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COVID-19 and Renin Angiotensin Blockers | Circulation
www.ahajournals.org/doi/10.1161/CIRCULATIONAHA...
Franz H. Messerli, MD, Swiss Cardiovascular Center, University Hospital Bern, Inselspital. ... in the form of a nasal spray to treat COVID-19. Because pneumonia is a ...
Several potential therapeutic/preventive approaches to address angiotensin-converting enzyme 2 (ACE2)-mediated COVID-19 have been described, including the suggestion that ARBs could be administered in the form of a nasal spray to treat COVID-19. Because pneumonia is a common potentially fatal complication in COVID-19 infection, we wondered whether RAS blockade could exert a favorable effect on pneumonia-related outcomes.
https://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.120.047022
Mambisa's results are evaluated in its short vaccination schedule
CUBANEW/ACN
02 FEBRUARY 2021
Ayala Avila explained that the intramuscular and intranasal route of administration is explored, one group is evaluated with a first intramuscular immunization and two others by nasal route (with spray); while another group only studies the nasal route with the three immunizations.
Mambisa (CIGB-669) is based on the formulation of the RBD (Receptor Binding Domain) protein and an immunopotentiator evaluated by the center: the Hepatitis B nucleocapsid antigen.
In turn, Abdala, which began its Phase II study on Monday, is based on the formulation of the recombinant RBD protein adjuvant in aluminum hydroxide.
Both candidates began their studies on December 7, 2020 and 56 days after administration are safe, with mild adverse events.
The RBD recombinant protein is produced by the CIGB in yeast cells, a technology widely used in Cuba and the world to obtain subunit vaccines.
http://www.cubanews.acn.cu/cuba/12361-mambisa-s-results-are-evaluated-in-its-short-vaccination-schedule
HAVANA, Cuba, Feb 5 (ACN) The Center for Genetic Engineering and Biotechnology (CIGB) expects to advance in March to Phase III of the clinical trials of the Abdala vaccine candidate (CIGB-66), after more than 300 individuals participated in the second stage of its short vaccination scheme.
http://www.cubanews.acn.cu/science/12417-cuba-abdala-and-mambisa-vaccines-clinical-trials-progress-with-encouraging-results
Cuba announces Phase 3 for vaccines Abdala (CIGB-66) and ...
www.emergency-live.com/health-and-safety/cuba...
Cuba, the Caribbean island's independently produced vaccines are now in their final definition phase. Abdala (CIGB-66) and Soberana 02...
https://www.emergency-live.com/health-and-safety/cuba-ministry-of-health-announces-phase-3-for-abdala-cigb-66-and-soberana-02-its-two-covid-19-vaccines/
Honduran scientist Maria Elena Bottazzi is vaccinated against covid-19
Maira Medina
14 Jan. 2021
"I wish I could send something to everyone in need, especially Honduras," she said in a message posted on Twitter
Honduran scientist Maria Elena Bottazzi received on Thursday (14.01.2021) the first dose of the covid-19 vaccine in the United States, where she stands out for her professionalism and participation in the development of an anti-vid vaccine.
As she made his Twitteraccount known, Bottazzi vacued at Texas Children's Hospital, whereshe is co-director of the Center for Vaccine Development.
I am "so happy and grateful to the Children's Hospital for the privilege of receiving my first dose of the covid-19 vaccine," she wrote.
VEA: Russian vaccine has no scientific evidence warned Honduran Maria Elena Bottazzi
"I wish I could send something to everyone in need, especially Honduras. But it will happen very soon, so don't despair and use a water cover (using an emoji)," was the message Bottazzi added,attaching the image showing the time of his vaccination.
https://www.tunota.com/cientifica-hondurena-maria-elena-bottazzi-se-aplica-vacuna-contra-el-covid-19
MAMBISA Study
General information
Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.
Scientific title:
Adaptive phase I / II clinical trial, randomized, of parallel groups, to evaluate the safety and immunogenicity in adults of two vaccine candidates, based on recombinant RBD subunits for the prevention of COVID-19 in regimens that use the nasal route of administration. (COVID-19)
Secondary indentifying numbers:
IG/VPIN/CVD19/2001
Issuing authority of the secondary identifying numbers:
Center for Genetic Engineering and Biotechnology (CIGB)
Primary sponsor:
Center for Genetic Engineering and Biotechnology (CIGB), in Havana
Secondary sponsor:
Not applicable
Source(s) of monetary or material support:
Center for Genetic Engineering and Biotechnology (CIGB), Havana.
Authorization for beginning
Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.
Regulatory instance to authorize the initiation of the study:
Center for State Control of Drugs, Medical Devices and Equipment (CECMED)
Reference number:
In process
Principal investigator
Section to complete information about Email address, telephone number and postal address of the Principal Investigator.
First name:
Carlos
Midle name:
Alberto
Last name:
Gonzalez Delgado
Medical Specialty :
2nd degree specialist in Pharmacology; Master in Toxicology; Assistant Researcher.
Affiliation:
National Toxicology Center (CENATOX)
Postal address:
Ave 31 y 114, Marianao
City:
Havana
Country:
Cuba
Zip Code:
11500
Email address:
eclinicos@infomed.sld.cu
Clinical sites to participate
Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.
Countries of recruitment:
Cuba
Clinical sites:
Not applicable
Recruitment status
Section to complete information about the recruitment status and the date of first enrolment subject
Recruitment status:
Pending
Date of first enrollment:
07/12/2020
Health condition and Intervention
Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).
