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KB at 3 Conferences: 3/17, 18, 4/19.
This lecture will examine the stages, Trials, safety profile, and thermostability of the syntactic DNA vaccine INO-4800.
March 17th 6p-7p
Qatar Environment and Energy Research Institute
Moderator- Dr. Hyung-Goo Kim
Senior Scientist, Neurological Disorders Research Center, QBRI
Speaker - Kate Broderick
Senior Vice President and R&D Lead, INOVIO
https://www.hbku.edu.qa/en/academic-events/dna-based-vaccine
Oppenheimer 31st Annual Healthcare Conference
Date: Thursday, March 18, 2021
Time: 10:40 a.m. ET
Presentation Format: Corporate Presentation
Virtual Event: Taking on Covid-19
Monday, April 19, 2021
10:00am –11:15am
Some of the Panelist are:
Kate Broderick
David Weiner
Moderator:
John George
Senior Reporter - Philadelphia Business Journal
https://www.bizjournals.com/philadelphia/event/167121/2021/virtual-event-taking-on-covid19
Dr. Kate Broderick is an accomplished scientist and recognized vaccine expert who leads a diverse team of researchers discovering and developing DNA medicines in her role as INOVIO’s Senior Vice President of Research and Development. Working out of the company’s research labs in San Diego, she is focused on the development and enhanced delivery of a broad range of DNA medicines designed to prevent a range of often deadly infectious diseases and cancers. Most recently, she is responsible for driving the development of a DNA vaccine for COVID-19. She also led the teams that brought the first in human Lassa fever vaccine into the clinic as well as advanced the development of a DNA vaccine for the MERS virus. Over the course of her career, Dr. Broderick has authored and co-authored more than 60 peer-reviewed articles, and her team regularly publishes and presents their findings in leading scientific publications and at conferences worldwide. Dr. Broderick has participated by invitation at advisory meetings convened by the World Health Organization to discuss DNA vaccines and their delivery. She is a co-inventor on multiple patents related to DNA vaccine delivery and has served as a principal investigator on grants, awards, and contracts from leading government agencies and not-for-profit organizations, including the National Institutes of Health, the U.S. Department of Defense, the Small Business Innovation Research program, and including a $56M award from the Coalition for Epidemic Preparedness Innovations (CEPI). With a keen interest in electroporation device design in the context of transdermal delivery, Dr. Broderick has helped drive the development of novel prototypes and designs of INOVIO’s proprietary smart device CELLECTRA®, which delivers the company’s DNA medicines directly into cells in the body. Dr. Broderick received her Ph.D. from the University of Glasgow, Scotland, and conducted post-doctoral research at the University of California, San Diego. She joined INOVIO in 2006. In 2018, Dr. Broderick was named Business Women of the Year by San Diego Business Journal.
Dr. Weiner directs a translational molecular immunology research team focused on creating novel approaches for disease prevention and treatment using synthetic nucleic acid technology. With help from collaborators, his group is one of the pioneering research teams in the field of DNA vaccines and immunotherapies and has developed the first clinical studies of DNA vaccines. The Weiner lab has made synthetic DNA platform advances by creating the world’s first Zika vaccine, the first and most advanced MERS coronavirus vaccine and developing an advanced Ebola vaccine, among others. In oncology, the Weiner lab has helped to develop immunotherapy approaches for HPV-associated cancers, prostate cancer and glioblastoma multiforme (GMB), among others, which are currently in clinical testing. His work has led to the first clinically efficacious therapeutic DNA vaccine (VGX3100) for HPV cervical intraepithelial neoplasia (CIN), which is now in licensure trials (REVEAL). The Weiner lab has published more than 428 papers, chapters and reviews, and members have participated in hundreds of scientific lectures. Dr. Weiner is a Professor Emeritus at the University of Pennsylvania Perelman School of Medicine and sits on multiple academic and industry advisories and review panels. He has received several awards and honors for these accomplishments, including inclusion as one of the top 40 most influential vaccine scientists in the world (2015), the W.W. Smith Charitable Trust Professorship in Cancer Research (2016), and the Vaccine Industry Excellence Award for Best Academic Research Team (2015 & 2016). Dr. Weiner was named among the Top 20 Translational Researchers by Nature Biotechnology in 2016, 2017 and 2018 (ranked #2), and received the Stone Family Award for Cancer Research (2014), the NIH Director’s Translational Research Award (2011), and the Life Sciences PA Scientific Achievement Award (2018). He is a Fellow of the American Association for the Advancement of Science (2011), Fellow of the International Society for Vaccines and President of the International Society for Vaccines (2018-2020), Dr. Weiner is highly committed to developing of the careers of young scientists and has been an avid trainer, advisor, and advocate for students, fellows and junior faculty.
Corona: A new INO-4800 vaccine is being worked on in RH’s Bovenau
Status: 10.03.2021 8:00 a.m.
In the middle of the countryside in Schleswig-Holstein, a north German company is producing a new type of corona vaccine for a US pharmaceutical giant. Both companies hope for approval by the end of the year.
by Christian Wolf
On the trip to the Richter-Helm Biologics company in Bovenau (Rendsburg-Eckernförde district), guests pass fields, cows and small forests. Probably very few visitors get the idea that the most modern technology is being used in an inconspicuous building complex - and that a new type of corona vaccine is being worked on. This is supposed to make the human body immune to the corona virus. Unlike other providers who, for example, administer an mRNA vaccine, Richter-Helm Biologics works with pDNA, plasmid DNA. This contains information on how the human body can produce its own mRNA.
Infectiologist Rupp: DNA vaccines are more stable and robust
The new active ingredient from Bovenau is exciting and promising for Professor Jan Rupp, Director of the Clinic for Infectious Diseases and Microbiology at the UKSH location in Lübeck. The doctor also makes it clear: "As with any technology, there will always be advantages and disadvantages. That has to do with the effectiveness of the vaccination, but also with side effects." At the same time, he also makes it clear that it is important to have a practical and stable vaccine: "One expects a lot from the DNA vaccines because they are more stable and robust. And we want to get the vaccines as quickly as possible vaccinated by general practitioners like any other vaccine. " The mRNA vaccine must be stored very cold and should only be stable for 60 days. None of this is the case with the Bovenau DNA vaccine.Handling is therefore correspondingly easier.
Possibly a new type of vaccination
The way of vaccination is also completely new. The US pharmaceutical company Inovio has developed a kind of pistol for its drug that uses electricity to transfer the plasmid into a skin cell. The electric field creates small pores in the skin cell, which allows the plasmid to penetrate. "That is the most exciting thing about this vaccine," explains Professor Jan Rupp. "The DNA is then read and enables the body to produce antigens, which in the end protects us from the virus." People shouldn't feel the transmission, just a tingling sensation, explains Kai Pohlmeyer, managing director of the bio-tech company from Bovenau: "In addition, there are no more stings or cuts during the vaccination."
Difference between mRNA and pDNA
The corona virus uses mRNA to spread in the human body. In the vaccines approved so far, artificial mRNA is injected. This is taken up by the cells, whereby antigens are produced. When infected with the virus, they prevent it from making people sick. With the DNA vaccine, on the other hand, the body receives information on how it produces its own mRNA. This then immunizes in the same way as the previously approved products. Basically, mRNA and pDNA work the same, just have a different way of producing the antigens.
No approval for DNA vaccines yet
However, there are still some hurdles to overcome. Because so far only phase II has been completed on the way to approval. In this phase, the dosage of the vaccine is adjusted and the tolerance and immune reaction are tested. "Phase III should begin in the second quarter. We expect approval for the end of the year," continues the managing director of Richter-Helm-Biologics. It would be a breakthrough. Because pDNA vaccinations are not yet approved worldwide.
So far only animals can be vaccinated in this way. The basic research comes from the USA from the pharmaceutical company. The active ingredient is cultivated and propagated in Bovenau. This happens in a fermenter, which is located in a clean room. Even the smallest contamination must be prevented in the clean room. "Under certain conditions, the plasmid is multiplied here and then harvested later. It is then cleaned under the strictest hygiene regulations," says Kai Pohlmeyer
A lot of effort for the vaccine
In Bovenau they put a lot of effort into producing the vaccine. For example, water for injection purposes (WFI) is produced in the plant's basement. 4,000 liters are constantly in a ring line at 83 degrees so that no germs or the like can form. An incredible amount of material is also required in the manufacture of vaccines. One ton of various substances such as glycerine, potassium, ammonium sulfate and acetate result in 150 grams of active ingredient. There are also around 10,000 liters of WFI. The finished vaccine is then filled into 20 liter bags and sent to the pharmaceutical company. This then ensures that it comes in syringes, for example.
Growth in Bovenau
With the outbreak of the corona pandemic, the global demand for bio-tech has meanwhile become insatiable. According to their own statements, the manufacturer from Bovenau occupies one of the top places. "We will triple our capacities here at the site. The groundbreaking ceremony will take place next month," explains Managing Director Kai Pohlmeyer. Production is to start in the new buildings in three years. Richter-Helm-Biologics is investing a two-digit million sum for this and wants to almost double the number of employees in Bovenau from the current 100. Perhaps the new active ingredient in the fight against the corona pandemic will then also be manufactured here.
https://vbsyeeipvxomalu46s3ocyeiqm-adwhj77lcyoafdy-www-ndr-de.translate.goog/nachrichten/schleswig-holstein/Corona-In-Bovenau-wird-an-einem-neuen-Impfstoff-gearbeitet,bovenau124.html
Based on 7 analysts offering 12 mo. price targets for Ino in the last 3 mos. The avg price target is $17.17 with a high forecast of $35.00 and a low forecast of $7.00. The average price target represents a 62.44% increase from the last price of $10.57. From TipRanks.
Top 10 Owners of Inovio Pharmaceuticals Inc
Stockholder Stake Shares
owned Total value ($) Shares
bought / sold Total
change
BlackRock Fund Advisors 5.72% 11,855,887 131,600,346 +448,210 +3.93%
SSgA Funds Management, Inc. 4.29% 8,894,555 98,729,561 +893,135 +11.16%
The Vanguard Group, Inc. 4.19% 8,684,511 96,398,072 -192,259 -2.17%
Wasatch Advisors, Inc. 1.90% 3,939,018 43,723,100 +556,017 +16.44%
Coatue Management LLC 1.73% 3,576,923 39,703,845 0 0.00%
Geode Capital Management LLC 1.22% 2,524,403 28,020,873 +128,954 +5.38%
Northern Trust Investments, Inc.(... 0.92% 1,903,696 21,131,026 -12,525 -0.65%
Norges Bank Investment Management 0.73% 1,517,269 16,841,686 +1,517,269 --
Charles Schwab Investment Managem... 0.53% 1,095,477 12,159,795 +19,369 +1.80%
JPMorgan Asset Management (UK) Lt... 0.49% 1,023,275 11,358,353 +452,977 +79.43%
“Norway is proud to be a founding member of CEPI. With the pandemic, CEPI is more important than ever. Ensuring access to vaccines for all is a necessity, not a luxury. As the emergence of new variants tells us: No one is safe before everyone is safe. The mutations underline the need for a continued investment in vaccine development.
Norway will continue to mobilize around CEPI and other much-needed building blocks in global health. If anything, the pandemic has reminded all of us that we need better preparedness and response. We have focused on this agenda for a long time. This is not the time to give up. You can count on Norway’s continued support.”
