
Influenza vaccine market size was estimated to grow from USD 4.9 billion in 2017, to reach USD 11.4 billion by 2025, at a CAGR of 11.0% from 2018 to 2025.
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4. HIV-1 Prophylactic. This is a very promising Vaccine. The preclinical studies done have shown amazing results. You can read about them here: https://www.mymetics.com/vaccine-pipeline/hiv-aids/
Now more studies are being done and funded by the NIH, and the first results are expected to be reported in 2020.
Epalinges, Switzerland, April 29, 2019 ...announced today that the National Institutes of Health (NIH) has awarded Mymetics and Texas Biomedical Research Institute (Texas Biomed) a five-year grant for the project called “Cold Chain-independent, Needle-free Mucosal Virosomal Vaccine to Prevent HIV-1
Acquisition at Mucosal Levels”.
You can read more about it here: https://www.mymetics.com/media-center/mymetics-receives-funding-nih-novel-hiv-vaccine-study/
Over the years, the rising prevalence of HIV disease worldwide has positively influenced the demand for HIV drugs. HIV drugs help in preventing the multiplication of HIV virus, thereby reducing the risk of its transmission.
According to a report, the global HIV drugs market exceeded a value of US$ 24.7 Billion in 2018. Looking forward, the market value is projected to reach US$ 22.5 Billion by 2024, declining at a CAGR of 2.5% during 2019-2024. https://www.globenewswire.com/news-release/2019/04/16/1804569/0/en/HIV-Drugs-Industry-Insights-Forecast-to-2024-The-Market-Will-Decline-at-a-CAGR-of-2-5-during-2019-2024.html
The adjuvanted HIV candidate powder form vaccine, to be administered by capsules or nasal spray, will first require a toxicology study, before human clinical trials (Phase I/II trial, then a Phase III trial with at least 10 000 volunteers).
Currently the NIH has given funding to Mymetics for the pre-clinical studies. The overall portion of the NIH grant allocated to the Company is USD 6.76 million, with USD 1.2 million approved for the first year (2019).
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5. Malaria. Mymetics has two Malaria Vaccines. The most recent annual report states:
"Mymetics is currently evaluating possible the further development of a malaria vaccine in collaboration with PATH-MVI and LMIV. In parallel, Mymetics is in collaboration with the Swiss Tropical and Public Health Institute and researchers at Oxford University to add two important antigens for a possible malaria vaccine candidate, the RH5 and the CyRPA peptides and has received access to EU supported laboratories under the Transvac2 program to execute the development of the tetra-valent malaria vaccine candidate and test this in pre-clinical studies in 2019."
(RH5 and CyRPA with Swiss TPH)
Sep. 2015 - Start of exploratory study of two new malaria antigens with Swiss Tropical & Public Health Institute and University of Zurich. (From the Company Overview)
Development of a Virosomal Malaria Vaccine Candidate
A promising concept of malaria vaccines are reconstituted influenza virosomes which display synthetic peptides of P. falciparum target antigenes on their surface. Recently, a new formulation incorporating two synthetic peptides has been demonstrated safety, immunogenicity and pilot efficacy in humans. However, we assume that a highly effective malaria subunit vaccine has to incorporate more than two components. Goal of this project is to develop additional peptide mimetics derived from the novel blood stage antigens CyRPA and RH5 and to evaluate their protective efficacy in an innovative P. falciparum infection mouse model.
https://www.swisstph.ch/en/topics/malaria/malaria-vaccines/
STATUS
Since 2017 Mymetics is developing an improved second malaria vaccine candidate, which includes besides the existing antigens, two other possible antigens which will cover the complete life cycle of the parasite in humans. This vaccine candidate is being developed with funds from the EU and collaborations with the NIH, MVI, the University of Oxford and the Swiss Tropical and Public Health institute.
Pre-clinical data is expected in the second half of 2019.
The transmission blocking malaria vaccine, is in its preclinical stage and Mymetics collaborates with the NIH and LMIV to further advance this promising vaccine.
The first initial results from the study showed that the virosome vaccine candidates, at the highest dose tested, generate high antibody titers against the required antigens and they were able to significantly reduce (97-100%) the transmission of the Plasmodium falciparum parasite.
Pending the pre-clinical results, Mymetics will evaluate funding opportunities for further development of these two vaccine candidates, which are based on the virosome platform.
https://www.mymetics.com/vaccine-pipeline/malaria/
Market Size and Forecast (2016-2024)
Global malaria vaccines market was valued at USD 0.07 billion in 2016 and is expected to witness a modest CAGR during the forecast period (2016 – 2024). It is projected to reach USD 0.6 billion by 2024.
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6. Allergy Immunotherapy. In April 2018 Mymetics announced that it signed an agreement for a feasibility study with Anergis SA to evaluate the use of virosomes for the for the ultra-fast allergy immunotherapy against birch pollen.
