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U19AI142636 2022
Description
Abstract Text
The overall objective of administrative Core A is to provide this multi-PI, multi-institutional U19 IPCAVD Project the opportunity to interact synergistically by facilitating the communication among the Project Leaders and all participating scientists. Core A will also serve as liaison between Research Administration at the contact institution, the Texas Biomedical Research Institute (TxBiomed), all the affiliated institutions both in the US and in Europe, and NIAD representatives. The network of partnering scientists includes researchers in Texas, Louisiana, Georgia and several countries in Europe; the major partner is Mymetics in Switzerland. The innovative biotech company has developed gp41-based virosomes into to a novel vaccine platform that is cold-chain independent and can be administered mucosally without needles. The Specific Aims of Core A are to: 1. Provide administrative support and facilitate the collaboration among Projects 1 and 2 and the various subcontract/subaward leaders and partners. This will include the exchange of information, reagents, and material transfer agreements. 2. Set priorities, monitor progress and jointly make go/no-go decisions. This will be achieved with input from the External Scientific Advisory Board (ESAB) and the NIAID IPCAVD Program Officer. 3. Assist in the design of experiments in rhesus macaques (RMs), protocol design and submission, and exchange of samples between the New Iberia Research Center (NIRC), where the primate studies will be conducted, and TxBiomed. 4. Provide statistical support for all IPCAVD scientists through the participation of Dr. Sarah Ratcliffe through a subaward with the University of Virginia (UVA). 5. Provide financial oversight and assure prompt payment of bills as well as the timely achievement of the experimental goals within budget limits. 6. Organize the yearly NIH Site Visit and the External Scientific Advisory Board (ESAB) meeting in the Washington, D.C. area, as well as individual visits between Drs. Ruprecht, Villinger, Santangelo and Fleury. 7. Address intellectual property (IP) issues fairly, timely, and equitably. 8. Facilitate the submission of reports, dissemination of data at meetings, and publication of manuscripts. To meet the goals of this translational, highly interactive U19 Research Program, the Core A Leader/Contact PI depends on the trained professionals with excellent organization skills as well as basic understanding of science and medicine to make this U19 network of scientists successful.
Abstract Text
Project 2 seeks to test virosomal vaccine immunogenicity and efficacy in the rhesus macaque (RM)/SHIV model. Mymetics has improved virosomal vaccines built from empty influenza virus-like particles that display an elongated HIV gp41 peptide on their surface (virosome-P1) or recombinant truncated HIV gp41 (virosome- rgp41). Earlier, Chinese RMs given two intramuscular (IM) primes followed by two intranasal (IN) boosts were 100% protected from persistent systemic infection and did not seroconvert to SIV Gag after low-dose intravaginal SHIV challenges. A follow-up study in Indian RMs showed 78% to 87% protection as long as the SHIV dose was ~7x104 times the median HIV inoculum in human male-to-female HIV transmission, but when the SHIV inoculum was ~105x greater, protection was lost. In these NHP studies, unadjuvanted, liquid formulations of the combination of virosome-P1 + virosome-rgp41 were used. To improve immunogenicity, Mymetics embedded the toll-like receptor (TLR)7/8 adjuvant 3M-052 directly into virosome membranes and developed solid, cold-chain independent vaccine formulations that can be administered needle-free. The powdered virosome forms can be given as IN spray, sublingual (SL) tablets, or packaged into oral capsules (PO). Our overall hypothesis is that the cold-chain independent, needle-free adjuvanted solid virosome forms are significantly more immunogenic than their earlier liquid form in RMs and will induce higher mucosal fluid Ab levels after mucosal priming/mucosal boosting via different routes. Mymetics has performed pilot tests in small animals with the IN and SL forms; vaccine delivery via oral capsules needs to be optimized in RMs. The Specific Aims for Project 2 are to: 1. Optimize vaccine delivery to the ileum via enteric-coated capsules; a) monitor passage of capsules containing 99mTc or 64Cu by scans; b) attach fluorescent labels to the virosomal vaccines for detection in the near-infrared spectrum. Tissues collected at necropsy will be tested by fluorescent microscopy. 2. Test the immunogenicity of different routes of the novel adjuvanted virosomes through a prime/boost approach. We will test their relative immunogenicity via IN, SL and PO routes; boosts will be given via a different mucosal route, a novel approach. Controls will be immunized IM with the soluble virosomal vaccine. 3. Test the efficacy of the cold-chain independent, needle-free, adjuvanted virosomal vaccines against repeated low-dose intrarectal (IR) clade B SHIV (SHIV-B) challenges. The most immunogenic mucosal prime/mucosal boost regimen (see Aim 2) will be used to immunize a group of 12 RMs; control (n=12) will receive empty virosomes. All RMs will undergo ~10 weekly low-dose IR challenges with the tier 2, R5 clade B SHIVSF162P3. 4. Test whether RMs that resisted multiple SHIV-B challenges will be protected against cross-clade challenge with the tier 2 R5 clade C SHIV. Protected RMs will be used to determine correlates of protection. These innovations are highly significant for the developing world, where our novel vaccine will be a major plus to combat the AIDS epidemic.
