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7/28 @benmat07 Mexico will continue to lead and promote a vision of solidarity in Latin America against the pandemic: Ebrard (México continuará liderando y promoviendo visión solidaria en América Latina contra la pandemia: Ebrard)
7/27 In addition, he recalled that they are in the process of authorization by the @COFEPRIS the phase III clinical trials of the Walwax, Institute of Medical Biology, Inovio, and Sanofi vaccines, as well as the authorizations for emergency use of Sinopharm and Moderna. @MarthaDelgado
https://www.reddit.com/r/Inovio/comments/otebcf/728_benmat07_mexico_will_continue_to_lead_and/?utm_source=share&utm_medium=ios_app&utm_name=iossmf
https://www.reddit.com/r/Inovio/comments/osp0se/727_in_addition_he_recalled_that_they_are_in_the/?utm_source=share&utm_medium=ios_app&utm_name=iossmf
CELLECTRA™ 2000 was approved by FDA 7/27/21. Official Title: A Phase 2, Randomized, Open Label, Efficacy Study of VGX-3100 Delivered Intramuscularly Followed by Electroporation With CELLECTRA™ 2000 Alone or in Combination With Imiquimod, for the Treatment of HPV-16 and/or HPV-18 Related High Grade Squamous Intraepithelial Lesion (HSIL) of the Vulva
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No => Yes
Unapproved/Uncleared Device: [Blank]
https://clinicaltrials.gov/ct2/history/NCT03180684?A=36&B=37&C=merged#StudyPageTop
7/28 Largest ever Lassa fever study expands to more countries in West Africa.
CEPI is providing US$ 10.3 million in funding to partners in Benin, Guinea, Liberia, and Sierra Leone to participate in the epidemiological research programme Enable, which will enrol up to 23,000 participants, including Nigeria, which began collecting participant data in December 2020. The in-country partners selected for the research are Fondation pour la Recherche Scientifique (FORS) in Benin, Phebe Hospital in partnership with the National Public Health Institute of Liberia (NPHIL) in Liberia, supported by University of North Carolina at Chapel Hill (UNC), Kenema Government Hospital in Sierra Leone (KGH) in cooperation with Tulane University, and Université Gamal Nasser de Conakry (UGANC) in Guinea, in partnership with Robert Koch Institut (RKI).
First identified in 1969, Lassa fever is a potentially deadly haemorrhagic illness occurring across West Africa, with an estimated 1% of cases proving fatal. It is listed on the World Health Organization (WHO) R&D Blueprint as an emerging infectious disease in urgent need of research and development and is also recognised in CEPI’s ambitious $3.5bn plan to tackle future epidemics and pandemics caused by known and unknown threats.
The Enable study therefore aims to better understand the rate, location, and spread of Lassa virus across the region. Data collected in the countries will highlight any differences in the age and gender of people who become infected, while also providing a more accurate overview on the proportion of asymptomatic and symptomatic cases.
In addition, results from Enable will be crucial in supporting CEPI’s goal, as part of its five-year lookahead strategy, of producing a licenced Lassa vaccine for routine immunisation. As a leading funder of Lassa vaccine development, CEPI has already supported the development of six Lassa vaccine candidates. Two of these vaccines, developed by partners Inovio and Themis Bioscience, entered Phase I trials in 2019, and a further vaccine candidate, developed by IAVI, started in-human testing this year.
Data provided from the Enable research programme may therefore guide the location and implementation of future late-stage efficacy trials to evaluate these or other Lassa vaccine candidates. It could also help to define an appropriate vaccination strategy once a Lassa vaccine is approved for use, for example by helping to identify priority populations at risk.
A subset of those enrolled will also take part in an additional assessment to look at the prevalence of Lassa fever antibodies–biomarkers of the immune response–among participants. This will act as an indicator to better guide estimates of how many individuals in the general population are likely to have previously been infected with the virus and are, at present, protected against (immune from) the disease; it is generally assumed that a single infection with Lassa fever virus will produce life-long protective immunity.
https://cepi.net/news_cepi/largest-ever-lassa-fever-study-expands-to-more-countries-in-west-africa/
7/27 Update: Evaluation of VGX-3100 and Electroporation Alone or in Combination With Imiquimod for the Treatment of HPV-16 and/or HPV-18 Related Vulvar HSIL.
U.S. FDA-regulated Device: No => Yes
https://clinicaltrials.gov/ct2/history/NCT03180684?A=36&B=37&C=merged#StudyPageTop
7/22 Update: P1, open label, single center, dose escalation study to evaluate the safety, tolerability and pharmacokinetic profile of dMAb-ZK190 following delivery of INO-A002 with Hylenex® recombinant delivered IM followed by EP in healthy adult Dengue naïve volunteers ages 18-60 year
Locations: United States
University of Pennsylvania
[Recruiting]
Philadelphia, Pennsylvania, United States, 19104
Contact:Contact: Pablo Tebas, MD 215-349-8092 Pablo.Tebas@pennmedicine.upenn.edu
Added 5th cohort.
Experimental: Cohort E
Participants (n=6 per cohort) will be administered 2 injections (Day 0 and Day 3) of INO-A002 at 4 mg DNA/dose. Inoculation will be administered as 1 ml IM injection followed by electroporation with the CELLECTRA® 2000 device with Side Port needle.
Biological: INO-A002
Participants will receive one or two 1 ml IM injections (in different arms) into the deltoid region at day 0 (all groups), and in addition on day 3 (in the 2 mg and 4 mg cohorts).
Device: CELLECTRA® 2000
Inoculation will be followed by electroporation with the CELLECTRA® 2000 device.
Device: Dengue Fever Antibodies (IgG)
To determine if the subject is Dengue seronegative at baseline
https://clinicaltrials.gov/ct2/history/NCT03831503?A=7&B=8&C=merged#StudyPageTop
7/27/21 DNA vaccine that is designed to target HPV- 16/18 E6 and E7 proteins robustly induced HPV-16/18-specific immune response in pa- tients with HPV-associated cervical intraepithelial neoplasia [145] and head and neck can- cer [146]. One patient who previously received anti-PD-1 antibody showed complete tu- mor regression (NCT03162224). Similar strategies were also tested in patients with HPV- associated cervix cancer [147], showing encouraging results.
MEDI0457 (INO-3112) targeting the HPV-16/18 E6, E7 proteins
Patient Population: HPV-associated recurrent and/or meta- Ib/IIa static HNSCC
Combined ICIs: Durvalumab
Clinicaltrials ID: NCT0316222
Combining Cancer Vaccines with Immunotherapy: Establishing a New Immunological Approach
Chang Gon Kim 1,†, Yun Beom Sang 2,†, Ji Hyun Lee 1 and Hong Jae Chon 2,
Received: 7 July 2021 Accepted: 23 July 2021 Published: 27 July 2021
https://res.mdpi.com/d_attachment/ijms/ijms-22-08035/article_deploy/ijms-22-08035.pdf
7/27 Marcelo Ebrard, Secretary of Foreign Relations (SRE), reported that the Federal Commission for the Protection against Sanitary Risks (Cofepris) is analyzing the authorization of phase 3 clinical trials in Mexico of anticovid vaccines from Walvax, Imbcams, Inovio and Sanofi .
In a morning press conference of President Andrés Manuel López Obrador , the Foreign Minister commented that work is being done on expanding the portfolio of vaccines in Mexico.
“We continue with the effort to expand the Mexican portfolio, all these studies are being analyzed by Cofepris: Walvax, Imbcams, Inovio and Sanofi , which we hope will present their dossier today or tomorrow. These will make Mexico one of the countries with a broader portfolio of vaccines ”, he pointed out.
Marcelo Ebrard indicated that the Sinopharm and Moderna vaccines are in the authorization process for emergency use. In addition, this week the 85 million doses will be exceeded and "we are already going for 90, so the supply is in due time and form."
"We are going to ensure a route to expand capacities in Latin America. This strategy, development, products, purchase and invoices were presented by the Economic Commission for Latin America and the Caribbean.”
https://www-milenio-com.translate.goog/politica/cofepris-analiza-autorizar-ensayos-clinicos-4-vacunas-anticovid?_x_tr_sl=auto&_x_tr_tl=en&_x_tr_hl=en&_x_tr_pto=ajax,nv,elem
NOVIO to Report Second Quarter 2021 Financial Results on August 9, 2021
July 26, 2021
PLYMOUTH MEETING, Pa., July 26, 2021 /PRNewswire/ -- INOVIO (NASDAQ: INO) announced today that second quarter 2021 financial results will be released after the market close on August 9, 2021. Following the release, INOVIO will host a live conference call and webcast at 4:30 p.m. ET to discuss financial results and provide a general business update regarding its DNA Medicines Platform, including the company's ongoing vaccine developments for COVID-19.
A live and archived version of the audio presentation will be available online at http://ir.inovio.com/events-and-presentations/default.aspx
CEPI partners with Shanghai Zerun Biotech to develop COVID-19 variant vaccine, 7/21. 4802 is next. Oslo, Norway—CEPI, the Coalition for Epidemic Preparedness Innovations, today announced that it would partner with Shanghai Zerun Biotechnology Co., Ltd. (ZerunBio) and its parent company Walvax Biotechnology Co., Ltd.(Walvax), to advance development of both COVID-19 prototype and variant vaccine candidates. CEPI will provide US$13.1 million to support phase I clinical trial, process optimisation and scale-up of the prototype vaccine, and preclinical studies and phase I clinical trial of the variant vaccine.
This funding forms part of CEPI’s programme to develop “next-generation” COVID-19 vaccines that are differentiated from those already in advanced development and can be used against COVID-19 variants. CEPI’s portfolio of “next-generation” vaccines currently includes the GBP510 (developed by SK Bioscience) and an intranasal vaccine candidate (developed by the University of Hong Kong), which can be made globally accessible through COVAX.