Erna Solberg
Prime Minister of Norway
Norges bank investment management
Invested globally outside Norway
The fund is the largest single owner in the world’s stock markets. and is broadly invested across countries, sectors and currencies. It holds shares, bonds and real estate all around the world, but invests only abroad so that the Norwegian economy does not overheat.
3/11 Qiu Si-nian said that VGX-3100 is the project that Dongfang has put in the most energy for a long time. "Now that China has also entered clinical phase III trials, we will quickly promote it and strive to be listed simultaneously with the United States."
As the world's fastest-growing DNA therapy, VGX-3100 is expected to become the world's first DNA drug. It is worth noting that as early as 2017, Dongfang Strategy obtained the exclusive development, production and commercialization rights of VGX-3100 in Greater China through the form of license-in at a total transaction price of 43 million US dollars.
The first phase III trial obtained positive results. While further confirming the concept of DNA medicine, it also greatly improved the success rate of VGX-3100 through the entire clinical trial. Qiu Si Nian, chairman of Dongfang Lv, said that the REVEAL 1 trial will continue for an 18-month safety and durable response rate, which will not be too long from the end of the ongoing Phase III REVEAL 2 trial. If all goes well, VGX-3100 will submit a listing application within two years.
If it is successfully marketed, VGX-3100 will achieve two firsts: the world's first DNA therapy drug and the world's first cervical precancerous lesion therapy drug.
https://av3w77yuysrmn6a5zvysoziqgi-adwhj77lcyoafdy-xueqiu-com.translate.goog/3483303916/174179856
World Health Organization data shows that cervical cancer is the second most common cancer among women in developing countries, and HPV virus is the main cause of cervical cancer. High-risk HPV can cause precancerous lesions in the genital tract, anus, oral cavity and other parts. Without medical intervention, it may progress to cancer. Studies have shown that more than 90% of cervical cancers are related to HPV infection, among which high-risk HPV16 and HPV18 are the most prominent, causing 70%-80% of cervical cancers. Some people with HPV infection will develop precancerous lesions or cervical cancer within a few years.
In 2006, the FDA approved the world's first preventive vaccine for cervical cancer, and the HPV vaccine did not enter China until ten years later. Because the HPV vaccine immune response is closely related to age, WHO recommends girls between 9 and 14 years old as the primary vaccinations. Hundreds of millions of women in China have missed the optimal age for vaccination.
According to statistics, there are millions of new patients with cervical precancerous lesions in China each year, and the number of patients currently exceeds 10 million. However, there is no therapeutic drug for cervical precancerous lesions worldwide, and surgical resection is the only treatment. However, surgical treatment is not only accompanied by risks such as pain, bleeding, and infection, but also cannot completely eliminate the HPV virus, so there is a certain risk of recurrence.
Qiu Si-nian said that unlike HPV preventive vaccines for healthy people, VGX-3100 as a DNA drug targets people who have been infected with HPV virus and have precancerous lesions, and there is no age limit. Compared with surgical resection, VGX-3100 only requires three injections, which is convenient, safe and effective.
Congress-passes-American-Rescue-Plan/with-$500M-for-FDA’s-COVID-19-activities,$78B-for-vaccines, testing and surveillance
BY STEVE USDIN, WASHINGTON EDITOR
MAR 10, 2021 | 1:01 PM PST
UPDATED ON MAR 10, 2021 AT 4:20 PM PST
The American Rescue Plan, passed Wednesday by the House of Representatives, includes $500 million for FDA’s COVID-19 activities and billions of dollars to support acquisition and deployment of vaccines, therapies and tests. President Joe Biden is expected to sign the legislation into law on Friday.
The legislation will give FDA a great deal of discretion to allocate the funding bolus. Allowable uses include evaluating the “continued performance, safety, and effectiveness, including with respect to emerging COVID–19 variants, of vaccines, therapeutics, and diagnostics approved, cleared, licensed, or authorized” for COVID–19, as well as evaluating advanced continuous manufacturing activities related to vaccine production.
Congress specified that FDA can use the funding to review devices authorized to treat, prevent, or diagnose COVID–19. The funding is needed in part because emergency use authorizations have been to rapidly deploy COVID-19 countermeasures and there are no user fees associated with EUAs.
The agency is also permitted to use the funds to conduct of inspections of medical product manufacturing facilities that were delayed or canceled for reasons related to COVID.
Other uses specified in the bill include oversight of the supply chain and mitigation of shortages of vaccines, therapeutics and devices for COVID-19.
Beyond FDA, the bill provides $6 billion for COVID-19 medical countermeasures R&D, manufacturing and acquisitions.
It allocates $1.8 billion for genomic sequencing and surveillance.
The law also funds the establishment and operation of a disease warning system and forecasting system aimed both at tracking COVID-19 and ongoing surveillance of emerging biological threats worldwide.
Another $10 billion will go for the purchase, production (including the construction, repair and retrofitting of government or private manufacturing facilities), and distribution of medical supplies related to combating the pandemic.
$47.8 billion to improve the detection, diagnoses, tracing and monitoring of Covid;
$7.5 billion to promote, distribute, administer, monitor and track Covid vaccines;
$1.75 billion to strengthen and expand activities and the workforce related to genomic sequencing, analytics and disease surveillance;
$1 billion to strengthen vaccine confidence;
$750 million for the CDC to work outside the US to combat Covid and other emerging infectious disease threats;
$500 million to modernize the CDC’s public health data surveillance and analytics infrastructure.
https://www.biocentury.com/article/634897/congress-passes-american-rescue-plan-with-500m-for-fda-s-covid-19-activities
1. NIH is funding Therapeutic Vaccination in Treated HIV Disease P2, 56 ppl
Finished enrollment 2/12/21
Biological: PENNVAX-GPBiological: INO-6145Biological: INO-9012Device: CELLECTRA 2000
Collaborators:
National Institute of Allergy and Infectious Diseases (NIAID)
University of California, Los Angeles
Inovio Pharmaceuticals
Info provided by (Responsible Party):Steven Deeks, University of California, San Francisco
2. Inovio Received NIH Funding to Target its dMAb® Technology Against Antimicrobial-Resistant Infection
3. Inovio Received NIH Grant To Evaluate HIV Immunotherapy Ability To End Lifetime Of Drug Therapy
4. NIH COVID-19 grant Ino applied for: Emergency Awards: Notice of Special Interest (NOSI) on Pan-Coronavirus Vaccine Development Program Projects
https://grants.nih.gov/grants/guide/COVID-Related.cfm
Release Date:
November 10, 2020
First Available Due Date:
January 11, 2021
Expiration Date:
June 12, 2021
3/2/21 Sch 13F/A Central Bank of Norway owns over 1.5 M shares of INO. Speaking at our $3.5bn launch event today, Prime Minister of Norway and CEPI founder @erna_solberg shared her support for our ambitious plans
“Norway is proud to be a founding member of CEPI. With the pandemic, CEPI is more important than ever. Ensuring access to vaccines for all is a necessity, not a luxury. As the emergence of new variants tells us: No one is safe before everyone is safe. The mutations underline the need for a continued investment in vaccine development.
Norway will continue to mobilize around CEPI and other much-needed building blocks in global health. If anything, the pandemic has reminded all of us that we need better preparedness and response. We have focused on this agenda for a long time. This is not the time to give up. You can count on Norway’s continued support.”
Erna Solberg
Prime Minister of Norway
Dr. Stanley Plotkin, Ino Scientific Advisory Board and CEPI SAC voting member
Some CEPI Scientific Advisory SAC voting members friendly to Ino.
Delese Mimi Darko Ghana Food and Drug Authority
Xiaoping Chinese Center for Disease Control and Prevention
Helen ReesWits Reproductive Health and HIV Institute (Chair of CEPI Scientific Advisory Committee)
Paula Bryant US National Institutes of Health
Penny Heaton Bill & Melinda Gates Medical Research Institute
Ralf Clemens Independent Consultant (also for Bill & Melinda Gates Foundation)
With $3.5B CEPI will: $0.78B Pan-CV, $1.1B Chikungunya, Ebola, Lassa fever, MERS, Nipah, Rift Valley Fever, $1.37B Disease X: Creation of a “library of vaccines”, manufacturing innovations, $0.2B Manufacturing network,
Global research network
Innovations that will be support by CEPI
Prepare
$0.78B
Covid-19: Development of second wave candidates and accelerated COVID-19 research for the development of a broadly protective vaccine against beta-coronaviruses
$1.1B
Chikungunya: A licensed vaccine with WHO prequalification
Ebola: Completed clinical trial programme for a vaccine candidate
Lassa Fever: A licensed vaccine based on field efficacy trial for routine immunisation
MERS: Development of a vaccine stockpile for control of regional outbreaks and consolidation of MERS R&D into wider coronavirus portfolio
Nipah: A licensed vaccine or prophylactic monoclonal antibody
Rift Valley Fever: Completion of preclinical proof-of-concept testing
Transform
$1.37B
Disease X: Creation of a “library of vaccines” targeting different virus families and developing those vaccines through phase 1, using rapid response platforms that will allow adaptation in the event related viruses emerge
Manufacturing Innovations: Development of manufacturing innovations that can accelerate epidemic and pandemic responses or enable the scaling of production of vaccines and other biological countermeasures, particularly in LMIC settings.
Connect
$0.2B
Manufacturing network: Strategic alliances with key manufacturers and coordinated investments in increasing global manufacturing capacity
Global research network: Establish global networks for lab capacity, assays, and animal models that are critical for rapid vaccine development
A strong post-pandemic global coalition: CEPI will connect countries at all levels of development, industry, public and private sectors, and global health partners to develop vaccines and build commitment to preparedness and equitable access.
https://cepi.net/wp-content/uploads/2021/03/CEPI_3.5_billion_investment_case_10032021.pdf
3/8 Prostate Cancer Cohort C: CDX-301 + INO-5151 + Nivolumab, 45 ppl
Oregon Health & Science University
[Completed]
Portland, Oregon, United States, 97239
This study is designed to evaluate multiple clinical hypotheses and mechanistically-defined combinations to evaluate the safety and efficacy of immunotherapy combinations in participants with mCRPC who have received prior secondary androgen receptor signaling inhibitor therapy (eg, abiraterone, enzalutamide, apalutamide).
Collaborators: Bristol-Myers Squibb
Celldex Therapeutics
Cancer Research Institute, New York City
Inovio Pharmaceuticals
Oncovir, Inc.
https://www.clinicaltrials.gov/ct2/history/NCT03835533?A=12&B=13&C=merged#StudyPageTop
3/9 Inovio sees opportunity for a 'pan-variant' COVID vaccine
By: Derek Staahl
Posted at 6:20 PM, Mar 09, 2021 and last updated 6:22 PM, Mar 09, 2021
SAN DIEGO (KGTV) -- Early in the race for a COVID vaccine, a small drugmaker with ties to San Diego was getting a lot of attention. Then Inovio Pharmaceuticals had a setback.
In September, the Food and Drug Administration put the clinical trials of the company’s investigational DNA vaccine on hold. Inovio’s vaccine has still not undergone a large-scale Phase 3 trial with thousands of volunteers.