ABSTRACT – PROJECT 1
The induction of frontline defenses in genital and rectal tissues to prevent sexual HIV transmission is challenging, particularly with standard liquid subunit vaccines generally given intramuscularly. This multi-PI application is a collaboration between Mymetics (Dr. Sylvain Fleury, Project 1 Lead) and the Texas Biomedical Research Institute (Dr. Ruth Ruprecht, Project 2 Lead) that seeks to bring a promising mucosal HIV/AIDS vaccine approach into clinical development. Mymetics had inserted HIV gp41 antigens into the membranes of influenza virosomes, which have an excellent safety record in humans. These earlier, unadjuvanted liquid virosomal HIV gp41 vaccines were >80% efficacious in two independent nonhuman primate (NHP) studies. One of the gp41 vaccines, termed virosome-P1, was also safe and immunogenic in a Phase I trial in healthy women. To improve mucosal immunogenicity in the genital and intestinal tracts, Mymetics has adjuvanted the HIV vaccine formulation with the 3M-052 adjuvant that activates the toll-like receptor (TLR) 7/8; the 3M-052 adjuvant was active in infants, children, teenagers and adults. New, promising “all-in-one” HIV gp41 vaccines were specifically developed for various mucosal administration sites, with the aim to induce more efficient mucosal tissue coverage. A key innovation is the development of needle-free, solid-dosage vaccine formulations that are thermostable: nasal powder spray, sublingual tablets, or oral enteric-coated capsules filled with vaccine powder. All of these new vaccine formulations can withstand high/low temperatures outside the recommended cold-chain conditions without compromising product bioactivity. These novel, solid-form vaccines contain no free-form adjuvant; the HIV gp41-derived antigens as well as the 3M-052 adjuvant are physically bound to surface of the same particle. This prevents systemic adjuvant spread and thus avoids non-specific immune activation. Mymetics and its network of Contract Manufacturing Organizations (CMOs) will manufacture these different vaccines to test the hypothesis that the novel, cold chain-independent, needle-free, adjuvanted solid virosome forms are significantly more immunogenic than the earlier liquid form in NHPs, particularly when administered by mucosal routes. The Specific Aims for Project 1 are to: 1. Select a suitable enteric-coated capsule for vaccine delivery to the small intestine in rhesus macaques 2. Manufacture non-GMP batches of the different solid dosage forms for the NHP studies 3. Optimize the analytical methods and GMP manufacturing processes for the selected vaccine solid forms 4. Perform toxicology studies to show good safety profiles of the solid-form, adjuvanted virosomal vaccines given by mucosal routes – and to generate GMP vaccine for a Phase I trial to be conducted with the HVTN. This Project is significant because thermostable, solid-dosage forms of HIV gp41 virosomal vaccines offering mucosal protection could play a key role in preventing the further spread of HIV in the developing world, where the AIDS epidemic remains a serious problem.
Abstract Text
PROJECT SUMMARY – OVERALL This multi-PI application is a collaboration between Mymetics and the Texas Biomedical Research Institute (TxBiomed), with Drs. Sylvain Fleury (Project 1 Lead; Mymetics) and Ruth Ruprecht (Project 2 Lead; TxBiomed) serving as PIs. We seek to bring a promising HIV/AIDS vaccine approach to the clinic. The vaccine is based upon influenza virosomes, enveloped virus-like particles that display on their surface elongated HIV gp41 peptides (virosome-P1) or recombinant truncated HIV gp41 (virosome-rgp41). Mymetics' Phase I clinical trial with virosome-P1 in healthy women showed safety and immunogenicity. Two independent nonhuman primate (NHP) studies demonstrated the safety and high efficacy of the combination of virosome-P1 + virosome rgp41 against repeated low-dose intravaginal challenges with a tier 2 R5 SHIV in Chinese and Indian-origin rhesus macaques (RMs). In the latter, 78-87% efficacy was noted when the SHIV challenge dose was ~7x104 times the median HIV inoculum in male-to-female HIV transmission. However, when this HIV inoculum was exceeded 105- fold by an even higher SHIV inoculum, protection in Indian RMs was lost, implying a threshold effect whereby vaccine-induced mucosal antibodies were unable to ward off the higher number of invading SHIV particles. The soluble vaccine used in both NHP studies was unadjuvanted. To improve immunogenicity, 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. The Specific Aims of this IPCAVD project are to: 1. Assess the immunogenicity of the new vaccine candidates, the newly 3M-052-adjuvanted HIV virosome-P1 and virosome-rgp41, under solid dosage forms delivered IN, SL, or orally to Indian RMs in order to select the two most immunogenic formulations for subsequent mucosal prime/mucosal boost immunization. 2. Assess the efficacy of the cold-chain independent virosomal vaccine delivered by combined mucosal immunization routes against repeated intrarectal challenges with the heterologous R5 clade B SHIVSF162P3. Protected RMs will be rechallenged with an R5 tier 2 clade C SHIV. 3. Optimize the GMP manufacturing process for the selected virosomal formulations for mucosal delivery, and 4. Perform toxicology studies to show good safety profiles of the adjuvanted, solid-form vaccines given by selected mucosal routes – and generate GMP vaccine for a Phase I trial to be conducted with the HVTN. Our vaccine development plans represent major advances, as the novel needle-free, solid vaccine dosage forms are cold-chain independent and will be mucosally delivered – unique aspects that make the novel virosomal vaccines especially attractive for the developing world, where the AIDS epidemic remains a serious problem
https://reporter.nih.gov/search/K-ztMzgyCk25GZC9F4Nb-A/projects
Why would our Ceo talt
a failed AdImmune covid nasal spray & hide the results of his own right in the mist of revealing his own which someone else did for the first time but didn't completely do on that ?