The ZerunBio vaccine candidate
The spike protein in SARS-CoV-2 naturally occurs as a “trimer”—a molecule consisting of three identical parts. ZerunBio’s vaccine candidate uses a stabilised version of the SARS-CoV-2 spike protein in trimer form, and includes several structural changes designed to improve its ability to stimulate immune responses against new SARS-CoV-2 variants, as well as significantly improve yield. The vaccine candidate will also include an adjuvant, CpG7909, to boost the immune response. Previous preclinical studies of this vaccine candidate, carried out by ZerunBio, have shown that it induces very high titres of neutralising antibodies and robust T-cell immune responses. Potential advantages of this candidate include scalability, thermostability, and the ability to cross protect against some of the new variants of SARS-CoV-2. The prototype COVID-19 vaccine based on this technology has recently entered Phase I/II clinical trials in Henan Province, China.
Enabling equitable access
The results of these CEPI-backed clinical trials will inform planning for efficacy trials and manufacturing scale-up, potentially enabling the annual production of hundreds of millions of doses. If the early stage clinical development is successful, CEPI will have the opportunity to grant additional investment in this vaccine candidate through to licensure in China and globally.
“
The Delta variant is already rendering our current batch of vaccines less able to prevent symptomatic infection. Thankfully, they are still effective at preventing severe disease and hospitalisation; but we cannot afford to be complacent. CEPI and ZerunBio’s partnership will strengthen our ability to control COVID-19.
Dr. Richard Hatchett
Chief Executive Officer, CEPI
7/19/21 Safety, Tolerability and Immunogenicity of INO-4700 for MERS-CoV in Healthy Volunteers P2, 542 ppl, all 4 sites are recruiting in Jordan, Lebanon
Pharmaceutical Research Center / Jordan University of Science and Technology
[ Not yet => Recruiting]
Irbid, Jordan, 22110
Last Update Posted: July 19, 2021 [Actual]
Jordan
Clinical Research Center, Irbid Specialty Hospital (CRC/ISH) Not yet recruiting
Irbid, Jordan, 21110
Pharmaceutical Research Center / Jordan University of Science and Technology Recruiting
Irbid, Jordan, 22110
Lebanon
American University of Beirut Medical Center Recruiting
Beirut, Lebanon
Hammoud Hospital University Medical Center Recruiting
Saida, Lebanon
https://clinicaltrials.gov/ct2/history/NCT04588428?A=10&B=11&C=merged#StudyPageTop
Actual rollout of WHO’s vaccine trials, PH’s study on COVID-19 vaccine mixing, matching eyed by ‘end of July, early August’
NationalNews
Charissa Luci-Atienza July 10, 2021
The Department of Science and Technology (DOST) said on Saturday, July 10, that the actual rollout of the the World Health Organization’s (WHO) Solidarity Vaccine Trial (SVT), and the Philippines’ study on the safety and efficacy of mixing and matching five coronavirus disease (COVID-19) vaccines could be expected by end of this month or early August.
DOST Undersecretary for Research and Development Rowena Cristina L. Guevara, who chairs the Task Group on Vaccine Evaluation and Selection (TG-VES), said both the WHO and the proponents from the Philippine Society for Allergy, Asthma, and Immunology (PSAAI), led by Dr. Michelle De Vera were “in the same stage” of securing permits from the Food and Drug Administration (FDA), Philippine Health Research Ethics Board (PHREB), and Vaccine Expert Panel (VEP), chaired by Dr. Nina Gloriani.
“For WHO SVT, they have already submitted application for permit to conduct clinical trial with FDA, ethics board and Vaccine Expert Panel. Mix and Match is also in the same stage as SVT,” she told the Manila Bulletin in a VIber message.
“In a way, they have already started since these permits are part of the project. The vaccination will start once the permits are granted, perhaps towards end of month or early August,” she added.
DOST Secretary Fortunato “Boy” T. de la Peña announced on DOSTv Facebook page on June 18 that the final protocol for the WHO’s SVT is expected to be finalized.
He said the WHO headquarters in Geneva, Switzerland forwarded the letter of agreement on June 11 “for review” of the Department of Health (DOH), DOST, and the Philippine Solidarity Vaccine Trial team.
The WHO’s SVT has a project duration of 18 months and is funded by the Philippine government through DOH and DOST.
The department has been waiting for the final Standard Operating Procedures (SOPs) and specific protocols for the conduct of the SVT in the country since January this year.
Meanwhile, the DOST was expecting the PSAAI to conduct its study on the safety and efficacy of mixing and matching of COVID-19 vaccines this month.
Guevara had disclosed that five vaccine brands will be used for the PSAAI study, which was initially targeted to start by June this year. These are Sinovac, Sputnik V, AstraZeneca, Pfizer and Moderna.
She said the clinical trial, which will be conducted for 18 months, will involve 3,000 participants aged 18 and above.
Guevara said the participants will come from Ai to A4 priority groups under the country’s inoculation program amid fears that such study will affect the country’s vaccine supply.
She said the study will look into the efficacy of the booster doses, apart from determining the safety and immunogenicity of interchanging vaccine brands to complete COVID-19 vaccine series.
The DOST official said the study aims to determine if the high-risk population who already completed the dosing regimen of the Sinovac vaccine would elicit a better immune response after the immunization of a booster dose from a different vaccine platform or brand.
https://mb.com.ph/2021/07/10/actual-rollout-of-whos-vaccine-trials-phs-study-on-covid-19-vaccine-mixing-matching-eyed-by-end-of-july-early-august/
Scientists could create a single vaccine that fights multiple coronaviruses within 5 years, potentially preventing the next pandemic, an expert says
Dr. Catherine Schuster-Bruce Jul 14, 2021, 2:00 AM
Twenty groups of scientists are trying to create a single vaccine that fights multiple coronaviruses.
Coronavirus is the virus family that SARS-CoV-2 — which caused the COVID-19 pandemic — belongs to.
An expert said scientists could make the vaccine within five years, preventing future pandemics.
Scientists could soon create a vaccine that fights most coronaviruses, potentially preventing future pandemics, a foundation that funds vaccine development has said.
More than 20 research groups are trying to develop "broadly-protective" vaccines that can work against multiple coronaviruses. This is the family of viruses that SARS-CoV-2, the virus that caused the COVID-19 pandemic, belongs to.
If these researchers are successful then the next time a coronavirus crosses from animals to humans — which is seen as the most likely cause of future coronavirus pandemics — we would immediately deploy vaccines that work against it.
In March, the Coalition for Epidemic Preparedness Innovations (CEPI) announced up to $200 million for broadly-protective vaccines. CEPI was co-founded in 2017 by the Bill and Melinda Gates Foundation, the Wellcome Trust, and several countries to fund vaccine research for emerging diseases, including Disease X, an unspecified organism that could cause future epidemics.
Nick Jackson, head of programmes and innovative technology at CEPI, told Insider he was optimistic that scientists could make a fully-tested vaccine that works against most coronaviruses in three to five years.
Broadly protective vaccines would "cover the majority of known coronavirus threats" and "if really successful" would also protect against unknown viruses that are yet to emerge, he said.
Jackson said CEPI wanted to help create a vaccine for each theoretical future threat, creating "libraries" of vaccines parked around the world at strategic geographical locations. "So if Disease X happens to emerge in Sub-Saharan Africa, we have a solution in our library that can be used right away," Jackson said.
Jackson cautioned that a "universal" coronavirus vaccine for all coronaviruses was a "tall order," and potentially "unfeasible," because the coronavirus family was so large. In the past 10 years, the National Institute of Allergy and Infectious Disease has identified hundreds of new coronaviruses, he said.
Kirsty Le Doare, professor of Vaccinology and Immunology at St. George's,University of London, told Insider that it would take five to ten years of continued investment to develop broadly protective-coronavirus vaccines. "Scientifically there's always been the opportunity, but there's been no investment," she said.
CEPI has already invested $33 million in US-based biotech VBI Vaccines and $170 million in Korea's SKI bioscience to develop "variant-proof" vaccines that protect against multiple COVID-19 variants in a single shot.
https://www.businessinsider.com/coronavirus-vaccine-broadly-protective-covid-vaccines-pandemic-cepi-development-2021-7
The Latest: SKorea sees 11th straight day over 1,000 cases 7/16/21
SEOUL, South Korea – South Korea has reported another new 1,455 cases of the coronavirus, its 11th straight day over 1,000, as officials push to tighten pandemic restrictions nationwide.
SEOUL, South Korea – South Korea has reported another new 1,455 cases of the coronavirus, its 11th straight day over 1,000, as officials push to tighten pandemic restrictions nationwide.
The numbers reported by the Korea Disease Control and Prevention Agency on Saturday brought the national caseload to 176,500, including 2,055 deaths.
The record-breaking surge has been mostly driven by transmissions in the greater Seoul region, home to half of the country’s population of more than 51 million. Officials here have enforced the country’s toughest social distancing restrictions, which prohibit private social gatherings of three or more people after 6 p.m., ban visitors at hospitals and nursing homes, and shut down nightclubs and churches.
Officials are also discussing whether to enforce four-person limits on gatherings after 6 p.m. in all areas outside the capital region to prevent the virus from spreading and could announce a decision as early as Sunday.
Fatalities and hospitalizations have slowed compared to the previous surge in the winter after officials concentrated limited vaccine supplies to high-risk groups, including elders and people in long-term care settings. Still, the number of COVID-19 patients in serious condition increased by 14 over the past 24 hours to 185.
https://www.squamishchief.com/the-mix/the-latest-skorea-sees-11th-straight-day-over-1000-cases-3960942
“We do not need the hold on Cellectra lifted by the FDA to start our trial. We have been in talks with our target countries and are trying to get the trial started ASAP. As it is the first time we are working on some of these countries, it has been a learning experience for us as well. We had underestimated the time required.