So does that mean the race is over for Inovio in the U.S.? President Joe Biden announced the country is on pace to have enough COVID-19 vaccines for every American adult by the end of May using supplies from Pfizer, Moderna and Johnson & Johnson.
Don’t count Inovio out yet, said Dr. Kate Broderick, who leads the company’s COVID-19 vaccine development from its San Diego office.
“Unfortunately, the virus is doing exactly what a virus does, which is mutate and change,” she said. “And so I think there might well be room for new vaccines, what we call next-generation vaccines, that are specifically tailored to these new strains of the virus.”
Inovio is already developing a next-generation vaccine with the help of artificial intelligence that it hopes can target multiple variants -- ones we know about now, and ones we don’t. By combining bits of genetic code from multiple variants and using predictive AI, the company hopes to create what it’s calling a “pan-variant vaccine.”
The Pennsylvania-based company is also hoping its originally formulated vaccine can be a major player on the world stage. The DNA-based vaccine does not require ultra-cold storage freezers that mRNA-based vaccines do.
Inovio signed an agreement with a Chinese drug manufacturer in January and is also pursuing trials in that country.
“I feel very confident that Inovio’s vaccines, be it our original vaccine or our potential pan-variant vaccine, is going to have a huge impact globally,” Dr. Broderick said.
But to have an impact, Inovio will first have to complete clinical trials. The FDA paused Inovio’s trials in September because of questions about its proprietary delivery device.
Instead of a needle and syringe, Inovio uses a AA battery-powered device that looks like an electric toothbrush to introduce tiny circles of DNA into cells. (DNA vaccines have been undergoing testing for decades, and no, they cannot modify your chromosomal DNA, Broderick says.)
Broderick said the FDA’s questions were related to the use of the device, not its safety.
Regulators allowed Inovio to move forward with a Phase 2 trial in November. The company plans to announce data from that trial next month.
The FDA will have to sign off before Inovio advances to the final, Phase 3 clinical stage. The company is hoping to begin those trials in the second quarter.
That means by the time Inovio finishes the required testing, the U.S. will likely already have enough doses for every American. The FDA requires a median of two months of follow-up after volunteers are vaccinated, then data must be analyzed and submitted for regulatory review.
However, Dr. Broderick is thinking about a longer timeline.
“I think we should maybe all be trying to wrap our heads around the fact that COVID is here to stay, potentially, and that we should view it more like the flu,” she said.
Broderick thinks the virus will become endemic, meaning we might need seasonal shots every year or so. And she says Inovio will be ready.
“I think, unfortunately, COVID-19 is not going anywhere. And we're going to need a lot of different types of vaccines,” she said.
JK, PK, LH exercised RSU and hold. Read the fine print - all 4 of them sold some and increased their direct ownership of shares. All four sold what was required for tax withholding purposes.
$INO
?? SEC Form 4: Joseph Jong Kim exercised 183,800 units of Common Stock at a strike of $0.00 and disposed of $893,811 worth of Common Stock (98,297 units at $9.09), increasing direct ownership by 8% to 1,163,816 units
?? SEC Form 4: Peter Kies exercised 49,033 units of Common Stock at a strike of $0.00 and disposed of $234,511 worth of Common Stock (25,862 units at $9.07), increasing direct ownership by 19% to 142,461 units
$INO
?? SEC Form 4: Laurent Humeau exercised 47,466 units of Common Stock at a strike of $0.00 and disposed of $149,837 worth of Common Stock (16,514 units at $9.07), increasing direct ownership by 126% to 55,452 units
NIH COVID-19 grants Ino applied for. Emergency Awards: Notice of Special Interest (NOSI) on Pan-Coronavirus Vaccine Development Program Projects
https://grants.nih.gov/grants/guide/COVID-Related.cfm
Release Date:
November 10, 2020
First Available Due Date:
January 11, 2021
Expiration Date:
June 12, 2021
https://grants.nih.gov/grants/guide/notice-files/NOT-AI-21-002.html
3/5 REVEAL2 3 Brazil, 3 US sites finished recruiting, 2 US sites completed study
Unified Women's Clinical Research - Greensboro finished recruiting [Active, not recruiting]
Greensboro, North Carolina, United States, 27408
New Jersey Medical School
[Active, not recruiting]
Newark, New Jersey, United States, 07103
Augusta University
[Active, not recruiting]
Augusta, Georgia, United States, 30912
Brazil, Bahia
Associação Obras Sociais Irmã Dulce Hospital Santo Antônio
[Active, not recruiting]
Salvador, Bahia, Brazil, 40420-000
Brazil, Goiás
Hospital das Clinicas de Goiânia
[Active, not recruiting]
Goiânia, Goiás, Brazil, 74605-050
Brazil, Paraná
Hospital Erasto Gaertner
[Active, not recruiting]
2 US sites completed REVEAL2 study
Unified Women's Clinical Research - Hagerstown
[Completed]
Hagerstown, Maryland, United States, 21740
Unified Women's Clinical Research - Morehead City
[Completed]
Morehead City, North Carolina, United States, 28557
https://clinicaltrials.gov/ct2/history/NCT03721978?A=27&B=28&C=merged#StudyPageTop
3/9 Search for 'universal' coronavirus vaccine heats up with major “nine-figure” CEPI cash funding injection. There have been three major new coronavirus threats in recent years - developing a broadly protective vaccine is urgent, say scientists
Jennifer Rigby, Global Health Security Correspondent
9 MARCH 2021 • 12:13 PM
The hunt for a vaccine that protects against all Covid-19 variants as well as other coronaviruses is set to heat up with “nine-figure” funding injection, The Telegraph can reveal.
Around 20 teams around the world are at the early stages of developing vaccines that offer broader protection against a range of coronaviruses, from Covid-19 to Sars. So-called universal vaccines of this type have long been a holy grail in the fight against infectious diseases, such as flu, and could be important not just for this pandemic but for heading off future threats.
Now the Coalition for Epidemic Preparedness Innovations (Cepi), a key player in the development of Covid-19 vaccines, is set to announce a “call for proposals” for researchers working on universal coronavirus vaccines, with hundreds of millions of dollars of funding available.
Dr Richard Hatchett, chief executive of Cepi, told The Telegraph: “This is the third coronavirus in the 21st century, and that ought to be the hair-on-fire urgency to take coronavirus off the table.
“So in the next couple of weeks we’ll be announcing a very significant investment in developing broadly protecting or even universal coronavirus vaccine.”
However, he stressed that there was a lot of work to be done before any vaccines of this type are likely to be available. For example, scientists have been trying to develop a universal flu vaccine for decades, without success.
One of the key sticking points is making sure that any vaccine against different viruses from the same family generates a strong enough immune response to each in order to protect against infection.
However, Dr Hatchett said the progress made so far in developing vaccines for Covid-19 was an “encouraging” sign.
A number of teams, including the cancer company Scancell and scientists from the University of Nottingham, have showed promising early results in animal testing of their vaccine candidates, which have the potential to offer broader protection because of how they are designed.
“The question is, can we find that Achilles heel across the whole family that would be something that we could target, that is conserved, and important, in a way that we could leverage,” said Dr Hatchett.
“There is a lot of work to be done.”
As well as antibodies, the body’s T-cell response is also increasingly thought to be important and targetable for coronavirus vaccines.
Other vaccine candidates in development target different parts of the immune system depending on how they are administered: for example, nasal spray vaccines.
Cepi is funded by governments and global philanthropic organisations, including the Bill and Melinda Gates Foundation and the Wellcome Trust. The organisation is set to outline its priorities for the next five years, including how to prevent the next pandemic, at a high-profile event on Wednesday this week.
https://www.telegraph.co.uk/global-health/science-and-disease/search-universal-coronavirus-vaccine-heats-major-cash-injection/
Dr. Kate Broderick speaks at Sachs Meeting March 9, 2021
https://www.reddit.com/r/Inovio/comments/m1gdnv/dr_broderick_at_sachs_meeting_march_9_2021/?utm_source=share&utm_medium=ios_app&utm_name=iossmf
seasonal booster for endemic, jury is out on current vaccine against new mutants, no cold store required, correlation of protection of Pan-Covid vaccine.
COVID-19 Vaccine Combos Aim to Boost Immunity. Mix-and-match shots could simplify vaccine rollout and stimulate more-robust immune responses. Ongoing clinical trials will soon give answers.
https://www.the-scientist.com/news-opinion/covid-19-vaccine-combos-aim-to-boost-immunity-68529
A robust immune response involves not only virus-neutralizing antibodies but also helper T cells, which boost antibody production, and cytotoxic T cells, which clear away infected cells. T cells are therefore likely to be important for long-lasting immunity, and two non-peer reviewed studies suggest that they are better than antibodies at thwarting SARS-CoV-2 variants in vitro.
Previous studies on other diseases have found that while some vaccine formats are better at inducing antibodies, others do a better job at stimulating T cell production. DNA and mRNA vaccines provoke the body to produce the antigen itself, a process that activates T cells and facilitates the production of antibody-producing B cells, explains Lu. In contrast, “protein vaccines or inactivated vaccines don’t involve T cells very much because the antigen isn’t actually produced inside the body,”
If you alternate between platforms, it turns out you can get more than the sum of the two.
—Wolfgang Leitner, National Institute of Allergy and Infectious Diseases
Other heterologous prime boost strategies have paired two different vaccine formats. In Lu’s work on HIV vaccines, he and his colleagues found that a prime shot of a circular piece of viral DNA followed by a boost of recombinant protein induced better immune responses than either shot alone or in the reverse order. Phase 3 trials of this vaccine are currently underway.
“The order matters,” says Lu. “We found that DNA first, protein after is better than protein first, DNA after. You cannot reverse that.” DNA vaccines for other diseases, when used alone, have failed to confer strong immunity. This may be because, unlike protein-based or adenovirus vector vaccines, DNA vaccines don’t induce the production of enough antigen to stimulate high antibody titers, a reason why DNA may be better suited as the prime shot.
Yet heterologous prime boost vaccinations for different diseases have occasionally reversed this order. And studies have found other combinations, such as an adenovirus vector with a protein subunit vaccine, can produce promising results. “It is virtually impossible to make predictions of which combination in which order is going to be the best,” says Leitner.
Another strategy is the codelivery of different vaccine formats in the same shot, Lu says. In a study published on March 1 in Emerging Microbes & Infections, he and his colleagues describe a novel COVID-19 vaccine that delivers DNA encoding the SARS-CoV-2 spike protein as part of a larger piece of circular DNA called a plasmid, and the recombinant spike protein itself in a single shot. In monkeys, the injection induced strong antibody and T cell responses and completely prevented infection when they were exposed to the coronavirus. Several other DNA-based COVID-19 vaccines are in clinical trials.
3/9 Meeting discusses COVID-19 vaccine manufacturing bottlenecks that must be urgently tackled for COVID-19 vaccine output to reach its full potential
https://cepi.net/news_cepi/meeting-discusses-covid-19-vaccine-manufacturing-bottlenecks-that-must-be-urgently-tackled-for-covid-19-vaccine-output-to-reach-its-full-potential/
9 March 2021: Chatham House, in collaboration with COVAX, IFPMA, DVCMN, and BIO, convened a Global COVID-19 Vaccine Supply Chain & Manufacturing Summit on 8th and 9th March. The unprecedented scaling up of vaccine manufacturing, from zero to billions of doses in record time, has led to shortages that are impacting the entire vaccine supply chain. Open dialogue among manufacturers, suppliers, international organizations and governments is urgently needed to address these shortages so that they do not interrupt vaccine manufacturing. The meeting aimed to kick start the dialogue to identify, understand, and discuss potential solutions for these supply chain challenges. Held under the Chatham House Rule, the meeting provided the opportunity for frank, open and problem-solving discussions while respecting anti-trust rules.