He wants his stock price lower for some reason ?
Transparency @ Biopole
LOL
CEO Grant Pickering said capacity constraints at Vaxcyte’s contract development and manufacturing organization (CDMO) Lonza and the impact of the COVID-19 pandemic prompted the delay.
This was expanded upon by COO James Wassil who told analysts on Vaxyte’s earnings call manufacture of the 24 conjugated drug substances at larger scale at Lonza’s site is taking longer than company had anticipated.
https://bioprocessintl.com/bioprocess-insider/regulations/cdmo-and-covid-delays-push-back-vaxcyte-pneumococcal-vaccine-ind/
We believe that an efficient and high-quality manufacturing process is critical to our long-term success. We have strategically aligned with our contract manufacturer, Lonza Ltd., or Lonza, a globally recognized contract development and manufacturing organization based in Switzerland, to develop a robust and scalable manufacturing process for VAX-24. We have partnered closely with Lonza to transfer technology and develop and optimize processes to produce clinical trial material, and are in discussions to expand the scope to scale up for potential commercial production of VAX-24. With this ongoing partnership, we believe we are addressing the complexity of vaccine development and production, thus establishing barriers to entry to protect our PCV franchise.
https://www.sec.gov/Archives/edgar/data/1649094/000119312520150234/d802328ds1.htm
April 18, 2022 8K
Item 1.01. Entry into a Material Definitive Agreement.
Master Services Agreement for Drug Product Development and Manufacturing with Lonza Ltd
On April 12, 2022, Vaxcyte, Inc. (“Vaxcyte”) entered into a master services agreement for drug product development and manufacturing (the “Master Services Agreement”) with Lonza Ltd (“Lonza”), effective as of March 22, 2022, pursuant to which Lonza will perform manufacturing process development and clinical manufacture and supply of Vaxcyte’s proprietary pneumococcal conjugate vaccine. Under the Master Services Agreement, Vaxcyte will pay Lonza for manufacturing services and pass-through expenses incurred by Lonza for raw materials, as well as a customary procurement and handling fee.
Under the Master Services Agreement, Vaxcyte shall own all right, title and interest in and to any and all Intellectual Property that Lonza and/or its affiliates, the External Laboratories or other contractors or agents of Lonza develops, conceives, invents, first reduces to practice or makes, solely or jointly with us or others, in the performance of the Services (each term as defined in the Master Services Agreement), to the extent such Intellectual Property is a direct derivative of or improvement to Drug Product, Product, Drug Substances, Customer Materials, Customer Information and/or Customer Background Intellectual Property (each as defined in the Master Services Agreement). Lonza shall own all right, title and interest in Intellectual Property that Lonza and/or its Affiliates, the External Laboratories or other contractors or agents of Lonza, solely or jointly with Vaxcyte, develops, conceives, invents or first reduces to practice or makes in the course of performance of the Services to the extent such Intellectual Property (i) is generally applicable to the development or manufacture of chemical or biological products or product components, and could reasonably have been made without the use of the Customer Materials, Customer Information or Customer Background Intellectual Property and (ii) is an improvement of, or direct derivative of, any Lonza Background Intellectual Property (each term as defined in the Master Services Agreement).
Unless earlier terminated, the Master Services Agreement shall remain in place for a period of five years. Either party may terminate the Master Services Agreement for any reason on prior written notice to the other party, provided that Lonza may not exercise such right until a specified future date. In addition, either party may terminate the Master Services Agreement (i) within a given time period upon any material breach that is left uncured by the other party, or (ii) immediately if the other party becomes insolvent. Vaxcyte may also terminate the Master Services Agreement upon an extended force majeure event. Upon expiration and/or termination of the Master Services Agreement and/or any purchase order, Vaxcyte will pay Lonza for all service rendered, all costs incurred, all unreimbursed capital equipment and any cancellation fees.
The foregoing description of the terms of the Master Services Agreement does not purport to be complete and is subject to, and qualified in its entirety by reference to, the complete text of the Master Services Agreement, which will be filed with the Securities and Exchange Commission as an exhibit to Vaxcyte’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2022. Vaxcyte intends to request confidential treatment for certain terms of the Master Services Agreement.
https://www.marketwatch.com/investing/secfile/15736695
Thanks same to you brother
Headquartered in Rockville, Maryland, Vigene features 10 fully equipped GMP clean room suites for AAV, lentivirus, retrovirus, adenovirus and plasmids GMP production, respectively. In addition, Vigene also develops and owns a panel of intellectual properties including proprietary high productivity cell lines (suspension and adherent cells) for viral vector packaging and patents for increasing viral vector packaging efficiency. Vigene offers FDA and EMA compliant cGMP production for viral vector and plasmid production with the mission of making gene therapy affordable.
https://seekingalpha.com/news/3593537-altimmune-secures-supply-of-covidminus-19-nasal-spray-vaccine
The purpose of this study is to evaluate the humoral immune response and safety of the parenteral formulation of the 2010/2011 season virosomal subunit influenza vaccine Inflexal V using two different HA antigen providers (AdImmune and CSL), in groups of young people. and elderly adults, using the EMA (European Medicines Agency) regulation as a guideline.