The Advaccine IPO, while delayed, should be approved. They are using top bankers and our science is sound and holds a tremendous promise. The trial delay is not related to Advaccine’s IPO delay.” 7/15/21
“to vaccinate the world’s adult population by the end of the year, we must achieve the estimated production of 11 billion doses of COVID-19 vaccines. To do this, it is essential to optimize production, as well urgently increase dose sharing and remove trade barriers. A delay in the delivery of a bioreactor plastic bag can halt a whole production line and delay a batch of thousands of litres for weeks, if not months. To alert the international community to the challenges associated with this historic scaling up of vaccine production, in March 2021 we joined the Chatham House Summit on COVID-19 Vaccine Manufacturing Supply Chain. One of the recommendations, strongly endorsed by industrialised, developing world vaccine manufacturers and biotech companies, was to find a practical solution to removing the inevitable bottlenecks for raw materials and components. We are delighted to have been able to contribute to the creation of this platform to facilitate matching supplies with buyers, thereby ensuring manufacturing supplies for COVID-19 vaccines. Speed is of the essence to achieve vaccine equity. This marketplace will hopefully make an important contribution towards the global endeavour of achieving the 11 billion doses target this year.”
CEPI launches COVAX Marketplace to match buyers and sellers of critical manufacturing supplies and speed up global access to COVID-19 vaccines through COVAX, 7/15/21
https://cepi.net/news_cepi/cepi-launches-covax-marketplace-to-match-buyers-and-sellers-of-critical-manufacturing-supplies-and-speed-up-global-access-to-covid-19-vaccines-through-covax/
Leveraging Optimized DNA Plasmid Design and Delivery to Treat Glioblastoma Multiforme and Prostate Cancer
• Presentation of clinical trial data to show a DNA based cancer vaccine in combination with FLT3 ligand and PD-1 targeting metastatic castration resistant prostate cancer
• Updates on clinical status of a GBM vaccine in combination with cemiplimab (PD-1 inhibitor)
Next Gen Cancer Vaccine Development Summit 9/7-9/21
Conference Day Two
Wednesday, September 8
Laurent Humeau
Chief Scientific Officer
Inovio 11:15A PST
A Multicenter, Open-Label, Exploratory Platform Study to Evaluate Biomarkers and Immunotherapy Combinations for the Treatment of Patients With Metastatic Castration-resistant Prostate Cancer P1, 45ppl
Platform Study for Prostate Researching Translational Endpoints Correlated to Response to Inform Use of Novel Combinations (PORTER)
Recruitment Status : Recruiting
First Posted : February 8, 2019
Last Update Posted : March 8, 2021
Actual Study Start Date :
June 21, 2019
Estimated Primary Completion Date :
March 2022
Collaborators:
Bristol-Myers Squibb
Celldex Therapeutics
Cancer Research Institute, New York City
Inovio Pharmaceuticals
Oncovir, Inc.
Information provided by (Responsible Party):
Parker Institute for Cancer Immunotherapy
https://clinicaltrials.gov/ct2/show/NCT03835533
INO-5401 and INO-9012 Delivered by Electroporation (EP) in Combination With Cemiplimab (REGN2810) in Newly-Diagnosed Glioblastoma (GBM) P2, 52 ppl
Recruitment Status : Active, not recruiting
First Posted : April 9, 2018
Last Update Posted : July 6, 2021
Actual Study Start Date :
May 31, 2018
Estimated Primary Completion Date :
December 30, 2021
Estimated Study Completion Date :
December 30, 2021
Actual Study Start Date :
May 31, 2018
Estimated Primary Completion Date :
December 30, 2021
Estimated Study Completion Date :
December 30, 2021
INO 5401 Vaccination in BRCA1/2 Mutation Carriers P1, 44 ppl
Recruitment Status : Recruiting
First Posted : April 29, 2020
Last Update Posted : April 26, 2021
Actual Study Start Date :
April 20, 2021
Estimated Primary Completion Date :
December 2025
https://clinicaltrials.gov/ct2/show/NCT04367675
Conference Day One
Tuesday, September 7
Niranjan Sardesai 1:45P PST
CEO
Geneos
Targeting Unique Neoantigens From Individual Patient Tumors
To Develop Novel Treatment For Cancer
• Optimized DNA plasmid containing encoded neoantigens, used in combination with IL-2 to boost T cell response
• Electroporation-based delivery system for enhanced and efficient plasmid uptake to allow optimal antigen production
• Combination therapy shows robust functional antigen specific CD4+ and CD8+ killer T cells
Neoantigen-based Personalized DNA Vaccine in Patients With Newly Diagnosed, Unmethylated Glioblastoma
Glioblastoma P1, 12 ppl
Recruitment Status : Recruiting
First Posted : July 11, 2019
Last Update Posted : July 13, 2021
Interventions:
Biological: Personalized neoantigen DNA vaccine supplied by Geneos Therapeutics
Device: CELLECTRA®2000 EP Device supplied by Geneos Therapeutics
Drug: Plasmid encoded IL-12
Locations:
Washington University School of Medicine
Saint Louis, Missouri, United States
https://clinicaltrials.gov/ct2/show/NCT04015700
GNOS-PV02 Personalized Neoantigen Vaccine, INO-9012 and Pembrolizumab in Subjects With Advanced HCC
HCC P1/2, 24 ppl
An Open-label, Multi-center, Phase I/IIa Study of a Personalized Neoantigen DNA Vaccine (GNOS-PV02) and Plasmid Encoded IL-12 (INO-9012) in Combination With Pembrolizumab (MK-3475) in Subjects With Advanced Hepatocellular Carcinoma
Actual Study Start Date :
March 1, 2020
Estimated Primary Completion Date :
December 2021
Recruitment Status : Recruiting
First Posted : January 31, 2020
Last Update Posted : December 8, 2020
Interventions:
Biological: GNOS-PV02
Biological: INO-9012
Drug: Pembrolizumab
Device: CELLECTRA®2000 EP Device
Locations:
Johns Hopkins Hospital
Baltimore, Maryland, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Auckland Clinical Studies
Auckland, New Zealand
https://clinicaltrials.gov/ct2/show/NCT04251117
David Reardon 7A PST
Clinical Director, Center for Neuro- Oncology Dana-Farber Cancer Institute
Neoantigen Vaccination for Glioblastoma: Does Timing of Anti-PD-1 Matter?
• Better understand the rationale of combining neoantigen vaccination with anti-PD-1 therapy;
• Gain awareness of increasing preclinical data implicating how the timing of anti-PD-1 therapy may impact on anti-tumor immune responses generated by neoantigen vaccination;
• Appreciate the challenges of assessing the impact of anti-PD-1 timing on anti-tumor immune responses generated by neoantigen vaccination in a prospective clinical trial.
KB at Disease Prevention 2021 - Day 1, 7/20/21 @ 13:50. PANEL: Vaccine development for COVID-19
-New technology such as mRNA that allows for rapid vaccine development-Fast-tracking clinical trials-Development of booster shots-Vaccines to look for in 2021, 2022, and beyond
Moderator: Sarah Browne, Senior Director, Vaccine Development, Altimmune
Kate Broderick, Senior Vice President, Research And Development, Inovio Pharmaceuticals
Jerald Sadoff, Senior Advisor Vaccine Development, Janssen Vaccines & Prevention B.V.
Kayvon Modjarrad, Director, Emerging Infectious Diseases Branch, Walter Reed Army Institute of Research
KATE BRODERICK | SENIOR VICE PRESIDENT, RESEARCH AND DEVELOPMENT
INOVIO PHARMACEUTICALS
Kate Broderick, Senior Vice President, Research And Development, Inovio Pharmaceuticals
Dr Broderick has a broad background in the product development and device development DNA therapeutic and drug delivery field, with specific expertise in in vivo DNA therapeutic animal studies and product development in relation to DNA delivery. Her particular area of focus is infectious diseases with an emphasis on emerging targets and those from a bio-threat potential. On the bio-engineering side, Dr Broderick leads the device design efforts specifically pertaining to tissue delivery and she has been central to the development of Inovio novel prototypes and designs. Dr Broderick leads a diverse team of researches which encompasses early discovery work through to IND enabling studies and she is subsequently involved in the clinical and regulatory development of these products. Dr Broderick has authored and co-authored over 70 peer reviewed article and her group regularly publish their findings and present their work in the public forum at conferences. Due to her expertise in the area, Dr Broderick has been invited to participate in WHO advisory meetings related to DNA vaccines and their delivery.
Dr Broderick is also a co-inventor on multiple patents related to DNA vaccine delivery and is principal investigator on grants, awards and contracts from funding bodies such as The Gates Foundation, NIH, Department of Defense and SBIR. She was recently awarded a contract of $56 million from CEPI to fast-track DNA based vaccine candidates for Lassa and MERS through clinical testing.