Health condition(s) or Problem(s) studied:
COVID-19
Health condition(s) code:
Disease Prevention
Coronavirus Infections
SARS Virus
Coronaviridae Infections
Betacoronavirus
Health condition keyword:
COVID-19
SARS-CoV2
Intervention(s):
Group 1: CIGB-669 (50 µg RBD + 40 µg AgnHB); In each administration (nasal spray) the dose of the product is 200 µL (100 µL for each nostril) corresponding to 50 µg of receptor-binding domain (RBD) recombinant protein and 40 µg of nucleocapsid antigen of the virus. hepatitis B (AgnHB), without adjuvant or preservation; short scheme: 0 (nasal) - 14 (nasal) - 28 (nasal) days. Group 2: CIGB-669 (RBD 50 µg + AgnHB 40 µg) intranasally (nasal spray) 200 µL (100 µL for each nostril); long scheme: 0 (nasal) - 28 (nasal) - 56 (nasal) days. Group 3: CIGB-66 (RBD 50 mcg + aluminum hydroxide 0.30 mg); 0.5 mL intramuscularly in the deltoid region in the 1st dose, followed by another two doses with CIGB-669 (RBD 50 µg + AgnHB 40 µg) intranasally (nasal spray) 200 µL (100 µL for each nostril) ; short scheme: 0 (intramuscular) - 14 (nasal) - 28 (nasal) days. Group 4: CIGB-66 (RBD 50 mcg + aluminum hydroxide 0.30 mg); 0.5 mL intramuscularly in the deltoid region in the 1st dose, followed by another two doses with CIGB-669 (RBD 50 µg + AgnHB 40 µg) intranasally (nasal spray) 200 µL (100 µL for each nostril) ; long scheme: 0 (intramuscular) - 28 (nasal) - 56 (nasal) days. These interventions will be carried out during the first stage (phase I). Subsequently, an intermediate analysis will be carried out where doses and immunization schedules for phase II will be defined.
Intervention code:
Immunogenicity, Vaccine
Immunotherapy, Active
Vaccination
Nasal Sprays
Injections, Intramuscular
Administration, Intranasal
Intervention keyword:
CIGB-669, CIGB-66
Outcomes and Timepoint
Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.
Primary outcome(s):
1. Safety - Clinical Adverse Events-AE (They will be measured as: -Occurrence of AE (Yes, No), -Description of AE (name of event), -Intensity of AE (mild, moderate, severe), -Casuality relationship ( unrelated, doubtful, possible, probable, definitive), -Measures adopted (None, Administration of any pharmacological therapy, Addition of a non-pharmacological therapy, Study exit, Hospitalization / prolongation of hospitalization), -Result (Completely resolved, Resolved with sequelae, Conditions in improvement, Condition present and unchanged, Worsening, Death caused by this event)). Measurement time: within 28 days after the application of each dose. 2. Proportion of subjects with seroconversion of anti-RBD IgG antibodies to SARS-CoV-2 (seroconversion will be considered as that ≥ 4 times the initial determination of the antibody titer). Measurement time: on days 14, 28 and 42 (for the short scheme 0-14-28) and 14, 28, 56 and 70 (for the long scheme 0-28-56), with respect to the baseline time.
Key secondary outcomes:
1. Specific anti-RBD IgG antibodies (geometric mean). Measurement time: on days 0, 14, 28 and 42 (for the short vaccination schedule: 0-14-28) and 0, 14, 28, 42, 56 and 70 (for the long schedule: 0-28- 56). 2. ACE2 inhibition (by ELISA - Enzyme-linked immunoadsorption assay). Measurement time: on days 0, 28 and 42 (for the short vaccination scheme) and 0, 28, 56 and 70 (for the long scheme). 3. Humoral response of specific anti-RBD IgM antibodies. Measurement time: on days 0, 28 and 42 (for the short vaccination scheme) and 0, 28, 56 and 70 (for the long scheme). 4. Humoral and mucosal response of anti-RBD Antibodies (IgA). Measurement time: at screening and at day 42 for short schedules and at screening and at day 70 for long vaccination schedules for mucosal response. The baseline value in the case of humoral IgA would be t = 0.
Selection criterias
Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.
Gender:
Male/Female
Minimum age:
19 years
Maximum age:
54 years
Inclusion criteria:
1) Women and men, 19 to 54 years of age (Phase I) and 19 to 80 years of age (Phase II). 2) Physical examination without clinically significant alterations. 3) Laboratory tests within or outside the reference range, but not clinically significant. 4) Willingness of the subject to participate expressed through the delivery of signed informed consent.