https://ichgcp-net.translate.goog/es/clinical-trials-registry/NCT01412281?_x_tr_sl=es&_x_tr_tl=en&_x_tr_hl=en&_x_tr_pto=sc
Trivalent virosomal influenza vaccine - Adimmune; Virosomal influenza vaccine
https://adisinsight.springer.com/drugs/800039934
(AdImmune and CSL),
inactivated, virosome, using CSL HA Antigen) 2010/2011
https://clinicaltrials.gov/ct2/show/NCT01229371
Altimmune ditches COVID-19 nasal spray vaccine, halts therapeutic enrollment after trial setbacks
https://www.fiercebiotech.com/biotech/altimmune-to-ditch-covid-19-nasal-spray-vaccine-and-stop-enrollment-therapeutic-program
In addition, we rely at least in part on third-party suppliers including CSL and Novartis for the supply of crucial materials for the production of some of our marketed products or those under development, including starting materials as well as antigens present in the final product.
In addition, our agreement with CSL for the supply of flu antigen for the production of our flu vaccine Inflexal will terminate as of December 31, 2009. Due to the shortage of antigen production capacity worldwide, we anticipate that it may be difficult to establish a new contract for the supply of flu antigen on the terms and conditions we currently have.
CSL Pharmaceuticals
In November 2001 Berna Biotech entered into an agreement with CSL Pharmaceuticals, pursuant to which CSL supplies flu antigen to Berna for the manufacture and sale of virosome-based flu vaccines, such as Inflexal. Under the agreement, Berna is entitled to a minimum quantity of seasonal flu antigens, which is adjusted upward each year. However, due to external factors, such as slower growth rates of certain seasonal flu strains, even the minimum quantities may be difficult to obtain in time for a particular year’s flu season, or at all. This may affect revenues in any given year in which this occurs. The agreement terminates after 2009. Due to the shortage of antigen production capacity worldwide, it may be difficult to renew the contract against the same terms and conditions, or at all. If this risk materializes it will adversely affect our results.
Supply Agreement dated November 12, 2001 and the Letter of Amendment to the same Agreement, dated June 24, 2004 between CSL Limited and Berna Biotech Limited******
https://www.sec.gov/Archives/edgar/data/1126136/000110465907047370/a07-7572_120f.htm
Problem solved, let's hear it for Biosimilars
Priority Target for Big Pharma: GSK, Merck, Sanofi, Pfizer, Seqirus-CSL (80%-85% of vaccine market)
https://www.mymetics.com/files/8116/2081/0445/May21-Mymetics_Overview.pdf
https://patents.google.com/patent/EP1755666B1/en
Thank you Phosphene & Ronald Kempers
LOL really hard
In addition to the granting of the PEV7 option, the two companies have signed a long-term supply agreement, whereby CSL manufactures certain biological components that are being used by Pevion in the in vitro assembly process of its virosomes. Virosomes are a regulatory and market-approved vaccine technology that fulfills multiple carrier and adjuvant functions in one. They form the basis of all of Pevion's proprietary and partnered pipeline products. Pevion has developed the second generation of virosomes that allow alternative product formulations, such as capsules.
https://www.prnewswire.com/news-releases/pevion-grants-csl-option-right-to-its-therapeutic-candida-vaccine-128868393.html
Further terms of the agreement were not disclosed.
Andreas Kammer
Senior Scientist Complianc
CSL Behring
Dec 2013 - Present
8 years 7 months
Bern Area, Switzerland
Pevion Biotech AG
10 years 6 months
https://ch.linkedin.com/in/andreas-kammer-b7915a54?original_referer=https%3A%2F%2Fsearch.yahoo.com%2F
Mymx Csl Lonza Bern
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=165670117
Go Ronald Kempers & crew
LOL
DR. ROBERT ZIMMER, Executive Director of Eptingerstrasse 51, CH-4132 Muttenz, Switzerland
Executive Director of Jago Pharma AG
https://www.sec.gov/Archives/edgar/data/880643/0000912057-96-013937.txt
https://en.wikipedia.org/wiki/Genta_(company)
Go
Lanstead Capital Investors L.P.
Oregon State University
https://investorshub.advfn.com/boards/replies.aspx?msg=168030478
Let's hear it for Vir Gsk & TB & MGF
ImmuPharma PLC (LSE:IMM) (Euronext Growth Brussels: ALIMM), the specialist drug discovery and development company, announces that Dr Robert Zimmer, President & Chief Science Officer has confirmed to the Company that he will not be seeking re-election at the forthcoming Annual General Meeting scheduled for 28 June 2021 and will be retiring from ImmuPharma PLC and leaving the Board with effect from then.
https://www.immupharma.co.uk/director-retirement/
The Board would like to express its gratitude to Dr Zimmer for his 16 years of service and wishes him well for the future.
As a substantial shareholder in ImmuPharma and to demonstrate his continued support of the Company, Dr Zimmer has entered into a lock-in agreement, to not dispose of shares in which he has an interest, for a period of three years or, if earlier than three years, the date of the reporting by the Company of the preliminary results of the next Phase 3 clinical trial of Lupuzor™.
Commenting on the announcement, Dimitri Dimitriou, CEO of ImmuPharma said: “Having co-founded ImmuPharma in 2005, Robert has been a driving force in the business for many years, both scientifically and through our strategic collaborations, in particular the longstanding relationship with the CNRS*. On behalf of the Board and all our colleagues, I thank him for his invaluable and unique contribution.”