Dr Broderick received her PhD from the University of Glasgow in Scotland and performed her post-doctoral research at the University of California, San Diego. She joined Inovio Pharmaceuticals in 2006 where she currently leads a diverse research group focused on enhanced delivery techniques for gene based therapeutics as the Senior Vice President, Preclinical R&D.
https://www.terrapinn.com/conference/disease-prevention-control-summit-america/speaker-kate-BRODERICK.stm
“Advaccine is seeking to list in the HK stock exchange. We believe the timeline for the listing will be late fall. There have been a deluge of IPO applications to the HK stock exchange and it is having an impact on the listing process. We are waiting for reply from various governmental and non-governmental agencies regarding our 4800 trials. We are also frustrated by the delay. We know that our investors are also frustrated and anxious. The IVI trial in Korea is winding down. The last dosing was completed recently; however, there will be follow-up bloodwork analysis and other data analysis which must be completed…” 7/14/21
Next Gen Cancer Vaccine Development Summit 9/7-9/21: Laurent Humeau GBM, Prostate. David Reardon: GBM
Conference Day One
Tuesday, September 7
David Reardon 7A PST
Clinical Director, Center for Neuro- Oncology Dana-Farber Cancer Institute
Neoantigen Vaccination for Glioblastoma: Does Timing of Anti-PD-1 Matter?
• Better understand the rationale of combining neoantigen vaccination with anti-PD-1 therapy;
• Gain awareness of increasing preclinical data implicating how the timing of anti-PD-1 therapy may impact on anti-tumor immune responses generated by neoantigen vaccination;
• Appreciate the challenges of assessing the impact of anti-PD-1 timing on anti-tumor immune responses generated by neoantigen vaccination in a prospective clinical trial.
Niranjan Sardesai 1:45P PST
CEO
Geneos
Targeting Unique Neoantigens From Individual Patient Tumors
To Develop Novel Treatment For Cancer
• Optimized DNA plasmid containing encoded neoantigens, used in combination with IL-2 to boost T cell response
• Electroporation-based delivery system for enhanced and efficient plasmid uptake to allow optimal antigen production
• Combination therapy shows robust functional antigen specific CD4+ and CD8+ killer T cells
Conference Day Two
Wednesday, September 8
Laurent Humeau
Chief Scientific Officer
Inovio 11:15A PST
Leveraging Optimized DNA Plasmid Design and Delivery to Treat Glioblastoma Multiforme and Prostate Cancer
• Presentation of clinical trial data to show a DNA based cancer vaccine in combination with FLT3 ligand and PD-1 targeting metastatic castration resistant prostate cancer
• Updates on clinical status of a GBM vaccine in combination with cemiplimab (PD-1 inhibitor)
https://cancer-vaccine-development.com/whats-on/full-event-guide/
“Thanks for your belief in our company. As a publicly traded company, we must be very careful about our communications with the public. We obviously do not want to selectively disclose information to our investors.
That being said, we understand your frustration. We have submitted documents to both governmental and non-governmental organizations regarding our P3 trial and are waiting reply from them. We had expected to hear from them by end of June… We know that our investors are frustrated by the lack of updates. We do hope to share some news with you soon.” 7/13/21
[non-governmental organizations, aka, NGOs such as CEPI, COVAX, BMGF]
“The article has some information that is true and others that are not exactly true. Perhaps, it is a translation issue. Chinese is one of the hardest languages to translate via AI. I have native Chinese friends who always shake their heads when reading an AI translated article. As we had mentioned in the previous email, Inovio has submitted documents to various regulatory bodies in Latin America and Asia. We hope to begin our global trials very shortly.” 7/12/21 8:16A
Latin America: Brazil (ANVISA), Peru, Argentina, Columbia, Paraguay
Asia: Indonesia, Philippines, Malaysia, India
https://www-sciencetimes-co-kr.translate.goog/news/????-dna-???-???-??/?cat=17302&_x_tr_sl=ko&_x_tr_tl=en&_x_tr_hl=en-US&_x_tr_pto=ajax,nv,elem
“A DNA vaccine for COVID-19 is being developed by US bio company inovio, which is run by a Korean president. However, the development process seems a bit difficult. Initially, it received full support from the U.S. government, but failed to produce any noticeable results. In September of last year, the U.S. Food and Drug Administration (FDA) suspended the clinical trial of Inovio. In June, Inovio announced that it would start phase 3 clinical trials, and interest is gathering in how it will proceed.”
The Lassa virus is a National Institutes of Allergy and Infectious Disease (NIAID) Biodefense category A agent and also classified as a Biosafety Level 4 (BSL4) agent with currently no approved vaccine available for use (5,18). Considering the significant mortality associated with Lassa haemorrhagic fever, the WHO listed the virus as a high priority organism requiring prophylaxis and treatment. Different vaccine candidates involving human monoclonal antibodies have undergone pre-clinical trials, with some showing efficacy in animal models. However, only one vaccine candidate has progressed to clinical trials (23). A DNA vaccine candidate INO-4500 has been developed for Lassa fever by INOVIO; and in February, 2021, the first trial patient was dosed in Ghana, in its Phase 1B human trial. About 220 adults aged 18 – 50yrs will be enrolled for the clinical trial by receiving a two-dose regimen injection on Day 0 and Day 28 while being evaluated for immunogenicity and safety within an African population (24,25). The DNA plasmid induces target antigen production, which triggers T cell and antibody mediated cellular immunity. A major factor limiting the Lassa fever vaccine development has been associated with the high cost of bio-containment required.
Lassa fever outbreak in Nigeria has shown an upward trend in recent years and despite the novel Coronavirus disease 2019 (COVID-19) pandemic, there is still a surge in its incidence with high case fatality. While there are different reports from the Federal Ministry of Health and Nigeria Centre for Disease Control (NCDC) on the yearly case burden of Lassa fever in Nigeria, there are limited studies that give a detailed meta-analysis of Lassa fever from January 2015 to 11 th June, 2021. Method: Previous studies on Lassa fever in Nigeria available on PubMed, Google and epidemiological data from NCDC were evaluated. The review was done using percentages, cross-tabulation and graphical charts. Results: The predominant age group infected was 21-40 years with a male to female ratio of 1: 0.8-1. Clinical signs and symptoms observed include fever, headache, diarrhoea, tachycardia, neurological disorientation, amongst others, with the onset of haemorrhage being associated with high mortality. A total of 3,234 laboratory-confirmed Lassa fever cases out of 19,597 suspected cased were identified from 29 States. Edo, Ondo, Taraba, Ebonyi, Bauchi, Plateau and Nasarawa had yearly Lassa fever incidence over the time frame considered. Contact tracing was done on over 33,723 individuals with over 89% completing follow up. Case fatality rate within the period ranged from 9.3% to 29.2%. There is a sharp decline in the epidemiological trend of Lassa fever in the yearly seasonal peaks from Week 1-13 with about 75% reduction in incidence between 2020 and 2021. Conclusion: Lassa is endemic in Nigeria with rising cases occurring concurrently with COVID-19. Priority needs to be given to preventive methods, prompt laboratory diagnosis, timely treatment, cross-border surveillance, contact tracing, community awareness and vector control in order to curb the spread. The DNA vaccine candidate in the Phase 1B clinical trial gives hope of a possible vaccine for Lassa fever.
INOVIO previously received a $56 million grant from CEPI in 2018, under which the company is developing vaccine candidates for Lassa fever and Middle East Respiratory Syndrome (MERS). INOVIO and CEPI are committed to making a vaccine available as soon as possible for emergency use as a stockpile product post-Phase 2 testing. 2/23/21
A Review of Lassa fever Epidemiological Trend in Nigeria Jan 2015 - 6/11/21
https://www.researchgate.net/publication/352880279_A_Review_of_Lassa_fever_Epidemiological_Trend_in_Nigeria_from_January_2015_-_11th_June_2021
Advaccine started INO-4800 (pGX9501) P3 in Latin America and other places on June 8, and plans to complete the market application within this year. 7/8/21
Ai Di Weixin is not in a hurry about not running into the first echelon.
The world's first DNA Covid-19 vaccine will be put into use in August.
According to foreign media reports, the chairman of the National Immunization Advisory Group of India said that this vaccine was developed by Zydus cadila R&D company and is suitable for people over 12 years old. This is also the world's first large-scale vaccinated DNA vaccine. DNA vaccines have not been used in all disease fields before.
If we can reach a global herd immunity, the vaccine will be the new crown in the history of the number one selling drug, the huge drug market ceiling is still rising.
Beijing Aidiweixin Biotechnology Co., Ltd. (hereinafter referred to as "Aidiweixin") is a domestic DNA vaccine research and development company. As a member of the National Covid-19 Vaccine Pioneer Team, Ai Diweixin was one of the first companies to invest in the research and development of Covid-19 vaccines, undertaking five domestic technical routes (inactivated vaccines, recombinant protein vaccines, adenovirus vector vaccines, attenuated influenza virus vector vaccines , Nucleic Acid Vaccine) , the development of DNA vaccines under the route of nucleic acid vaccines.
However, the domestic vaccination work has been in full swing for half a year. Compared with the familiar Sinopharm, Kexing, and Kangsino, the name of Ai Di Weixin is still very unfamiliar.
Because Ai Diweixin's vaccine has not yet been launched. The DNA new crown vaccine pGX9501 (named INO-4801 approved in the U.S.) developed by Ai Diweixin and Inovio, a US vaccine research and development company , started phase three clinical trials in Latin America and other places on June 8, and plans to complete the market application within this year.
But Ai Di Weixin himself is already on the way to market. Ai Diweixin submitted the prospectus to the main board of the Hong Kong Stock Exchange on April 26 as early as 2021, but there has been no new progress so far. Jingwei Venture Capital and Fortune Capital are its top ten shareholders. Ai Di Weixin has obtained the vaccine production license and the plant is ready. The production capacity is expected to reach 100 million doses in 2021. In addition to the new crown vaccine, which is undergoing Phase III clinical trials, Ai Diweixin has four vaccine pipelines, none of which have yet to be commercialized.
In keeping with the progress of the epidemic, "new crown concept stocks" are also the most watched concept in the secondary market. CanSino returned to the Sci-tech Innovation Board as the "first share of the new crown vaccine" in August last year, becoming the first "A+H" vaccine company and the second most expensive company on the Sci-Tech Innovation Board. This benefited As its Hong Kong stock price rose during the epidemic.
