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Mymetics Corporation (MYMX)

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http://www.mymetics.com/

COMPANY OVERVIEW 

https://www.mymetics.com/files/5015/3606/2025/180831_Mymetics_Company_Overview_-_website.pdf

 

Mymetics Corporation is US registered biotechnology company with its main offices in Switzerland and the Netherlands.
Focused on developing next generation preventative vaccines for infectious 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.


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."


 


Current Share Structure:

Outstanding Shares: 303.7 million (as of 01/18/2019 unchanged since 2014)
Floating Shares: 79.8 million*  (a/o 01/18/19)
(
https://www.otcmarkets.com/stock/MYMX/profile)

 


 

Current Projects and Pipeline


 
 
https://www.maciviva.eu

Rationale and Impact of MACIVIVA

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.

 


MYMETICS BV
Expertise: R&D on virosome formulations

Project responsability: Investigating and compiling the results about the physical and biochemical properties of the virosome-based vaccines obtained by spray-drying and lyophilization.

MYMETICS SA
Expertise : Non-GMP and GMP virosome production, clinical development

Project responsability: Excipient selection for liquid virosomes, supervising the non-GMP and GMP manufacturing of the liquid virosomes and development of analytical methods.

UPPERTON LIMITED
Expertise: Non-GMP and GMP Spray drying

Project responsability: Identification of excipients and experimental conditions suitable for virosome spray drying, production of non-GMP and GMP powder forms for nasal and oral delivery.

CATALENT U.K. SWINDON ZYDIS LIMITED
Expertise: Zydis technology for fast-dissolving tablet, world leader in drug formulation and distribution

Project responsability: Identification of excipients and experimental conditions suitable for virosome lyophylization, according to the Zydis technology, non-GMP and GMP tablets for sublingual delivery.

CHIMERA BIOTEC GMBH
Expertise: Ultra sensitive immunoassays development and bioanalysis based on Imperacer® (Immuno-PCR) technology.

Project responsability: Immunogenicity study in animals with spray-dried and lyophilized virosomes. Imperacer® immunoassay development and evaluation of the vaccine-induced antibody response.

BACHEM AG
Expertise: R&D, non-GMP and GMP manufacturing of API, world supplier

Project responsability: Process Development and manufacture of peptide P1, GMP-grade, including development and validation of analytical methods.

 

PXTHERAPEUTICS announces the successful completion of RGP41 GMP manufacturing for Mymetics  

Grenoble, France, and Epalinges, Switzerland, December 12th, 2017 – PXTherapeutics, a CDMO specializing in the development of recombinant proteins for human and animal health, is proud to announce the end of the rgp41 manufacturing campaign and batch certification for clinical application. This drug substance will be used by Mymetics to develop a new vaccine formulation, within the framework of the MACIVIVA project, sustained by the European Union’s Horizon 2020 research and innovation program and the Swiss State Secretariat for Education, Research and Innovation (SERI) for the Swiss based consortium partners. 

Rgp41 protein is one of the HIV-1 gp41 derived antigens constituting Mymetics’ HIV-1 vaccine that is anchored to the membrane surface of the virosome particle, which acts as vaccine delivery vehicle for soliciting the immune system for inducing the production of protective serum and mucosal antibodies. 

PXTherapeutics and Mymetics joined forces several years ago to work on rgp41 protein design and development of the production and purification processes of the molecule. PX teams managed to develop an efficient, scalable and GMP-compliant process. A clinical batch was produced from a scale fermentation volume of 120 L to deliver a sufficient quantity for formulation studies and clinical trials. 

Claire Untereiner, Chief Operating Officer of PXTherapeutics, commented as follows: “We are so happy to see the progress made with this molecule and to be part of this fantastic project. MACIVIVA’s objective, the development of cold-chain independent and virosome-based vaccines, responds to a real medical need, particularly in emerging countries, and is in line with PXTherapeutics’ mission, to support and accelerate the development of innovative medicines”. 