A discussion document was prepared to help inform participants, giving an overview of the current landscape of COVID-19 vaccine manufacturing and emerging supply chain challenges. Vaccine manufacturers, and suppliers of vaccine components, are part of a global supply chain that is scaling up from zero to billions of doses in record time and tripling previous annual vaccine output. As founding partners of COVAX, vaccine manufacturers are playing their part in achieving fair and equitable access to vaccines.
“ Let’s put the current challenge in perspective: pre-Covid-19 global vaccine manufacturing capacity was 3.5 bn doses per year, 5bn if you include seasonal flu shots. This year for Covid-19 vaccines alone, manufacturers have scaled up new capacity from zero to 10bn. Doubling world vaccine capacity of what is a very complex process in a matter of months; thanks to unprecedented industry commitment and collaboration. We should not be surprised if there are bumps along the road, in the manufacturing process itself as well as strains on the whole supply chain; starting with hundreds of raw materials needed to make vaccines.”
Thomas Cueni
Director General of the International Federation of Pharmaceutical Manufacturers (IFPMA)
https://cepi.net/wp-content/uploads/2021/03/Landscape_of_current_C19_supply_chain_manufacturing_capacity.pdf
pg 8, Key insights
? Global demand for COVID-19 vaccines could range from ~10-14 billion doses in 2021 depending on the final aspired coverage rate, need for re-vaccination and boosters. There is currently large geographic variability in announced deals and demand. Estimates of the percentage of the population required to meet herd immunity vary, but a working estimate is 70%, or about 5.5 billion people worldwide, thus requiring 11 billion doses of a two-dose regimen (subject to change if new variants are more transmissible).
? Manufacturers have announced a supply target of up to 14 billion doses – this would triple previous annual vaccine output.
? The degree to which disparities between supply and demand will continue depends on future developments, including approval of late-stage candidates, optimisation and ramp-up of manufacturing processes in line with plans, input supply challenges (e.g. bioreactor bags, filters), and the impact of variants
Pg 10, Supply:
Success of pivoting to new vaccines, if required: when new variants/mutations emerge, there is a risk that some platforms and/or vaccines could show reduced effectiveness. This will affect supply capacity in two ways: first, there is de facto less supply. If more variants of concern emerge (for which vaccines would need to be adapted), the existing vaccine manufacturing capacity might need to be split towards each relevant strain. Second, it takes time to adjust vaccines for new variants. While production of prior versions of the vaccine can likely continue during the majority of the adjustment process, it will take months or years (depending on the tech platform) until capacity for vaccines efficacious for the new variant is ramped-up. For example more than 50% of supplies are likely to need 6-12 months or more to adjust for new variants. Further details can be found in Annex 4.
Pg 20, Deep-Dive on Fill-and-Finish
Fill-and-finish capacity is needed for all COVID-19 vaccines, and beyond that for many other vaccines (i.e. all that come in vials) and health products, such as biologics. While there are no accurate estimates of worldwide fill-and-finish capacity, it could be well over 10 billion vials, according to industry observers. This includes pre-existing capacity for the production of vaccines (likely to have been 3.5-5.5 billion doses annually pre-COVID-19), biologics, and other health products, new capacity brought online since the outset of the pandemic, and potential excess capacity in the system.
The available capacity to meet the 2.8 billion or less required vial-capacity* for COVID-19 vaccines and potential repercussion for the production of other health products is currently largely unknown. Assuming five doses per vial (although there are vaccines with over 20 doses per vial), around 2.8 billion vials fill-and-finish capacity would be needed to meet the 2021 announced supply target of up to 14 billion doses, potentially even less†. The available capacity for these 2.8 billion vials, and repercussions on other health products requiring fill- and-finish, depends, among other considerations, on the assumption of doses per vial and according to implications on productivity (e.g. due to slower filling times), newly built capacity, and repurposing. The latter repurposing potential depends predominantly on potential needs for requalification, retooling, and reengineering needs for production lines, implications of productivity (e.g. because of longer filling times), and the potential to leverage fill-and-finish capacity beyond other vaccines e.g. from animal health products. Moreover, biosafety requirements (e.g. BSL-2 for viral vector or BSL-3 for inactivated virus) of the filling lines need to be put into consideration.
China pushes on with vaccine efforts: A DNA-based vaccine that Inovio and the International Vaccine Institute are working on with a Chinese partner, Advaccine Biopharmaceuticals Suzhou Co. Ltd. It is currently in phase II/III trials.
With an array of late-stage vaccines in its arsenal, China has already exported its candidates beyond its borders and will continue to do so through partnerships. In October 2020, China signed an agreement with Gavi, an international vaccine alliance, to officially join the global vaccine initiative known as COVAX, led by the WHO.
As a gesture to show its participation and accommodate the interests of other countries, China also plans to purchase COVID-19 vaccines for 1% of its population, about 15 million people, through the COVAX initiative. A foreign ministry spokeswoman reasoned that a larger order could lead to a shortages of a first batch of vaccines.
https://www.bioworld.com/articles/503942-china-pushes-on-with-vaccine-efforts-with-16-candidates-approved-for-trials
Bullish Analyst, Fund Stake Prop Up Stock: Oppenheimer analyst Hartaj Singh initiated coverage of Inovio shares with an Outperform rating and $35 price target in a Thursday note.
Although current mRNA vaccines have set a high efficacy bar in Phase 3 settings, INO-4800 has a differentiated profile, with a better safety and tolerability profile; longer shelf-life and easier storage; and potential flexibility to adjust for mutations and boosting, the analyst said.
Inovio's deep expertise and decades-long history in DNA science, he said, could bring the company to the "finish line" soon, in a fashion similar to mRNA-based vaccines.
Singh is also left impressed with the rest of Inovio's pipeline and its execution over the last 12 months.
The analyst highlighted Inovio's unique cancer vaccine candidate INO-5401.
It has intriguing early-stage efficacy in a hard-to-treat cancer, namely glioblastoma, and an HPV-targeted DNA vaccine candidate, codenamed VGX-3100, has a Phase 3 readout scheduled for the first half of 2021 in high-grade cervical dysplasia, Singh said.
Inovio's stock is set up well, with value-driving catalysts approaching, according to Oppenheimer.
"In our view, INO-4800 could potentially make INO break-even in 2022, and its newsflow could 'turbo-charge' the platform value growth."
Separately, 13G filings done in the the last two days showed that State Street Corp had 8.895 million shares in Inovio, giving it a 5.25% stake.
Vanguard Group held about 9.186 million shares, or a 5.42% stake, and Wasatch Advisors beneficially owned 3.93 million shares, or a 2.3% stake in the company.
The Invoio Stock Trajectory: Inovio shares peaked at $33.79 in late June 2020 amid progress in the company's vaccine program. The company began developing a DNA vaccine codenamed INO-4800 against the novel coronavirus in January 2020, with claims of having successfully developed the vaccine construct in three hours after receiving the genetic sequence from Chinese researchers.
Following successful preclinical testing, the company commenced a Phase 1 study in the U.S. in early April. It was followed up by the initiation of CEPI-funded Phase 1/2 study of the vaccine candidate in South Korea in early June.
The company announced positive interim readout from the U.S. Phase 1 study June 30, and the June 26 high was in anticipation of the readout.
The rally began to lose steam thereafter, and a partial clinical hold imposed by the FDA on the start of the Phase 2/3 study on Sept. 28 pressured the stock further. Inovio received the green light to proceed with the Phase 2 part of the trial in mid-November.
After trading at sub-$10 levels for much of January, the stock began gathering some momentum in February.
https://m.benzinga.com/article/19641651?utm_referrer=https%3A%2F%2Fnews.google.com&utm_source=https%3A%2F%2Fnews.google.com
“We also continue to monitor developments in the vaccine candidates of Inovio Pharmaceuticals and Arcturus Therapeutics to potentially include in the mix of vaccines for the Philippines,” he added.
Secretary Carlito Galvez Jr., chief implementer of the National Task Force Against COVID-19, earlier said that vaccines from Pfizer and Sinovac Biotech are expected to arrive in the country in February through the COVAX pool.
With regard to Sinovac, Galvez estimated that 1 million to 3 million vaccine doses would be available beginning February.
https://newsinfo.inquirer.net/1389960/56m-doses-expected-from-us-in-may-says-ph-envoy
3/8: Richard Hatchett, CEO of CEPI: call for March 2021 Pan-covid vaccine funding proposals
In terms of CEPI’s future, are you talking about the process of getting to next-generation Covid-19 vaccines?
Initially we were thinking about the next-generation vaccines as just offering attributes that you would want in vaccines for managing Covid for the long term. So, you know, low cost. Ideally in a single dose. Ease of administration might be factors. More thermal-stable products. But I think the introduction of the variants also forces us to think about multivalent vaccines [meaning they would protect against several strains of the virus] or vaccines that can be easily turned from one strain to another if we get into that kind of a dynamic.
Flu vaccines have to be updated virtually annually, and their efficacy is far from ideal. It would be such a missed opportunity if the world follows that paradigm again and then never comes up with a pan-coronavirus vaccine. Wouldn’t it be better to not follow the flu path if we didn’t need to?
The answer is yes. And I think you will be pleased to hear that we are very shortly going to be putting out a call for proposals around … we’re calling them fully protective betacoronavirus vaccines, which seem to be the main threat. [Both SARS-1, which caused a less widespread outbreak in 2003, and SARS-CoV-2, which causes Covid, are betacoronaviruses.]
There’s been quite a buzz about that recently. Our timing seems to have been good. I mean, we’ve been working on gearing this initiative up for some time and didn’t know that all these efforts were going to be attracting the attention that they’ve attracted in the last month or so. But there are at least 20 groups around the world that are trying to move in that direction. And we’re going to be putting out a major initiative, and hopefully by the end of this month, actually.
A number of wealthy countries have locked up a lot of vaccine doses — more than they’ll actually need for their populations. Is this getting in the way of the rest of the world accessing vaccine? Should countries like the U.S. be saying to some of the manufacturers: We’re not going to need that order. You can sell it to somebody else or we’re donating it to COVAX.
And the third argument that has entered the discussions — and I think, somewhat to my surprise actually, seems to be the most impactful — is the argument from biology that the virus is out there mutating. And it may be that your huge investment in vaccine is completely upended by variants that evade the immunity that the vaccine provides. And there’s been a real sea change, with G7 and other wealthy nations really realizing they do need to figure out how to end the pandemic.
https://www.statnews.com/2021/03/08/a-pandemic-expert-weighs-in-on-the-long-road-ahead-for-covid-19-vaccine-distribution/
NT Catalysts
* Booster result 2Q21
KB 3/1 “3rd booster with INO-4800 in 93 out of 120 subjects from our P1 clinical study. The subject received the booster doses 6 to 10 months post 2nd vaccination.