With the advancement of large-scale vaccination, vaccine stocks have begun to enter the cash-back period. According to Cansino's first quarter annual report, the company achieved a total operating income of 470 million in the first quarter of 2021, a year-on-year increase of 11483.2%. Fosun Pharma, which was approved by Pfizer in April 2021 and announced that it will launch a vaccination program in Hong Kong and Macau, has a cumulative increase of nearly 90% in the month alone. Other vaccine stocks, such as Zhifei Bio, Kangtai Bio, Watson Bio, etc., have doubled their share prices since 2020.
Why should a new vaccine be developed when there are multiple vaccines to choose from? To what extent can the emergence of new types of vaccines alleviate the current shortage of vaccine production capacity? What are the reasons why Ai Diweixin chose to conduct an IPO while conducting clinical trials? "Jiazi Guangnian" obtained the following conclusions through the dismantling of the prospectus and the dialogue with relevant people in the industry:
The new crown vaccine research and development competition is still going on. Iterative vaccines, vaccine boosters, and vaccine needs for special populations still exist;
Ai Diweixin’s opportunity: insufficient global production capacity and the particularity of DNA vaccines;
Disadvantages of DNA vaccines: There is no precedent for mass population vaccination. The injection method is limited, a special syringe is required, or the vaccine cost is increased;
When will Ai Diweixin's new crown vaccine start mass production, and how will the development progress of the other four pipelines advance? All depend on the progress and results of the Phase III clinical trial of the new crown vaccine;
The new crown epidemic has become the biggest thrust of Ai Diweixin's IPO.
The new crown vaccine research and development competition is still going on. Iterative vaccines, vaccine boosters, and vaccine needs for special populations still exist;
Ai Diweixin’s opportunity: insufficient global production capacity and the particularity of DNA vaccines;
Disadvantages of DNA vaccines: There is no precedent for mass population vaccination. The injection method is limited, a special syringe is required, or the vaccine cost is increased;
When will Ai Diweixin's new crown vaccine start mass production, and how will the development progress of the other four pipelines advance? All depend on the progress and results of the Phase III clinical trial of the new crown vaccine;
The new crown epidemic has become the biggest thrust of Ai Diweixin's IPO.
1. Why do we need a new vaccine?
Even if the global inoculation rate has increased by more than tens of millions of times a day, scientists still dare not slow down. According to WHO statistics, there are still more than two hundred kinds of new coronavirus vaccines under research in the world. According to data from the National Health Commission on June 7, there are still 21 new coronavirus vaccines undergoing clinical trials in China.
The market demand for the new crown vaccine is still far from being met. Everyone in the world may need to be vaccinated with two or three doses of the vaccine. At present, in most countries in the world, the vaccination rate is less than 10%, and the new crown vaccine is still very large. Market space. According to reliable sources, Ai Diweixin's DNA vaccine is expected to complete Phase III clinical trials within this year.
Ai Diweixin's research and development of the new crown vaccine is also continuing to advance with all its strength. Dr. Liu Xiaoyan, Strategic Director of Ai Di Weixin Biopharmaceuticals, explained to Jiazi Guangnian that this is mainly due to three reasons:
First, the current protective effect of domestic vaccines is to "prevent the disease" , that is, to reduce the severity of the disease and avoid death. The ideal state that the vaccine can achieve is "prevention of infection", that is, it can protect the vaccinated person from infection.
The DNA vaccine developed by Ai Diweixin belongs to the nucleic acid vaccine, because the nucleic acid vaccine can induce the immune response of T cells in the human body and can block the infection. In order to achieve the optimal immune effect, the research and development of nucleic acid vaccines will continue.
Second, how long the protective effect of the vaccine will last, and how effective it will be in the face of mutated strains, is still inconclusive. The new crown for human cognitive evolution, evolution vaccine, the virus also own evolution, even if the vaccine has been inoculated with a new crown, may also need to continue after inoculation under different technical route booster.
The research and development of enhanced needles is still in the early stage. Vaccine research and development companies such as Sinopharm, Kangsino, and Kexing are starting clinical trials of enhanced needles. Ai Diweixin's specific plan for enhanced needles has not yet been disclosed.
Third, there are already listed in large quantities of vaccine, most of them are for 18 to 60 years old, no special disease populations, children, the elderly, pregnant women and other special populations vaccines still in development stage.
Ai Di Weixin is also paralleling the main line branch, carrying out an all-round "chasing and intercepting" the new crown virus. In addition to the Phase III clinical trials being conducted in South America and other regions, research on enhanced needles and vaccine development for variant strains are also underway.
2. Double-sided DNA vaccine: pros and cons
The DNA vaccine first appeared on the stage of history, perhaps just recently. Zydus Cadila, an Indian vaccine developer, has submitted a marketing application for the DNA vaccine ZyCov-D to the local government in mid-June. At the same time, it is also actively expanding its production capacity and is expected to produce 30 million doses this year.
In addition, the DNA vaccine of Japanese vaccine developer AnGes has entered phase III clinical trials in March 2021, and the DNA vaccine GX-19N developed in cooperation with Indonesian pharmaceutical company Kalbe Farma is currently undergoing phase II clinical trials.
At present, no DNA vaccine for humans has been approved for marketing, but DNA vaccines have been used in the field of animal vaccines for many years, and a variety of animal DNA vaccines have been approved.
Compared with traditional vaccine development technology, DNA vaccines have obvious advantages: no risk of infection, simple production methods, low production costs, and stable storage at room temperature. According to previous research results Inovio, DNA vaccines can be stored at standard refrigeration temperatures for up to five years .
In addition, the CMC (chemical, manufacturing and control) of nucleic acid vaccines can use the accumulation of all previous processes to form a platform technology. Compared with recombinant protein vaccines and inactivated vaccines, the whole cell line needs to be re-constructed for each pathological change. Nucleic acid vaccines only need to adjust the variant sequence and do not need to repeat the construction and expression related work.
However, DNA vaccines also have challenges, and DNA vaccines require higher delivery systems.
According to public information, compared with traditional intramuscular injection, the vaccine effect can be at least 600 times higher with the use of special DNA vaccine equipment for vaccination. Ai Diweixin’s partner Inovio owns the patent right of the DNA vaccine dedicated syringe CELLECTRA. Previously, the US Department of Defense (DOD) allocated 70 million US dollars to Inovio for mass production of the syringe.
However, special equipment will lead to a corresponding increase in costs. Ai Diweixin has not disclosed the relevant details of the syringe patent and production. Previously, Jiangsu Province purchased vaccines, and Kexing's winning bid price was 200 yuan per tube. BioNTech's mRNA vaccine is about $19 (approximately $ 125) per dose .
3. Where is Ai Di Weixin's market?
The insufficient production capacity of the new crown vaccine is a global problem. According to the “New Coronary Pneumonia Vaccine Market Launch and Scale Calculation Table” previously released by Duke University in the United States, it is calculated that only 2 doses per person can achieve the initial immunity and 70% of the world’s population is vaccinated to reach the herd immunity threshold. 110 doses of new crown vaccine.
For major overseas vaccine manufacturers, Moderna’s planned annual production capacity in 2021 is 600 million doses, BioNTech and Pfizer have set a planned production capacity of 2 billion doses, and AstraZeneca has signed a contract volume of approximately 1.45 billion doses as of May. Johnson & Johnson has signed a contract volume of 1.1 billion doses as of May.
According to the current domestic production plan for inactivated vaccines, it can basically meet the domestic primary vaccination needs. At this year's Boao Forum, Zheng Zhongwei, head of the vaccine research and development working group of the Joint Prevention and Control Mechanism Research Group of the State Council, proposed that China's vaccine production capacity will reach 5 billion in 2021, and the production of vaccines will exceed 3 billion.
Regarding Ai Di Weixin’s future production capacity plan, Dr. Liu Xiaoyan told “Jiazi Lightyear”, “In the future, Ai Di Weixin’s vaccine will not only serve as a primary vaccination, but also meet the demand for booster vaccination. The demand for immunization and export to overseas markets where vaccines are in short supply."
Strengthening the needle is becoming a necessary option, and the global production gap is further expanding.
"The ultimate goal of product research and development is to bring it to the market quickly, to prevent and control the epidemic as soon as possible, and to realize commercial value." Dr. Liu Xiaoyan told "Jiazi Guangnian" that the rebuilding cycle will be relatively long, so they chose to pass Mergers and acquisitions integrate existing resources. Ai Di Weixin is already preparing for mass production in the early stages of vaccine development.
According to the prospectus, Ai Di Weixin will acquire Suzhou Sio Biotech on September 30, 2020 and make corresponding transformations to its production line. The production capacity is expected to reach 100 million doses in 2021.
Ai Diweixin has completed the first phase of the transformation of the original plant in Slovakia, and has obtained a vaccine production license. At present, the plant is in the trial production stage, and at the same time, the second phase of production line expansion is already underway.
Ai Di Weixin is already "all things ready" in terms of production capacity, but the time for large-scale production still has to wait for the progress and results of Phase III clinical trials.
4. The new crown affects more than the new crown vaccine
In addition to the new crown vaccine, Ai Diweixin currently has five pipelines under research. Only the RSV preventive vaccine has entered the clinical trial stage, and the rest are in the research and development stage. The company's revenue in 2019 and 2020 is only 8,000 yuan and 308,000 yuan respectively.
The vaccine pipeline that has achieved results and is in progress. Since 2020, due to the sharp tilt of research and development resources to the new crown vaccine and the suspension of global clinical trials, the progress has slowed down, but this situation is improving. The direct impact of the new crown on other vaccines is gradually fading, including the complete failure of clinical trials and the occupation of clinical resources. This is a common phenomenon in the industry.