Dr Robert Zimmer, added: “I have taken great pride at being at the helm of ImmuPharma, working with such highly committed and exceptionally talented colleagues. Whilst my retirement from the Company will allow me to focus on the many endeavours now afforded to me, as a major shareholder in ImmuPharma, I remain fully supportive of the Company, its diverse pipeline and technology but most specifically, the long-term success of Lupuzor™. As such, I have every confidence that Lupuzor™ has the potential of becoming a first line treatment for the many lupus patient sufferers around the world.”
*CNRS : Centre National de la Recherche Scientifique
This announcement contains inside information as stipulated under the UK version of the Market Abuse Regulation no 596/2014 which is part of English law by virtue of the European (withdrawal) Act 2018, as amended. on publication of this announcement via a regulatory information service, this information is considered to be in the public domain.
https://www-cnrs-fr.translate.goog/?_x_tr_sl=fr&_x_tr_tl=en&_x_tr_hl=en&_x_tr_pto=sc
Robert Zimmer biography
Dr. Robert Henri Zimmer, M.D, Ph.D., is President, Chief Scientific Officer, Director of Immupharma Plc. Dr. Zimmer was the CEO and founder of ImmuPharma’s operations in Switzerland and France. He is a physician and obtained his MD at Strasbourg Medical School and his PhD at the University of Aix-Marseille. He became a department director at the “Fondation de Recherche en Hormonologie” in Paris. He began his career in the industry in 1985 in Roche’s headquarters in Basle, Switzerland responsible for numerous clinical studies. He was a director and head of R&D at SkyePharma plc. He was instrumental in the development of a substantial number of products for companies including Roche, GlaxoSmithKline, Abbott, Searle, Sanofi-Aventis and Lilly; some of which reached the market, such as Paxil CR (GSK), Xatral LP (Sanofi ) and Madopar CR (Roche).
https://wallmine.com/euronext/alimm/officer/2019006/robert-zimmer
Dr. Erwann Loret (Marseille University, France}
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=159283863
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=163114060
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=155119925
ImmuPharma PLC (LSE AIM: IMM - Euronext Growth: ALIMM), the specialist drug discovery and development company, is pleased to announce subscriptions to raise £1.5 million (the "Subscriptions") through the issue of 15,000,000 new ordinary share of 10 pence each in the Company ("Ordinary Shares") (the "Subscription Shares") at a price of 10p per Ordinary Share ("Issue Price"). The Subscriptions comprise a £200,000 subscription from Dr Robert Zimmer, (Director, President & Chief Scientific Officer of ImmuPharma) through Luca and Associates AG ("Luca")( a company to which he is connected) and a £1.3 million subscription with Lanstead Capital Investors L.P. ("Lanstead"), an institutional investor and substantial shareholder, together with a related sharing agreement, to raise in aggregate £1.5 million before expenses.
https://www.investegate.co.uk/immupharma-plc/rns/-1.5m-subscrip-n-to-fund-r-d-pipeline--replacement/202003300802150090I/
LUCA & Associates AG
https://www.dnb.com/business-directory/company-profiles.luca__associates_ag.9981d20aec76f83cfad45abc9cb29c86.html
B. SEARCH & IDENTIFICATION WILL BE DONE BY NEXT FRIDAY
ROBERT ZIMMER
Mymx gave him 400,000 shares
or by our outside directors, Professor Stanley A. Plotkin, M.D. and Dr. Robert Zimmer
Dr. Zimmer is a graduate of the Ecole Centrale de Lyon, M.D. and Sc.D., a
former: (i) assistant-professor at the Faculty of Medicine of Strasbourg
(France), (ii) department head at the Foundation for hormonology research in
Paris from 1979 to 1985, (iii) responsible for the coordination of the Clinical
Pharmacology at Hoffmann La Roche in Basle (Switzerland) from 1985 to 1990, (iv)
Senior Executive President and CSO of Jago Pharma AG, a drug delivery specialist
later acquired by Skyepharma plc from 1990 to 1999. Dr. Zimmer is currently
Chairman and CEO of Bio Delivery Systems S.A. (BDS), a French company
specializing in drug delivery technologies, and Chairman of Zimmer & Associates
AG, a Swiss consulting firm specialized in strategic development of
pharmaceutical products. On July 30, 2003, Dr. Zimmer was elected as Director,
and appointed as Vice President, Head of Business Development of Mymetics
Corporation. Owing however to unexpected but positive developments at BDS which
interfered with his capacity to effectively discharge his duties as an officer
of Mymetics, Dr. Zimmer resigned his officer position on September 1, 2003,
while agreeing to remain as an outside director of the Company.
https://www.sec.gov/Archives/edgar/data/927761/000095015205003197/j1231402e10vk.txt
Patents Assigned to Zimmer & Associates AG
https://patents.justia.com/assignee/zimmer-associates-ag
United States International Organization
Kagenstrasse 12
Ch 4153 Reinach
SWITZERLAND
https://www.plainsite.org/profiles/zimmer-and-associates-ag/
My humble apologies to you & all over my last post, that didn't exactly come out right but you get my point about the press & facial pain, over & over & over.
lol
You see any facial pain in that ?
