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04:55 01/25/22 Inovio management to meet virtually today with Oppenheimer 04:55 INO Virtual Meetings to be held on January 25-26 hosted by Oppenheimer.
https://thefly.com/landingPageNews.php?id=3442177&headline=INO-Inovio-management-to-meet-virtually-with-Oppenheimer
Mixing Sinovac With Different Boosters Increases Protection
Pfizer shot outperforms Astra, J&J, Sinovac in study
Brazil study finds that third Sinovac shot is still helpful
January 21, 2022, 3:30 PM PST
People who had two doses of the Covid-19 vaccine made by China’s Sinovac Biotech Ltd. should get boosted with a different shot to amp up their protection against omicron, according to a study by researchers from Brazil and the University of Oxford.
The research, published Friday in The Lancet, tested booster combinations on 1,240 people from Brazil above 18 years old who had been immunized with Sinovac’s shot, one of the most widely used globally, six months prior. While those who received a third Sinovac dose did experience a boost in antibodies 28 days later, the level of improvement was found to be much higher in people who were boosted with vaccines from Pfizer Inc., AstraZeneca Plc, or Johnson & Johnson.
The “mix-and-match” booster approach induced stronger antibody protection against both delta and omicron, compared with a third dose of Sinovac’s vaccine, known as CoronaVac, the study showed. This is in line with findings from other studies that support so-called heterologous boosting schedules.
Evidence that Sinovac’s booster increases antibody levels at all is good news for the company, as well as for China and the rest of the developing world, where the product is the vaccine of choice. The Chinese company said at the end of last year it was bracing for a revenue slump as several studies raised doubts about the efficacy of its vaccine against omicron, even after a booster shot. Still, the other combinations were better.
The data show the “extraordinary response to a third dose of coronavirus vaccines in a heterologous vaccine schedule,” said Sue Ann Costa Clemens, director of the Oxford Vaccine Group in Brazil, adding: “These data will also guide other low- and middle-income countries in setting up the most optimal and affordable booster programs.”
The Pfizer booster increased antibodies 152 times, the biggest rise across all shots studied. The increase from a third CoronaVac dose was 12-fold.
Sinovac and Sinopharm, the other major Covid shot provider in China, both rely on more traditional, inactivated vaccine technology, whereas Pfizer uses the newer messenger RNA tech in their inoculations.
Neutralizing capacity against omicron was induced for almost all those who mixed CoronaVac with another vaccine. In contrast, researchers said only about a third of those boosted with Sinovac’s shot had detectable levels of neutralization against the latest variant.
The study also found all boosters are safe as follow-ups to two doses of CoronaVac. One person boosted with the Johnson & Johnson shot and two receiving Pfizer suffered serious adverse effects potentially linked to the vaccine, but all recovered completely.
One of the study’s limitations is that it didn’t measure T-cell immunity, which would give an indication of protection against severe disease.
https://www.bloomberg.com/news/articles/2022-01-21/mixing-sinovac-with-different-boosters-increases-protection
11/9/21 INOVIO's partner Advaccine received regulatory approval to conduct two clinical trials in China investigating boosting with INO-4800. The studies will include prime-boost sequential immunizations using INO-4800 and an inactivated COVID-19 vaccine. [Sinovac‘s Coronavac]
https://ir.inovio.com/news-releases/news-releases-details/2021/INOVIO-Reports-Third-Quarter-2021-Financial-Results/default.aspx
Dose-ranging Study: Safety, Tolerability and Immunogenicity of INO-4500 in Healthy Volunteers in Ghana
Estimated Primary Completion Date : September 2022
Last Update Posted: December 20, 2021 => January 20, 2022 [Actual]
https://clinicaltrials.gov/ct2/history/NCT04093076?A=23&B=24&C=merged#StudyPageTop
P2 Safety, Tolerability and Immunogenicity of INO-4700 for MERS-CoV in Healthy Volunteers
Last Update Posted: December 20, 2021 => January 20, 2022 [Actual]
https://clinicaltrials.gov/ct2/history/NCT04588428?A=16&B=17&C=merged#StudyPageTop
Kenya
Kenya Medical Research Institute (KEMRI)/Walter Reed Project (WRP)
[Recruiting] <= DoD quietly funds on top of CEPI
Kericho, Kenya, 20200
Ino was awarded up to US $56 million from CEPI in 2018 under which INOVIO is advancing vaccine candidates against Lassa fever and Middle East Respiratory Syndrome (MERS). INOVIO and CEPI plan to establish a stockpile of these vaccines for emergency use after Phase 2 testing, if successful. As part of CEPI's $3.5 billion plan to reduce, or even eradicate, the risk of epidemics and pandemics, CEPI's goal is to get a licensed Lassa vaccine for use in endemic countries.
https://ir.inovio.com/news-releases/news-releases-details/2021/INOVIO-Completes-Enrollment-of-Phase-1B-Clinical-Trial-for-its-DNA-Vaccine-Candidate-Against-Lassa-Fever-INO-4500-in-West-Africa/default.aspx
“And while we think the emergence of C-19 variants has kept investors acutely focused on INO-4800, we expect interest to return to the non-C-19 pipeline in 2022, which we believe has more attractive opportunities,” the analyst wrote.
“In fact, we think VGX-3100 (HPV program) and INO-5401 (GBM program) will be the main value drivers for Inovio moving forward, and while we don’t expect any catalysts for these programs in 1H22, we expect readouts for INO-4500 in Lassa fever and INO-3107 in RRP in 1H22 to further de-risk the platform and add momentum to the story,” BofA Analyst: Geoff Meacham added 1/21/22
https://www.google.com/amp/s/www.benzinga.com/amp/content/25160570
Inovio upgraded to Neutral at BofA on valuation, COVID vaccine viability 06:22 INO BofA analyst Geoff Meacham upgraded Inovio to Neutral from Underperform with a price target of $10, up from $8. The analyst cites the stock's recent weakness and contends that the majority of remaining COVID-19 value has been removed from valuation following the recent 18% year-to-date pullback. Meacham adds that Inovio's commercial outlook for its COVID-19 vaccine has not changed, and the data generated from the program has demonstrated a favorable safety-profile and robust efficacy.