Exclusion criteria:
1) History of COVID-19 or current condition of COVID-19 +, confirmed by laboratory PCR and / or rapid test). 2) Contact or suspect of COVID-19 at the time of inclusion. 3) Presence of fever or cough or shortness of breath or anosmia / ageusia, or acute infection during the 15 days prior to the administration of the vaccine candidate or at the time of its application. 4) Decompensated chronic diseases. 5) Those who have been at high risk of exposure: close contacts of confirmed cases of SARS-CoV-2 infection, front-line healthcare professionals for COVID-19 patients working in the ER, ICU and other areas higher risk. 6) Any finding or medical condition in the nostrils that makes it difficult to properly administer the product and follow-up (eg, chronic obstructive allergic rhinitis, obstructive nasal septum deviation, benign and malignant nostril tumors such as polyposis and squamous cell carcinoma). 7) Tattoos in both deltoid regions that make it difficult to observe the injection site, taking into account the random nature of the allocation of treatment. 8) Findings in laboratory tests outside the reference values ??and that are clinically significant. 9) Obesity (BMI ≥ 35 Kg / m2) or underweight (BMI ≤18 Kg / m2) 10) Have previously received a licensed or investigational vaccine, specific for coronavirus. 11) Use of any investigational product (drug or vaccine) within 3 months prior to recruitment, or planned for during the study period. 12) Having been treated within the previous three months or the possibility of requiring treatment during the trial for any underlying condition with: immunomodulators (eg some type of Interferon, Transfer Factor, Biomodulin T, Immunoferon, Thymosin), or with steroids by any route of administration, or with cytostatics. 13) Have received blood, immunoglobulins and / or any blood product within the three months prior to inclusion. 14) Allergy to Thimerosal or any other component of the formulations under study (Allergy to Thimerosal in Phase II is not relevant if the group with CIGB 66 is not selected). 15) History or suspicion of alcoholism or drug dependence. 16) Pregnancy, breastfeeding or willingness to get pregnant during the study. Women of childbearing potential who do not agree to use effective contraception within 3 months after completing the third study dose. 17) Presence of mental and / or psychiatric disorders that make it impossible to sign the informed consent or follow-up of the volunteer.
Type of population:
Adults
Type of participant:
Healthy volunteers
Study design
Section to complete information about the characteristics of the study design.
Type study:
Interventional
Purpose:
Prevention
Allocation:
Randomized trial
Masking:
Open
Control group:
Uncontrolled
Study design:
Parallel
Phase:
1-2
Target sample size:
88
Contact for public queries
Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status
First Name:
Zurina
Last Name:
Cinza Estevez
Specialty:
1st degree specialist in Clinical Biochemistry; Master in Clinical Trials.
Affiliation:
Center for Genetic Engineering and Biotechnology (CIGB).
Postal Address:
Ave. 31 entre 158 y 190, Cubanacan, Playa.
City:
Havana
Country:
Cuba
Zip Code:
11300
Telephone:
+53-72716022
Email :
zurina.cinza@cigb.edu.cu
Contact for scientific queries
Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.
First Name:
Zurina
Last Name:
Cinza Estevez
Specialty:
1st degree specialist in Clinical Biochemistry; Master in Clinical Trials.
Affiliation:
Center for Genetic Engineering and Biotechnology (CIGB).
Postal Address:
Ave. 31 entre 158 y 190, Cubanacan, Playa.
City:
Havana
Country:
Cuba
Zip Code:
11300
Telephone:
+53-72716022
Email :
zurina.cinza@cigb.edu.cu
Data Sharing
Section to complete the data related to the data sharing plan.
Data sharing plan:
No
Research Ethics Committees
Section to complete the data related to the review ethics committees.
Name of Research Ethics Committees:
National Toxicology Center (CENATOX)
Status of evaluation:
Approved
Status of evaluation date of Ethic Committee:
20/11/2020
Postal address of Ethic Committee :
Avenida 31 y 114, Marianao, Havana, ZC: 11500, Cuba
Telephone:
-
Email:
cenatox@infomed.sld.cu
About study completion
Section to complete the data related to the study completion.
Study completion date:
31/05/2021
Date of available results:
30/06/2021
Date of first publication:
30/07/2021
Registration and Update
Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).
Primary registry:
RPCEC
Unique ID number:
RPCEC00000345
Date of Registration in Primary Registry:
26/11/2020
Record Verification Date:
2020/11/27
Next update date:
2021/11/27
Link to the spanish version:
Click here
Printer-friendly versionPrinter-friendly version
About the RPCEC
Structure and governance
Policy
Publications
Awards
Communications
News
Useful resources
Fundamentals of the registry
References of clinical trials
Cuban regulations
Other registries
International Clinical Trials Registry Platform
Equipo de Trabajo del RPCEC | CENCEC - MINSAP
rpcec@cencec.sld.cu
Calle 5ta A Edificio CECMED-CENCEC 2do piso e/ 60 y 62 Miramar, Playa.CP 11300. La Habana, Cuba
Telef: (537) 216-4126 | (537) 216-4218.
Copyright © 2014 All Rights Reserved.
https://rpcec.sld.cu/en/trials/RPCEC00000345-En
An international team from Germany, Switzerland and the U.S. successfully showed that the LY6E-Protein prevents coronaviruses from causing an
infection.
If the virus is unable to fuse with these cells, it can’t cause infection,” explains corresponding author Professor Volker Thiel from the University of Bern.
The validation in an animal model succeeded thanks to a collaboration with the laboratory of John Schoggins at the Southwestern Medical Center of the University of Texas.