In December 2018 Anergis and Mymetics announced that the pre-clinical proof-of-concept study for birch pollen allergies, met all the success criteria.
Anergis SA has now a time limited exclusive option to sign a License and Collaboration Agreement with Mymetics to license the virosome technology from Mymetics.
In October 2018 I found this video on Youtube:
https://www.youtube.com/watch?v=mzO6ZqyMe4U
In the Video, the CEO of Anergis discusses how the market for Allergy Immunotherapy is projected to be $15 Billion USD by the year 2027 at 1:37 seconds into the video. He also describes how he believes his company can capture 2-4 Billion dollars of this market in realized annual revenues. He also discusses the potential partnership with Mymetics throughout the whole video as the whole purpose of his fundraising activity is to initiate the "2nd generation" of his allergy vaccines.
An 8k was filed with the SEC in april 2018 which states:
"In the event that the results of the pre-clinical study program are successful, Anergis has the option to obtain an exclusive worldwide license of Mymetics’ virosome technology for the development of allergy vaccines. Should Anergis and Mymetics execute a License and Collaboration Agreement (LCA), Anergis would make an upfront payment to Mymetics in an amount that increases as the date of executing the LCA is delayed, milestone payments based on certain regulatory clearances and royalties for net sales."
It is of my opinion, that due to the evidence in the youtube video, I believe they will sign the LCA, I believe the upfront payment will be for multi-millions of dollars, and I believe it will happen any day now.
There are conflicting reports on how long this will take. But I will not believe anything other than what comes out of the CEO's mouth here in this video. Watch the entire video to see their projected timelines and what to expect. I also believe the deal will be for "Double-Digit royalties on net sales" which ultimately means that if the Allergy vaccines are successfully commercialized, Mymetics would receive a large amount of money that could be upwards of several hundred million dollars over the lifetime- in royalties depending on how well the sales are and how long sales would take place. This video was taken at the Sachs Investor conference. Mymetics was present at this conference. This conference' purpose was obviously to raise money in a room full of venture capitalist for series funding.
In the past Anergis has successfully raised apx. 50 Million USD.
https://www.crunchbase.com/organization/anergis#section-overview
One of our great board members here pointed out how Sten Verland, PHD. is on the B.O.D. of Anergis and was a founder of one of the main funding organizations involved in previous rounds of funding.
http://www.anergis.ch/about-us/board-of-directors/38-sten-verland-phd.html
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7. Cancer Immunotherapy. Mymetics' virosomes, enveloped virus like particles, are able to trigger both specific CD4+ and CD8+ T cells, as virosomes are processed by dendritic cells and presented to both MHC Class I and MHC Class II pathways.
As virosomes have a proven safety track record and Mymetics is able to produce these at GMP, it is a very attractive choice to increase specific T-cells for cancer treatment through incorporating specific cancer antigens and combining these with other treatments like check point blockade or check point inhibitors.
Mymetics is currently engaged with several small biotech companies in the oncology field to evaluate the improvements that can be generated in pre-clinical studies.
Mymetics is actively seeking additional partnerships to enhance existing cancer immunotherapies by use of the virosome VLP platform.
16-10-2018 - Mymetics Corporation, has entered into a research collaboration project
with eTheRNA immunotherapy NV, a clinical stage biotech company developing novel mRNA cancer
immunotherapies. https://www.etherna.be/
https://www.mymetics.com/media-center/mymetics-starts-research-collaboration-project-cancer-immunotherapy-etherna/
Global oncology market to reach $200 BILLION by 2022: Iqvia report
https://www.outsourcing-pharma.com/Article/2018/05/29/Global-oncology-market-to-reach-200bn-by-2022-Iqvia-report
With a $200 Billion dollar market, one hint of Mymetics virosomes successfully becoming the delivery system for eTheRNA based TRI-Mix cancer vaccines will surely bring much wanted price appreciation to the shares of $MYMX. Here is more research I have done on this matter: https://investorshub.advfn.com/boards/read_msg.aspx?message_id=147408322
We don't know when they will report updates to us on this, but we pray they are positive when they do. I will leave you with this statement:
“mRNA-based therapies have a unique potential to enhance cancer immunotherapy. For mRNA to reach its target, the cellular cytosol and have an optimal effect, the selection of an appropriate delivery vehicle is key. As viruses have evolved highly effective mechanisms to deliver their nucleic acids across cellular membranes, we believe Mymetics’ virosomes might synergize with our mRNA platform and thus further boost the potency of eTheRNA’s mRNA immunotherapies,” stated Peter Tomme, head of preclinical development of eTheRNA.