Read more at:
https://thefly.com/n.php?id=3444250
1/18/22 Sinovac applies for emergency use of CoronaVac on children aged 3 to 17
Chinese pharmaceutical company Sinovac Biotech has sought the approval of the Food and Drug Administration (FDA) for the emergency use of its coronavirus disease (COVID-19) vaccine, CoronaVac, on children aged three to 17 years old.
Vaccine czar Carlito Galvez Jr. said Sinovac is applying for FDA’s amendments on CoronaVac’s emergency use authorization (EUA) so that it can be used to cover those aged three to 17 using a children’s solution.
“For zero to four years old, we will wait for the release of the emergency amendment in other countries and the advice of our experts,” Galvez said..com.ph/2022/01/18/sinova...
Chinese pharmaceutical company Sinovac Biotech has sought the approval of the Food and Drug Administration (FDA) for the emergency use of its coronavirus disease (COVID-19) vaccine, CoronaVac, on children aged three to 17 years old.
Vaccine czar Carlito Galvez Jr. said Sinovac is applying for FDA’s amendments on CoronaVac’s emergency use authorization (EUA) so that it can be used to cover those aged three to 17 using a children’s solution.
“For zero to four years old, we will wait for the release of the emergency amendment in other countries and the advice of our experts,” Galvez said.
https://mb.com.ph/2022/01/18/sinovac-applies-for-emergency-use-of-coronavac-on-children-aged-3-to-17/
Inovio management to meet virtually with Oppenheimer next Tues-Wed. INO Virtual Meetings to be held on January 25-26 hosted by Oppenheimer.
https://thefly.com/news.php?symbol=INO
Covid play is NOT dead for 2 reasons.
1) The mrNA are too short lived and without bi-yearly boosters (at least) Covid will be back in the fall. Sone of those that ACTUALLY caught Covid are immune (and that does not include false positives from PCR tests with high cycle count). They can be infected multiple times with new VoCs. Omicron might have helped increase the Herd Immunity in richest countries to possibly 40%. Because of all this I believe Covid will be back in the fall. I believe the Dr's know this too and will be addressing it with longer length of immunity, duration of protection vaccines (T-killer cell, memory T-cell, B helper cell) over the summer and Fall Such as INO-4800, 4802.
2) A good % of the world population still needs to be vaccinated. No cold chain required vaccine is needed to stop emerging VoCs in LMICs such as Africa, …
The Covid play is not dead. Oppenheimer still believes we can get to $35, and even the BofA busstards believe we can get to $10.
RealBruce said
“Reading the numbers in the recently posted Dec 2021 study synopsis, I can see why INO-4800 has had such a problem getting traction. It's called "Feature Shopping" I see it all the time with people who come to me for advise with Stereo, TV or Computer shopping. Everyone was GHz this, GBytes, Hundreds of Watts of power etc. When none of that really matters, as all that power and storage and size is rarely used, and actually cause shorter life cycle of the device.
My point is, once the MrNA's came out with their stellar NAb numbers, that became the "Feature" everyone was shopping for. And let's face it the politicians making the buying decisions these days are rarely even medical professionals, and don't listen very well. But the reality is they were buying a feature that only ensured the Covid crisis would be prolonged, not halted. Yes, NAb can and will block an infection when at full strength, but with a 28 day half life, they found that protection was short lived, and without CD4+ and CD8+ TCell backup, the NAb can do little but stave off severe infections for a few months.
Now that INO-4800 is in Phase 3, the world is going to see the REAL WORLD RESULTS of how much more effective and long lived the NAb, BAb and TCell 1,2,3 punch is at providing IMMUNITY and BLOCKING TRANSMISSION in addition to keeping people out of the hospitals. All that combined with simple production, long shelf life, and stellar safety profile makes INO-4800 the Marantz or Bryston of the Vaccine world.
1/21/22 The Inovio Pharmaceuticals Analyst: Geoff Meacham upgraded the rating for Inovio Pharmaceuticals from Underperform to Neutral while raising the price target from $8 to $10.
The Inovio Pharmaceuticals Thesis: While the stock has shed 18% year to date, data generated from the COVID-19 program seems to suggest “a favorable safety profile and robust efficacy,” which “bolsters our confidence in Inovio’s DNA vaccine platform,” Meacham said in the upgrade note.
“And while we think the emergence of C-19 variants has kept investors acutely focused on INO-4800, we expect interest to return to the non-C-19 pipeline in 2022, which we believe has more attractive opportunities,” the analyst wrote.
“In fact, we think VGX-3100 (HPV program) and INO-5401 (GBM program) will be the main value drivers for Inovio moving forward, and while we don’t expect any catalysts for these programs in 1H22, we expect readouts for INO-4500 in Lassa fever and INO-3107 in RRP in 1H22 to further de-risk the platform and add momentum to the story,” he added.
Why This Analyst Has Increased Confidence In Inovio Pharmaceuticals
January 21, 2022 11:50 AM ET
Following the recent pullback in Inovio Pharmaceuticals Inc.’s (NASDAQ:INO) shares, the stock valuation seems to have been stripped of most of the remaining COVID-19 value, according to BofA Securities.
INO Price Action: Shares of Inovio Pharmaceuticals had declined by 0.97% to $4.06 Friday morning at publication.
https://www.google.com/amp/s/www.benzinga.com/amp/content/25160570
DOST explains why WHO Solidarity Trial Vaccines is important
NationalNews
Charissa Luci-Atienza December 17, 2021
The Department of Science and Technology (DOST) cited on Friday, Dec. 17, the importance of the World Health Organization (WHO) Solidarity Trial Vaccines (STV), which is now being rolled out in eight study sites in Metro Manila.
https://www.google.com/amp/s/mb.com.ph/2021/12/17/dost-explains-why-who-solidarity-trial-vaccines-is-important/%3famp
(MANILA BULLETIN FILE)
DOST Undersecretary for Research and Development Dr. Rowena Cristina L. Guevara said as early as last year, they started reaching out to the country’s international partners to explore partnership opportunities that will allow the Philippines to conduct vaccine clinical trials in the country.