https://debuglies.com/2020/07/29/coronaviruses-are-inhibited-by-ly6e-protein/?__cf_chl_jschl_tk__=88f8be59c075694be944eb0e431f0454729f480f-1614483969-0-AXY3Xm68xzvvdvdLTgnkPcUqR5bGGGZ2N57K5niZ7rPe5-cgQJjHTTsNphgyEHLU_Nj-0_vLw9QVZDa7Vrsoha5ZygF9GLBd7E_ZqMsml070NkpsZObp-DSj5ILkkpDBiXZwVNV5cY20Jdgg3Td8dunLvt9itmjFGleoWyQhr8R_q7-rTddRLXfpsSqnGFpkZFY3zrZmuLVDtbU8n2WyO0i8GyKD3zYbLVnhsjxUPHprXEhtSnAh5fGtQjUx5IPEaQSgqWqJZ_tN7rJ6TUu1kjlE3h5ksbbujDARhvWozwa8qQaT0IQ2talSbTYyfaIJxFmlNT1lnst85pRvYYNmO-doL95z_1dMUdOpFHSdvP1YJ1jgZif90oPIc9TqyxcDeudZ4Up5ex7PcXziANzdd2ZvvbWAsSd-zQskmhl1heq42ps41pfJh4OgTA_VzFGt5g
https://www.lung.org/blog/researcher-contrains-covid19
reddit
Posted byu/cluelessindc 55.5 k MEMBERS r/stocks and Trading on reddit
16 days ago
$MYMX (Mymetics) - Swiss company working on next gen vaccines
Discussion
$MYMX - seems unknown, unloved, unfollowed... it’s of course a risky penny stock. But it’s a real company with some really good brains (and sone funding) leading the charge.
Anyone here follow it? The stock seemed to get some action today. No idea why, but someone on another board cited a NYT article about related vaccine efforts.
Scientists are ramping up research into creating a vaccine that would be effective against all types of corona viruses as new strains have been reported around the world.
(From the yahoo post) In the story Dr. Maria Elena Bottazzi is noted as saying "how she and her team had applied for funding from the U.S. government to produce a universal coronavirus vaccine in 2016 but were rejected. "They said there's no interest in pancorona," Bottazzi told the Times. "It's been a struggle," she added. Apparently now there is a big interest. Also note that Dr. Bottazzi is part of the collaboration between Mymetics and Baylor
https://www.reddit.com/r/StocksAndTrading/comments/lhbd33/mymx_mymetics_swiss_company_working_on_next_gen/
Anergis S.A., in Epalinges, CH-550-1026283-9 (FOSC du 29.08.
2012, p. 0/6827542). Rohmer Jean-Paul is no longer a director;
his signature is canceled.
Daily register no 7148 of 26.04.2013 / CH-550.1.026.283-9 / 07172288
https://www.shab.ch/shabforms/servlet/Search?EID=7&DOCID=7172288
Jean-Paul Rohmer Anergis SA Liquidation
https://business-monitor.ch/en/p/jean-paul-rohmer-3413053?utf8=%E2%9C%93&included%5B%5D=3413053
Anergis S.A., in Epalinges, CH-550-1026283-9, development of
anti-allergic and immune therapies (FOSC of 03.03.2010, p.
18/5521872). New administrator with collective signature at
two: Rohmer Jean-Paul, from France, in Paris (France). Collective signature for two is conferred on Charlon Vincent, from France, in SaintMartin-d'Uriage (France), and Reymond Christophe, from Gimel, in
Prilly, directors.
Daily register no 11795 of 12.07.2010 / CH-550.1.026.283-9 / 05731670
https://business-monitor.ch/en/p/jean-paul-rohmer-3413053?utf8=%E2%9C%93&included%5B%5D=3413053
Hmmm!! Maria Bottazzi and Sarah Gilbert have been collaborating on what Nasal Sprays? The WHO and PATH!! What Martin Bachmann where is he?
Oxford University and Imperial College London looking into different vaccines
Believe nasal spray or inhaler might be better way of priming lungs for infection
Influenza vaccine is already administered to children in the UK via nasal spray
By CONNOR BOYD HEALTH REPORTER FOR MAILONLINE
PUBLISHED: 10:40 EST, 23 June 2020 | UPDATED: 11:21 EST, 23 June 2020
Covid-19 vaccine may work better as a nasal spray instead of an injection, top scientists claim
Sarah Gilbert, professor of vaccinology at Oxford University, added: 'With oral or nasal you would have much stronger mucosal response.
'That's probably really important in the protection against respiratory pathogens. It's also very difficult to study and we're not yet very good at measuring it.
But, as Professor Shattock said, we're very interested in looking at delivery to the respiratory tract, either intranasal delivery [via a nasal spray] or aerosol delivery [using an inhaler].
https://www.dailymail.co.uk/news/article-8451067/Covid-19-vaccine-work-best-nasal-spray-instead-injection.html
Media release, 26 February 2021
SARS-CoV-2 mutations in competition
How dangerous are new mutations of the SARS-CoV-2 virus? An international team
involving researchers from the Institute of Virology and Immunology (IVI) of the Federal
Food Safety and Veterinary Office BLV and the University of Bern (Switzerland), the Centers
for Disease Control and Prevention (USA), and the Friedrich-Loeffler Institute (Germany),
has developed an approach that can accurately assess the transmissibility of new virus
mutants.
https://www.unibe.ch/unibe/portal/content/e796/e803/e59463/e805/e1027714/e1029489/e1050374/media_service1050387/files1050388/20210226_MediareleaseUniBE_SARS-CoV-2_D614G_eng.pdf
Wanted to find this for ya!! :)
Acknowledgments
M. Juliana McElrath is a member of the scientific advisory board of Mymetics Corporation (Epalinges, Switzerland), but had no role in the design or evaluation of the experiments reported in Bomsel et al.
https://www.sciencedirect.com/science/article/pii/S1074761311000525
https://www.seattlecca.org/providers/m-juliana-mcelrath
Interesting!