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=169037597
I'm telling you that if I see Maria & Texas Pete w/ her, Ruth Sara & Adrian
I'm going to burn Rk to the ground w/ google
& there w/ being nothing google can do about it w/ that chitty lil patent Sara has
Just for fun
Morgane Bomsel: researcher
https://transversalmag-fr.translate.goog/articles-vih-sida/843-Morgane-Bomsel-tete-chercheuse?_x_tr_sl=fr&_x_tr_tl=en&_x_tr_hl=en&_x_tr_pto=sc
https://wikimili.com/en/Prix_Jaff%C3%A9
https://www.nytimes.com/1993/10/31/us/french-researchers-discover-a-molecule-that-hinders-hiv.html
Superlab Suisse Lausanne
https://bioalps.org/superlab-suisse-lausanne/
https://superlabsuisse.com/
Three Wyss Centers in Switzerland
& Bern just presented the Novel nasal virosome spray vaccine to protect against COVID-19
https://bioalps.org/hansjorg-wyss-philanthropist/
Hail Harvard
https://www.wyssacademy.org/project-bern
https://rogerfedererfoundation.org/who-we-are/our-partners
EPFL Grant-making Foundation
https://memento.epfl.ch/event/epfl-grant-making-foundation-days-3/
Financial, Advisory & Investors who attended in 2021 included:
BRESLIN AG
https://www.sachsforum.com/
The first Sachs-Biopôle Investment Seminar
16TH JUNE 2022
https://www.sachsforum.com/sbiss-about.html
https://www.sachsforum.com/sbiss-sponsors.html
FINANCING OF R&D PROJECTS
Two national organizations help to raise funds to finance projects dedicated to research and development (R&D).
Innosuisse
Innosuisse is the Swiss agency for the promotion of innovation and encourages innovation projects based on science that (primarily small and medium-sized) businesses carry out in conjunction with research partners. It supports start-ups in their evolution, businesses in terms of international cooperation, and start-ups which are looking to establish themselves abroad. Innosuisse also promotes networks and events in important fields of innovation.
Euresearch
Financed by the State Secretariat for Education, Research, and Innovation (SEFRI), Euresearch is the Swiss network which connects research and European innovation programs. Horizon2020 in particular offers a number of scholarships to top-class researchers based in Switzerland (24.4 billion euros). The initiative also supports industrial leadership projects (17 billion euros) and ones which tackle societal challenges, for example in the fields of health, climatology, and security (29.7 billion euros).
https://www.invest-vaud.ch/success
Rue Caroline 11
CH–1014 Lausanne
Yah 2's look distant now
They are small so maybe I'm 2 hard on them
https://www-breslin-ch.translate.goog/clients?_x_tr_sl=de&_x_tr_tl=en&_x_tr_hl=en&_x_tr_pto=sc
Not sure this is still so but it's a guide
Check ya later
Still hanging around are they
They must think there is money in white papers
lol
Conflict of Interest
MA and SF are employees of Mymetics SA; MS is presently an employee of Bayer and the contribution to the work was made as an iBET employee.
The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
Tiziana Patrizia Cremona
must have presented
From Universität Bern
eP320 - Novel nasal virosome spray vaccine to protect against COVID-19 - Tiziana Patrizia Cremona, Switzerland
https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=&ved=2ahUKEwiqjZ2at434AhX0mYQIHZdhCCs4ChAWegQIAhAB&url=http%3A%2F%2Fwww.ersnet.org%2Fwp-content%2Fuploads%2F2022%2F03%2FLSC-2022-programme_04.03.2022.pdf&usg=AOvVaw2KE4t29mPZ_HQqbxC9tE2B
Harvard University | Harvard · Harvard School of Public Health
PhD ?
https://www.researchgate.net/profile/Tiziana-Cremona
https://www.google.com/search?q=Tiziana+Patrizia+Cremona+bern&tbm=isch&source=iu&ictx=1&vet=1&fir=U8qKHPN1AKsrCM%252C4Nsfvv2b7oDtfM%252C_%253Bm7h4M2PLNtm3mM%252Cm439HV5CpoSfVM%252C_%253B7j0wcxLOoOJtYM%252CwYs5rtJOcDNbWM%252C_%253Bg6XhritCTf8FtM%252Cm439HV5CpoSfVM%252C_%253B1iuBOzS_KJdKOM%252C4Nsfvv2b7oDtfM%252C_%253Bq2O3eCNqclhMKM%252Cm439HV5CpoSfVM%252C_%253BsmtJT_g_fJJ-iM%252CXhyQsQS2EFzbRM%252C_%253B50Bcw8Ly7FSUJM%252Cm439HV5CpoSfVM%252C_%253Bl95Rdw4en0JW9M%252C4Nsfvv2b7oDtfM%252C_%253B3SowGTm4daegLM%252C54AHJUkAstsafM%252C_&usg=AI4_-kTl9_f2iC8XD8XOi1qIYYSpypUEZg&sa=X&ved=2ahUKEwjl-JmZuY34AhUfg4kEHTWWAY0Q9QF6BAgUEAE#imgrc=U8qKHPN1AKsrCM