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8. Chikungunya virus (CHIKV): There are no vaccines available for Chikungunya although there are several in development, of which one is in a clinical trial Phase II. Mymetics’ novel approach in CHIKV vaccine development is the generation of virosomal vaccines using the CHIKV envelope glycoproteins produced in insect cells. Virosomes are reconstituted viral envelopes, consisting of membrane lipids and viral spike glycoproteins. The external surface of the virosome resembles that of a virus particle, with spike (glyco) proteins protruding from the lipid membrane. Virosomes lack viral genetic material. The advantage is that highly purified CHIKV spikes (expressed in insect cells) will be used to constitute the virosomes. Thus, insect cell material (DNA, proteins) will be completely absent from the virosomal vaccine material. CHIKV spikes can be obtained from different sources: VLPs, from baculovirus virions or from the plasma membrane of insect cells.
Jan. 2016 to date: Mymetics has started the discovery phase of this project where we are assessing the overall CHIKV glycoprotein yields in scale up insect cell culture. In this project we have worked with the University of Wageningen in the Netherlands that has extensive expertise in this field. The project has been delayed due to other priorities and the aim is to start preclinical animal studies during 2019 if resources are available.
We are not sure if they will launch studies this year, however I think we can not underestimate the potential marketing and/or partnership capabilities for this Vaccine.
https://www.marketwatch.com/press-release/chikungunya-fever-market-2018-highlight-demand-for-quinine-related-drugs-cagr-of-586-with-leading-vendors-and-foreseen-to-2023-2018-04-26
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9. Cold-Chain Independent Virosome Based Vaccines.
Developing a thermostable needle-free vaccine
Most vaccines are highly vulnerable to damage. If not stored at the recommended temperature, they can become ineffective. MACIVIVA has developed a thermostable vaccine in powder form which supports high temperature variations, and is administered by capsules or nasal spray.
With few exceptions, commercialized vaccines are generally delivered by injection through the intramuscular or subcutaneous route.Vaccines contain immunogens classically found within a large variety of biological compounds such as peptides, proteins, glycoproteins and sometimes carbohydrates and lipids.These immunogens may trigger the immune system for producing antibodies and/or cytotoxic T cells for preventing the pathogen transmission or blocking and/or slowing down the disease progression.
However, these vaccines generally exist as liquid formulation that are inherently prone to physical and/or chemical modifications. The cold chain storage is still fundamental for preserving the
bioactivity of most liquid and freeze-dried vaccines. For reconstituted freeze dried vaccines, they harbor important instability and must be used within hours and kept refrigerated. Vaccine degradation generally takes place during shipment and/or storage of liquid or lyophilized products, which may affect the immunological properties of the immunogens, with unwanted immune responses or insufficient immune protection.
There is growing evidence that solid dosage formats (e.g. powder form) for vaccines may offer several advantages over the liquid formulations, such as the prevention of molecular motion and shear-induced degradation,and slowing down modifications and degradation reactions involving water and oxygen radicals, resulting in improved stability, enhanced shelf-life of vaccines and greatly simplified logistics.
Today, no commercial vaccine has been developed yet under thermostable solid form (cold chain independent) for direct nasal or oral delivery (ex. intranasal powder delivery or sublingual pills) without the need of reconstitution with a liquid.
Vaccines are poorly accessible in developing countries
Vaccines require cold-chain storage and are often delivered by injection, which is undesirable, less safe and more expensive to administer.
Developing thermostable solid form vaccines through non-invasive routes may represent a long-term global solution to the vaccination challenge (Amorij, 2008).
Virosomes are an efficient vaccine delivery system
Virosomes are spherical, unilamellar lipid-based carriers, intercalated with functional glycoproteins to reflect the natural virus, however the lack of viral RNA means there is no risk of infection
(Figure 1). Virosomes can be tagged with different antigens and adjuvants, meaning they can be tailored to target different viruses, and offer increased immunogenicity over inactivated viruses.
Currently, virosomal influenza vaccines are only available in liquid form (Amorij, 2008).
Spray drying can produce dry powders for a range of dosage forms, including inhaled or nasal drug delivery.
A dry powder is formed when a liquid feed solution or suspension is atomised using a spray nozzle, and rapidly dried using hot air. However, while the drying process is gentle due to evaporative cooling,
there is still the potential to stress and inactivate vaccine components. It has been found that subunit and live-attenuated vaccines (and other delicate molecules such as proteins)
can be protected during processing b by incorporating them in an amorphous sugar matrix, which also offers longer term stability during storage (Kanojia, 2016).
A method has been developed to produce a powder form of virosome based influenza vaccine using spray-drying.
Formulations have been optimised for oral and nasal delivery.
It is of my opinion that this Vaccine Manufacturing process could result in future contracts with multiple Big Pharma companies and could ultimately become the WORLDWIDE STANDARD of how vaccines are delivered to the ENTIRE HUMAN POPULATION (No more needles). Mymetics has pioneered this proprietary process and I think it has many different applications to the Vaccine industry. We have yet to have confirmation of a Manufacturing contract agreement, but I do believe this process will generate large mega-million dollar revenues for Mymetics in the future. Perhaps sooner than we all think.