Guardian® vaccine is a multiple antigen product which includes a cell-free extract of K99 pilus type of Escherichia coli, a unique combination of two inactivated coronaviruses, two G-types of inactivated rotaviruses and a bacterin-toxoid from Clostridium perfringens Types C and D. It is recommended for use in healthy pregnant heifers and cows as an aid in the prevention of neonatal calf diarrhea caused by enterotoxigenic E. coli pilus type K99, bovine Group A Serotype G6 rotaviruses, enterotoxemia caused by C. perfringens Types C and D, and as an aid in the control of neonatal calf diarrhea caused by bovine coronaviruses.
https://merckusa.cvpservice.com/product/basic/view/1047241
https://www.merck-animal-health-usa.com/product/guardian
Article Escherichia Coli Based Cell Free Protein Synthesis ...
www.mdpi.com/2076-393X/9/3/193/pdf (MERCK)
Vaccines 2021, 9, 193 3 of 28 There are three tandem-core VLPs that are of particular interest to this project (see Figure 2). The first is the tandem-core dimer called the K1K1 VLP which contains a single
Abstract: Tandem-core hepatitis B core antigen (HBcAg) virus-like particles (VLPs), in which two
HBcAg monomers are joined together by a peptide linker, can be used to display two different
antigens on the VLP surface. We produced universal influenza vaccine candidates that use this
scaffold in an Escherichia coli-based cell-free protein synthesis (CFPS) platform. We then used the
CFPS system to rapidly test modifications to the arginine-rich region typically found in wild-type
HBcAg, the peptide linkers around the influenza antigen inserts, and the plasmid vector backbone
to improve titer and quality. Using a minimal plasmid vector backbone designed for CFPS improved
titers by at least 1.4-fold over the original constructs. When the linker lengths for the influenza
inserts were more consistent in length and a greater variety of codons for glycine and serine were
utilized, titers were further increased to over 70 µg/mL (4.0-fold greater than the original construct)
and the presence of lower molecular weight product-related impurities was significantly reduced,
although improvements in particle assembly were not seen. Furthermore, any constructs with the
C-terminal arginine-rich region removed resulted in asymmetric particles of poor quality. This
demonstrates the potential for CFPS as a screening platform for VLPs.
Keywords: Cell-Free Protein Synthesis; Virus-Like Particle; Tandem-Core; Influenza Vaccine
. By expressing tandem-core HBcAg VLPs in our CFPS system and
designing and expressing modified versions of those VLPs, we have demonstrated that
our CFPS system is not only capable of generating complex self-assembling products for
vaccine production, but it is a useful screening tool for the iteration and improvement of
vaccine product design.
Vaccination with virosomally formulated recombinant CyRPA ...
www.nature.com/articles/s41541-020-0158-9
Jan 31, 2020 · Plasmids were amplified by transforming chemically competent Escherichia coli bacteria and used for transfection of human embryonic kidney HEK 293 cells. The histidine-tagged protein was purified ...
https://www.nature.com/articles/s41541-020-0158-9
Merck to buy Pandion Therapeutics for 134% premium
Published: Feb. 25, 2021 at 6:57 a.m. ET
https://www.marketwatch.com/story/merck-to-buy-pandion-therapeutics-for-134-premium-2021-02-25?siteid=yhoof2&yptr=yahoo
TALON™ Platform
Modular Approach: Enabled by our TALON Platform
Pandion’s Therapeutic Autoimmune reguLatOry proteiN (TALON) drug design platform has enabled the development of pipeline of product candidates for the treatment of autoimmune disease.
https://pandiontx.com/our-science/talon-platform/
SPL7013 from previously announced respiratory viruses, including SARS-CoV-2 (the coronavirus causing COVID-19) and influenza
https://starpharma.com/news/story/spl7013-shows-potent-antiviral-activity-in-rsv-expanding-use-for-nasal-spray
https://starpharma.com/assets/asxannouncements/200903%20Starpharma%20awarded%20$1M%20grant%20for%20COVID-19%20nasal%20spray.pdf
Looks like they used Remdesivir was used as the antiviral positive control for the CPE inhibition assays and the experimental EC50 was consistent with published data generated with a different clinical isolate of SARS-CoV-2 (Wang et al., 2020).
Astodrimer sodium is a polyanionic dendrimer currently being reformulated for potential use as a topical, nasally administered antiviral agent to help prevent acquisition and transmission of SARS-CoV-2 infection. The potential advantages of astodrimer sodium over other technologies include its lack of systemic absorption following topical application (Chen et al., 2009; O’Loughlin et al., 2010; McGowan et al., 2011). In addition, the SI of astodrimer sodium for SARS-CoV-2 is high and in a vaginal gel formulation (10 mg/mL), the compound has been shown to be safe and effective in phase 2 and large phase 3 trials for treatment and prevention of BV (Schwebke et al., 2019; Chavoustie et al., 2020; Waldbaum et al., 2020) and is now marketed in Europe, Australia, New Zealand and several countries in Asia. Astodrimer sodium is also the active antiviral substance in VivaGel® condom products that have marketing authorization in Europe, Japan, Australia/New Zealand and Canada. However, these current formulations are not appropriate for use to protect the respiratory tract from SARS-CoV-2 infection.
https://www.biorxiv.org/content/10.1101/2020.08.20.260190v1.full
Kemper's better get his A** IN Geer!!
