Mymetics Corp (MYMX)

[TheHungryHippo]

Mymetics $MYMX All-In-One DD & Potential Catalyst (Updated)



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. HIV-1 Prophylactic. Vaccine name: MYM V202

MYM V202 is the 2nd generation of the vaccine MYM V101

Here is the history of the research that went into Virosome Vaccine MYM V101,
and eventually led to the 2nd Generation Virosome Vaccine Candidate: MYM V202

In 2008, Mymetics performed a 12 months pre-clinical trial at ILAS (Institute of Animal Laboratory Science) in Beijing, China. The study involved several groups of female Chinese macaques, which received multiple challenges with the live virus. The results were overwhelmingly convincing: The group that was vaccinated with Mymetics’ preventive HIV vaccine candidate showed 100% protection, while the non-vaccinated control group was fully infected. These ground breaking scientific results have been presented at key world leading HIV congresses and have triggered strong attention from the HIV scientific community. See more

In 2011, Mymetics successfully completed a Phase I human clinical trial involving 24 healthy women in Belgium. The results showed a good safety and tolerance profile. All vaccinated women confirmed the high efficacy of the influenza virosomes as carriers/adjuvants for inducing a Th2 (T helper type 2) response. The functional antiviral activity of these mucosal antibodies was demonstrated by the inhibition of HIV-1 trancytosis, as reported by Dr. Morgane Bomsel (INSERM/Cochin Institute, France), a key academic partner. See more

In April 2016 Mymetics announced the results of a non-human primate (NHP) study led by Dr. Ruth Ruprecht, Scientist & Director at the Texas Biomedical Research Institute. This study was funded by the Bill & Melinda Gates Foundation. The study showed that the HIV vaccine significant efficacy of 87% in delaying the time to persistent infection versus the control group after 7 intravaginal virus challenges. The study aimed to mimic the exposure of women to semen from HIV-infected men, although the viral dose of each of these 7 animal challenges represented about 70,000 times the average human HIV dose passed during sexual intercourse from an HIV-infected male to an uninfected female. During the second part of the study the animal viral challenge dose was increased by 50% starting from the 8th challenge onward, reaching more than 100,000 times the average amount of virus passed from an infected man to a female partner. At this virus dose, the vaccine did not show significant protection in the animals as the immune system was overloaded.

In May 2015 Mymetics started the MACIVIVA project, funded by the EU Horizon 2020 program to develop cold chain independent virosome based vaccines, with the HIV vaccine as pilot formulation. This project was successfully finished in November 2018 and Mymetics, though their consortium partners, was able to develop a GMP production line for a newly adjuvanted HIV vaccine candidate which is thermostable and in powder or tablet form formulations. These new formulations showed the maintenance of the structural integrity of the virosome and of the antigens and adjuvant, all on the same particle and good immunogenicity, while having been exposed to temperature fluctuations during storage.

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”.

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).

"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.

MACIVIVA Project Final Results can be read here:
https://cordis.europa.eu/project/rcn/194414/reporting/en

Dr Fleury States:
"However, 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).

The team is presently seeking funding to start the clinical trials, first in adults and then with the vaccination of children and teenagers to prevent HIV-1 infection, the priority target population"

Comment on new MYM V202 Formulation:

Mymetics has embedded the toll-like receptor (TLR)7/8 adjuvant 3M-052 into virosomal envelopes. Moreover, Mymetics has developed a powdered form of virosomes that is no longer cold-chain dependent and can be administered as intranasal (IN) spray, sublingual (SL) tablets, or packaged into oral capsules. We hypothesize that these novel solid virosome formulations are significantly more immunogenic, particularly when administered via mucosal routes, than the unadjuvanted liquid form used earlier in NHPs.

https://www.mymetics.com/vaccine-pipeline/hiv-aids/

Market:

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

Summary:

OVERALL We seek to bring a promising AIDS vaccine candidate into the clinic, based on conserved gp41 regions of the HIV envelope anchored to the surface of particles termed virosomes. The vaccine is designed to induce protective mucosal antibodies acting as frontline defense against sexual HIV transmission. The new solid powder forms of the vaccine can be directly administered to mucosal tissues (nose, sublingual or oral) without needles and do not depend on refrigeration, which makes the new vaccine attractive for the developing world that is severely affected by the AIDS epidemic.

_______________________________________________________________________________________

2. "MACIVIVA Project" Cold-Chain Independent Virosome Based Vaccines.

(Manufacturing Needle-Free Vaccines that do not need refrigeration)

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.