Dr. Fleury states : "Currently, the technology is available to companies interested in manufacturing products by spray drying or lyophilisation. The first generation liquid form HIV vaccine has been shown to be safe and well tolerated in human trials."
Great read right here:
https://cordis.europa.eu/project/rcn/194414/brief/en
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10. SUMMARY.
Friends, What we have found with this Swiss biotech company is rare and unique compared to 99.9% of anything ever found in the OTC market. What we have here with this stock- is access to Multi-Billion dollar markets. It may take several years to accomplish some of these milestones and see those revenues, However all it takes is one major positive event to set a new ground floor for the share price. Right now the Market value is approximately 12 million USD at .04 cents trading.The potential for exponential gains is here deep into the future. License and collaboration agreements are signed during pre-clinical stages, and right now we have several possibilities to see some new agreements take place that could move this stock higher with funding and upfront cash payments, and we also have the possibility to see one or more vaccine candidates move into phase 2 near term. Improvements year over year with this company are expected to take place with the ultimate company objective always in mind:
Objective: "Build small / medium size innovative R&D virosome vaccine company with strong
partnerships, Phase II – III clinical vaccine pipeline and have optionality for M&A or sale."
MYMETICS CORPORATION
Founded in 1990.
Mymetics Corporation is US registered biotechnology company with its main offices in Switzerland and the Netherlands. Focused on developing next generation vaccines for infectious and life threatening diseases. Mymetics core technology and expertise are in the use of virosomes, lipid-based carriers containing functional fusion viral proteins in combination with rationally designed antigens and membrane proteins. Mymetics currently has the following vaccines in its pipeline: HIV/AIDS. intranasal Influenza, RSV, Malaria and Chikungunya and collaboration projects in the allergy and cancer immunotherapy field.
Objective: "Build small / medium size innovative R&D virosome vaccine company with strong
partnerships, Phase II – III clinical vaccine pipeline and have optionality for M&A or sale."
PIPELINE:
1. RSV Prophylactic. Back in 2013/2014 Mymetics was engaged with Astellas Pharmaceuticals (Japanese) to collaborate and develop a Virosome RSV Vaccine. Mymetics received a $5,000,000.00 upfront payment. Mymetics stood to receive up to $82 million in upfront and milestone payments for its technology for RSV through a licensing deal. I also read in the filings that is was to be "Double-Digit Royalties upon commercialization."
This deal was terminated in 2016:
“Due to fast evolving market dynamics in the RSV vaccine market and in particular the development by several major pharma companies of promising candidates already at clinical stage, we have decided to focus our priorities on other areas and therapeutic needs,” said George Siber, MD Chief Scientific Officer of RSVC. “We’re very appreciative of the efforts by the Mymetics team to advance the project.”
“While being terminated, this partnership has nevertheless allowed Mymetics to further strengthen its know-how and expertise in the RSV field and enveloped viruses. We will build on this to create additional value for virosome based vaccines for infectious diseases,” said Ronald Kempers, CEO of Mymetics
And Strengthen their expertise they did. In 2018 Mymetics announced the...
"Development of a Virosomal RSV Vaccine Containing 3D-PHAD® Adjuvant: Formulation, Composition, and Long-Term Stability." https://www.ncbi.nlm.nih.gov/pubmed/29971500
https://www.mymetics.com/media-center/development-virosomal-rsv-vaccine-containing-3d-phad-adjuvant-formulation-composition-and-long-term-stability/
RSV TARGET POPULATION AND MARKET SIZE
Mymetics RSV vaccine candidate is targeting the elderly population, representing a target population in the Western world of about 150 million. The potential RSV vaccine sales is estimated between USD 1. 2 and USD 1.5 billion USD a year and is thereby one of the few remaining vaccines with block-buster potential.
No vaccine is currently approved for respiratory syncytial virus, or RSV
ENCOURAGING RESULTS
In pre-clinical studies Mymetics’ vaccine has shown strong safety and immunogenicity and the vaccine did not induce enhanced disease, while mice and cotton rats were completely protected against a live virus challenge.
If you would like to read about the competition and how far along they currently are with RSV vaccine development you can read about it here:
https://www.healio.com/pediatrics/vaccine-preventable-diseases/news/print/infectious-diseases-in-children/%7B8c78b63a-2b98-47d5-b353-e7a83c64dfcd%7D/rsv-vaccine-development-about-to-enter-golden-age?page=6
POTENTIAL FOR GROWTH
New research indicates that the respiratory syncytial virus (RSV) market is expected to grow from $418.6 million in 2018 to $5.39 billion by 2028 across the seven major markets (7MM: USA, France, Germany, Italy, Spain, UK and Japan) at a compound annual growth rate (CAGR) of 29.1%.