World Health Organization
Public statement for collaboration on COVID-19 vaccine development
13 April 2020
Last updated 16 April 2020
Paul Henri Lambert, Centre of Vaccinology, University of Geneva, Switzerland
https://www.who.int/news/item/13-04-2020-public-statement-for-collaboration-on-covid-19-vaccine-development
Virometix
Advisory Board
Prof. Paul-Henri Lambert, MD
Prof. Paul-Henri Lambert, MD, is now associated with the Centre of Vaccinology in the Department of Pathology and Immunology at University of Geneva. He is directing the International Advanced Course of Vaccinology (ADVAC) organized under the auspices of the Fondation Mérieux and University of Geneva. He is a member of the Governing Board of the Tuberculosis Vaccine Initiative (TBVI), past-chairman of the Human Vaccine Committee of the International Association for Biologicals (IABS) and of the Global Advisory Committee on Vaccine Safety of the World Health Organization (WHO). In 1987, he was appointed as chief of Microbiology and Immunology at the World Health Organization and in 1994, chief of the Vaccine Research and Development, WHO Global Program for Vaccines and Immunization. During this time he was deeply involved in co-ordination of research aiming at the development of vaccines against diseases of major importance in developing countries.
https://www.virometix.com/about-us/our-company/#Advisory-Board
Virometix Announces Initiation of Phase 1 Clinical Trial With Its V-306 Vaccine Candidate (RSV Vaccine)
https://www.businesswire.com/news/home/20200311005786/en/Virometix-Announces-Initiation-Phase-1-Clinical-Trial
Research projects 2019
Efficient pulmonary mucosal allergen immunotherapy in allergic airways disease employing virosomes as nanocarriers for antigen and adjuvant Dr. phil. Fabian Blank 50'000.00
https://www.lungenliga.ch/de/lungenliga-bern/fachpersonen/newsletter/nl-02-20/forschungsprojekte-2019.html
Novel Vaccine Strategy Developed For Human Respiratory Syncytial Virus Infection
JULY 21, 2015
Remarkably, rats vaccinated with two doses of RSV VLPs [using monophosphoryl lipid A (MPLA) and alum as adjuvants to enhance immunogenicity] developed a strong neutralizing antibody response and were protected from viral infection in both the lower and upper respiratory tract. According to the authors, this is the first VLP/virosome vaccine study that resulted in a protective effect on the lower but also the upper respiratory tract.
https://lungdiseasenews.com/2015/07/21/novel-vaccine-strategy-developed-human-respiratory-syncytial-virus-infection/
So if this study was done in 2015! Using just RSV VLP/VIROSOME with the MPLA Without ALUM would work better? Since Alum causes inflammation!! Just Saying.. RSV-MPLA virosomes
? MPLA in IN-administered RSV virosomes increases serum IgG. ? MPLA in IN-administered RSV virosomes increases sIgA. ? MPLA in IN-administered RSV virosomes skews towards Th1 response. ? RSV-MPLA virosomes induce protective immunity. ? RSV-MPLA virosomes do not prime for enhanced
Taken together, these data show that mucosally administered RSV-MPLA virosomes hold promise for a safe and effective vaccine against RSV.
Covid in the Lungs?
https://www.sciencedirect.com/science/article/pii/S0264410X13002326
Why Swiss participation in WHO’s Covid-19 vaccine plan matters
Thomas Cueni, director general of the International Federation of Pharmaceutical Manufacturers (IFPMA), says Swiss participation is vital. Given its role as host country to the WHO and the Gavi Vaccine Alliance organisation, as well as co-chair (with Singapore) of the Friends of COVAX External link, “I personally feel that Switzerland was a little bit late in announcing its support for the COVAX Facility,” he told swissinfo.ch.
Switzerland was not on the WHO’s initial list on September 21 of countries that had signed up, causing a few raised eyebrows. However, it announced External link a few days later that it had joined the vaccine pool. A spokesman for the Swiss Federal Office of Public Health (FOPH) told swissinfo.ch that the delay was due to the “signing process” and that Bern’s commitment is “firm”.
https://www.swissinfo.ch/eng/politics/why-swiss-participation-in-who-s-covid-19-vaccine-plan-matters-/46140342
The how’s and what’s of vaccine reactogenicity | npj Vaccines
www.nature.com/articles/s41541-019-0132-6)
Examples of newer adjuvants in use today include virosomes, ... A. et al. A dose-dependent plasma signature of the safety and immunogenicity of the rVSV-Ebola vaccine in Europe and Africa. Sci ...
https://www.nature.com/articles/s41541-019-0132-6)
One of the vaccines, «rVSV-ZEBOV», has now been tested in the first large field trial of efficacy and effectiveness in Guinea, West Africa. CTU Bern was involved in the development of the study design of this «Ebola ça suffit» trial and responsible for the data management. The initial results of the study show that the vaccine can effectively contain the further spread of the Ebola virus. The results of the field study and the innovative study methods were just published in th e «Lanc et» and «BMJ».
https://www.ctu.unibe.ch/about_us/news/ebola_vaccine_tested_successfully_for_the_first_time/index_eng.html
Lancet
. 2017 Feb 4;389(10068):505-518. doi: 10.1016/S0140-6736(16)32621-6. Epub 2016 Dec 23.
Efficacy and effectiveness of an rVSV-vectored vaccine in preventing Ebola virus disease: final results from the Guinea ring vaccination, open-label, cluster-randomised trial (Ebola Ça Suffit!)
https://pubmed.ncbi.nlm.nih.gov/28017403/
Nice! Your right friend!! Have a GN Friend!!
Second-Generation Lung-on-a-Chip Developed
NEWS Feb 11, 2021 | Original story from the University of Bern
Watch the video INTERESTING!!