“By joining in this global action led by WHO, we can generate safety and efficacy data of the vaccine candidates directly attributed to the Filipino people and work with multiple countries for collective problem-solving,” she said during the World Health Organization (WHO) Solidarity Trial Vaccines (STV) Public Announcement on Friday, Dec. 17.
She said the WHO STV, which is separate from the government’s ongoing coronavirus disease (COVID-19) vaccination program aims to look at the efficacy and safety of candidate vaccines.
Serving as lead investigators of the trial are Dr. Jodor A. Lim and Dr. Marissa M. Alejandria from the University of the Philippines (UP) Manila-Philippine General Hospital (PGH). Around 15,000 to 20,000 eligible, “healthy” participants who are 16 years old and above are targeted to participate in the STV.
The Philippines’ participation in the vaccine clinical trials remains of utmost importance, especially as the current global vaccine supply is still limited, Guevara explained.
“Participation in this trial will also help us generate the study vaccines’ efficacy against the newly emerging variants.”
She said in preparation for the WHO STV, they worked closely with various agencies from the local up to the national level to prepare the trial sites, and train healthcare workers or volunteers.
The DOST official assured the public that the conduct of the trial will adhere to the highest ethical and scientific standards.
“Before they are even approved for implementation in the country, clinical trials like the WHO-STV undergo a rigorous review process by the FDA and its partner evaluators.”
Guevara said through the country’s participation in the WHO STV, “we aim to contribute to the global pandemic response with science at the forefront of our initiatives.”
“Our actions must match and contribute to the global solution aimed at ending this pandemic. As we recognize that no one is safe until everyone is safe, we enjoin everyone to support our scientific initiatives that will help alleviate the burden brought by COVID-19, and ultimately help every country, including the Philippines, put an end to this health crisis.”
During the official launch of the WHO Solidarity Trial Vaccines, she drummed up public support and cooperation in ensuring smooth clinical research operations, in order to find safe and effective vaccines for everyone.
“In partnership with our local government units, rest assured that we at the Task Group on Vaccine Evaluation and Selection will actively assist and oversee the participation in such vaccine trials.”
1/20/22 GENEVA, Switzerland — The Covax scheme for ensuring COVID-19 vaccines reach poorer countries said Wednesday it needed $5.2 billion within the next three months to fund jabs for the world in 2022.
Covax reached the milestone of shipping its billionth vaccine dose at the weekend, after a surge in deliveries to countries in November and December, but hopes to ramp up the flow of vaccines this year.
“In 2022, we can help break Covid by adapting our support to ensure doses are used rapidly, get into arms safely, are responsive to country preferences and coverage targets,” said Gavi vaccine alliance chief Seth Berkley.
“This will help the world to reduce pandemic risks and uncertainties.” Gavi, along with the World Health Organization (WHO), is one of the co-leaders of the Covax scheme.
Covax wants $3.7 billion (3.26 billion euros) to fund a pool of 600 million doses, to ensure a reliable supply to the poorest countries, and cover eventual variables such as boosters or new variant vaccines.
A further $1 billion would go towards supporting readiness and delivery in poorer nations, and $545 million to cover the costs for rolling out donated doses, such as syringes, transportation and insurance.
The appeal has received $192 million so far from donors.
Berkley expects the next billion doses to take four to five months to deliver, rather than a year for the first billion.
Covax says it has enough confirmed supplies to vaccinate around 45 percent of the population in the 92 countries that receive donor-funded doses.
However, up to 25 of those nations are lagging behind in installing the capacity to get doses from airports into arms.
Covax reckons that it could save more than a million lives in 2022, and halve the economic cost of the pandemic in some countries, with a rapid roll-out.
WHO chief Tedros Adhanom Ghebreyesus said that while nearly 10 billion doses have been administered so far, approaching half the world’s population is completely unvaccinated.
He said the imbalance had led to new variants such as Omicron emerging, and “the next one could well be worse”.
“In 2022 we can end the acute phase of the pandemic or prolong it. World leaders have a choice.”
https://mb.com.ph/2022/01/20/covax-wants-5-2-bn-to-fund-2022-vaccine-drive/
1of402Phase2TrialUSA 1/20/22
01:17 PM
As an FYI- They have the previously collected blood data to show the result vs Omicron. Now they're collecting the final data of "in person blood draws" this week of the phase 2 subjects. They don't need to collect all of it to PROVE the vaccine works vs omicron, just enough. I had my blood draw on Tuesday (1/18/22).
https://stocktwits.com/1of402Phase2TrialUSA/message/428661549
DAKAR, Senegal and OSLO, Norway; 18 January 2022: CEPI and the Institut Pasteur de Dakar (IPD) have signed a Memorandum of Understanding (MoU) to formalize the partnership between the two organizations to advance IPD’s MADIBA project, a regional manufacturing hub for COVID-19 and other vaccines in Dakar, Sénégal. In its initial phase, IPD’s new modular facility will manufacture up to 300 million doses of COVID-19 vaccine annually for use in Africa.
With the manufacturing facility in advanced construction, IPD is on track to start vaccine production in 3Q22. IPD has previously signed an MOU with BioNTech to pursue mRNA vaccine manufacturing and is actively exploring partnerships with other vaccine companies to produce licensed COVID-19 vaccines in its new manufacturing facility. In the future, IPD plans to expand to produce vaccines against other pathogens that are relevant to the region – potentially also new vaccines funded by CEPI.
https://cepi.net/news_cepi/cepi-and-institut-pasteur-de-dakar-partner-to-advance-covid-19-vaccine-manufacturing-in-africa/
1/19/22 Wellcome and Bill & Melinda Gates Foundation Pledge US$300 Million to CEPI for COVID-19 Pandemic Response and to Accelerate Epidemic Preparedness
The foundations call on world leaders to support the Coalition for Epidemic Preparedness Innovations (CEPI) to help end the Covid-19 crisis, prepare for future pandemics, and address epidemic threats.