I believe there is potential here to strike a new licensing and collaboration agreement with another Big Pharma sponsor in the near term to initiate a new partnership. The niche market for the elderly should give us relevance if the vaccine makes it to clinical trials. Near term we could see an upfront payment, then milestone payments (phase 1,2,3), and eventually royalties on potential sales in the billions-- should MYMX make a new partnership with their RSV vaccine.
___________________________________________
2. HSV Virus: On hold for now. Not much is known about the status of this Pre-clinical Vaccine.
___________________________________________
3. Influenza Intra-Nasal Application Prophylactic. Mymetics originally licensed their Influenza vaccine to Solvay Pharmaceuticals. The Product being developed was called: Influvac TC (the cell-cultured version of Influvac) Solvay had made plans to spend 50 million euros in order to ramp up production of this particular "TC" version of influvac. Solvay was suddenly bought by Abbott and Abbott apparently did not want to invest their money into this. You can read more about it here in my previous post:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=141909826
Some 10 years ago, Solvay was the clear leader in the development of a cell-based seasonal influenza vaccine. Its cell-based version of Influvac, named Influvac TC, was approved in the Netherlands in 2001 as the first vaccine to be manufactured in MDCK cells. However, despite benefiting from a $298m US grant which it received in 2006 for the development of Influvac TC, Solvay failed to capitalize on this competitive advantage in the following years.
https://www.biospace.com/article/around-the-web/datamonitor-report-abbott-laboratories-s-flu-vaccine-business-may-represent-a-good-deal-for-acquisitive-drug-makers-/
Influvac (Which is now owned by Mylan because a deal they made with Abbott) was making sales as of recent and it is of my opinion that if Abbott did not buyout Solvay at the time they did, Mymetics would have made multiple millions of dollars on their "TC" version of the vaccine and still be collecting royalties today.
In December 2016 Shares of Mymetics spiked to .085 on a few million shares traded due to news that Sanofi announcing they would be collaborating with Mymetics on "Evaluating Mymetics Intra-nasal Influenza Vaccine."
Ultimately in late 2018/ early 2019 Sanofi decided to no longer purse this with Mymetics. However Mymetics had this to say in the most recent Annual Report:
"The results were positive for most of Mymetics virosome formulations, some virosomes generated significantly higher HA inhibition (HAI) titers and good antibody titers. Although this study was successful and the Company has discussed the results with Sanofi, Mymetics for the time being will not be continuing its collaboration with Sanofi due to other priorities of Sanofi. We are evaluating the possible publication of the results."
Then shortly after, this statement appeared on the Mymetics website:
During 2017 and 2018 Mymetics partnered with Sanofi to test different influenza virosome formulations with different HA And NA concentrations in pre-clinical mice models. Although the first study did not trigger the results that were expected, a second study corrected this and showed good and improved HAI titers. Due to changes in strategy at Sanofi this project is currently not advancing with Sanofi and Mymetics is taking this further by itself.
What I believe happened, is that Sanofi was "interviewing" Mymetics and at the same time as "Protein Sciences" for potential buyout or license... they ended up going with Protein sciences and their "Flu-Bok" vaccine instead of Mymetics and just flat out bought Protein Sciences. (Sanofi completes acquisition of Protein Sciences http://www.news.sanofi.us/press-releases?item=137157";)
Nevertheless. Mymetics claims it will take this further by itself. We are unaware of the current plans for this path forward. It remains a mystery as to whether or not they will attempt a new partnership for this application. The filing states: "influenza for elderly which has finished a clinical trial Phase I"
Influenza vaccine market size was estimated to grow from USD 4.9 billion in 2017, to reach USD 11.4 billion by 2025, at a CAGR of 11.0% from 2018 to 2025.
___________________________________________
4. HIV-1 Prophylactic. This is a very promising Vaccine. The preclinical studies done have shown amazing results. You can read about them here: https://www.mymetics.com/vaccine-pipeline/hiv-aids/
Now more studies are being done and funded by the NIH, and the first results are expected to be reported in 2020.
Epalinges, Switzerland, April 29, 2019 ...announced today that the National Institutes of Health (NIH) has awarded Mymetics and Texas Biomedical Research Institute (Texas Biomed) a five-year grant for the project called “Cold Chain-independent, Needle-free Mucosal Virosomal Vaccine to Prevent HIV-1
Acquisition at Mucosal Levels”.
You can read more about it here: https://www.mymetics.com/media-center/mymetics-receives-funding-nih-novel-hiv-vaccine-study/
Over the years, the rising prevalence of HIV disease worldwide has positively influenced the demand for HIV drugs. HIV drugs help in preventing the multiplication of HIV virus, thereby reducing the risk of its transmission.