To date, the safety and tolerability data has been consistent with what we observed from our platform data and from our Phase 1 trial of INO-4800. We look forward to sharing the immune response data with you in the second quarter.”
* In active discussions with additional manufacturers to join the consortium.
brought on several contract manufacturers to produce global supply of single-use arrays which will be used both by the CELLECTRA 2000 and the CELLECTRA 3PSP.
* China INO-4800 Phase III initiation is imminent.
* FDA lift of their P3 hold and approval of the 3PSP CELLECTRA device which INO plans to commercialize for use with INO-4800 in May unleashing CEPI vaccine manufacturing scale-up funding.
* Result of testing the impact new strains have on the immunogenicity profile of 4800 through an assessment of neutralizing antibodies in both live and pseudovirus assays as well as assessing the impact of the generated T cell responses on these variants.
* NIH funds Ino Pan-Covid preclinical, P2 trials in US. CEPI funds the same ex-US.
* OWS funds Ino Pan-Covid vaccine and device manufacturing scale-up in US with additional $14B vaccine fund from $1.9T stimulus bill due to great NHP challenge result
* Will we learn more on South Korean trials?
KB 3/1/21 “ international vaccine Institute in South Korea is also in a Phase 2a segment of its Phase 1/2a trial of INO-4800. We expect that the data from these two trials will be available later this year.”
* More devices may be needed in China however, if they don't expand the geographic locations to meet the target population, as part of the trials, the current clinical sites with the CELLECTRA device should be adequate as CELLECTRA has been reported to be capable of producing 5,000 EP applications, per device.
* The DoD contact for 900 CELLECTRA devices was completed by the end of Q4/20. With 30 DSO per contract, DoD already paid the bill at Jan end. Rev will be booked 1Q21.
* Inovio is on track to announce the initiation of 3 drugs into phase III trials this year. RRP, AIN, VIN. Could we see another "Orphan Drug Designation"?
RRP already obtained ODD in 2020.
Prakash Bhuyan 3/1/21:
“We plan to seek P3 regulatory guidance on the pathway to develop VGX-3100 to treat HPV-driven Vulvar and Anal HSIL. We are also seeking orphan designations for these indications.”
* VGX-3100 REVEAL2 finished enrollment. QIAGEN finished biomarker to guide patient selection for cost-effective, non-invasive alternative to surgical removal of cervical lesions paving the way for commercialization, health insurance coverage. High Potential collaboration and licensing agreement.
* GBM / Regeneron. Glioblastoma continues to loom large as we wait for the median survival in the last cohort. Dr. Jeffrey Skolink's presentation on YouTube is eye popping. OS24, PFS due in early May. Monetize REGN w/ a collaboration and licensing agreement
* On January 30, 2021 we learned that INO is in play in the Philippines after they started talks with several US companies developing vaccines though the COVAX Facility Agreement.
if CEPI-funds-INO-Pan-Covid, can-INO-go-right-into-a-P3-in-Europe-where-Cellectra-is accepted?
You are quite astute about a better level playing field. C-2K had CE Mark for years, prestigious European medical device approval honored everywhere in the world except US where there are most COVID cases and deaths on earth.
With more than 3,000 patients receiving INOVIO investigational DNA medicines in more than 7,000 applications across a range of clinical trials, INOVIO has a strong track record of rapidly generating DNA medicine candidates with potential to meet urgent global health needs.
Yes, FDA device hold doesn’t apply ex-US. CEPI is widely respected in Europe. CEPI sponsored and funded trial would grease the skid for Fast Track Designation by EMEA and England medical authorities. No more knee on neck jujitsu - being cordial with another...
Some CEPI Scientific Advisory SAC voting members friendly to Ino.
Delese Mimi DarkoGhana Food and Drug Authority
XiaopingChinese Center for Disease Control and Prevention
Helen ReesWits Reproductive Health and HIV Institute (Chair of CEPI Scientific Advisory Committee)
Paula BryantUS National Institutes of Health
Penny HeatonBill & Melinda Gates Medical Research Institute
Ralf ClemensIndependent Consultant (also for Bill & Melinda Gates Foundation)
Dr. Stanley Plotkin, Ino Scientific Advisory Board and CEPI SAC
NIH is funding Therapeutic Vaccination in Treated HIV Disease P2, 56 ppl
Finished enrollment 2/12/21
Biological: PENNVAX-GPBiological: INO-6145Biological: INO-9012Device: CELLECTRA 2000
Collaborators:
National Institute of Allergy and Infectious Diseases (NIAID)
University of California, Los Angeles
Inovio Pharmaceuticals
Info provided by (Responsible Party):Steven Deeks, University of California, San Francisco
https://clinicaltrials.gov/ct2/history/NCT03606213?A=5&B=6&C=merged#StudyPageTop
Ino could get CEPI grant for Pan-COVID vaccine
https://cepi.net/news_cepi/going-universal-the-search-for-an-all-in-one-coronavirus-vaccine/
KB 3/1/21 “ we are also developing a next-generation pan-COVID vaccine candidate, using our proprietary AI-driven SynCon gene sequence algorithm to create a synthetic SARS-CoV-2 genetic design. The pan-COVID candidate is designed to provide protection against the U.K., South African, and Brazilian stream as well as potentially the currently unknown SARS-CoV-2 variant.
I should also note that the pan-COVID vaccine candidate is expected to share a similar safety and thermal stability profile to INO-4800.”
Ino-will-likely-receive-NIH’s NIAID-Funding-for-Program-Projects-To-Advance-Pan-Coronavirus-Vaccine-Candidates
we intend to fund collaborative, multidisciplinary P01 awards to discover, design, and develop pan-CoV vaccine candidates through Emergency Awards: Notice of Special Interest (NOSI) on Pan-Coronavirus Vaccine Development Program Projects
The NOSI has only two receipt dates: January 11, 2021, and June 11, 2021. We will accept resubmission (A1) applications in response to this NOSI.
NIAID is especially interested in program projects that accomplish the following:
Identification of broadly reactive B- and T-cell epitopes
Structural studies of CoV proteins related to designing novel, effective immunogens
Rational design of CoV immunogens to elicit broadly neutralizing, durable antibodies against multiple CoVs
Studies to understand the role of antigen-specific T-cell responses in immunity to CoVs, including strategies to induce T-cell immunity
Studies to identify correlates of protection against CoVs following natural infection or vaccination
Studies to understand vaccine-induced
responses across the lifespan, including investigation of age- or sex-related effects on vaccine efficacy
Studies to understand the impact of previous exposure to CoVs on subsequent vaccine responses
Studies to identify antigen/adjuvant combinations to induce potent and broad protection against multiple CoVs
Development of multi-valent and next-generation vaccine platforms/strategies to provide durable immunity to multiple CoVs, and that are suitable for use in vulnerable populations
Iterative studies and head-to-head comparisons of candidate vaccines in relevant preclinical models are encouraged to advance the most promising vaccine candidates
Strategies to direct protective immune responses to relevant tissues, such as mucosal sites
if your application proposes basic studies of COVID-19 immunology without targeted vaccine design and evaluation of vaccine candidates in preclinical models, NIAID will consider it nonresponsive to this NOSI.
https://grants.nih.gov/grants/guide/notice-files/NOT-AI-21-002.html
Looking Ahead To Potential Near Term Catalysts
* China INO-4800 Phase III initiation is imminent.
* Will we learn more on South Korean trials?
KB 3/1/21 “ international vaccine Institute in South Korea is also in a Phase 2a segment of its Phase 1/2a trial of INO-4800. We expect that the data from these two trials will be available later this year.”
* More devices may be needed in China however, if they don't expand the geographic locations to meet the target population, as part of the trials, the current clinical sites with the CELLECTRA device should be adequate as CELLECTRA has been reported to be capable of producing 5,000 EP applications, per device.
* The DoD contact for 900 CELLECTRA devices was completed by the end of Q4/20. With 30 DSO per contract, DoD already paid the bill at Jan end. Rev will be booked 1Q21.
* Inovio is on track to announce the initiation of 3 drugs into phase III trials this year. RRP, AIN, VIN. Could we see another "Orphan Drug Designation"?
RRP already obtained ODD in 2020. Prakash Bhuyan 3/1/21:
“We plan to seek P3 regulatory guidance on the pathway to develop VGX-3100 to treat HPV-driven Vulvar and Anal HSIL. We are also seeking orphan designations for these indications.”
* GBM / Regeneron. Glioblastoma continues to loom large as we wait for the median survival in the last cohort. Dr. Jeffrey Skolink's presentation on YouTube is eye popping.
* FDA lift of their hold and approval of the 3PSP CELLECTRA device which INO plans to commercialize for use with INO-4800 is pending any time.
* On January 30, 2021 we learned that INO is in play in the Philippines after they started talks with several US companies developing vaccines though the COVAX Facility Agreement.
https://newsinfo.inquirer.net/1389960/56m-doses-expected-from-us-in-may-says-ph-envoy
INO-4800 is in PHII in China and they have completed enrollment of over 600 people, in a partnership with Advaccine. China moves quickly and if they are running their studies concurrently, as US BP ran trials in the United States, they will be soon enrolling for PHIII. PHIII is going to be a much bigger trial with thousands of participants.
DoD is only funding the PHII and PHIII trials in the US. If China goes full steam ahead and approves INO-4800, INO will need to manufacture hundred, if not thousands of CELLECTRA devices. AS I recall, the DoD paid north of $70M dollars to get 900 devices. I can see where the production of more devices, transcribed into the Chinese language, etc. will need something similar.
Next, FDA approval for the commercialization of the 3PSP CELLECTRA device could also come within the next quarter. Inovio will need additional money to fund the manufacturing and delivery of the new FDA approved devices in order to be prepared for commercialization.
This will all come quickly. INO cannot wait until the summer to raise more capital and burn through their existing money. They have several trials going on that need the working capital available. To me, this raise signifies that they are taking all the necessary steps to stay in the game.
Advaccine has contractually agreed to manufacture DNA plasmids for other products in the Inovio pipeline but, more importantly agreed to sublicense their plasmid manufacturing process to Inovio's other manufacturing partners.
Officially, Inovio has added Advaccine to their consortium of plasmid manufacturers alongside plasmid titans Thermo-Fisher (TMO), Richter-Helms Biologics, Kaneka Eurogentec and the DoD contract manufacturer, Ology Biosciences. With plasmid manufacturing out of the way and trials in China running as planned, the picture surrounding (INO) vaccine progress around the Asian-Pacific region is beginning to come into better view. Based on the aforementioned, near term catalysts include an announcement from China that they have begun a much larger PHIII trial. This will require 1000's of participants across China, a large order of Cellectra devices and the revenue to manufacture and deliver them will be needed.
By David M. Eberhart 1/31/21. New info added by Uncle 3/5/21.
25-01-2021 , Ai Di Weixin’s strategic director, Dr. Xiaoyan Liu, said in an interview with reporters recently, “This vaccine may become the first DNA vaccine approved for marketing in history."
"It is expected that in the first quarter of this year, we will be able to start phase 3 clinical trials."
The phase 2 clinical trials of INO-4800 in China and the first phase 2/3 clinical trials in the United States are independent of each other. in China and the United States, so phase 1 and phase 2 clinical trials were carried out independently.