https://www.google.com/search?q=Tiziana+Patrizia+Cremona+bern&tbm=isch&source=iu&ictx=1&vet=1&fir=U8qKHPN1AKsrCM%252C4Nsfvv2b7oDtfM%252C_%253Bm7h4M2PLNtm3mM%252Cm439HV5CpoSfVM%252C_%253B7j0wcxLOoOJtYM%252CwYs5rtJOcDNbWM%252C_%253Bg6XhritCTf8FtM%252Cm439HV5CpoSfVM%252C_%253B1iuBOzS_KJdKOM%252C4Nsfvv2b7oDtfM%252C_%253Bq2O3eCNqclhMKM%252Cm439HV5CpoSfVM%252C_%253BsmtJT_g_fJJ-iM%252CXhyQsQS2EFzbRM%252C_%253B50Bcw8Ly7FSUJM%252Cm439HV5CpoSfVM%252C_%253Bl95Rdw4en0JW9M%252C4Nsfvv2b7oDtfM%252C_%253B3SowGTm4daegLM%252C54AHJUkAstsafM%252C_&usg=AI4_-kTl9_f2iC8XD8XOi1qIYYSpypUEZg&sa=X&ved=2ahUKEwjl-JmZuY34AhUfg4kEHTWWAY0Q9QF6BAgUEAE#imgrc=m7h4M2PLNtm3mM
https://www.google.com/search?q=Tiziana+Patrizia+Cremona+bern&tbm=isch&source=iu&ictx=1&vet=1&fir=U8qKHPN1AKsrCM%252C4Nsfvv2b7oDtfM%252C_%253Bm7h4M2PLNtm3mM%252Cm439HV5CpoSfVM%252C_%253B7j0wcxLOoOJtYM%252CwYs5rtJOcDNbWM%252C_%253Bg6XhritCTf8FtM%252Cm439HV5CpoSfVM%252C_%253B1iuBOzS_KJdKOM%252C4Nsfvv2b7oDtfM%252C_%253Bq2O3eCNqclhMKM%252Cm439HV5CpoSfVM%252C_%253BsmtJT_g_fJJ-iM%252CXhyQsQS2EFzbRM%252C_%253B50Bcw8Ly7FSUJM%252Cm439HV5CpoSfVM%252C_%253Bl95Rdw4en0JW9M%252C4Nsfvv2b7oDtfM%252C_%253B3SowGTm4daegLM%252C54AHJUkAstsafM%252C_&usg=AI4_-kTl9_f2iC8XD8XOi1qIYYSpypUEZg&sa=X&ved=2ahUKEwjl-JmZuY34AhUfg4kEHTWWAY0Q9QF6BAgUEAE#imgrc=7j0wcxLOoOJtYM
This article was presented at the 2022 ERS Lung Science Conference, in session “Poster Session 2”.
https://www.ersnet.org/ers-respiratory-channel/lung-science-conference-2022/
https://www.ers-education.org/events/conferences/?idP=255013
Present Address:
Marcos Sousa,
Bayer AG, Pharmaceuticals-Product
Supply, Leverkusen, Germany
Marcos Sousa
Cell Culture Expert at Bayer AG
Cologne, North Rhine-Westphalia, Germany500+ connections
Bayer AG Bayer AG
About
Senior Bioprocess Engineer with almost 20 years’ experience in upstream process development in areas such as recombinant protein, viral vectors, vaccines and VLP production, optimization of human stem cells expansion and differentiation. Expertise in several designs of bioreactors and process scale-up bioengineering criteria. Experienced in technology transfer from R&D to late stage of development (pilot scale) and to GMP environment, including projects with companies. Successfully supporting multiple projects both independently and as a part of global team with proven track record on deliverables and milestone achievements.
https://pt.linkedin.com/in/marcos-sousa-2a6a9116?challengeId=AQFl6NKgyqhV4wAAAYEhbtoTLitl9uWgJF8zt_aVSGtqfDr23G-8mVEVRWjpBH2U0N1whEvy-5EPqNig2Pt9r62Y6mdlzlDVlw&submissionId=6e6ddea4-65a0-f416-5f6b-6fd6309f1455
NHPs still is my guess then human trials
Assuming they can raise the money for a trial
Don't understand why the insiders won't fund it but they are obviously seeking a partner for that
Strange lil company they have
Later
Next steps
We getting there brother
lol
A. PREPARATION IS DONE
B. SEARCH & IDENTIFICATION WILL BE DONE BY @ LEAST THE 17TH
LOL @ Rk Baylor Bern Amsterdam & Hzi for revolutionized pre clinical studies
LOL
U19AI142636 Vaccine development and production
2022
https://reporter.nih.gov/search/-r-U3sXM-kqITdVB_I5KPw/projects
Could easily see 1.50
but the problem is that there is no truth to this company which begs the question
Is Ronald Kempers a fake ?
Outta here, have a good week & weekend
University of Washington School of Medicine-Gonzaga University Health Partnership’s medical and health education, research and innovation center.
https://www.gonzaga.edu/news-events/stories/2021/6/30/in-the-news-spokane-medical-education-hub-expands
https://www.gonzaga.edu/student-life/career-services/students/professional-graduate-school-resources/health-professions-pathways-program/why-pursue-health-professions-at-gonzaga/healthcare-in-spokane
Bill Gates to speak on polio eradication during regional Rotary conference in Spokane
https://www.spokesman.com/stories/2019/may/10/bill-gates-to-speak-on-polio-eradication-during-re/
You aren't the only one w/ that thought
It can even come across as an act of desperation
There will be no cheap biotech buyout pump for Ronald Kempers
Later
I know that is how I'd do it
pay him over 300k a year to hire someone to sell the company in the last year of a 5 year Nih grant
or @ least the last year per him & the Nih as of May 19 but who counts fuzzy math, right
Someone is under water Grant
ENTASIS THERAPEUTICS INVESTOR ALERT by the Former Attorney General of Louisiana: Kahn Swick & Foti, LLC Investigates Adequacy of Price and Process in Proposed Sale of Entasis Therapeutics Holdings Inc.