The future development progress of specific pipelines also depends on the results and progress of the third phase of the new crown vaccine.
Dr. Liu Xiaoyan told the "six decades light years", "we put the crown on the new vaccine will still accounted for the recent high because clinical trials research and development costs are very high , with a new crown Phase III clinical trials currently being launched, for example, global multi-center clinical The cost of the trial requires hundreds of millions of dollars.” In their plan, clinical trials for each vaccine can be carried out simultaneously but with emphasis. After the research and development of the new crown is over, the company's investment in research and development expenses will shift to the clinical of the next vaccine.
In addition to the new crown vaccine, the RSV preventive vaccine has the fastest progress in Ai Di Weixin's pipeline and will be the next focus of research and development.
According to the WHO report, about 200,000 children under the age of 5 die every year from the RSV virus (respiratory syncytial virus) , and there is no medicine to treat it so far. Since the human body cannot produce sustained protective immunity against RSV infection, a person can be repeatedly infected with RSV throughout his life. For people with poor immune systems, 65 years of age and older, and chronic lung diseases, the mortality rate after infection with RSV is as high as 40%.
The market size of RSV preventive vaccines is in the billions of dollars and is the focus of global pharmaceutical companies' R&D competition. The difficulty of the RSV vaccine is the VED response (Vaccine enhanced disease, that is, lung damage caused by the vaccine) . Ai Diweixin is trying to use technical means to solve this problem. The vaccine has entered Phase II clinical trials in Australia.
Hepatitis B vaccine is another focus of Ai Diweixin. So far there is no effective therapeutic hepatitis B vaccine on the market. According to WHO estimates, more than 2 billion people in the world have been infected, and cirrhosis and hepatocellular carcinoma cause about 600,000 deaths each year.
Public information shows that Ai Diweixin's hepatitis B vaccine has carried out a clinical trial initiated by investigators with 720 patients in the early stage. The treatment group showed a surface antigen conversion rate of 15.4%, that is, the clinical cure ratio. This is the best result of drug therapy in this field in the world.
5. IPO driven by the new crown epidemic
The positive impact of the new crown epidemic on the vaccine industry is an important reason why Ai Diweixin chose to conduct an IPO at this time.
"After this new crown, China's vaccine power has been on the world stage, and domestic products have been exported to dozens or hundreds of countries, and they have gained international recognition." Liu Xiaoyan said.
First of all, this epidemic has given everyone a new understanding of vaccines and increased acceptance; secondly, everyone is deeply aware of the problem of insufficient production capacity, and global production capacity will be greatly expanded, which can solve some traditional problems in the vaccine industry; finally, The accumulation of new technology applications and research in secondary vaccine research and development will further promote future nucleic acid vaccines to become the mainstream, which also provides a broader development space for innovative vaccine companies such as Ai Diweixin.
In fact, until today, the "rational return" of the new crown concept stocks in the secondary market is still slow. In the past year or so, news related to vaccines has caused dramatic market volatility. On November 10, 2020, as Pfizer announced that the vaccine's effectiveness exceeded 90%, the European and American markets rose by an average of over 5% that day, and the global stock market staged a collective carnival.
According to the agreement disclosed in the prospectus, if Inovio does not start Phase III clinical trials in the United States within one year of the signing of the cooperation agreement, Ai Di Weixin will choose regions outside of Greater China to conduct Phase III clinical trials at its own cost. However, on June 8, 2021, Ai Di Weixin and Inovio announced that they have expanded the scope of the agreement to jointly carry out the ongoing global Phase III clinical trial and share research and development costs.
As of the end of February 2021, Ai Diweixin's unaudited and approved cash and equivalents totaled 218 million yuan. According to Ai Di Weixin's financial forecast, if the cash consumption rate in 2021 is 1.3 times the average cash consumption rate in 2020, the company's current cash flow can support at least 22 months of normal operating activities.
For Ai Di Weixin, the problem still lies in the timing of the effective results of the Phase III clinical trial. The progress of Phase III clinical trials is difficult to precisely control. The number of subjects, the speed of enrollment of subjects, and the speed of acquiring infection cases among subjects will affect the presentation of the final trial results. Previously, there were many including Johnson & Johnson and the United Kingdom. Vaccine research and development institutions including Oxford have been suspended due to obvious side effects of vaccination. The Phase III clinical trial of pGX9501 has just begun, and no one dares to say when the trial will be successful and whether the product will be launched as scheduled.
Ai Diweixin hopes that through the IPO, it can supplement the funds needed for R&D and production, accelerate the development of vaccine technology, product promotion and the construction of large-scale production facilities, and take the opportunity to expand the advantages it has accumulated in the field of vaccines.
Richter-Helm prepares for the future and triples biopharmaceutical production capacity
A broad range of various approaches exist to produce biopharmaceuticals. Different sources for products can be used, like mammalian cell culture or microbial fermentation processes in bacteria and yeast. Microbial derived products include a variety of product classes: therapeutic proteins, peptides, antibody formats, bacterial vaccines and plasmid DNA as starting material or drug substance. All of these classes need to be produced to the highest international standards of cGMP and compete for production in highly complex facilities with limited capacities worldwide. This limitation is due to a growing market and was made even more obvious during the worldwide pandemic since 2020.
From the long list of product classes it is obvious that related high quality production is as versatile as the products themselves. Nevertheless manufacturing can be executed in general with the same equipment in multipurpose facilities. This needs adequate flexibility not only for the equipment itself, but also the organizational procedure and the quality system.
Richter-Helm ensures highest pharmaceutical quality standards as verified by major regulatory bodies including EMA [EU], FDA, PMDA [Pharmaceuticals and Medical Devices Agency is an Independent Administrative Institution responsible for ensuring the safety, efficacy and quality of pharmaceuticals and medical devices in Japan], ANVISA [Brazil FDA, one 4800 P3 and 4802 P1/2 site], Health Canada and MFDS [Ministry of Food and Drug Safety, formerly known as the Korea Food & Drug Administration, is a South Korea], as well as by numerous customer audits.
After completion of conceptual and basic design studies Richter-Helm yet started construction of two highly flexible production trains with fully separated flows in a new facility building. Two new bioreactors with capacities of 300 and 1,500 liters will be installed. Those can be operated in parallel for different products. The midstream- and downstream operations will be executed in suites in the same building. Individual bioreactors and suites can be arranged variably to offer multiple combinations for any manufacturing process. This allows for flexible combination of processes demanding different volumes for up- and downstream capacities. Equipment can be adapted to specific needs easily.
A few weeks ago construction works started. Detailed engineering is on strong progress. It is expected that ambitious construction of the new facility will be completed within the next 2 years. By the end of 2023 first productions shall be executed.
After completion of the expansion Richter-Helm manufacturing facilities will provide three-fold cGMP production capacities within the current range of bioreactor scales, covering fermenter volumes from 10 to 1,500 liters. Specific requirements like 100% oxygen aeration for high cell density fermentation, methanol feed for cultivation of Pichia pastoris or multiple fermentation runs of various bacteria for vaccination can be offered as CDMO service for all production trains in Bovenau. Richter-Helm further provides state-of-the-art, highly flexible downstream processing. Specialized solutions, such as preparative HPLC or pegylation (catalyzed either enzymatically or chemically) complete the CDMO´s capabilities.
In the course of the REVEAL 1 and REVEAL 2 clinical trials, INOVIO continues to pursue development of a pre-treatment RNA-based biomarker blood test which could be used to identify prospective VGX-3100 patients who would be most likely to respond to the immunotherapy. INOVIO believes this will be an important element of VGX-3100 product and market development.
INOVIO announced in February that it is continuing its partnership with QIAGEN to co-develop an in-vitro diagnostic based on RNA sequencing technology to guide clinical decision-making for the use of VGX-3100 in cervical HSIL. This technology had previously been employed in a post-hoc assessment of VGX-3100 Phase 2 data by INOVIO, in which 85% of VGX-3100 treated subjects who had the biomarker experienced regression of HPV-16- and/or HPV-18-associated cervical HSIL.
“What's different about REVEAL 1 and REVEAL 2 is they're identical across the design, except for the safety follow-up. So REVEAL 1 has a one year safety follow-up from the 36 week initial primary time point. REVEAL 2 has a one month follow-up. So it's much closer to finish from the primary endpoint. So we're very looking forward to having both REVEAL 1 full data set this year and REVEAL 2 in 2022. So that program is moving well, and we're very active and very excited.
the side effects of this current standard treatment besides the typical surgical related side effects is a reduction in capabilities to carry the babies post surgery. So, it's been well published that the surgery doubles the rate of spontaneous abortions and preterm birth.
So what VGX-3100 offers these patients is an opportunity to avoid surgery and treat the disease and the original cause of the disease, which is an HPV infection in the first place.
there's a strong market need for and want for a therapeutic like VGX-3100 and we'll demonstrate the efficacy through our pivotal trials, but we will also be able to present this strong case for the patients and the providers alike. So we think 3100 is a great immunotherapy candidate, and bringing in this new therapeutic option for the patient.
there are other diseases caused by the same viral infection in the other parts of the body, like the vulvar area for women and anal tracts for men and women, similar types of disease caused by the same viral infection but in different locations.