Ai Di Weixin is building China’s largest DNA vaccine and plasmid production base in the Suzhou Biomedical Industrial Park. The covid-19 vaccine industrialization project is being constructed in phases. The first phase is designed to produce 20 million doses per year, and 2nd phase is designed to produce 100 million doses/year, as of Jan21, the first phase of construction is nearing completion.
http://news.cnnb.com.cn/system/2021/01/25/030223838.shtml?fbclid=IwAR3wbDZwAw_VwFEd8R0r0OYJgGGfu-2o21s93sAprdPWo3F1TTFwJroTJys
Advaccine Measure time point of outcome: 30 days after the second dose of vaccine
Study execute time:
From 2020-12-02 To 2021-01-31
Date of Last Refreshed on:
2021-01-29
1/31 is Sun. Let’s use 1/28 Thurs as the last 2nd dose. 30-day readout is 2/27 Sat.
Let’s assume it takes a week to run assays, analyze data. Advaccine can submit P2 data to NMPA on 3/8. NMPA reviews data on a rolling basis. Since FDA hold on CELLECTRA® 2000 doesn’t apply in China, NMPA can approve P3 to start on 3/15/21. This would be a strong catalyst.
http://www.chictr.org.cn/showprojen.aspx?proj=64452
PLYMOUTH MEETING, Pa., March 4, 2021 /PRNewswire/ -- INOVIO (NASDAQ:INO), a biotechnology company focused on bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases and cancer, today announced that Dr. J. Joseph Kim, President and CEO, along with other members of INOVIO management, will present at the following investor conferences in March:
H.C. Wainwright Global Life Sciences Conference
Date: Tuesday, March 9, 2021
Virtual 1x1 meetings only
Oppenheimer 31st Annual Healthcare Conference
Date: Thursday, March 18, 2021
Time: 10:40 a.m. ET
Presentation Format: Corporate Presentation.
3/8-9 2ND ANNUAL EUROPEAN HEALTHTECH CEO FORUM: Kate B., QIAGEN, TMO, HCW
12:10 CET 3/9/21 Overview of Vaccine Development & Roll Out Panel
Co-Chaired by:
Thomas Shrader, Managing Director & Healthcare Analyst, BTIG, LLC
Timothy Herpin, VP, BD, Infectious Diseases & Vaccines, Johnson & Johnson Innovation | Janssen Business Development
Panelists:
Andreas Neubert, Chief Scientific Officer, IDT Biologika GmbH
Johan Van Hoof, Global Therapeutic Area Head of ID & Vaccines & Managing Director, Janssen Vaccines & Prevention B.V.
Kate Broderick, Senior Vice President, Preclinical R&D, INOVIO Pharmaceuticals, Inc.
Nicholas Jackson, Head of Programmes & Innovation Technology for Vaccine R&D, CEPI.
15:30 Diagnostics: New Technologies Panel
Chaired by:
Rainer Metzger, Head of Integrated Clinical Services, Medicover AB
Panelists:
Alexandra Vallon-Eberhard, Sr. Director Global BD - Diagnostics Biomarkers & Digital Healthcare Solutions, F. Hoffmann-La Roche Ltd. Christoph Pedain, Head of Point of Care Diagnostics, Siemens Healthineers AG
Jim Harper, Co-Founder & COO, Sonde Health
Martin Potgeter, Vice President, Corporate Business Development, QIAGEN GmbH
15:00 Keynote: “Blitzscaling” Atoms vs Bytes: Key Learnings from Pandemic Response
by Mark Stevenson, Executive Vice President & Chief Operating Officer, Thermo Fisher Scientific.
https://www.sachsforum.com/uploads/5/1/9/6/51964431/ehtf_draft_agenda.pdf
JK&Mgmt Present at HCW 3/9, Oppenheimer 3/18 10:40A ET
PLYMOUTH MEETING, Pa., March 4, 2021 /PRNewswire/ -- INOVIO (NASDAQ:INO), a biotechnology company focused on bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases and cancer, today announced that Dr. J. Joseph Kim, President and CEO, along with other members of INOVIO management, will present at the following investor conferences in March:
H.C. Wainwright Global Life Sciences Conference
Date: Tuesday, March 9, 2021
Virtual 1x1 meetings only
Oppenheimer 31st Annual Healthcare Conference
Date: Thursday, March 18, 2021
Time: 10:40 a.m. ET
Presentation Format: Corporate Presentation
Live and archived versions of the virtual presentations will be available through the INOVIO Investor Relations Events page and may be accessed by visiting INOVIO's.
INOVIO has 15 DNA medicine clinical programs currently in development focused on HPV-associated diseases, cancer, and infectious diseases, including coronaviruses associated with COVID-19 and MERS, for which programs are being developed with funding support from the U.S. Department of Defense and CEPI.
With more than 3,000 patients receiving INOVIO investigational DNA medicines in more than 7,000 applications across a range of clinical trials, INOVIO's lead immunotherapy candidate, VGX-3100, currently in Phase 3 trials for precancerous cervical dysplasia, cleared high-risk HPV-16 and/or HPV-18 in a Phase 2b clinical trial. High-risk HPV is responsible for 70% of cervical cancer, 91% of anal cancer, and 69% of vulvar cancer. Also in development are programs targeting HPV-related cancers and a rare HPV-related disease, recurrent respiratory papillomatosis (RRP); non-HPV-related cancers glioblastoma multiforme (GBM) and prostate cancer; as well as infectious disease DNA vaccine development programs in coronaviruses associated with COVID-19 diseases and MERS, Lassa fever, Ebola, and HIV.
2/19 P2 fully enrolled. 2/18 last 1st dose. 3/18 last 2nd dose. 4/1 wk6 Readout. 4/15 wk8 safety & 2-wk analysis finish & booster study & C-2K data. 4/16 submit to FDA. 30-day response 5/16 or 5/17 Mon.
JK responded to Chris Raymond -- Piper Sandler:
“we've been guiding by end of March or early second quarter, I believe, beginning of this year as well. It's just compiling all of the data and even from the data from our booster studies, which would provide a comprehensive package for the FDA, including all of the device related and other responses. So we are on track to do that in the early part of second quarter now.”
Advaccine Measure time point of outcome: 30 days after the second dose of vaccine
Study execute time:
From 2020-12-02 To 2021-01-31
Date of Last Refreshed on:
2021-01-29
1/31 is Sun. Let’s use 1/28 Thurs as the last 2nd dose. 30-day readout is 2/27 Sat.
Let’s assume it takes a week to run assays, analyze data. Advaccine can submit P2 data to NMPA on 3/8. NMPA reviews data on a rolling basis. Since FDA hold on CELLECTRA® 2000 doesn’t apply in China, NMPA can approve P3 to start on 3/15/21. This would be a strong catalyst.
Inovio is already trying to improve response rates, and to this end is working with Qiagen on a companion diagnostic to identify women most likely to benefit from VGX-3100. A post-hoc analysis of the project’s phase II trial found that the test predicted response in 85% of patients.
Still, this needs to be proved prospectively, and this is what Inovio aims to do in VGX-3100’s second pivotal study, Reveal 2. But this trial’s enrolment was hit by the coronavirus pandemic, and the company is not saying when it will be completed.
The pressure is now on Reveal 2 to deliver, and Inovio’s efforts to develop a biomarker will also be “critical to any commercialisation strategy”, Stifel analysts noted. Sellside consensus puts VGX-3100’s 2026 sales at $400M according to EvaluatePharma.
Bill to pay is one month (DSO) per contract. Ino likely shipped 900 devices and hundreds of thousands 4800 doses by end of Dec 2020. $71M DoD payment would arrive by Feb. This would make 1Q21 a gang buster. The $20.05M P2 DoD will be accounted as contra-R&D expense, not revenue if you read the last 4 qtrs of 10-Qs.
Anyhow, 1Q21, 2Q21 will shape up to be a great qtr. That’s why BoD set the stock option strike price at $11.1 with 1/4 vested on 2/26/21.
Both P2 AIN and VIN trials are updated 3/3/21. Ino is applying for Rare and Orphan Designations, will obtain such status and start P3’s this year.
H.C. Wainwright analyst Ram Selvaraju notes that the Ghanaian trial is the first West African study of Lassa fever. Moreover, INO-4500 notches another first; it is the only Lassa fever vaccine candidate to enter a human study.
“We believe an ideal dosing regimen could be selected from the Phase 1b study and advanced into a Phase 2 trial in West Africa,” the 5-star analyst said. “Positive Phase 2 data may allow INO-4500 to be stockpiled for emergency use, in our view. Importantly, Inovio’s DNA medicine platform has produced and advanced multiple vaccine candidates for infectious diseases into human trials, including the COVID-19 vaccine candidate INO-4800, which provide the company with multiple shots on goal in the vaccine space.”
3/8-9 2ND ANNUAL EUROPEAN HEALTHTECH CEO FORUM: Kate B., QIAGEN, TMO, HCW
12:10 CET 3/9/21 Overview of Vaccine Development & Roll Out Panel
Co-Chaired by:
Thomas Shrader, Managing Director & Healthcare Analyst, BTIG, LLC
Timothy Herpin, VP, BD, Infectious Diseases & Vaccines, Johnson & Johnson Innovation | Janssen Business Development
Panelists:
Andreas Neubert, Chief Scientific Officer, IDT Biologika GmbH
Johan Van Hoof, Global Therapeutic Area Head of ID & Vaccines & Managing Director, Janssen Vaccines & Prevention B.V.
Kate Broderick, Senior Vice President, Preclinical R&D, INOVIO Pharmaceuticals, Inc.
Nicholas Jackson, Head of Programmes & Innovation Technology for Vaccine R&D, CEPI.
15:30 Diagnostics: New Technologies Panel
Chaired by:
Rainer Metzger, Head of Integrated Clinical Services, Medicover AB
Panelists:
Alexandra Vallon-Eberhard, Sr. Director Global BD - Diagnostics Biomarkers & Digital Healthcare Solutions, F. Hoffmann-La Roche Ltd. Christoph Pedain, Head of Point of Care Diagnostics, Siemens Healthineers AG
Jim Harper, Co-Founder & COO, Sonde Health
Martin Potgeter, Vice President, Corporate Business Development, QIAGEN GmbH
15:00 Keynote: “Blitzscaling” Atoms vs Bytes: Key Learnings from Pandemic Response
by Mark Stevenson, Executive Vice President & Chief Operating Officer, Thermo Fisher Scientific.
AIN and VIN P2 trials updated 3/3/21. Ino is applying for Rare and Orphan Designations, will obtain such status and start P3’s this year.
VGX-3100 Delivered Intramuscularly (IM) Followed by Electroporation (EP) for the Treatment of HPV-16 and/or HPV-18 Related Anal or Anal/Peri-Anal, High Grade Squamous Intraepithelial Lesion (HSIL) in Individuals Seronegative for Human Immunodeficiency Virus (HIV)-1/2
https://clinicaltrials.gov/ct2/show/NCT03499795?term=Inovio&draw=3&rank=13
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 (Also Referred as: VIN 2 or VIN 3)
https://clinicaltrials.gov/ct2/show/NCT03180684?term=Inovio&draw=3&rank=16
3/2/21 Maxim Group analyst Jason McCarthy reiterated Buy on Ino, expected $0.12 EPS 1Q21, setting $20 target, 99.60% above the present share price of $10.02. McCarthy expects Inovio Pharmaceuticals to post earnings per share (EPS) of $0.12 for the first quarter of 2021 [thanks to $71M DoD contract for Cellectra 2K, 3PSP, hundreds of thousands 4800 doses, and P2 401 ppl $20.05M bill paid].