Today Wellcome and the Bill & Melinda Gates Foundation each pledged US$150 million for a total of US$300 million to the Coalition for Epidemic Preparedness Innovations (CEPI), a global partnership launched five years ago this week by the governments of Norway, Germany, Japan and India, the Gates Foundation, Wellcome, and the World Economic Forum. The pledges come ahead of a global replenishment conference in March to support CEPI’s visionary five-year plan to better prepare for, prevent, and equitably respond to future epidemics and pandemics.
“As the world responds to the challenge of a rapidly evolving virus, the need to deliver new, lifesaving tools has never been more urgent,” said Bill Gates, co-chair of the Gates Foundation. “Our work over the past 20 years has taught us that early investment in research and development can save lives and prevent worst-case scenarios. Five years ago, following the Ebola and Zika epidemics, our foundation helped launch CEPI. Today, we’re increasing our commitment and pledging an additional $150 million to help CEPI accelerate the development of safe and effective vaccines against emerging variants of the coronavirus and to prepare for, and possibly even prevent, the next pandemic.”
Since its inception, CEPI has played a central scientific role in curbing epidemics around the world, overseeing a number of scientific breakthroughs and putting pandemic preparedness at the center of the global health R&D agenda. When the Covid-19 pandemic began, CEPI responded immediately, building one of the world’s largest and most diverse portfolios of Covid-19 vaccine candidates—14 in all, including six of which continue to receive funding, and three of which have been granted emergency use listing by the World Health Organization (WHO).
CEPI made early investments in the development of the Oxford-AstraZeneca COVID-19 vaccine, which is now saving lives around the world. Last month, Novavax’s protein-based Covid-19 vaccine—funded largely by CEPI—received WHO emergency use listing and is poised to help efforts to control the pandemic globally. More than 1 billion doses of the Novavax vaccine are now available to COVAX, the global initiative co-led by CEPI that aims to deliver equitable access to Covid-19 vaccines. CEPI also continues to work on next-generation Covid-19 vaccines, including “variant-proof” Covid-19 vaccines and shots that could protect against all coronaviruses, potentially removing the threat of future coronavirus pandemics.
“The overriding lesson from this pandemic is the need for effective organizations and systems to be in place and ready before a crisis, as well as acting rapidly based on well-established science when such crises inevitably occur,” said Dr. Jeremy Farrar, director of Wellcome. “Wellcome proudly founded CEPI in 2017 along with partners from Norway, India, the Bill & Melinda Gates Foundation, and the World Economic Forum following the devastating 2014–16 Ebola epidemic. We learned the importance of conducting high-quality research during a crisis. Since then, CEPI has worked tirelessly, and by fostering global collaboration, it has played a truly integral role in the global pandemic response from early January 2020 onwards.”
“Our new commitment of $150 million recognizes the enormous potential CEPI has to protect lives against emerging infectious diseases,” Dr. Farrar continued. “The effects of Covid-19 have been sobering. We urge leaders to provide their support and ensure that CEPI reaches its funding target. It is in the world’s collective interest to avoid repeating mistakes and to help future generations prevent epidemics.”
Beyond Covid-19, CEPI has filled a vital gap in supporting vaccine equity alongside R&D. CEPI is currently supporting the research and development of accessible vaccines against other infectious diseases, including the first-ever vaccines to reach clinical trials against the deadly Nipah and Lassa viruses. The organization has also played a critical role in efforts to end Ebola, including supporting the development of a second Ebola vaccine by Janssen. In addition to advancing the science underlying vaccine development and new vaccine platforms, CEPI is focused on dramatically reducing the time it takes to develop lifesaving vaccines against any new viral threat (referred to as “Disease X”)—to within 100 days of a pathogen being sequenced. This represents a combination of scale and speed that could save millions of lives and trillions of dollars.
“The Covid-19 pandemic has revealed how inequitable access to vaccines can put the entire planet at risk and disrupt decades of global health progress,” said Awa Marie Coll Seck, minister of state to the president of the Republic of Senegal. “Innovative global partnerships like CEPI play a critical role in advancing the R&D needed to prevent future pandemics. Importantly, those investments in vaccine technology, particularly in Africa, can also help accelerate progress against other diseases—like HIV, TB, and malaria—that still affect the world’s most vulnerable populations.”
The pandemic has rebounded in waves around the world, highlighting the important role of international organizations like CEPI that put equitable access at the core of their mission. Recent data from Northeastern University show that had the availability of vaccines in lower-income countries like Kenya been akin to that in high-income countries like the UK or the U.S., 70 percent of Covid-19 deaths to date would have been averted.
“The world must do better at protecting everyone, everywhere against the greatest health threats—from Covid-19 and beyond,” said Melinda French Gates, co-chair of the Gates Foundation. “CEPI’s investments in groundbreaking R&D, commitments to equitable access, and cooperation across the public and private sectors are vital in this effort. We call on global leaders to help CEPI reach its funding target of $3.5 billion.”
The United Kingdom will host CEPI’s replenishment conference on March 8, 2022, in London. The fundraising event will convene governments, philanthropists, and other donors to support CEPI’s five-year plan to tackle the risk of pandemics and epidemics, potentially preventing millions of deaths and trillions of dollars in economic damage.
https://wellcome.org/news/wellcome-and-bill-melinda-gates-foundation-pledge-us300-million-cepi-covid-19-pandemic
the MEDI0457 vaccine, which contained VGX-3100 plasmid coupled with an IL-12 expression plasmid to promote T-cell function, evaluated the disease progression-free survival (PFS) at 12 months, which was estimated as 88.9% overall. These findings strengthen the hypothesis that DNA therapeutic vaccines could effectively induce de novo or boost existing immune responses.