VGX-3100 has the potential to become a pan-anal genital immunotherapy those are caused by HPV-16 and 18.“ JK 6/1/21
JK 6/1/21 “once our first country is set and we're rolling out the trial, and there will be multiple countries at once, we will fully disclose and articulate our strategy and the design more fully.
where we have selected the countries and the regions are -- where there are still very much active infections going on and there's lack of available vaccines for the people, that window is wide open right now. So we're planning to execute our INNOVATE Phase 3 trials this year, starting this summer, potentially have the early interim efficacy readout by the end of the year.
you asked about the FDA partial hold. We still want to clear that up. As I articulated our strategy long-term submit our BLA. And also we want to make sure that all of the hard work that our team has done is fully realized. So we still plan to do that. But our primary focus right now is executing and opening the countries and the sites for our Phase 3 outside the U.S. using CELLECTRA 2000 delivering INO-4800. And we're on track as we had anticipated earlier this year that we'll be starting this summer and data -- interim data by year end.
INO-4800’s ability to cross-protect against those variants, of UK variant, the Brazil variant, really is in our sweet spot. So we're going to go where those variants and the original strains are more dominant, and those are the areas of you can imagine, Latin America, Asian Pacific and so on. So there's plenty of regions that we can execute our trial. We overlay that with our own variants levels in those regions, as well as our CROs.
So we selected a handful of great countries do these trials.
U.S. FDA partial hold on our CELLECTRA 2000 device, there's no bearing in any other territories. In fact, it's the same device that we had received CE marking from the EU several years ago. So most of the countries outside the U.S. follow the CE marking for medical devices, the EU convention. So we feel very good about the acceptability of our device outside the U.S. And of course, the gating factor for our Phase 3 start is really -- and we've already begun this process is submitting all of our Phase 3 plans, and getting them approved through various countries that we have planned.“
P3 REVEAL 1 Completed 4/7/21, 7/6/21 Update (Evaluation-of VGX-3100-and-Electroporation-for-Treatment-of-Cervical-HSIL)
Actual Study Start Date :
June 28, 2017
Actual Primary Completion Date :
July 8, 2020
Actual Study Completion Date :
April 7, 2021
https://clinicaltrials.gov/ct2/history/NCT03185013?A=40&B=41&C=merged#StudyPageTop
hTERT-encoded-INO-1400,1401 with-or-w/o IL-12 DNA 9012 covers-9-Cancers: Breast, Lung, Pancreatic, Head and Neck, Ovarian, ColoRectal, Gastric, Esophageal, HepatoCellular Carcinoma
https://clinicaltrials.gov/ct2/show/NCT02960594
https://clinicaltrials.gov/ct2/show/NCT04367675
https://jitc.bmj.com/content/9/7/e003019
7/7/21 P1 study of safety, tolerability and immunogenicity of the human telomerase (hTERT)-encoded DNA plasmids INO-1400 and INO-1401 with or without IL-12 DNA plasmid INO-9012 in adult patients with solid tumors
Background Human telomerase reverse transcriptase (hTERT) is frequently classified as a ‘universal’ tumor associated antigen due to its expression in a vast number of cancers. We evaluated plasmid DNA-encoded hTERT as an immunotherapy across nine cancer types.
Methods A phase 1 clinical trial was conducted in adult patients with no evidence of disease following definitive surgery and standard therapy, who were at high risk of relapse. Plasmid DNA encoding one of two hTERT variants (INO-1400 or INO-1401) with or without plasmid DNA encoding interleukin 12 (IL-12) (INO-9012) was delivered intramuscularly concurrent with the application of the CELLECTRA constant-current electroporation device 4 times across 12 weeks. Safety assessments and immune monitoring against native (germline, non-mutated, non-plasmid matched) hTERT antigen were performed. The largest cohort of patients enrolled had pancreatic cancer, allowing for additional targeted assessments for this tumor type.
Results Of the 93 enrolled patients who received at least one dose, 88 had at least one adverse event; the majority were grade 1 or 2, related to injection site. At 18 months, 54.8% (51/93) patients were disease-free, with median disease-free survival (DFS) not reached by end of study. For patients with pancreatic cancer, the median DFS was 9 months, with 41.4% of these patients remaining disease-free at 18 months. hTERT immunotherapy induced a de novo cellular immune response or enhanced pre-existing cellular responses to native hTERT in 96% (88/92) of patients with various cancer types. Treatment with INO-1400/INO-1401±INO-9012 drove hTERT-specific IFN-? production, generated hTERT-specific CD4+ and?CD8+ T cells expressing the activation marker CD38, and induced hTERT-specific activated CD8 +CTLs as defined by cells expressing perforin and granzymes. The addition of plasmid IL-12 adjuvant elicited higher magnitudes of cellular responses including IFN-? production, activated CD4+ and?CD8+ T cells, and activated CD8+CTLs. In a subset analysis of pancreatic cancer patients, the presence of immunotherapy-induced activated CD8+ T cells expressing PD-1, granzymes and perforin correlated with survival.
Conclusions Plasmid DNA-encoded hTERT/IL-12 DNA immunotherapy was well-tolerated, immune responses were noted across all tumor types, and a specific CD8+ phenotype increased by the immunotherapy was significantly correlated with survival in patients with pancreatic cancer.
The data provided by our analyses nevertheless suggest a possible survival benefit in those patients who manifest an anti-hTERT response via INO-1400/1401; further research is required to confirm this observation. Based on these results, INO-1401 is included as an important component in a new combination immunotherapy, INO-5401, along with plasmids encoding for other tumor-associated antigens Wilms Tumor-1 and prostate specific membrane antigen in an ongoing study in subjects with known germline mutations in BRCA1/2 with, or at high risk for developing, cancer (NCT04367675). Taken together, these data support future examination of INO-1400/INO-1401 and INO-9012 as an immunotherapy in pancreatic cancers as well as other tumor types overexpressing hTERT.
Immunotherapy and delivery using CELLECTRA device
INO-1400 and INO-1401 are synthetic DNA plasmids encoding for a modified human telomerase protein. INO-9012 consists of a DNA plasmid encoding for synthetic human IL-12 (p35 and p40 subunits). All constructs were designed using proprietary technology (Inovio Pharmaceuticals, Inc.). The CELLECTRA 2000 adaptive constant current electroporation device (EP; Inovio Pharmaceuticals) delivers three 52?ms controlled electric pulses, spaced in 1?s intervals, through a sterile, disposable array to the injection site. INO-1400/1401 with or without INO-9012 was formulated in sterile water for injection and delivered intramuscularly (IM) in a 1?mL volume followed immediately by EP.
Authors
Robert H Vonderheide 1 , Kimberly A Kraynyak 2 , Anthony F Shields 3 , Autumn J McRee 4 , Jennifer M Johnson 5 , Weijing Sun 6 , Ashish V Chintakuntlawar 7 , Jan Pawlicki 8 , Albert J Sylvester 8 , Trevor McMullan 8 , Robert Samuels 8 , Joseph J Kim 8 , David Weiner 9 , Jean D Boyer 8 , Matthew P Morrow 8 , Laurent Humeau 8 , Jeffrey M Skolnik 8
Affiliations
1 Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
2 Inovio Pharmaceuticals, Plymouth Meeting, Pennsylvania, USA kim.kraynyak@inovio.com.
3 Karmanos Cancer Institute, Wayne State University, Detroit, Michigan, USA.
4 University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, USA.
5 Sidney Kimmel Cancer Center, Thomas Jefferson University, Philadelphia, Pennsylvania, USA.
6 University of Kansas Medical Center, Department of Medicine, Division of Medical Oncology, Kansas City, Kansas, USA.
7 Division of Medical Oncology, Mayo Clinic, Rochester, Minnesota, USA.
8 Inovio Pharmaceuticals, Plymouth Meeting, Pennsylvania, USA.
9 Wistar Institute, Philadelphia, Pennsylvania, USA.
R.H.V. is supported by grants from the Breast Cancer Research Foundation and the Basser Center for BRCA.
https://jitc.bmj.com/content/9/7/e003019
“What's different about REVEAL 1 and REVEAL 2 is they're identical across the design, except for the safety follow-up. So REVEAL 1 has a one year safety follow-up from the 36 week initial primary time point. REVEAL 2 has a one month follow-up. So it's much closer to finish from the primary endpoint. So we're very looking forward to having both REVEAL 1 full data set this year and REVEAL 2 in 2022. So that program is moving well, and we're very active and very excited.
the side effects of this current standard treatment besides the typical surgical related side effects is a reduction in capabilities to carry the babies post surgery. So, it's been well published that the surgery doubles the rate of spontaneous abortions and preterm birth.
So what VGX-3100 offers these patients is an opportunity to avoid surgery and treat the disease and the original cause of the disease, which is an HPV infection in the first place.
there's a strong market need for and want for a therapeutic like VGX-3100 and we'll demonstrate the efficacy through our pivotal trials, but we will also be able to present this strong case for the patients and the providers alike. So we think 3100 is a great immunotherapy candidate, and bringing in this new therapeutic option for the patient.
there are other diseases caused by the same viral infection in the other parts of the body, like the vulvar area for women and anal tracts for men and women, similar types of disease caused by the same viral infection but in different locations.
VGX-3100 has the potential to become a pan-anal genital immunotherapy those are caused by HPV-16 and 18.“
obx4me, 06:47 AM 7/3/21: I'm in P2 trial. Talked to my P2 clinic trial location yesterday. I asked them... keep asking... when will blind be lifted? Was told INOVIO still needs / wants more data. Blind not lifted. P2 still collecting data. Going back for 6 months after 2nd dosing in 1 week.
Giving more blood for more data.
Moderna and Pfizer removed blind so those with placebo got offered approved vaccine. Not yet with INO.
INO is moving g forward. I see this as positive signs.
rdawgstonks
09:55 AM 7/3/21
@obx4me Hello, thank you for your update. I am P2 as well (2mg) and was hoping to be unblinded come August when I go for a blood draw. I will keep doing what is asked of me for the research however. Take care.