The current consensus among 7 TipRanks analysts is for a Moderate Buy rating of shares in Inovio Pharmaceuticals, with an average price target of $17.17.
The analysts price targets range from a high of $35 to a low of $7.
https://m.investing.com/news/maxim-group-stick-to-their-buy-rating-for-inovio-pharmaceuticals-2435717
Maxim Group Stick to Their Buy Rating for Inovio Pharmaceuticals
Investing.com | Mar 03, 2021 06:55AM ET
Bio Asia 2/26/21: Dr. Jerome Kim (Leader of IVI), running INO's SK INO-4800 Trials. In this video he talks about his partnership with INOVIO then goes on to say that at this point huge PIII trials with placebo controls might not be worth it. They are looking at measuring safety and immunogenicity, running larger trials in countries that do not have vaccines yet.
Guangyung’scomment:
Once safety has been established, they just do observation trial where they measure the atk rate of vaccinated group vs the national atk rate which is
cumulative infection rate. If 33M were infected within 3-months and population size is 330M, that’s 10% atk rate in 3-month cum.
its better to vaccinate a small town and then just compare the infection rate of the town to another unvaccinated town with same population.
it shouldnt be in US anymore - could just be a low income country thats suffering since cold chain is not a problem for Ino.
2/27/21 Multivalent DNA Vaccines as A Strategy to Combat Multiple Concurrent Epidemics: Mosquito-Borne and Hemorrhagic Fever Viruses
by Jingjing Jiang 1, Stephanie J. Ramos 1, Preeti Bangalore 1, Dustin Elwood 1, Kathleen A. Cashman 3, Sagar B. Kudchodkar 2, Katherine Schultheis 1, Holly Pugh 1, Jewell Walters 1, Jared Tur 1, Jian Yan 1, Ami Patel 3, Kar Muthumani 2, Connie S. Schmaljohn 3, David B. Weiner 2, Laurent M. Humeau 1,* and Kate E. Broderick 1
1
Inovio Pharmaceuticals Inc., Plymouth Meeting, PA 19462, USA
2
Vaccine & Immunotherapy Center, The Wistar Institute of Anatomy and Biology, Philadelphia, PA 19104, USA
3
United States Army Medical Research Institute of Infectious Diseases, Fort Detrick, MD 21702, USA
*
Author to whom correspondence should be addressed.
Academic Editors: B.A.M. (Ben) van der Zeijst and P.J.M. (Peter) Rottier
Viruses 2021, 13(3), 382; https://doi.org/10.3390/v13030382 (registering DOI)
Received: 15 January 2021 / Revised: 22 February 2021 / Accepted: 26 February 2021 / Published: 27 February 2021
(This article belongs to the Special Issue Nucleic Acid Vaccines)
Abstract
The emergence of multiple concurrent infectious diseases localized in the world creates a complex burden on global public health systems. Outbreaks of Ebola, Lassa, and Marburg viruses in overlapping regions of central and West Africa and the co-circulation of Zika, Dengue, and Chikungunya viruses in areas with A. aegypti mosquitos highlight the need for a rapidly deployable, safe, and versatile vaccine platform readily available to respond. The DNA vaccine platform stands out as such an application. Here, we present proof-of-concept studies from mice, guinea pigs, and nonhuman primates for two multivalent DNA vaccines delivered using in vivo electroporation (EP) targeting mosquito-borne (MMBV) and hemorrhagic fever (MHFV) viruses. Immunization with MMBV or MHFV vaccines via intradermal EP delivery generated robust cellular and humoral immune responses against all target viral antigens in all species. MMBV vaccine generated antigen-specific binding antibodies and IFN?-secreting lymphocytes detected in NHPs up to six months post final immunization, suggesting induction of long-term immune memory. Serum from MHFV vaccinated NHPs demonstrated neutralizing activity in Ebola, Lassa, and Marburg pseudovirus assays indicating the potential to offer protection. Together, these data strongly support and demonstrate the versatility of DNA vaccines as a multivalent vaccine development platform for emerging infectious diseases.
The next-generation non-live vaccine approach, DNA vaccines, are an advantageous platform for multivalent infectious disease vaccine development compared to other vac- cine platforms, such as live-attenuated, subunit or viral vectored vaccines. These benefits include the absence of pre-existing or acquired vector immunity; relatively rapid, and low-cost manufacturing methods; stable multi-agent formulation capability; no need for cold-chain storage; a favorable safety profile; and the ability to generate both humoral and cellular immune responses.
Historically DNA vaccines against infectious diseases and on- cological disorders have advanced into early phase clinical trials with limited success. Ad- vancements in design (highly optimized DNA encoded immunogens) and delivery (in vivo electroporation (EP)) have greatly improved immunogenicity of DNA vaccines in large animals and human subjects [13–15]. Recently we demonstrated in a Phase 2b clini- cal trial that the human papillomavirus (HPV) DNA vaccine VGX-3100 delivered via in- tramuscular injection with EP (IM-EP) is capable of driving an effective, therapeutic im- mune response in which vaccinated patients with cervical intraepithelial neoplasia not only saw regression of their lesions but also cleared the disease-causing virus [16]. Addi- tionally, we have previously reported on an in vivo intradermal electroporation (ID-EP) device for administering DNA vaccines to the skin and demonstrated plasmid gene ex- pression and functional immune responses using this delivery method [17]. This device is currently being used in early clinical trials and has already demonstrated induction of potent immunity of DNA vaccines against HIV (NCT02431767), EBOV (NCT02464670) [18], and the first-in-human ZIKV vaccine (NCT02809443) [19]. Most recently ID delivery of a DNA vaccine for COVID-19 by the same ID-EP device (INO-4800) was developed showing both immunogenicity and protection in rodents and NHPs [20,21]. INO-4800 has successfully completed a Phase I clinical trial (NCT04336410) and entered Phase II/III (NCT04642638), demonstrating rapid roll-out and successful immunogenicity of the plat- form [22].
Plasmid Vaccine ConstructionsMultivalent Hemorrhagic Fever Virus (MHFV) Vaccine: The MHFV vaccine was gen- erated as a combination of DNA vaccines targeting EBOV, MARV, and LASV as described below. The pEBOV plasmid encodes full-length Ebola Zaire glycoprotein (GP) with the SynCon consensus strategy as previously described [27]. The pMARV plasmid encodes full-length Marburg 2005 Angola strain GP proteins as previously described [27]. EBOV and MARV plasmids were codon optimized and cloned into modified pVAX1 mamma- lian expression vectors. The pLASV plasmid encodes a codon-optimized LASV Josiah gly- coprotein complex precursor (GPC) as previously described [40]. The following plasmids were generated for the purposes of in vivo antigen expression studies: pEBOV-FLAG plas- mid encoding the same protein as pEBOV labeled with a C-terminal DYKDDDDK FLAG tag; pMARV-His plasmid encoding the same protein as pMARV labeled with a C-terminal 6-His tag; pLASV-Myc plasmid encoding the same protein as pLASV labeled with a C- terminal EQKLISEEDL myc tag.
Multivalent Mosquito-borne Virus (MMBV) Vaccine: The MMBV vaccine was gener- ated as a combination of DNA vaccines targeting ZIKV, DENV serotypes 1?4 and CHIKV antigens as described below. The pZIKV plasmid DNA construct encodes a consensus full-length ZIKV precursor of membrane (prM) and envelope (E) proteins as previously described [38]. The pCHIKV DNA construct encodes consensus CHIKV E3, E2, and E1 envelope proteins as previous described [39]. To generate DENV serotype-specific prM and envelope consensus sequences, DENV serotypes 1?4 prM gene sequences; DENV serotypes 1?4 envelope sequences representing the sequences from various regions of the world were collected from GenBank to avoid sampling bias. The DENV serotype-specific prM and envelope consensus protein sequence was obtained after performing multiple alignments. The DENV serotype-specific consensus prM and envelope sequences were assembled together to construct the prME consensus sequences. A highly efficient leader sequence was fused in frame upstream of the start codon to facilitate the expression. Fur- thermore, in order to have a higher level of expression, the codon usage of this gene was adapted to the codon bias of #$%$ sapiens genes. In addition, RNA optimization was also performed: regions of very high (>80%) or very low (<30%) GC content and the cis- acting sequence motifs such as internal TATA boxes, chi-sites, and ribosomal entry sites were avoided. The genes encoding modified DENV1?4 prME proteins were synthesizedand sequence verified by GeneArt (Thermo Fisher, Waltham, MA). The synthetic engi- neered DENV1?4 prME genes were 2094, 2094, 2088, and 2094 bp in length and were sub- cloned into the expression vector pGX0001 at the BamHI and NotI sites for further study. These constructs were named as pDENV1, pDENV2, pDENV3, and pDENV4.
https://www.mdpi.com/1999-4915/13/3/382
https://res.mdpi.com/d_attachment/viruses/viruses-13-00382/article_deploy/viruses-13-00382.pdf
JK got 79,950 option shares $11.1 strike price vested on February 26, 2021. ST if he pumps the pps to $22.2, he will net $799,500 which is more than 68,767 *$11.1 vested next 2/26/22. He has a strong incentive to perform. $11.1 indicated BoD believed it was the bottom.
Possible sing-dose-only 2mg, durability, no cold store requirement meet CEPI top priority for 2nd wave funding now that P2 completed enrollment.
This is not “annual” allotment due to huge amount of stock options and RSU, especially the vesting schedule - 1/4 of $11.1 option are already immediately vested 2/26/21.
If you use the dollar amount calculation, it indicates the first 3 goals are met. Number speaks louder than word.
For RSU, Kim got 65% of the $3.5M. The other three officers got 77.58% of $1.5M. So, all 3 targets must have been met.
Based on the reward:
1. 20% p2/3 fully enrolled
Done, 2/19 INNOVATE status changed to Active, Not Recruiting
2. 25% funding
DoD, immediate $384M CEPI funding announcement?
3. 25% 100M 1mg doses manufactured
Eurogentec and Thermo Fisher. Cellectra 2K, 3-prong array manufactured.
4. 30% BLA
Not met yet
JK: RSU 206300, Stock option 319800 strike price 11.1
206300*11.1=2,279,930=$3.5M*0.65%
(1) The vesting schedule for the 319,800 options is as follows: 79,950 shares vested on February 26, 2021; 79,950 shares will vest on February 26, 2022; 79,950
shares will vest on February 26, 2023; 79,950 shares will vest on February 26, 2024.
(2) Each restricted stock unit represents a contingent right to receive one share of common stock. The vesting schedule for the 206,300 restricted stock units is as follows: 68,767 shares will vest on February 26, 2022; 68,767 shares will vest on February 26, 2023; 68,766 shares will vest on February 26, 2024. Vested restricted stock units can be settled in shares of common stock, cash or a combination of both.
The first 1/3 RSU vesting schedule was changed to 2/26/22 from 50% now 2/26/21, then 50% 2/26/22. The option 1/4 vesting is immediate 2/26/21. There will be a new 8K to reflect this.