Sylvain Fleury, Chief Scientific Officer of Mymetics SA commented: “we are pleased that PXTherapeutics could address many technical challenges related to the GMP development of the recombinant rgp41 protein and achieve a production yield superior to our expectations. With this rgp41, Mymetics will further pursue the development of its HIV-1 candidate vaccine, which could be administered through various immunization routes, as a standalone product or combined with viral vectors in a prime-boost approach”. 





 

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.










 

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. 



Advantages of Virosomal Drug Delivery

         
         Virosomal technology is approved by the FDA for use in humans, and has a high safety profile
         Virosomes are biodegradable, biocompatible, and non-toxic12
         No disease-transmission risk
         No autoimmunogenity or anaphylaxis10
         Broadly applicable with almost all important drugs (anticancer drugs, proteins, peptides, nucleic acids, antibiotics, fungicides)
         Enables drug delivery into the cytoplasm of target cell
         Promotes fusion activity in the endolysosomal pathway
         Protects drugs against degradation


 

Virosomal Structure and Modifications


Image result for influenza virosome images

 
Figure 1: Virosomes are reconstituted influenza virus envelopes devoid of inner core and genetic information
 
Virosomes are spherical unilamellar vesicles with a mean diameter of around 150 nm. Influenza virus is most commonly used for virosome production. Virosomes cannot replicate but are pure fusion-active vesicles. In contrast to liposomes, vorosomes contain functional viral envelope glycoproteins: influenza virus hemagglutinin (HA) and neuraminidase (NA) are intercalated within the phospholipid bilayer membrane (Figure 1). Further characteristics of virosomes depend on the choice of bilayer components. Virosomes can be optimized for maximal incorporation of the drug, or for the best physiological effect by modifying the content or type of membrane lipids used. It is even possible to generate carriers for antisense-oligonucleotides or other genetic molecules, depending on whether positively or negatively loaded phospholipids are incorporated into the membrane. Various ligands, such as cytokines, peptides, and monoclonal antibodies (MAbs) can be incorporated into the virosome and displayed on the virosomal surface. Even tumor-specific monoclonal antibody fragments (Fab) can be linked to virosomes to direct the carrier to selected tumor cells.1,11
 

Intellectual  Property


WO/1999/025377 (GP41 mutee) Method for obtaining vaccines for preventing the pathogenic effects related to a retroviral infection Mymetics Corp. Expiration date: November 16, 2018
 
WO/2005/010033 (GP41 ter) New soluble and stabilized trimeric form of GP 41 polypeptide Mymetics Corp. Expiration date: July 28, 2024
 
WO/2007/099446 (Virosome-P1) Virosome-like vesicles comprising gp41 - derived antigens Mymetics Corp. + INSERM + Pevion Expiration date: January 3, 2027

US/61/202 215 (GP41 4th gen) Mymetics Corp. Expiration date: February 5, 2029
 
US/61/202 219 (Splitting GP41) Mymetics Corp. Expiration date: February 5, 2029
 
WO/2004/106366 (UK39) Methods for synthetizing conformationally constrained peptides, peptidomimetics and use of such peptidomimetics as synthetic vaccines Mymetics Corp. Expiration date: June 1, 2024
 
WO/2004/078099 (AMA49) Compositions and methods for the generation of immune response against Malaria Mymetics Corp. Expiration date: March 2, 2023
 
WO/2004/045641 (APRECS) Antigen-complexes Bestewil BV Expiration date: November 19, 2023
 
WO/2004/110486 (Lipopeptide) Functionally reconstituted viral membranes containing adjuvant Bestewil BV Expiration date: June 17, 2024
 