3 Takeaways From INO KOL Call, Oppenheimer Stays Bullish, July 2, 2021 8:16 AM. Oppenheimer analyst Hartaj Singh reiterated an Outperform rating and $35.00 price target on Inovio Pharmaceuticals (NASDAQ: INO) after hosting a ...
The analyst stated "We believe investors are not giving INO enough credit for VGX- 3100 and stay bullish
The World Health Organization (WHO) is calling on countries opening up their borders to recognize any COVID-19 vaccine it has authorized for emergency use.
In a joint statement Thursday with the COVAX initiative, the WHO urged "all regional, national and local government authorities" to recognize as fully vaccinated "all people who have received COVID-19 vaccines that have been deemed safe and effective by the World Health Organization."
The statement came as the European Union began rolling out its digital travel certificate that will allow vaccinated travelers to have unrestricted movement across the region.
But the EU program does not recognize the AstraZeneca vaccines manufactured in India by the country's Serum Institute - branded as Covishield-because they have not been cleared by E.U. regulators.
Only vaccines that have received EU marketing authorization are recognized, although individual countries can decide if they want to allow travelers who have received other vaccines.
There are just four vaccines that currently qualify under the EU certificate's criteria: Moderna, Pfizer-BioNTech, Johnson & Johnson and AstraZeneca doses manufactured in Europe by the company itself.
The European-manufactured AstraZeneca vaccines are not chemically different from the ones made in India.
The versions of AstraZeneca's vaccine that were made in India are intended to be a major part of the COVAX arsenal to use in developing countries.
By not recognizing those doses, the EU is effectively saying some vaccinated people don't count as being vaccinated, and is barring entry for people who live in countries that rely on COVAX for COVID-19 vaccines.
The COVAX initiative has distributed more than 89 million vaccines to 133 mainly low- and middle-income countries across Africa, Asia and Latin America.
"Any measure that only allows people protected by a subset of WHO-approved vaccines to benefit from the re-opening of travel into and with that region would effectively create a two-tier system, further widening the global vaccine divide and exacerbating the inequities we have already seen in the distribution of COVID-19 vaccines," the WHO and COVAX said in the statement.
"Such moves are already undermining confidence in life-saving vaccines that have already been shown to be safe and effective, affecting uptake of vaccines and potentially putting billions of people at risk. At a time when the world is trying to resume trade, commerce and travel, this is counter-effective, both in spirit and outcome," the statement added.
The E.U. program would also deny entry to people who have received either of the two Chinese-manufactured vaccines made by Sinovac and Sinopharm, though there are growing questions about the effectiveness of the shots.
https://thehill.com/policy/healthcare/561319-who-calls-on-countries-to-recognize-all-authorized-vaccines-for-travel
RE: South African INO-4802, “Yes. We are definitely considering doing our trial in the heart of the storm - South Africa, India, etc … We will keep you informed. Thanks as always.” Inovio Asia.
Germany planning order for 204 million COVID vaccine doses
Federal Health Minister Jens Spahn is in negotiations with six coronavirus vaccine suppliers to procure 204 million doses for 2022. According to a Ministry of Health report seen by the Handelsblatt, the order would be enough for “a little more than two doses per inhabitant… including a safety reserve.”
The report goes on to say that it is advisable to “secure additional vaccine doses in good time to protect against mutations and [provide] booster vaccinations.”
The order - which apparently totals some 3,9 billion euros - will be spread across several manufacturers. In addition to the 84,4 million doses ordered from BioNTech / Pfizer, Germany will also be lodging orders with Moderna and Johnson & Johnson, as well as with Sanofi, Novavax and Valneva, whose vaccines are yet to be approved for use in the EU.
AstraZeneca and CureVac - the German company whose vaccine candidate recently posted an efficacy of just 47 percent - are not included in the mix.
Concern about protection against Delta and other variants
While the seven-day coronavirus incidence rate in Germany still remains in the single digits, the rapid spread of the highly-contagious Delta variant is causing concern among experts. It is now estimated to account for one in every two coronavirus infections in the federal republic, according to the latest figures from the Robert Koch Institute.
The situation in countries like Israel and the UK - where cases are once again on the increase, despite a high vaccination rate - has led to questions about the effectiveness of the currently-approved vaccines against Delta and other new variants.
It is widely assumed that, long-term, vaccinations will have to be continually “topped up”, much like with the annual flu jab, to keep on top of coronavirus. In the UK, the Joint Committee on Vaccination and Immunisation has already recommended that vulnerable people receive booster shots this autumn.
According to the German government’s vaccine dashboard, 55,1 percent of the German population has now had at least one dose of a coronavirus vaccine, while 37,3 percent are fully-vaccinated.
https://www.iamexpat.de/expat-info/german-expat-news/germany-order-204-million-covid-vaccine-doses-booster-shots-2022
Jefferies analyst Kelechi Chikere thinks the company could potentially have a lot to offer and might be worth investors’ attention.
“INO has a large pipeline of over 15 different programs for infectious diseases (e.g., COVID-19 and MERs) and oncology (e.g., HPV+ cancers),” the analyst said. “Shares of INO have primarily been driven by its CV-19 vaccine. While initial Phase I and II data for its vaccine are encouraging, we think INO’s opportunity is becoming increasingly marginalized. However, on balance, INO has several other programs including a Phase III in cervical dysplasia and a Phase II in GBM that are interesting and warrant more investor interest.”
The company recently released results from the Phase 3 study of VGX-3100 in women with high grade HPV + precancerous cervical dysplasia, with the trial hitting both primary and secondary efficacy endpoints.
Chikere says questions remain on the treatment’s “clinical utility,” and admits the absolute placebo-corrected treatment effect in the Phase 3 testing of 13% is below the 26% exhibited in Phase 2. However, due to a dearth in non-surgical options, the analyst sees “room for the drug.”
Inovio is currently testing VGX-3100 in a second “nearly identical” Phase 3 study, with data expected next year. The final results, says Chikere will “help elucidate the clinical profile of VGX-3100 and potential market uptake.”
Another program piquing Chikere’s interest is the development of INO-5401 – a DNA vaccine against glioblastoma currently being tested together with Regeneron’s PD1 Libtayo – for which the “interesting early data” will be explored in larger studies.
On balance, however, while the analyst “likes the platform and sees upside as INO’s pipeline progresses,” Chikere considers the stock as “fairly valued.” As such, Chikere rates Inovio shares a Hold along with a $9 price target. suggesting shares will remain range bound for the foreseeable future.
On the other hand, the Street’s average price target implies healthy upside; at $13.83, the figure suggests one-year returns of ~50%. Overall, the stock has a Moderate Buy consensus rating, based on 2 Buys and 5 Holds. 6/30/21
Study highlights the importance of T cell cross reactivity in stopping severe COVID-19 infections 7/1/21
https://news.google.com/articles/CAIiEGyz0DvaO7_1JMWkSAJmQKYqMwgEKioIACIQZdRflS9INK7zM5FkBi3R3CoUCAoiEGXUX5UvSDSu8zORZAYt0dww_bXIBg?hl=en-US&gl=US&ceid=US%3Aen
Intradermal jet injection electroporation device Patent.
Inventors: McCoy; Jay; (Plymouth Meeting, PA) ; Broderick; Kate; (San Diego, CA) ; Kemmerrer; Stephen; (San Diego, CA)
An jet injection and electroporation device for use with an agent cartridge defining a volume containing a pre-measured dose of agent therein, the electroporation device including a housing having an axis extend therethrough, a nozzle at least partially positioned within the housing, and a cavity sized to receive at least a portion of the agent cartridge therein. The device also includes an array having a plurality of electrodes extending therefrom, a propulsion cartridge configured to operatively engage the cartridge when the agent cartridge is positioned within the cavity; and a power supply in electrical communication with the array.
https://pdfaiw.uspto.gov/.aiw?Docid=20190000489&homeurl=http%3A%2F%2Fappft.uspto.gov%2Fnetacgi%2Fnph-Parser%3FSect1%3DPTO1%2526Sect2%3DHITOFF%2526p%3D1%2526u%3D%2Fnetahtml%2FPTO%2Fsrchnum.html%2526r%3D1%2526f%3DG%2526l%3D50%2526d%3DPG01%2526s1%3D20190000489.PGNR.%2526OS%3D%2526RS%3D&PageNum=&Rtype=&SectionNum=&idkey=727F7DECBA9E
United States Patent Application: 0190000489
https://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&p=1&u=/netahtml/PTO/srchnum.html&r=1&f=G&l=50&d=PG01&s1=20190000489.PGNR.
“We believe in Cellectra. Its safety profile and effectiveness makes it a superior modality compared to other delivery mechanisms, in our opinion. We also acknowledge that it is currently a two step process. The first step being the injection of the plasmid and the second being the electroporation. We are also working to simply the process so that it can all be achieved in a single step.”, 5/5/21
I2C is 2 wire protocol and I2S is 3 wire protocol. I2C supports clock stretching and I2S does not have clock stretching. I2C has an extra overhead start and stop bits and I2S does not have any start and stop bits.
I²S, is an electrical serial bus interface standard used for connecting digital audio devices together. It is used to communicate PCM audio data between integrated circuits in an electronic device.
Width: 1 data line (SD) +; 2 clock lines (SCK, WS)
Designer: NXP
For stereo material, the I²S specification states that left audio is transmitted on the low cycle of the word select clock and the right channel is transmitted on the high cycle. It is typically synchronized to the falling edge of the serial clock, as the data is latched on the rising edge.
I2C is a serial protocol for two-wire interface to connect low-speed devices like microcontrollers, EEPROMs, A/D and D/A converters, I/O interfaces and other similar peripherals in embedded systems.