Other 3: RSU 104833, Stock option 67633
104833*11.1=1,163,646=$1.5M*77.58%
DW: RSU 60K, Stock Option 35K
9/3/20 8K:
Target Value Of Award ($)
3,500,000 J Kim
1,500,000 P Kies
1,500,000 L Humeau
1,500,000 J Shea
The Committee established the following performance goals and corresponding performance periods over which the performance goals must be attained, the satisfaction of which are conditions to earning the Awards.
1. The first 20% each Award will be earned if the Company’s planned Phase 2/3 clinical trial for INO-4800, the Company’s COVID-19 vaccine candidate, is fully enrolled.
2. An additional 25% of each Award will be earned if the Company receives more than a specified amount of non-dilutive, third- party funding for manufacturing and clinical development of INO-4800.
3. An additional 25% of each Award will be earned if the Company completes manufacture of at least 100 million (1 mg equivalent) doses of INO-4800 and arrays and a specified number of its delivery devices.
4. The remaining 30% of each Award will be earned if INO-4800 receives regulatory approval by the U.S. Food and Drug Administration and no more than a specified number of other COVID-19 vaccines have previously received such approval.
Once a goal has been achieved and the respective number of shares underlying the Award has been earned, 50% of the underlying shares earned will vest on the date of achievement, and the remaining 50% of the underlying shares earned will vest one year thereafter, subject to the executive officer’s continued employment with the Company through such date. In the event of a change in control (as defined in the Plan), earned but unvested Awards would automatically vest in full to the extent earned. In the event of a change in control, if a performance goal has been substantially completed, the Committee may, in its discretion, declare the applicable portion of the Award to be earned and may accelerate vesting of all or a portion of the Awards.
H.C. Wainwright analyst Ram Selvaraju notes that the Ghanaian trial is the first West African study of Lassa fever. Moreover, INO-4500 notches another first; it is the only Lassa fever vaccine candidate to enter a human study.
“We believe an ideal dosing regimen could be selected from the Phase 1b study and advanced into a Phase 2 trial in West Africa,” the 5-star analyst said. “Positive Phase 2 data may allow INO-4500 to be stockpiled for emergency use, in our view. Importantly, Inovio’s DNA medicine platform has produced and advanced multiple vaccine candidates for infectious diseases into human trials, including the COVID-19 vaccine candidate INO-4800, which provide the company with multiple shots on goal in the vaccine space.”
For now, however, Selvaraju remains on the sidelines with a Neutral (i.e. Hold) rating. Citing “market valuation and volatility,” the analyst refrains from providing a price target. (To watch Selvaraju’s track record, click here)
In contrast, on where the share price is heading, the rest of the Street takes a decidedly positive stance; at $18.25, the average price target implies gains of ~59% over the next 12 months. Based on 2 Buys and 3 Holds, the stock currently has a Moderate Buy consensus rating.
220 18- to 50-year-old participants are expected to enroll in the program, who will receive two vaccinations 28 days apart with either 1.0 mg or 2.0 mg of INO-4500.
The Coalition for Epidemic Preparedness Innovations (CEPI) is funding the study. CEPI has previously provided Inovio with Lassa fever related funding. In 2018, the foundation granted the company $56 million to develop vaccine candidates for Lassa fever and Middle East Respiratory Syndrome (MERS).
A Phase 1 study has already taken place in the US, for which the candidate produced strong antibody and T cell immune responses.
Measure time point of outcome: 30 days after the second dose of vaccine
Study execute time:
From2020-12-02To 2021-01-31
Date of Last Refreshed on:
2021-01-29
1/31 is Sun. Let’s use 1/28 Thurs as the last 2nd dose. 30-day readout is 2/27 Sat.
Let’s assume it takes a week to run assays, analyze data. Advaccine can submit P2 data to NMPA on 3/8. NMPA reviews data on a rolling basis. Since FDA hold on CELLECTRA® 2000 doesn’t apply in China, NMPA can approve P3 to start on 3/15/21. This would be a strong catalyst.
* Advaccine finished 2nd dosing 640 people in China P2 trial Jan 2021, to start P3 Mar 2021. Wk6 Data submitted to National Medical Products Administration which was founded on the basis of the former State Food and Drug Administration.
* INO-4800 is being tested against UK and S.Africa mutations, they will update INO-4800 design if needed
* Ino is developing Pan-CoV aka multi-valent vaccine concurrently with 3rd dose booster shot trial.
* US P3 trial to start in Q2 upon FDA approval
* Very well tolerated, only grade 1 side effects
* New Cellectra device is super cool, one button operated, gives visual and audio feedback when the procedure is completed, powered by alkaline or rechargeable batteries, USB port to charge the device etc.
Looks like an average person would be able to use it after 30 min of training :)
JK at NYAS:
1. 5 year shelf live vs 1 year shelf life of other vaccines
2. No need to freeze the vaccine, can handle all temperatures.
3. 1 & 2 means easier distribution of vaccine
4. Better immune response, T-cell response, makes the vaccine cross protective which means long term protection from Covid.
5. Better antibody response (meaning you won’t get Covid again)
6. Vaccine is all natural which means no allergic reaction like current vaccines with harmful PEG preservatives
7. Animals trials have shown you only need 1 dose not multiple doses like current vaccines. This could allude to adding a new single-dose-only 2mg P3 cohort in US and China
8. Has proven to also work on mutant strains. Most recently the newest mutation in Africa and UK. Also INO vaccine is the easiest to adjust for future mutations
9. Department of defense funding for vaccine
10. Plans to be #1 vaccine for second wave of Covid
11. China Phase 2 data will be out end of this Feb month
12. US Phase 3 data in second quarter
13. All clinical trial percentages were very high
https://drive.google.com/file/d/1K-VroKexp4TXKLAxd-8J4CaZqPda8Os8/view?usp=drivesdk
http://www.chictr.org.cn/showprojen.aspx?proj=64452
GameStop shares soar more than 100% amid executive shuffle. A handful of other Reddit trades (INO) rose in after hours trading 2/24. AMC popped 18% and Koss gained 54%.
Expect INO to follow through rebounding 2/25-26 propelled by Reddit crowd.
INOVIO plans to pursue a registrational P3 clinical trial for HPV-16-/18 associated Vulvar and anal dysplasia as well as to apply for rare and orphan disease designation in 2021.
Vulvar dysplasia: Open-label Phase 2 trial showed 8 out of 10 women had reduction in lesion area; 2 of 10 had no virus at 6 months (interim).
Anal dysplasia: Open-label Phase 2 trial showed clearance of precancerous lesions in 10 out of 20 patients, decrease in lesions for 15 of 20 (interim).
Cervical dysplasia: Phase 2b PoC trial demonstrated a complete response in 43 out of 107 patients in regression of high-grade cervical lesions and elimination of HPV infection.
The cervical dysplasia program is in late Phase 3 clinical trials (REVEAL 1 and REVEAL 2). VGX-3100 is designed to utilize the patient's own immune system to clear HPV-16/18-associated high-grade precancerous lesions with the aim of reducing the risk of cancer.
HPV is the most common viral infection of the reproductive tract and the fourth most common cancer among women. The World Health Organization (WHO) reported an estimated 570,000 new cases of cervical cancer and 311,000 deaths in 2018. Almost 300 million women globally are estimated to be infected with HPV, and about 30 million additional cases have progressed to the precancerous stage. At least 70% of cervical cancers are estimated to be the result of the high-risk HPV 16 and HPV 18 – genotypes that VGX-3100 instructs a suitable patient's immune system to reduce or fully eliminate.
Pilot study for Recurrent Respiratory Papillomatosis (RRP) demonstrated a clinical benefit in 2 out of 2 patients by delaying surgery due to lack of tumor recurrence
A Phase 1/2 clinical trial for treating RRP with INO-3107, which includes both HPV 6 and HPV 11 antigens, is currently recruiting
Phase 1 trial for HNSCC, 2 out of 4 patients treated with MEDI0457 and 2 different PD-1 checkpoint inhibitors experienced a long-term complete response for >2 years
MEDI0457 is licensed by AstraZeneca and currently in a Phase 1b/2a study in combination with durvalumab (PD-L1 checkpoint inhibitor)
http://s23.q4cdn.com/479936946/files/doc_downloads/banner_doc/2021/01/INOVIO-Investor-Deck-Presentation-210122.pdf
Of the three biggest vaccine candidates, Singh sees INO-4800 as the one offering the most immediate value, and contributing $20 per share to his $35 overall target price.
Less well known than competing coronavirus vaccines from Pfizer or Moderna, Singh notes that INO-4800 has several advantages to recommend it. For one, it’s DNA-based, and thus can theoretically be modified to combat mutated versions of the COVID-19 coronavirus. For another, it offers a better “safety/tolerability profile,” that could recommend it as an alternative to other vaccines. And for a third, INO-4800 is said to be both easier to store and has a longer shelf life than other vaccines on the market today, which might make it more suitable for stockpiling against future coronavirus outbreaks.
VGX-3100 is the next most valuable of Inovio’s vaccine candidates, thinks Singh, being worth perhaps $7 a share. It’s also, says the analyst, the vaccine with the “highest sustainability and potential upside on commercialization” for Inovio, as HPV will presumably remain a problem long after the coronavirus pandemic has gone away. Singh also sees “potential to expand into other (pre)cancerous indications” based on research done for VGX-3100.
Finally, Singh sees INO-5401 as worth perhaps $5 a share to Inovio stock. In the analyst’s view, INO-5401 could be a “potential breakthrough” drug for treating patients with glioblastoma, a cancer that has not seen a real improvement in treatment options “for decades.”
Other vaccine candidates in the pipeline, plus Inovio’s cash on hand, make up the final $3 of the analyst’s target valuation for Inovio.
Not all this value may be immediately apparent to investors, however. Notably, Singh admits that revenues at Inovio over the past three years have been measured in the low single digits of millions of dollars. It won’t be until next year, says the analyst before sales really grow appreciably. But once these vaccines begin coming to market, the analyst sees significant growth potential: $656 million in sales in 2022, twice that in 2023, $2.1 billion in 2024, and $3 billion in 2025.
Indeed, by 2025, the analyst forecasts that Inovio could be earning $6.48 per share, per year, making today’s price target of $35 (not to mention today’s actual share price of $15) look cheap indeed. And indeed, that’s probably why the analyst is rating the stock “outperform” and recommending that investors buy it.
In the meantime, though, investors will need to be patient, because Singh sees no chance of Inovio earning anything this year. Profits will only emerge alongside sales next year — $1.46 per share.
Shares of vaccine researcher Inovio Pharmaceuticals (INO) are currently trading around the $15 level, and one analyst thinks that’s a bargain.
Oppenheimer analyst Hartaj Singh makes the argument that progress on Inovio’s INO-4800 coronavirus vaccine, combined with its INO-5401 cancer vaccine and its Human papillomavirus (HPV) vaccine VGX-3100, could drive Inovio stock higher. How much higher?
Singh initiated coverage on INO with an Outperform (i.e. Buy) rating and set a Street high price target of $35. Should the target be met, investors could pocket gains of 128% over the next 12 months.
https://www.tipranks.com/news/corona/inovio-stock-gets-a-new-street-high-price-target/
Feb 12, 2021, 09:02 AM