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

Periodic Reporting for period 3 - MACIVIVA (MAnufacturing process for Cold-chain Independent VIrosome-based VAccines)
Reporting period: 2017-11-04 to 2018-11-03

"By the end of MACIVIVA in month 42 (November 3rd 2018), the consortium successfully achieved all the main objectives, with the 24 Deliverables initially planned that were completed and submitted to the European Commission. There were also eight Milestones that were successfully achieved, with the establishment and completion of the three GMP Pilot Lines with their corresponding GMP vaccine lots with a promising thermostable and immunogenic HIV-1 vaccine candidate as end-product. These new solid vaccine forms are making the virosome technology more attractive and competitive, and it opens the door to other future therapeutic and prophylactic vaccines based on virus-like particles, improving also the European competitiveness with this nanovaccine manufacturing technology".

"The new solid forms of the HIV-1 candidate vaccine manufactured by the three Pilot Lines (nasal, oral and sublingual vaccine) are not damaged by accidental freezing conditions at < -15oC and they can also support long time exposure to 40oC (at least 2-3 months) without affecting their ability to induce relevant antibodies, representing major innovations. Therefore, short term cold-chain independent vaccine transportation at room temperature (25oC) or under warm and humid conditions (40oC/75% humidity) could be possible during shipment from the primary storage facilities to the distant doctor offices, local hospitals and clinical sites , with limited risk to reduce vaccine bioactivity during that period. MACIVIVA vaccines fully comply with the WHO recommendations, as a vaccine maintaining its bioactivity at 40oC up to 1 month is already a major achievement and such vaccines will address an important issue in the vaccine industry".

Management believes that the Company’s research and development activities will result in valuable intellectual property that can generate significant revenues in the future through licensing.
- Regarding VLP spray drying (MACIVIVA)

For those of you who have not been following Upperton Ltd., they are a very unique company that is growing rapidly. They are providing alot of really solid manufacturing services to the pharmaceutical industry. This new deal with Upperton spells out how they and MYMX is now allowed to sell VLP spray drying to certain vaccine makers/developers:

On July 26, 2019 Mymetics and Upperton Ltd. signed a License Agreement (the “Agreement”) that sets out the rights and obligations of the two parties with respect to the development, manufacturing and exploitation of certain virus-like particles based vaccines (which includes virosomes) into solid (powder or tablet) form that are based on each party’s background or pre-existing intellectual property (“IP”) and the foreground IP rights or the IP that was developed by either party or both parties during the Maciviva project and could be developed during future collaborations.

Under the terms of the Agreement Mymetics receives an exclusive and royalty free, worldwide license to use the Upperton background IP for the development, research, sale or in/out license for virus-like particle vaccines that use the foreground IP rights. All title, right and interest in and to all foreground IP rights vests in Mymetics for such development, research, sale or in/out license, and Mymetics is free to use and exploit such foreground IP rights.

Mymetics has provided Upperton the non-exclusive license to manufacture virus-like particle based vaccines for third parties for indications other than respiratory viruses, certain allergies, HIV, malaria and chikungunya.

For these foreground IP licenses, the parties have agreed to pay each other a certain low single digit percentage of revenues, license fees and royalties that each of the parties receives from their exploitation.

Dr. Richard Johnson CEO of Upperton LTD (UK):
https://youtube.com/watch?v=ZANehvlBeB0

_______________________________________________________________________________________

3. Allergy Immunotherapy. Vaccine name: ALLERT

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 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 Anergis' 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."

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 the past Anergis has successfully raised apx. 50 Million USD.
https://www.crunchbase.com/organization/anergis#section-overview

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

"Anergis has now a time limited exclusive option until December 2019 to enter into a License and Collaboration Agreement (“LCA”) with Mymetics..."

____________________________________________________________________________________

4. Cancer Immunotherapy. RNA Vaccines

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

“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.

_______________________________________________________________________________________

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.


_______________________________________________________________________________________

6. 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 a new partnership or funding that could lead to an upfront payment, then milestone payments (phase 1,2,3), and eventually royalties on net sales-- should MYMX' RSV vaccine make it to commercialization.

_______________________________________________________________________________________

7. 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.

_______________________________________________________________________________________

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

_______________________________________________________________________________________

9. HSV Virus: On hold for now.

Not much is known about the status of this Pre-clinical Vaccine.

_______________________________________________________________________________________


ONLY A MATTER OF TIME BEFORE A MAJOR CATALYST HITS THE NEWS WIRES!