Mymetics Corp (MYMX)

[TheHungryHippo]

MALARIA DD, MYMX WORKING WITH U.S. GOVT
__________________________________________________________


1. PATH MVI, LMIV, NIAID, and Mymetics signed an agreement in 2014

In November 2014, Mymetics’ virosome technology platform and its specialist virosome know-how was selected to develop an innovative malaria transmission-blocking vaccine candidate in partnership with the Laboratory of Malaria Immunology and Vaccinology (LMIV) of the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).

National Institutes of Health (NIH) THATS THE U.S. GOVERNMENT FRIENDS.


2. IN 2015 DR SYLVAIN FLEURY CSO OF MYMETICS BEGAN RESEARCH WITH THE PATH MVI ORGANIZATION, AND THE U.S. DEPARTMENT OF DEFENSE

http://digitalcommons.unl.edu/usarmyresearch/341

http://digitalcommons.unl.edu/cgi/viewcontent.cgi?article=1340&context=usarmyresearch



IN MY FIRST SCREENSHOT UNDER "Particle-based platforms for malaria vaccines" YOU SEE "YIMIN WU."

Yimin Wu, Laboratory Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, Rockville, MD

IT SAYS SHE WORKED FOR THE L.M.I.V. AND THE N.I.A.I.D.

THEN, IN THE NEXT SCREENSHOT YOU SEE YIMIN WU,

COME TO FIND OUT SHES ALSO CURRENTLY WORKING FOR PATH MVI AS A "SCIENTIFIC ADVISOR" !!!!





http://www.malariavaccine.org/about-us/our-team

Check out her email:

Yimin Wu
Laboratory Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, Rockville, MD, [e-mail]




3. SO, 2016 CAME ALONG, AND BOOM! MYMX announced a Successful Pre-Clinical with PATH MVI/LMIV/NIAID for a "certain" Malaria Transmission Blocking Vaccine candidate




THEY BASICALLY SAID "WE WORKED ON A VACCINE CANDIDATE, AND THEY USED OUR PROPRIETARY VIROSOME TECHNOLOGY, AND

"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."

I GOOGLED "PFS25 AND 97-100% " , and it tells how the Antigen PFS25, is 97-100% effective.




AND HERE IS YIMIN WU IN THE ARTICLE Published online: 01 Jan 2011.

Article views: 179

TALKING ABOUT HOW PFS25 IS 97-100% EFFECTIVE.

"high titers of anti-Pfs25 Abs when administered with Alhydrogel as an adjuvant and showed 97–100% TBA." (T.B.A. Transmission Blocking Activity)

"SMFA demonstrated that animals immunized with Pfs25MF1E, Pfs25F3E or Pfs25MF3E and Alhydrogel as an adjuvant generated Abs that resulted in 97–100% reduction in the number of oocysts (Table 3). The level of mean oocyst reduc- tion was signi cantly less with the Pfs25F1E group"




http://www.tandfonline.com/doi/pdf/10.4161/hv.7.0.14588

BASICALLY THIS "PFS25 ANTIGEN" WHEN USED IN A VACCINE FORMULATION KICKS MALARIA'S ASS.

THE LMIV STARTED FIGURING THIS OUT BACK IN 2006, AND GUESS WHO WAS DOING THE RESEARCH:

YIMIN WU

.. BEFORE MYMETICS CAME ON BOARD.

2006 Nov 28
Sustained high-titer antibody responses induced by conjugating a malarial vaccine candidate to outer-membrane protein complex. The development of protein subunit vaccines to combat some of the world's deadliest pathogens such as a malaria parasite[/I]

https://www.ncbi.nlm.nih.gov/pubmed/17110440?dopt=Abstract

AND THEN IN 2011 YIMIN WU STARTS USING PFS230

"The aim of a malaria transmission-blocking vaccine is to block the development of malaria parasites in the mosquito and thus prevent subsequent infection of the human host. Previous studies have demonstrated that the gametocyte/gamete surface protein Pfs230 can induce transmission-blocking immunity and have evaluated Escherichia coli-produced Pfs230 as a transmission-blocking vaccine candidate."

N-terminal prodomain of Pfs230 synthesized using a cell-free system is sufficient to induce complement-dependent malaria transmission-blocking activity.

https://www.ncbi.nlm.nih.gov/pubmed/21715579?dopt=Abstract

SO THE PFS25 ANTIGEN, AND THE PFS230 ANTIGENS - ARE BOTH CONSIDERED VACCINE CANDIDATES AND OWNED BY THE U.S. GOVERNMENT.