No worries b/c he still has that Vaxcyte personal atm
Hew
You are, they must have something to sell
b/c it's always been about the data data data
So Nih funding on the 19th of May
Klaus Berding has more than 25 years’ work experience in banking and consulting, mainly focusing on the Life Sciences and Technology sectors.
In 2003, he started his own corporate finance and consulting business LSFA-Life Science & Financing, and he has been part of BRESLIN’s operating team since 2005. He is a co-founder of Amypopharma in Italy, a spin-off from UNIMIB, and he serves as a member of its board. For more than 10 years, Klaus has been active as a coach and expert reviewer for European VC events, organized by TechTour.
He before worked at Dresdner Kleinwort, starting in Equity Research and thereafter moving to Corporate Finance. As SVP and Director in the Industry Group Chemicals & Healthcare, he was responsible for managing member relations and had an active role in building the international equity business of the Bank. During this tenure, he was instrumental in setting up a joint collaboration with an Israeli Investment bank to develop its IPO business and corporate finance activities. He participated in or led over 40 IPOs and capital market transactions and was involved in spin-offs and M&A mandates.
Klaus holds an MBA from Ruhr University Bochum and has a post-graduate degree from the DVFA (Association of German Investment Professionals).
He participated in the 1st European seminar on “Business Development Basics Life Sciences”, jointly organized by BIO Organization, E.B.D. Group (Event Organizer), and LES (Licensing Executives Society) in Frankfurt (2003), as well as in the Private Equity & Venture Capital Management Training in Barcelona in 2004, organized by EVCA. He is also a member of the House of Pharma, an association actively supporting the development of the Life Sciences’ sector in Germany’s Rhein-Main area.
1.2
DETAILS & STRUCTURE OF BRESLIN’S ENGAGEMENT
The whole scope of services of BRESLIN could be divided into five phases of engagement (A to E):
A. PREPARATION (approx. 2 weeks)
a) Verifying base of collaboration between MYMETICS and the potential partner (collection & review of existing information);
b) Preparing information package in cooperation with MYMETICS.
B. SEARCH & IDENTIFICATION (approx. 2-3 weeks)
a) Screening of BRESLIN’s global network and international deal flow to identify potential and qualified partners for a strategic partnership, exit or equity financing;
b) Prioritizing potential partners based on previously defined criteria;
c) Deliverable: short list of at least 8 to 10 mutually agreed potential partners with prioritization to be approached in phase C.
C. APPROACH & CONTACTING (8 - 10 weeks)
a) Personal approach of selected potential partners by BRESLIN;
b) Providing interested potential partners with non-confidential information packages;
c) Submitting CDAs prior to disclosure of any confidential material to interested potential partners;
d) Organizing conference calls and preliminary negotiations with interested potential partners of possible terms and conditions, in particular financial terms;
e) Reporting to MYMETICS every two weeks by telephone conferences or by way of written activity spreadsheets;
f) Milestone: go / no-go decision of MYMETICS based on interest and likelihood of closing deal with interested potential partners.
D. NEGOTIATION & DUE DILIGENCE (6 - 8 weeks)
a) Organizing conference calls and detailed discussions with selected potential partners of terms and conditions, in particular financial terms; support and establishment of due diligence dataroom(s);
b) Negotiating with selected potential Partners together with the management of MYMETICS;
c) Support and assistance of pre-Transaction due diligence with various types of risk estimations and modifications of proposed models;
d) Signing of formal “Letter of Intent” (LOI);
e) Support and assistance with final due diligence of data, materials, agreements and selected potential partners; coordination of legal activities; coordination of individual participants and parties to the intranasal flu vaccination program, etc.
E. FINALIZATION & CLOSING (approx. 4 weeks)
a) Support and assistance in final negotiations with selected potential partners;
b) Last minute modifications of services upon MYMETICS’ request;
c) Coordination and support of all parties in closing procedures.
https://www.amypopharma.com/en
https://www.biovelocita.com/en/press/oncology-chronic-infectious-diseases-and-amyloidosis-the-focus-of-new-biovelocita%E2%80%99s-portfolio/1,388,1,
Cold Chain-Independent, Needle-Free Mucosal Virosomal Vaccine to Prevent HIV-1 Acquisition at Mucosal Levels
U19AI142636
5/19/2022 $1,615,853
https://taggs.hhs.gov/Detail/RecipDetail?arg_EntityId=OG0gXGMDRXW5A%2BeI5A9jkQ%3D%3D
ETTX Stock Alert: Halper Sadeh LLP Is Investigating Whether the Sale of Entasis Therapeutics Holdings Inc. Is Fair to Shareholders
Great, let's hear it for Grant Pickering, Debra Brix,
Oh, & Ronald Kempers & the Temple Of Doom
LMAO
First human patient injected with revolutionary cancer-killing virus
https://www.yahoo.com/entertainment/first-human-patient-injected-revolutionary-140900099.html
City of Hope and Imugene Announce First Patient Dosed in Phase 1 Trial to Test Cancer-Killing Oncolytic Virus Against Solid Tumors
May 17, 2022
https://www.cityofhope.org/city-hope-and-imugene-announce-first-patient-dosed-phase-1-trial-test-cancer-killing-oncolytic
Red Fraggle