University of Bern / HZI Helmholtz Lung on a chip
https://www.technologynetworks.com/cell-science/news/second-generation-lung-on-a-chip-developed-345489
We can’t wait until it happens to think about what we can do,” says Maria Elena Bottazzi, PhD, associate dean of the National School of Tropical Medicine at Baylor College of Medicine. In 2016, she and her collaborators applied for federal funding to develop a vaccine that would protect against multiple coronaviruses.
https://futurehuman.medium.com/the-search-for-one-vaccine-to-rule-them-all-d44bae3d634a
You got that right my friend!! :) Greatest respect for all longs here!! :)
I know your strong, You hung in there and that's why I have the greatest respect for you my friend!! ;)
We can’t wait until it happens to think about what we can do,” says Maria Elena Bottazzi, PhD, associate dean of the National School of Tropical Medicine at Baylor College of Medicine. In 2016, she and her collaborators applied for federal funding to develop a vaccine that would protect against multiple coronaviruses.
https://futurehuman.medium.com/the-search-for-one-vaccine-to-rule-them-all-d44bae3d634a
Door Number 1 $$$$$$$$$ :)
Universal Covid vaccine Maria Bottazzi Baylor
Could a single vaccine work against all coronaviruses ...
www.nytimes.com/2021/02/11/world/could-a-single...
Feb 11, 2021 · In 2016, Maria Elena Bottazzi, a virologist at Baylor College of Medicine, and her colleagues applied for support from the U.S. government to develop a pancoronavirus vaccine but did not receive it.
https://www.nytimes.com/2021/02/11/world/could-a-single-vaccine-work-against-all-coronaviruses-scientists-are-working-on-one.html
The Low-Down: Could 1 Vaccine Work Against All Coronaviruses?
www.thelowdownblog.com/2021/02/could-1-vaccine-work...
23 hours ago · In 2016, Maria Elena Bottazzi, a virologist at Baylor College of Medicine, and her colleagues applied for support from the American government to develop a pancoronavirus vaccine, but did not receive it. “They said there’s no interest in pancorona,” Dr. Bottazzi recalled.
http://www.thelowdownblog.com/2021/02/could-1-vaccine-work-against-all.html
Look who Julie is working with on covid!! :)
September 11, 2020
COVID-19 and the Path to Immunity
David S. Stephens, MD1; M. Juliana McElrath, MD, PhD2
Author Affiliations Article Information
1Emory University School of Medicine, Robert W. Woodruff Health Sciences Center, Emory University, Atlanta, Georgia
2Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington
https://jamanetwork.com/journals/jama/fullarticle/2770758
MAYBE A LITTLE MARIA-Baylor thing!!
Try JULIANA MCELRATH and Ruth Ruprecht.
Fred Hutchinson Cancer Research Center-Seattle ,WA ;)
https://research.fredhutch.org/mcelrath/en.html?_ga=2.176288611.735732399.1580147533-1610628307.1573860687
Liposome Manufacturing
Our Preferred Partner
Polymun Scientific Millipore Sigma is equipped to handle Drug Delivery Compounds and bulk APIs destined for parenteral use, but not to manufacture finished products.
Polymun Scientific is our preferred partner for liposome manufacturing. Merck KGaA, Darmstadt, Germany
The life science business of Merck KGaA, Darmstadt, Germany operates as Millipore Sigma in the US and Canada.
POLYMUN Scientific Immunbiologische Forschung GmbH
Dr. Dietmar Katinger
Nußdorfer Lände 11
1190 Vienna
Austria
https://www.emdmillipore.com/US/en/products/small-molecule-pharmaceuticals/formulation/bioavailability-enhancement/drug-delivery-compounds/services/liposome-manufacturing/bIub.qB.jjgAAAFRhWYEZcsR,nav?ReferrerURL=https%3A%2F%2Fsearch.yahoo.com%2F&bd=1
Success Story of
Polymun Scientific
Project type:
EU FP Project : HIV Virosomes
Project Title: Development of a New Vaccine Against HIV: Virosomes
Incorporating HIV proteins
https://www.fitforhealth.eu/cms/docs/Success_stories/Polymun_success_story.pdf
University of Groningen Toward a virosomal respiratory ...
www.rug.nl/research/portal/files/67431363/...
by treatment with benzonase (Novagus, Merck, Schwalbach am Taunus, Germany), and the supernatant was clarified through Sartopure PP2 filters with a pore size of 1.2 and 0.65 RSV-3D-phAD ® virosomes derived from thermostable RSV
PAGE NOT FOUND
https://research.rug.nl/en/files/67431363/chapter_6.pdf
US4880635B1 - Dehydrated liposomes - Google Patents
patents.google.com/patent/US4880635
Trehalose desiccant product and dehydration therewith ... Lyophilization of virosomes US7127357B1 (en) ... Merck & Co., Inc.
https://patents.google.com/patent/US4880635B1/en
The United States under new President Joe Biden recently said it would be taking part in Covax.
FEBRUARY 3, 2021
Covax issues distribution list for first vaccine wave
https://medicalxpress.com/news/2021-02-covax-vaccination.html
Dr. Anthony S. Fauci Remarks at the World Health Organization Executive Board Meeting
“Director-General Dr. Tedros, distinguished representatives, friends and colleagues: FOR IMMEDIATE RELEASE January 21, 2021
I am also pleased to announce today that the United States plans to work multilaterally to respond to and recover from the COVID-19 pandemic. President Biden will issue a directive later today which will include the intent of the U.S. to join COVAX and support the ACT-Accelerator to advance multilateral efforts for COVID-19 vaccine, therapeutic, and diagnostic distribution, equitable access, and research and development.