YOU GOT PATRICK DUFFY WHO WORKS FOR THE NIH NIAID AND LMIV

https://www.niaid.nih.gov/research/patrick-e-duffy-md-pathogenesis-and-immunity



"The basic immunology and pathogenesis research of our section aligns with the broader LMIV focus on the development of vaccines to interrupt malaria transmission (transmission-blocking and anti-infection vaccines) and vaccines to prevent severe malaria in pregnant women and children. "


THE NIH SPENDS MILLIONS OF DOLLARS ON MALARIA VACCINES EVERY YEAR.

https://report.nih.gov/categorical_spending.aspx

"U.S. funding for bilateral malaria control efforts and research activities was $873 million in FY 2016, up from $146 million in FY 2001."

https://www.kff.org/global-health-policy/fact-sheet/the-u-s-government-and-global-malaria/


WELL FAST FORWARD TO 2016. WE GET AN UPDATE FROM MYMETICS.

4. Mymetics announces successful preclinical results with malaria transmission-blocking vaccine candidate





OK. AWESOME. THE RESULTS OF THE PRE-CLINICAL WERE GOOD.

BASICALLY MYMETICS HAS HELPED MANUFACTURE THE GOVERNMENTS TRANSMISSION BLOCKING VACCINE, USING THEIR PROPRIETARY "VIROSOME BASED FORMULATIONS" -


WHICH MYMX HAS PATENTS FOR!!

1. Functionally reconstituted viral membranes containing adjuvant
WO 2004110486 A1

The invention provides a reconstituted viral membrane comprising an amphiphilic adjuvant and an antigen, wherein said adjuvant and said antigen interact through hydrophobic interactions, are both present with the lipid bilayer membrane of the reconstituted viral membranes, and in which the reconstituted viral membrane has membrane fusion activity that is superior to that of virosomes prepared according to EP 0 538 437

2. Virosome-like-particles
WO 2004071492 A1

The invention relates to the production of virosome-like-particles.

3. Antigen-complexes
WO 2004045641 A2

"The present invention provides novel methods and means for the preparation of vaccines that are capable of eliciting strong immune responses, especially through intranasal delivery."

Intellectual Property:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=135637349
______________________________________

SO BACK TO PATH MVI.


5. ON THE PATH MVI WEBSITE, THEY HAVE LISTED:

A CHART, OF THEIR ENTIRE PORTFOLIO OF VACCINES.

I HAVE RESEARCHED. EVERY SINGLE BUBBLE.

AND REMEMBER:

In November 2014, Mymetics’ virosome technology platform and its specialist virosome know-how was selected to develop an innovative malaria transmission-blocking vaccine candidate in partnership with the Laboratory of Malaria Immunology and Vaccinology (LMIV) of the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). [/I]







RTS-S IS THE ALTERNATIVE NAME FOR GLAXO SMITH KLINE AND WALTER REED'S "MOSQUIRIX"

AND ALSO NOTE THE "PFS25-EPA/AS01 & THE PFS230-EPA/ASO1 that says its in "pre clinical" on this chart....

and Also says GSK'S RTS-S HAS ONE OF THEIR RTS,S-AS01 FORMULATIONS UNDER REGULATORY REVIEW: "Data from a large-scale phase 3 efficacy and safety trial showed that the recommended four-dose regimen of RTS,S...."


SO GET THIS! GLAXO SMITH KLINE (GSK) ...WORKING WITH THE LMIV, NIAID , & THE NIH, AND

ACCORDING TO MYMETICS APRIL 5TH 2016 PRESS RELEASE, WHO WAS ALREADY WORKING WITH THE LMIV AND NIAID (NIH)

GLAXO SMITH JOINED IN AFTERWARDS.

LET PATRICK DUFFY EXPLAIN:

http://grantome.com/grant/NIH/ZIA-AI001009-10

Malaria Vaccines: Pfs25-rEPA and Pfs230-rEPA
Duffy, Patrick
NIAID Extramural Activities

WRITTEN IN 2016:



NOW REALLY ANALYZE WHAT HE IS SAYING:

Utilizing GSKs adjuvant AS01 with LMIVs leading TBV candidates, this proposed study attempts to explore Pfs25M-EPA/AS01 and Pfs230D1M-EPA/AS01 at full and fractional dosing. The preclinical and toxicology studies were completed in 2015-2016, with the protocol and FDA IND submission prepared and submitted in 2016. The study is planned to start in December 2016 in Mali, West Africa.