WO/2004071492 (DCPC) Virosome-like particles Bestewil BV Expiration date: December 2, 2023
  [Viruses that can be applied and used in the formation of the virosome-like-particles according to the invention can be derived from all sorts of viruses, non-limiting examples of     such viruses being: Retroviridae such as Human Immunodeficiency virus (HIV); rubellavirus; paramyxoviridae such as parainfluenza viruses, measles, mumps, respiratory syncytial virus, human metapneumovirus; flaviviridae such as yellow fever virus, dengue virus, Hepatitis C Virus (HCV), Japanese Encephalitis Virus (JEV), tick-borne encephalitis, St. Louis encephalitis or West Nile virus; Herpesviridae such as Herpes Simplex virus, cytomegalovirus, Epstein-Barr virus; Bunyaviridae; Arenaviridae; Hantaviridae such as Hantaan; Coronaviridae; Papovaviridae such as human Papillomavirus; Rhabdoviridae such as rabies virus. Coronaviridae such as human coronavirus; Alphaviridae, Arteriviridae, filoviridae such as Ebolavirus, Arenaviridae, poxyiridae such as smallpox virus, and African Swine Fever virus.]  
              



 



 


 
 
FOR ALL MYMX PRESS RELEASES CLICK HERE:

https://www.mymetics.com/media-center/
  

 





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MYMX News: Quarterly Report (10-q) 08/13/2019 08:51:05 AM
MYMX News: Quarterly Report (10-q) 05/15/2019 07:58:01 AM
PostSubject
#14504  Sticky Note Mymetics $MYMX All-In-One DD & Potential Catalyst (Updated) TheHungryHippo 10/17/19 03:10:51 AM
#14613   Im watching while we wait :-) sitting on Profit 10/23/19 07:29:01 PM
#14612   Long term trend change. When you Staypositive1 10/23/19 07:28:01 PM
#14611   Lol. It wasnt mine. But if Staypositive1 10/23/19 07:15:32 PM
#14610   Was that bid today just so they would Profit 10/23/19 07:07:29 PM
#14609   You are absolutely correct Trompete. Phosphene 10/23/19 02:29:53 PM
#14608   Hahahahaha what do you mean by contributing? You Trompete 10/23/19 02:16:01 PM
#14606   That's ok, and what has been basically achieved Trompete 10/23/19 12:21:49 PM
#14605   They have been around over 20 years that Staypositive1 10/23/19 07:15:48 AM
#14604   For now they proved nothing and this is Trompete 10/23/19 06:10:32 AM
#14603   Fwiw if u keep putting those .035s up Staypositive1 10/22/19 07:18:26 PM
#14602   The Virosomes are proving valuable thats why. TheHungryHippo 10/22/19 02:55:30 PM
#14601   It's so much better Work Harder 10/22/19 02:46:00 PM
#14600   And what exactly tells you it will succeed Trompete 10/22/19 02:45:45 PM
#14599   That's right.. noone knows what Mr. Kempers has TheHungryHippo 10/22/19 02:41:11 PM
#14598   It's the 035 chit show Work Harder 10/22/19 02:29:44 PM
#14597   MM NITE playing games. Wonder what he is TheHungryHippo 10/22/19 02:09:09 PM
#14596   Good morning MYMX Work Harder 10/22/19 08:15:43 AM
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#14594   Wow man, the financial backing we can get TheHungryHippo 10/22/19 01:02:14 AM
#14593   Did Anergis get the funding they needed from bow-tie 10/21/19 11:07:19 PM
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#14574   Billionaire Bertarelli Waypoint and Anergis wants to buyout bow-tie 10/21/19 09:04:07 PM
#14573   Think about it Ph Work Harder 10/21/19 07:41:26 PM
#14572   Francois Villinger on another one (DARPA funded): Phosphene 10/21/19 07:29:58 PM
#14571   Think Big Work Harder 10/21/19 07:28:48 PM
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#14569   Ubs ? Work Harder 10/21/19 07:13:38 PM
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#14565   Interesting day. Looks like the MMs have Staypositive1 10/21/19 06:30:19 PM
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PostSubject