As such, I am honored to announce that the United States will remain a member of the World Health Organization. Yesterday, President Biden signed letters retracting the previous Administration’s announcement to withdraw from the organization, and those letters have been transmitted to the Secretary-General of the United Nations and to you Dr. Tedros, my dear friend.
https://www.hhs.gov/about/news/2021/01/21/dr-anthony-s-fauci-remarks-world-health-organization-executive-board-meeting.html
LIVE: Dr Tedros' opening remarks at the WHO 148th Executive ...
rajawalisiber.com/live-dr-tedros-opening-remarks...
Jan 18, 2021 · COVAX is ready to deliver what it was created for. But in recent weeks I have heard from several Member States who have questioned whether COVAX will get the vaccines it needs, and whether high-income countries will keep the promises they have made. As the first vaccines begin to be deployed, the promise of equitable access is at serious risk.
https://rajawalisiber.com/live-dr-tedros-opening-remarks-at-the-who-148th-executive-board/
Good ole Vanya Beltrami spent alot of time in his Serono days!!
(Gonal-F; Laboratoires Serono, Merck, Aubonne, Switzerland)
Clinical Pharmacology of Recombinant Human Follicle-Stimulating Hormone. II. Single Doses and Steady State Pharmacokinetics
https://www.fertstert.org/article/S0015-0282(97)00525-6/fulltext
Gonal-F
https://www.drugs.com/pro/gonal-f.html
Mymetics Corporation 10-K Mar. 28, 2019 8:33 AM | Seeking Alpha
seekingalpha.com/filing/4421079
Mymetics believes that there was an issue with the influenza virosome formulations that were produced. ... sufficient information about a drug's pharmacokinetics and pharmacological effects should ...
Study Objective: The strategic goal of this Investment is to develop a safe, effective vaccine against HIV/AIDS capable of protecting a significant fraction of virus-exposed individuals from persistent, systemic infection. Vaccine development will be done in collaboration with Mymetics Corporation that is developing vaccines based on virosomes, a vaccine platform that has already been used in humans for over 10 years with an excellent safety record. Virosomes have been engineered to display either P1, a peptide derived from the transmembrane protein the HIV gp41, or rgp41, a truncated version of gp41. The resulting virosomes are termed virosome-P1 or virosome-rgp41, respectively. When the combination of the two HIV gp41-based virosomes was tested in Chinese rhesus monkeys (RMs), all animals were protected from persistent systemic infection after multiple challenges with a simian-human immunodeficiency virus (SHIV) that carries the HIV envelope.
https://atlas.scharp.org/cpas/project/VISC/Completed%20CAVD%20Studies/Ruprecht-VDC/Ruprecht_608.01/begin.view?
This Guy on linkedin on right hand side (People also viewed) with Vanya Beltrami linkedin Could be some connection!!! Just Saying!!
Christian Bindschaedler
Associate Manager chez Merck Group
Geneva, Geneva, Switzerland
Merck Serono
Université de Genève
About
Proven expert with solid history of delivering process validation data for drug registration. Strong record of products successfully transferred to the manufacturing site or a new manufacturing suite.
Experience
Merck Serono
Associate Manager, Manufacturing Department - Aseptic Filling / Finished Product
Company NameMerck Serono
Dates Employed2007 – Present
Employment Duration14 yrs
Location1170 Aubonne, Switzerland
Role & Responsibilities:
- Coordination and supervision of process validation activities for several injectable dosage forms: lyophilized powders in vials, pre-filled syringes, cartridges;
- In charge of internal and external technology transfers for several commercial drug products and Biotech drugs in Phase III;
- Site Program Manager / Site Molecule Expert for several molecules in clinical development;
- Management of the deviations and investigations pertaining to the lyophilization process;
- Support to other Merck sites for issues in freeze-drying processes and review of freeze-drying activities for drug product contract manufacturing and development.
Examples of achievements:
- Internally transferred 4 drug products (2 freeze-dried products and 2 multidose presentations in cartridges) to a new manufacturing suite;
- Transferred a novel therapeutic anticancer vaccine formulated as a lyophilized powder for liposomal suspension for injection;
- Prepared User Requirement Specifications for new freeze-dryers;
- Optimized and validated the processing of lyophilization stoppers (siliconization process and drying cycle) to ensure equivalent performance compared to old equipment, co-developed and validated a coulometric method for the determination of residual moisture in stoppers;
- Brought technical support for the validation of the manufacturing process for an anti cancerous drug product: freeze-drying of the drug substance in Lyoguard trays, milling, sieving, blending and tableting;
- Developed and validated PTFE coated lyophilization trays to reduce the level of scratched vials;
- Shortened the freeze-drying cycle time of a commercial drug product from three to two days.
Laboratoires Serono S.A.
Project Leader, Manufacturing Department
Company Name Laboratoires Serono S.A.
Dates Employed1995 – 2006
Employment Duration11 yrs
Location 1170 Aubonne, Switzerland
Role & Responsibilities:
- Coordination and supervision of process validation activities;
- Site Molecule Expert for several molecules in clinical development, produced batches for clinical trials;
Alumni Both Beltrami & Bindschaedler
https://ispso.unige.ch/labs/FATEC/staff3_Alumni_en.html
Yuppers!! I did!! Thank-You! They will never give it up!!
Agree!! Hope all is well friend!! :)