"LMIV is interested in additional vaccine strategies, including alterations in conjugation and by changing the adjuvant from Alhydrogel to a safe, but more potent AS01. Though AS01 adjuvants are not yet in licensed vaccines, one of the immunostimulant components, monophosphoryl lipid (MPL), is a component of a licensed GSK human papillomavirus vaccine, and the AS01 adjuvant system has been a key component of the Mosquirix and RTS,S/AS01B that has been widely tested in children and adults across Africa. "


WHAT I AM TRYING TO SAY IS:

ATTENTION MYMETICS SHAREHOLDERS...

THERE MAY HAVE BEEN AN IND SUBMITTED, AND WE ARE A PART OF IT.

BECAUSE NOW WE GO ON TO FIND!!!!!!!!!!!!!!

THAT...

THAT STUDY PATRICK DUFFY WAS TALKING ABOUT, WAS THE ONE WHERE...

"The preclinical and toxicology studies were completed in 2015-2016, with the protocol and FDA IND submission prepared and submitted in 2016"

I SUSPECT IS THE SAME ONE THAT MYMETICS ON APRIL 5TH, 2016 DID A PRESS RELEASE ABOUT BEING SUCCESSFUL (97-100%)

AND AND AND...

LOOK AT THIS!

IT LOOKS LIKE IT WENT ON TO GO INTO PHASE 1 ON OCTOBER 21ST, 2016 ACCORDING TO THIS CLINICAL TRIAL THAT WAS JUST RECENTLY FOUND BY THE SHAREHOLDERS:

Safety and Immunogenicity of Pfs25M-EPA/AS01 and Pfs230D1M-EPA/AS01 Vaccines, Transmission Blocking Vaccines Against Plasmodium Falciparum, at Full and Fractional Dosing in Adults in Mali

https://www.clinicaltrials.gov/ct2/show/NCT02942277?term=transmission+blocking+malaria+vaccine&cond=Malaria&rank=4

Estimated Enrollment: 900
Study Start Date: October 21, 2016
Estimated Study Completion Date: April 30, 2018

Locations
Mali
Bancoumana Malaria Vaccine Center
Bamako, Mali
Doneguebougou Malaria Research Center
Bamako, Mali
Sotuba
Bamako, Mali

Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: Sara A Healy, M.D. National Institute of Allergy and Infectious Diseases (NIAID)












Washington, DC, and Silver Spring, Md., September 8, 2017—PATH’s Malaria Vaccine Initiative (MVI) and the US Department of Defense’s Walter Reed Army Institute of Research (WRAIR) announced today that vaccinations are under way in a clinical trial to evaluate modifications to the vaccine regimen of GSK’s RTS,S/AS01 (RTS,S) malaria vaccine candidate.

RTS,S is the malaria vaccine most advanced in development globally and will be administered in selected areas of three countries in Africa—Ghana, Kenya, and Malawi—starting in 2018 through a pilot implementation program coordinated by the World Health Organization (WHO). It will be administered in a four-dose regimen, with the first dose given as soon as possible after the age of five months.

Pilot implementation of RTS,S is an important step to help protect young children in sub-Saharan Africa, the population most at risk of developing malaria. Data from a large-scale phase 3 efficacy and safety trial showed that the recommended four-dose regimen of RTS,S prevented four in ten cases of malaria over four years of follow-up.

IN THIS STUDY GSK MODIFIED RTS-S TO MAKE IT MORE EFFECTIVE.

"A recent study of the RTS,S malaria vaccine, which is based on the circumsporozoite protein (CSP), demonstrated an increase in efficacy from 50-60% to 80% when using a delayed fractional dose regimen"

Delayed fractional dose regimen of the RTS,S/AS01 malaria vaccine candidate enhances an IgG4 response that inhibits serum opsonophagocytosis.

https://www.ncbi.nlm.nih.gov/pubmed/28801554




http://www.malariavaccine.org/projects/vaccine-projects/rtss-as01-delayed-fractional-dose-field-study



PATH and Walter Reed Army Institute of Research announce largest-ever controlled malaria infection study