According to a report, the global HIV drugs market exceeded a value of US$ 24.7 Billion in 2018. Looking forward, the market value is projected to reach US$ 22.5 Billion by 2024, declining at a CAGR of 2.5% during 2019-2024. https://www.globenewswire.com/news-release/2019/04/16/1804569/0/en/HIV-Drugs-Industry-Insights-Forecast-to-2024-The-Market-Will-Decline-at-a-CAGR-of-2-5-during-2019-2024.html
The adjuvanted HIV candidate powder form vaccine, to be administered by capsules or nasal spray, will first require a toxicology study, before human clinical trials (Phase I/II trial, then a Phase III trial with at least 10 000 volunteers).
Currently the NIH has given funding to Mymetics for the pre-clinical studies. The overall portion of the NIH grant allocated to the Company is USD 6.76 million, with USD 1.2 million approved for the first year (2019).
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5. Malaria. Mymetics has two Malaria Vaccines. The most recent annual report states:
"Mymetics is currently evaluating possible the further development of a malaria vaccine in collaboration with PATH-MVI and LMIV. In parallel, Mymetics is in collaboration with the Swiss Tropical and Public Health Institute and researchers at Oxford University to add two important antigens for a possible malaria vaccine candidate, the RH5 and the CyRPA peptides and has received access to EU supported laboratories under the Transvac2 program to execute the development of the tetra-valent malaria vaccine candidate and test this in pre-clinical studies in 2019."
(RH5 and CyRPA with Swiss TPH)
Sep. 2015 - Start of exploratory study of two new malaria antigens with Swiss Tropical & Public Health Institute and University of Zurich. (From the Company Overview)
Development of a Virosomal Malaria Vaccine Candidate
A promising concept of malaria vaccines are reconstituted influenza virosomes which display synthetic peptides of P. falciparum target antigenes on their surface. Recently, a new formulation incorporating two synthetic peptides has been demonstrated safety, immunogenicity and pilot efficacy in humans. However, we assume that a highly effective malaria subunit vaccine has to incorporate more than two components. Goal of this project is to develop additional peptide mimetics derived from the novel blood stage antigens CyRPA and RH5 and to evaluate their protective efficacy in an innovative P. falciparum infection mouse model.
https://www.swisstph.ch/en/topics/malaria/malaria-vaccines/
STATUS
Since 2017 Mymetics is developing an improved second malaria vaccine candidate, which includes besides the existing antigens, two other possible antigens which will cover the complete life cycle of the parasite in humans. This vaccine candidate is being developed with funds from the EU and collaborations with the NIH, MVI, the University of Oxford and the Swiss Tropical and Public Health institute.
Pre-clinical data is expected in the second half of 2019.
The transmission blocking malaria vaccine, is in its preclinical stage and Mymetics collaborates with the NIH and LMIV to further advance this promising vaccine.
The first initial results from the study showed that the virosome vaccine candidates, at the highest dose tested, generate high antibody titers against the required antigens and they were able to significantly reduce (97-100%) the transmission of the Plasmodium falciparum parasite.
Pending the pre-clinical results, Mymetics will evaluate funding opportunities for further development of these two vaccine candidates, which are based on the virosome platform.
https://www.mymetics.com/vaccine-pipeline/malaria/
Market Size and Forecast (2016-2024)
Global malaria vaccines market was valued at USD 0.07 billion in 2016 and is expected to witness a modest CAGR during the forecast period (2016 – 2024). It is projected to reach USD 0.6 billion by 2024.
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6. Allergy Immunotherapy. In April 2018 Mymetics announced that it signed an agreement for a feasibility study with Anergis SA to evaluate the use of virosomes for the for the ultra-fast allergy immunotherapy against birch pollen.
In December 2018 Anergis and Mymetics announced that the pre-clinical proof-of-concept study for birch pollen allergies, met all the success criteria.
Anergis SA has now a time limited exclusive option to sign a License and Collaboration Agreement with Mymetics to license the virosome technology from Mymetics.
In October 2018 I found this video on Youtube:
https://www.youtube.com/watch?v=mzO6ZqyMe4U
In the Video, the CEO of Anergis discusses how the market for Allergy Immunotherapy is projected to be $15 Billion USD by the year 2027 at 1:37 seconds into the video. He also describes how he believes his company can capture 2-4 Billion dollars of this market in realized annual revenues. He also discusses the potential partnership with Mymetics throughout the whole video as the whole purpose of his fundraising activity is to initiate the "2nd generation" of his allergy vaccines.
An 8k was filed with the SEC in april 2018 which states:
"In the event that the results of the pre-clinical study program are successful, Anergis has the option to obtain an exclusive worldwide license of Mymetics’ virosome technology for the development of allergy vaccines. Should Anergis and Mymetics execute a License and Collaboration Agreement (LCA), Anergis would make an upfront payment to Mymetics in an amount that increases as the date of executing the LCA is delayed, milestone payments based on certain regulatory clearances and royalties for net sales."