The Efficacy of Therapeutic DNA Vaccines Expressing the Human Papillomavirus E6 and E7 Oncoproteins for Treatment of Cervical Cancer: Systematic Review
Received: 6 December 2021 / Revised: 24 December 2021 / Accepted: 27 December 2021 / Published: 31 December 2021
https://www.mdpi.com/2076-393X/10/1/53/htm?fbclid=IwAR0p8iXhwErzmuILwG0gejm47kf6gvqtfZcdkK_hx_m8ddjYnYBk0NdLAmk
With an extremely high Omicron worldwide attack rate, 4800 P3 INNOVATE most likely reach 75 cases for interim readout in 1Q22. Ditto the WHO’s STV trial. The WHO may grant Ino EUL in 2Q22. Expect Multiple large pre-orders. Congrats to all long suffering Longs !
OS30 tomorrow at 3rd GBM Drug Development Summit. Boston, 1/20/2022, 8:30 AM EST
A Deep Dive into DNA Damage Repair for GBM
Jeffrey Skolnik
VP Clinical Development Inovio
Methylated Median (cohort B) OS30 = OS24 (95% CI) = 55%, n Alive/N Total = 11/20.
Inovio’s DNA Medicine for the Treatment of Glioblastoma:
• Using novel DNA-encoded medicines to treat human cancers such as GBM
• Generating robust, specific anti-tumor T cells against GBM antigens
• Combining DNA medicine with immune checkpoint inhibitors to build clinical responses
1/15/22 BRUSSELS, Belgium — Poor countries refused to take around 100 million donated Covid-19 vaccine doses in December alone, chiefly due to their short shelf life, the United Nations said Thursday.
The World Health Organization (WHO) has slammed the deadly “moral shame” of high-income countries hogging vaccine supplies then offloading near-expiry doses to jab-starved poorer nations.
Stark images last month of Nigeria disposing of more than a million AstraZeneca doses that had gone off highlighted the issue.
UNICEF, the UN Children’s Fund, uses its vaccine logistics expertise to handle delivery flights for Covax, the global scheme set up to ensure a flow of doses to poorer nations.
In December, “we had almost more than 100 million doses that have been refused because of countries’ capacities”, UNICEF’s supply division director Etleva Kadilli told a European Parliament committee.
“The majority of refusals are due to product shelf life.”
“The short shelf life is really creating a major bottleneck for countries to plan their vaccination campaigns,” Kadilli explained.
“Until we have a better shelf life, this is going to be a pressure point for the countries, specifically when countries want to reach populations in hard-to-reach areas.” European Union donations account for a third of the doses delivered so far via Covax, Kadilli told lawmakers.
In October-November, 15 million EU-donated doses were rejected — 75 percent of them AstraZeneca shots with a shelf life of less than 10 weeks upon arrival.
Kadilli said that several nations were requesting for deliveries to be put off until after March, when they might be better able to handle the pressure on the cold storage chain.
Many countries “come back and request split shipments — they want to push doses towards the next quarter”, she said.
“And I’m talking here also for large, big countries where naturally you’d think that they do have the capacity.” –
‘Shame’ –
Covax is co-led by the WHO, the Gavi vaccine alliance, and CEPI, the Coalition for Epidemic Preparedness Innovations. Via UNICEF, it is about to deliver its billionth vaccine dose.
On December 29, the WHO announced that 92 of its 194 member states had missed its target of vaccinating 40 percent of their population by the end of 2021.
“This is due to a combination of limited supply going to low-income countries for most of the year and then subsequent vaccines arriving close to expiry and without key parts like the syringes,” said WHO chief Tedros Adhanom Ghebreyesus.
“It’s not only a moral shame; it cost lives.” In a speech on Thursday, he said that while more than 9.4 billion vaccine doses had been administered around the world, more than 85 percent of people in Africa are yet to receive a single dose.
“Some of the supply constraints we faced last year are now starting to ease, but we still have a long way to go to reach our target of vaccinating 70 percent of the population of every country by the middle of this year,” Tedros told member states.
https://www.google.com/amp/s/mb.com.ph/2022/01/15/short-shelf-lives-see-poor-nations-decline-millions-of-covid-jabs-un/%3famp
The case for Inovio Pharmaceuticals
Inovio Pharmaceuticals has also had its share of regulatory headwinds. The company's phase 3 portion of a phase 2/3 clinical study for its investigational COVID-19 vaccine, INO-4800, was placed on clinical hold by the FDA for a little more than a year. Regulators had concerns regarding Inovio Pharmaceuticals' Cellectra 2000 device. The company uses this gadget that resembles an electric toothbrush to administer INO-4800. The device uses electrical pulses to temporarily open small pores into a patient's cell to allow the vaccine to enter.
Fortunately, the FDA recently removed this clinical hold, which will allow the biotech to go ahead and conduct a phase 3 study for its vaccine.
The company has also received the regulatory nod to conduct its late-stage study in other countries, including Brazil, Mexico, the Philippines, Colombia, India, Thailand. Inovio Pharmaceuticals' strategy is to target underserved countries with its vaccine, once it proves safe and effective and earns approval. The company has also announced its intention to develop an omicron-specific COVID-19 vaccine, and other candidates that could address future variants of the coronavirus.
Beyond COVID-19, Inovio Pharmaceuticals' most advanced candidate is VGX-3100. It's a potential DNA vaccine aimed at treating a precancerous condition called cervical dysplasia, associated with the human papillomavirus (HPV). VGX-3100 is undergoing a pair of late-stage clinical trials. It has already delivered promising data in one of these trials, and Inovio Pharmaceuticals expects results from the other in the second half of the year.
The annual incidence of cervical dysplasia stands at 233,000 people in Europe and 195,000 people in the U.S. -- and there are currently no treatment options for the condition. VGX-3100 could be very successful if it makes it to the market.
The verdict
With the pending EUA in Canada, Ocugen looks closer to launching its vaccine on the market. However, the company will keep slightly less than half of the profits Covaxin will make in Canada. Meanwhile, Ocugen's chances to market Covaxin in the U.S. within the next year are bleak.
