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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 (03/2018 unchanged since 2014)
Floating Shares: 79.8 million*  (a/o 03/31/18)
(
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.


Toward cold chain free vaccines
 


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.











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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PostSubject
#9228  Sticky Note MYMX VACCINE COMPANY OVERVIEW TheHungryHippo 10/06/18 01:28:07 PM
#5685  Sticky Note Copy of MACIVIVA Presentation at World Vaccine Congress corpus 01/09/18 12:36:16 PM
#11178   A few of us are thinking this Work Harder 12/14/18 03:15:14 PM
#11177   Good points Corpus, Interesting indeed. TheHungryHippo 12/14/18 03:10:36 PM
#11176   The Question is: corpus 12/14/18 03:09:42 PM
#11175   It's Power Hour Work Harder 12/14/18 03:00:41 PM
#11174   I've got something up Work Harder 12/14/18 11:32:08 AM
#11173   I’m on the bid screw em I’ll take em TheHungryHippo 12/14/18 11:31:04 AM
#11172   https://www.flickr.com/photos/125874425@N03/15472808855 Long MYMX! Phosphene 12/14/18 11:30:29 AM
#11171   Maybe they are using Work Harder 12/14/18 11:29:00 AM
#11170   Agreed. Disappointing. Manipulation. Down 17% this week on 400k volume Phosphene 12/14/18 11:28:54 AM
#11169   All of them are a POS. Staypositive1 12/14/18 11:27:23 AM
#11168   MM's easy to see Work Harder 12/14/18 11:23:07 AM
#11167   Whose the turd wacker here? TheHungryHippo 12/14/18 11:17:47 AM
#11166   Looking like Sanofi Work Harder 12/14/18 10:45:22 AM
#11165   POS.... Staypositive1 12/14/18 10:40:54 AM
#11164   We should load OTCX up here Work Harder 12/14/18 10:40:29 AM
#11163   Gray trades on an unconfirmed Work Harder 12/14/18 10:39:11 AM
#11162   What a joke.... Cant make a run to save Staypositive1 12/14/18 10:36:31 AM
#11161   Finally someone gets it Work Harder 12/14/18 10:31:46 AM
#11160   Markus Hosang (Anergis BOD) bow-tie 12/14/18 10:29:11 AM
#11159   Nice call Work Harder 12/14/18 10:16:38 AM
#11158   Research Strategy Vincent Charlon (Anergis) Designing Trails For bow-tie 12/14/18 10:05:08 AM
#11157   So what will today bring more crappy sellers? Staypositive1 12/14/18 09:04:58 AM
#11156   Bill and Melinda Gates Foundation and Wellcome Trust, bow-tie 12/13/18 11:32:09 PM
#11155   UBS Group reaffirmed a “neutral” rating on shares bow-tie 12/13/18 10:39:00 PM
#11154   JP Morgan Chase likes Sanofi!!! ;) bow-tie 12/13/18 10:20:03 PM
#11153   Hell yeah. I found a lot of encouraging TheHungryHippo 12/13/18 10:12:55 PM
#11152   Great news today onward and upward. As for Profit 12/13/18 08:49:53 PM
#11151   Very, very small world amigo. Phosphene 12/13/18 06:36:45 PM
#11150   No, I think it was the Work Harder 12/13/18 05:34:33 PM
#11149   Just read your prior post boss. Phosphene 12/13/18 05:04:00 PM
#11148   Upperton: Consortium partner, MYMX public speaker and bullhorn Phosphene 12/13/18 04:07:47 PM
#11147   “We are very satisfied with these new results TheHungryHippo 12/13/18 02:24:03 PM
#11146   - The second-generation COP Allergy Vaccines met the TheHungryHippo 12/13/18 02:23:15 PM
#11145   Allergies are the most prevalent and fastest growing TheHungryHippo 12/13/18 02:22:28 PM
#11144   Cell culture-based influenza vaccines: A necessary and indispensable TheHungryHippo 12/13/18 02:21:04 PM
#11143   37th Annual J.P. Morgan HEALTHCARE CONFERENCE TheHungryHippo 12/13/18 02:16:12 PM
#11142   Thank you Mr. Kempers, MYMX employees and extended family! Phosphene 12/13/18 01:59:29 PM
#11141   How many shares have you sold? Just Staypositive1 12/13/18 01:11:03 PM
#11140   Harry I hope you watched the Youtube video TheHungryHippo 12/13/18 12:58:22 PM
#11139   Anergis release: Harry Wickey 12/13/18 12:56:04 PM
#11138   Yes Anergis is going well. Sanofi still a TheHungryHippo 12/13/18 12:44:57 PM
#11137   GREAT NEWS indeed! Kudos to you for all corpus 12/13/18 12:38:43 PM
#11136   Full PR on Yahoo: Harry Wickey 12/13/18 12:31:36 PM
#11135   This is great news. The biggest hurdle has TheHungryHippo 12/13/18 10:03:08 AM
#11134   We are very satisfied with these new results bow-tie 12/13/18 09:46:54 AM
#11133   That's Impressive!! :) bow-tie 12/13/18 09:42:45 AM
#11132   immunogenicity...which was a hundred times greater than TheHungryHippo 12/13/18 09:36:55 AM
#11131   http://republic-of-innovation.ch/mymetics-and-anergis-announce-successful-pre-cl bow-tie 12/13/18 09:31:50 AM
#11130   THEY BETTER HURRY BECAUSE... MYMX 8K STATES: TheHungryHippo 12/13/18 09:27:21 AM
#11129   Thank you Hungry hippo (HH) for all the bow-tie 12/13/18 09:26:08 AM
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