It is of my opinion, that due to the evidence in the youtube video, I believe they will sign the LCA, I believe the upfront payment will be for multi-millions of dollars, and I believe it will happen any day now.
There are conflicting reports on how long this will take. But I will not believe anything other than what comes out of the CEO's mouth here in this video. Watch the entire video to see their projected timelines and what to expect. I also believe the deal will be for "Double-Digit royalties on net sales" which ultimately means that if the Allergy vaccines are successfully commercialized, Mymetics would receive a large amount of money that could be upwards of several hundred million dollars over the lifetime- in royalties depending on how well the sales are and how long sales would take place. This video was taken at the Sachs Investor conference. Mymetics was present at this conference. This conference' purpose was obviously to raise money in a room full of venture capitalist for series funding.
In the past Anergis has successfully raised apx. 50 Million USD.
https://www.crunchbase.com/organization/anergis#section-overview
One of our great board members here pointed out how Sten Verland, PHD. is on the B.O.D. of Anergis and was a founder of one of the main funding organizations involved in previous rounds of funding.
http://www.anergis.ch/about-us/board-of-directors/38-sten-verland-phd.html
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7. Cancer Immunotherapy. Mymetics' virosomes, enveloped virus like particles, are able to trigger both specific CD4+ and CD8+ T cells, as virosomes are processed by dendritic cells and presented to both MHC Class I and MHC Class II pathways.
As virosomes have a proven safety track record and Mymetics is able to produce these at GMP, it is a very attractive choice to increase specific T-cells for cancer treatment through incorporating specific cancer antigens and combining these with other treatments like check point blockade or check point inhibitors.
Mymetics is currently engaged with several small biotech companies in the oncology field to evaluate the improvements that can be generated in pre-clinical studies.
Mymetics is actively seeking additional partnerships to enhance existing cancer immunotherapies by use of the virosome VLP platform.
16-10-2018 - Mymetics Corporation, has entered into a research collaboration project
with eTheRNA immunotherapy NV, a clinical stage biotech company developing novel mRNA cancer
immunotherapies. https://www.etherna.be/
https://www.mymetics.com/media-center/mymetics-starts-research-collaboration-project-cancer-immunotherapy-etherna/
Global oncology market to reach $200 BILLION by 2022: Iqvia report
https://www.outsourcing-pharma.com/Article/2018/05/29/Global-oncology-market-to-reach-200bn-by-2022-Iqvia-report
With a $200 Billion dollar market, one hint of Mymetics virosomes successfully becoming the delivery system for eTheRNA based TRI-Mix cancer vaccines will surely bring much wanted price appreciation to the shares of $MYMX. Here is more research I have done on this matter: https://investorshub.advfn.com/boards/read_msg.aspx?message_id=147408322
We don't know when they will report updates to us on this, but we pray they are positive when they do. I will leave you with this statement:
“mRNA-based therapies have a unique potential to enhance cancer immunotherapy. For mRNA to reach its target, the cellular cytosol and have an optimal effect, the selection of an appropriate delivery vehicle is key. As viruses have evolved highly effective mechanisms to deliver their nucleic acids across cellular membranes, we believe Mymetics’ virosomes might synergize with our mRNA platform and thus further boost the potency of eTheRNA’s mRNA immunotherapies,” stated Peter Tomme, head of preclinical development of eTheRNA.
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8. Chikungunya virus (CHIKV): There are no vaccines available for Chikungunya although there are several in development, of which one is in a clinical trial Phase II. Mymetics’ novel approach in CHIKV vaccine development is the generation of virosomal vaccines using the CHIKV envelope glycoproteins produced in insect cells. Virosomes are reconstituted viral envelopes, consisting of membrane lipids and viral spike glycoproteins. The external surface of the virosome resembles that of a virus particle, with spike (glyco) proteins protruding from the lipid membrane. Virosomes lack viral genetic material. The advantage is that highly purified CHIKV spikes (expressed in insect cells) will be used to constitute the virosomes. Thus, insect cell material (DNA, proteins) will be completely absent from the virosomal vaccine material. CHIKV spikes can be obtained from different sources: VLPs, from baculovirus virions or from the plasma membrane of insect cells.
Jan. 2016 to date: Mymetics has started the discovery phase of this project where we are assessing the overall CHIKV glycoprotein yields in scale up insect cell culture. In this project we have worked with the University of Wageningen in the Netherlands that has extensive expertise in this field. The project has been delayed due to other priorities and the aim is to start preclinical animal studies during 2019 if resources are available.
We are not sure if they will launch studies this year, however I think we can not underestimate the potential marketing and/or partnership capabilities for this Vaccine.
https://www.marketwatch.com/press-release/chikungunya-fever-market-2018-highlight-demand-for-quinine-related-drugs-cagr-of-586-with-leading-vendors-and-foreseen-to-2023-2018-04-26
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9. Cold-Chain Independent Virosome Based Vaccines.