Inovio Pharmaceuticals isn't close to launching its candidate either, but it will at least have a much broader market to work with if INO-4800 is approved. Moreover, while all of Ocugen's other candidates are far too early in their developmental stages to be meaningfully considered here, Inovio Pharmaceuticals has a promising late-stage program in VGX-3100.
Neither company generates any profit, but Inovio Pharmaceuticals ended the third quarter with $394.9 million in cash and cash equivalents compared to Ocugen's $107.5 million. Keep in mind that clinical-stage biotechs often resort to secondary offerings to raise additional capital, a dilutive method of financing that almost always results in a sell-off. But as the company with less cash on hand, perhaps Ocugen is a higher risk here.
Inovio Pharmaceuticals' cash cushion, combined with its more attractive overall late-stage pipeline, justifies the company's market cap of $984.6 million -- slightly higher than Ocugen's $834.6 million.
For investors focused on the long game, Inovio Pharmaceuticals looks like the better option right now.
https://www.fool.com/investing/2022/01/11/better-vaccine-stock-ocugen-vs-inovio-pharmaceutic/
Next Thurs, 3rd GBM Drug Development Summit. Boston, 1/20/2022, 8:30A EST
A Deep Dive into DNA Damage Repair for GBM
Jeffrey Skolnik
VP Clinical Development Inovio
Inovio’s DNA Medicine for the Treatment of Glioblastoma:
• Using novel DNA-encoded medicines to treat human cancers such as GBM
• Generating robust, specific anti-tumor T cells against GBM antigens
• Combining DNA medicine with immune checkpoint inhibitors to build clinical responses
• Inovio’s INO-5401 is a DNA medicine composed of plasmids that encode for the tumor associated antigens human telomerase (hTERT), Wilms tumor-1 (WT-1), and prostate-specific membrane antigen (PSMA); INO-9012 is a synthetic DNA plasmid that encodes for human IL-12 designed to stimulate T cells locally without a systemic effect
• Cemiplimab is a high-affinity, highly potent, human, hinge-stabilized IgG4 monoclonal antibody to the PD-1 receptor
https://glioblastoma-drugdevelopment.com/full-event-guide/
Jefferies analyst Roger Song assumed coverage of Inovio Pharmaceuticals with a Hold rating and price target of $6, down from $8. The analyst believes near-term stock movement will likely be driven by the company's COVID-19 program and he's cautious on the Phase 3 efficacy results in the first half of 2022. He's watching for the second Phase 3 precancerous cervical dysplasia data including biomarker results in 2022 to further assess potential uptake.
Read more at:
https://thefly.com/n.php?id=3432608
Thailand becomes 5th country to recognize Medigen COVID-19 vaccine
01/11/2022 02:36 PM
[Medigen and Ino were selected by the WHO’s SVT.]
Taipei, Jan. 11 (CNA) Thailand has become the fifth country in the world to recognize the COVID-19 vaccine developed by Taiwan-based Medigen Vaccine Biologics, according to a list released by Thailand's government on Monday.
The Medigen vaccine was added to a list of eight previously recognized vaccines that will enable travelers to visit Thailand under its new tourism sandbox plan, according to the Thailand foreign ministry's Department of Consular Affairs.
The previously accepted COVID-19 vaccine brands were Sinovac, AstraZeneca, Pfizer-BioNTech, Moderna, Sinopharm, Johnson & Johnson, Sputnik V, and Covaxin (a vaccine developed in India).
Under the tourism sandbox plan that began Tuesday, travelers fully vaccinated with one of the nine vaccine brands can stay in one of several designated locales, including Phuket, Phang-gna, Krabi, Koh Samui, Koh Tao, and Koh Pha-ngan, for seven days after arriving in the country.
Once the seven-day period has ended, they can then travel to other parts of Thailand.
The sandbox plan will replace Thailand's TEST & GO program, which was launched in November 2021 and suspended a month later. That program enabled travelers from low-risk countries including Taiwan, who tested negative for COVID, to avoid quarantine.
Thailand is now the fifth country around the globe that allows travelers who have received the Medigen vaccine to either enter the country or face a shorter mandatory quarantine period, after New Zealand, Palau, Indonesia, and Belize.
Medigen Vaccine Biologics said Tuesday it appreciated the Thailand government's recognition and that its main focus now was to gain EUA (emergency use authorization) approval from the World Health Organization (WHO).
Medigen is the only domestically developed COVID-19 vaccine that has received an EUA from Taiwan's Food and Drug Administration, and its rollout in Taiwan began on Aug. 23.
So far, no other country has given Medigen full or emergency use authorization.
Medigen's COVID-19 vaccine is currently undergoing a clinical trial in Paraguay and has also been chosen to take part in the Solidarity Trial Vaccines platform, an international clinical trial platform co-launched by the WHO.
Its vaccine has also passed the first hurdle in getting provisional approval for use in Australia after it was granted "provisional determination" status by the country's Therapeutic Goods Administration (TGA) in November 2021.
https://focustaiwan.tw/society/202201110009
Inovio INO-4800 could be administered as many times as needed unlike synthetic mRNA which just got the NO GO from the EU.
1/11/22 Frequent Boosters Spur Warning on Immune Response
European Union regulators warned that frequent Covid-19 booster shots could adversely affect the immune response and may not be feasible.
Repeat booster doses every four months could eventually weaken the immune response and tire out people, according to the European Medicines Agency. Instead, countries should leave more time between booster programs and tie them to the onset of the cold season in each hemisphere, following the blueprint set out by influenza vaccination strategies, the agency said.
The advice comes as some countries consider the possibility of offering people second booster shots in a bid to provide further protection against surging omicron infections. Earlier this month Israel became the first nation to start administering a second booster, or fourth shot, to those over 60. The U.K. has said that boosters are providing good levels of protection and there is no need for a second booster shot at the moment, but will review data as it evolves.
Boosters “can be done once, or maybe twice, but it’s not something that we can think should be repeated constantly,” Marco Cavaleri, the EMA head of biological health threats and vaccines strategy, said at a press briefing on Tuesday. “We need to think about how we can transition from the current pandemic setting to a more endemic setting.”
