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http://www.mymetics.com/
COMPANY OVERVIEW
https://www.mymetics.com/files/8116/2081/0445/May21-Mymetics_Overview.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)
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.
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.
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.
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
Intellectual Property
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