Developing a thermostable needle-free vaccine
Most vaccines are highly vulnerable to damage. If not stored at the recommended temperature, they can become ineffective. MACIVIVA has developed a thermostable vaccine in powder form which supports high temperature variations, and is administered by capsules or nasal spray.
With few exceptions, commercialized vaccines are generally delivered by injection through the intramuscular or subcutaneous route.Vaccines contain immunogens classically found within a large variety of biological compounds such as peptides, proteins, glycoproteins and sometimes carbohydrates and lipids.These immunogens may trigger the immune system for producing antibodies and/or cytotoxic T cells for preventing the pathogen transmission or blocking and/or slowing down the disease progression.
However, these vaccines generally exist as liquid formulation that are inherently prone to physical and/or chemical modifications. The cold chain storage is still fundamental for preserving the
bioactivity of most liquid and freeze-dried vaccines. For reconstituted freeze dried vaccines, they harbor important instability and must be used within hours and kept refrigerated. Vaccine degradation generally takes place during shipment and/or storage of liquid or lyophilized products, which may affect the immunological properties of the immunogens, with unwanted immune responses or insufficient immune protection.
There is growing evidence that solid dosage formats (e.g. powder form) for vaccines may offer several advantages over the liquid formulations, such as the prevention of molecular motion and shear-induced degradation,and slowing down modifications and degradation reactions involving water and oxygen radicals, resulting in improved stability, enhanced shelf-life of vaccines and greatly simplified logistics.
Today, no commercial vaccine has been developed yet under thermostable solid form (cold chain independent) for direct nasal or oral delivery (ex. intranasal powder delivery or sublingual pills) without the need of reconstitution with a liquid.
Vaccines are poorly accessible in developing countries
Vaccines require cold-chain storage and are often delivered by injection, which is undesirable, less safe and more expensive to administer.
Developing thermostable solid form vaccines through non-invasive routes may represent a long-term global solution to the vaccination challenge (Amorij, 2008).
Virosomes are an efficient vaccine delivery system
Virosomes are spherical, unilamellar lipid-based carriers, intercalated with functional glycoproteins to reflect the natural virus, however the lack of viral RNA means there is no risk of infection
(Figure 1). Virosomes can be tagged with different antigens and adjuvants, meaning they can be tailored to target different viruses, and offer increased immunogenicity over inactivated viruses.
Currently, virosomal influenza vaccines are only available in liquid form (Amorij, 2008).
Spray drying can produce dry powders for a range of dosage forms, including inhaled or nasal drug delivery.
A dry powder is formed when a liquid feed solution or suspension is atomised using a spray nozzle, and rapidly dried using hot air. However, while the drying process is gentle due to evaporative cooling,
there is still the potential to stress and inactivate vaccine components. It has been found that subunit and live-attenuated vaccines (and other delicate molecules such as proteins)
can be protected during processing b by incorporating them in an amorphous sugar matrix, which also offers longer term stability during storage (Kanojia, 2016).
A method has been developed to produce a powder form of virosome based influenza vaccine using spray-drying.
Formulations have been optimised for oral and nasal delivery.
It is of my opinion that this Vaccine Manufacturing process could result in future contracts with multiple Big Pharma companies and could ultimately become the WORLDWIDE STANDARD of how vaccines are delivered to the ENTIRE HUMAN POPULATION (No more needles). Mymetics has pioneered this proprietary process and I think it has many different applications to the Vaccine industry. We have yet to have confirmation of a Manufacturing contract agreement, but I do believe this process will generate large mega-million dollar revenues for Mymetics in the future. Perhaps sooner than we all think.
Dr. Fleury states : "Currently, the technology is available to companies interested in manufacturing products by spray drying or lyophilisation. The first generation liquid form HIV vaccine has been shown to be safe and well tolerated in human trials."
Great read right here:
https://cordis.europa.eu/project/rcn/194414/brief/en
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10. SUMMARY.
Friends, What we have found with this Swiss biotech company is rare and unique compared to 99.9% of anything ever found in the OTC market. What we have here with this stock- is access to Multi-Billion dollar markets. It may take several years to accomplish some of these milestones and see those revenues, However all it takes is one major positive event to set a new ground floor for the share price. Right now the Market value is approximately 12 million USD at .04 cents trading.The potential for exponential gains is here deep into the future. License and collaboration agreements are signed during pre-clinical stages, and right now we have several possibilities to see some new agreements take place that could move this stock higher with funding and upfront cash payments, and we also have the possibility to see one or more vaccine candidates move into phase 2 near term. Improvements year over year with this company are expected to take place with the ultimate company objective always in mind:
Objective: "Build small / medium size innovative R&D virosome vaccine company with strong
partnerships, Phase II – III clinical vaccine pipeline and have optionality for M&A or sale."
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