The EU regulator also said at the briefing that oral and intravenous antivirals, such as Paxlovid and Remdesivir, maintain their efficacy against omicron. The agency said that April is the soonest it could approve a new vaccine targeting a specific variant, as the process takes about three to four months. Some of the world’s largest vaccine-makers have said they are looking at producing vaccines that could target new variants.
https://www.bloomberg.com/news/articles/2022-01-11/repeat-booster-shots-risk-overloading-immune-system-ema-says
The upshot is REGN may exclusively lock Ino’s GBM treatment by a collaboration and licensing agreement with upfront, development and commercialization milestones payments while conducting P3.
”Inovio, which has fully sponsored the glioblastoma study, is currently having conversations about the next clinical step for the INO-5401 and INO-9012 combination. While the company has not formally partnered with Regeneron, Skolnik said the two companies have collaborated well on the trial, with Regeneron offering up Libtayo. He hopes that will continue as the combination moves into later development.
As for when the combo might be put to regulators, Skolnik said the FDA wants to see randomized data for trials like this, which Inovio has not done yet. The company’s next step is likely to try to compare the combo with standard of care.“
Inovio’s combo is designed to attack common tumor-associated antigens that are over expressed in glioblastoma.
“The idea is … Inovio builds a T cell army that's antigen specific. It goes after the tumor cell, the PD-1 inhibitor revs those cells up, gets them activated and allows that combination, potentially, to benefit the patient,” Skolnik explained.
Some genetic differences exist in glioblastoma patients. Skolnik explained that patients are split by a biomarker called MGMT promoter methylation status. Patients whose tumors are not methylated tend to have a worse prognosis. Inovio’s treatment could potentially be used for both types of patients, but the clinical trial may provide some clues about who might benefit the most.
“Ultimately, the question is, why are some patients doing better than others? Who are the patients that could benefit the best from this? Will it be everybody at the end of the story?” Skolnik said.
https://www.fiercebiotech.com/biotech/inovio-going-after-impossible-tumor-left-dust-new-cancer-meds
If by June 30, 2022, MGMT Methylated Median (cohort B) OS36 = OS30 = OS24 (95% CI) = 55%, n Alive/N Total = 11/20, Ino will extend the trial for another 6 month, could apply for Orphan Designation, qualify for Compassionate Use, and maybe lobby Biden for EUA in memory of Beau, aka Beau vaccine/treatment.
• Inovio’s INO-5401 is a DNA medicine composed of plasmids that encode for the tumor associated antigens human telomerase (hTERT), Wilms tumor-1 (WT-1), and prostate-specific membrane antigen (PSMA); INO-9012 is a synthetic DNA plasmid that encodes for human IL-12 designed to stimulate T cells locally without a systemic effect
• Cemiplimab is a high-affinity, highly potent, human, hinge-stabilized IgG4 monoclonal antibody to the PD-1 receptor
• Create an antigen-specific, activated T cell population
• Inovio has shown that INO-5401+INO-9012 with cemiplimab and 40 Gy radiation/TMZ have an acceptable safety profile and are immunogenic
The GBM INO-5401 trial extension to June 30, 2022 means Ino already had unpublished data for MGMT Methylated Median (cohort B) OS30 = OS24 (95% CI) = 55%, n Alive/N Total = 11/20.
Of course, OS30 data was shared with FDA to obtain trial extension.
MGMT Unmethylated (Cohort A) OS24 (95% CI) = 21.9%, n Alive/N Total = 7/32
OS18% (95% CI) = 50%, n Alive/N Total = 16/32
So, Median OS; unmethylated (A) = 18 months
https://clinicaltrials.gov/ct2/history/NCT03491683?A=31&B=32&C=merged#StudyPageTop
https://s23.q4cdn.com/479936946/files/doc_presentations/INOVIO-Investor-Deck-Presentation_Nov2021.pdf
1/6/22 Update: INO-5401 and INO-9012 Delivered by Electroporation (EP) in Combination With Cemiplimab (REGN2810) in Newly-Diagnosed Glioblastoma (GBM)
MGMT Methylated Median OS not yet reached. To gather OS36 for FDA Compassionate Use:
Primary Completion: December, 2021 => June 30, 2022 [Anticipated]
Study Completion: December 2021 => June 30, 2022 [Anticipated]
https://clinicaltrials.gov/ct2/history/NCT03491683?A=31&B=32&C=merged#StudyPageTop
1/7/22 INO-3107 With Electroporation (EP) in Participants With HPV-6- and/or HPV-11-Associated Recurrent Respiratory Papillomatosis (RRP) finished recruiting
Overall Status: Recruiting => Active, not recruiting
https://clinicaltrials.gov/ct2/history/NCT04398433?A=20&B=21&C=merged#StudyPageTop
1/7/22 REVEAL 2 Trial (Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL) finished recruiting
Overall Status: Recruiting => Active, not recruiting
https://clinicaltrials.gov/ct2/history/NCT03721978?A=33&B=34&C=merged#StudyPageTop
Repeated COVID boosters not a viable strategy: WHO
Agence-France-Presse January 12, 2022
Geneva, Switzerland –WHO experts warned Tuesday that repeating booster doses of the original Covid vaccines is not a viable strategy against emerging variants and called for new jabs that better protect against transmission.
An expert group created by the World Health Organization to assess the performance of Covid-19 vaccines said simply providing fresh jabs of existing Covid vaccines as new strains of the virus emerge was not the best way to fight the pandemic.
“A vaccination strategy based on repeated booster doses of the original vaccine composition is unlikely to be appropriate or sustainable,” the WHO Technical Advisory Group on Covid-19 Vaccine Composition (TAG-Co-VAC) said in a statement.
The group said there could be a need to update the existing vaccines to better target emerging Covid variants, like Omicron which has spread rapidly and has been detected in 149 countries so far.
And it called for the development of new jabs that not only protect people who contract Covid against falling seriously ill but also better prevent people from catching the virus in the first place.
– Prevent infection –
“Covid-19 vaccines that have high impact on prevention of infection and transmission, in addition to the prevention of severe disease and death, are needed and should be developed,” TAG-Co-VAC said.
This, it said, would help lower “community transmission and the need for stringent and broad-reaching public health and social measures.”
It also suggested that vaccine developers should strive to create jabs that “elicit immune responses that are broad, strong, and long-lasting in order to reduce the need for successive booster doses”.
According to the WHO, 331 candidate vaccines are currently being worked on around the world.
Until new vaccines have been developed, the group said, “the composition of current Covid-19 vaccines may need to be updated”.
This would “ensure that (they) continue to provide WHO-recommended levels of protection against infection and disease by VOCs (variants of concern), including Omicron and future variants.”
Just weeks after Omicron was first detected in southern Africa, it is becoming increasingly clear that it is not only far more transmissible than previous variants, but also better at dodging some vaccine protections.
The WHO has so far given its stamp of approval to versions of eight different vaccines.
TAG-Co-VAC stressed that those vaccines provide a high level of protection against severe disease and death caused by the various variants of the virus.
It said preliminary data indicated the existing vaccines were less effective at preventing symptomatic Covid disease in people who have contracted the Omicron variant.
But protection against severe disease, which is what the jabs were especially intended to do, “is more likely to be preserved”, it said.
“However, more data on vaccine effectiveness, particularly against hospitalisation, severe disease, and death are needed, including for each vaccine platform and for various vaccine dosing and product regimens,” it said.
– ‘Primary vaccination’ top priority –
In the meantime, TAG-Co-VAC echoed the WHO stance that “the immediate priority for the world is accelerating access to the primary vaccination”.
The UN health agency has resisted the push in a growing number of countries to roll out blanket booster programmes in the battle against new concerning variants like Omicron.
The WHO says this makes no sense as many people in poorer nations are still waiting for a first jab, dramatically increasing the chance of new, more dangerous variants emerging.
So far, more than eight billion doses of Covid-19 vaccines have been administered in at least 219 territories, according to an AFP count.
But while over 67 percent of people in high income countries have received at least one jab, fewer than 11 percent have in low income countries, according to UN numbers.
https://mb.com.ph/2022/01/12/repeated-covid-boosters-not-a-viable-strategy-who/
Background Human telomerase reverse transcriptase (hTERT) is frequently classified as a ‘universal’ tumor associated antigen due to its expression in a vast number of cancers. We evaluated plasmid DNA-encoded hTERT as an immunotherapy across nine cancer types.
Journal for ImmunoTherapy of Cancer Jul 2021, 9 (7) e003019; DOI: 10.1136/jitc-2021-003019
Methods A phase 1 clinical trial was conducted in adult patients with no evidence of disease following definitive surgery and standard therapy, who were at high risk of relapse. Plasmid DNA encoding one of two hTERT variants (INO-1400 or INO-1401) with or without plasmid DNA encoding interleukin 12 (IL-12) (INO-9012) was delivered intramuscularly concurrent with the application of the CELLECTRA constant-current electroporation device 4 times across 12 weeks. Safety assessments and immune monitoring against native (germline, non-mutated, non-plasmid matched) hTERT antigen were performed. The largest cohort of patients enrolled had pancreatic cancer, allowing for additional targeted assessments for this tumor type.
Results Of the 93 enrolled patients who received at least one dose, 88 had at least one adverse event; the majority were grade 1 or 2, related to injection site. At 18 months, 54.8% (51/93) patients were disease-free, with median disease-free survival (DFS) not reached by end of study. For patients with pancreatic cancer, the median DFS was 9 months, with 41.4% of these patients remaining disease-free at 18 months. hTERT immunotherapy induced a de novo cellular immune response or enhanced pre-existing cellular responses to native hTERT in 96% (88/92) of patients with various cancer types. Treatment with INO-1400/INO-1401±INO-9012 drove hTERT-specific IFN-? production, generated hTERT-specific CD4+ and?CD8+ T cells expressing the activation marker CD38, and induced hTERT-specific activated CD8 +CTLs as defined by cells expressing perforin and granzymes. The addition of plasmid IL-12 adjuvant elicited higher magnitudes of cellular responses including IFN-? production, activated CD4+ and?CD8+ T cells, and activated CD8+CTLs. In a subset analysis of pancreatic cancer patients, the presence of immunotherapy-induced activated CD8+ T cells expressing PD-1, granzymes and perforin correlated with survival.
Conclusions Plasmid DNA-encoded hTERT/IL-12 DNA immunotherapy was well-tolerated, immune responses were noted across all tumor types, and a specific CD8+ phenotype increased by the immunotherapy was significantly correlated with survival in patients with pancreatic cancer.
https://jitc.bmj.com/content/9/7/e003019
Phase 1 study of safety, tolerability and immunogenicity of the human telomerase (hTERT)-encoded DNA plasmids INO-1400 and INO-1401 with or without IL-12 DNA plasmid INO-9012 in adult patients with solid tumors
Robert H Vonderheide1, http://orcid.org/0000-0001-9233-8858Kimberly A Kraynyak2, Anthony F Shields3, Autumn J McRee4, Jennifer M Johnson5, Weijing Sun6, Ashish V Chintakuntlawar7, Jan Pawlicki2, Albert J Sylvester2, Trevor McMullan2, Robert Samuels2, Joseph J Kim2, David Weiner8, Jean D Boyer2, Matthew P Morrow2, Laurent Humeau2 and Jeffrey M Skolnik2
Correspondence to Dr Kimberly A Kraynyak; kim.kraynyak@inovio.com
More than 300 participants of the country’s “Mix and Match” (MnM) study have already received their first dose of Sinovac vaccine, the Department of Science and Technology (DOST) said Friday, Jan. 7.
The 18 month-long study seeks to evaluate the safety and immunogenicity of mixing different coronavirus disease (COVID-19) vaccines and vaccine platforms in Filipino adults. The project team is led by Dr. Michelle De Vera of the Philippine Society for Allergy, Asthma, and Immunology (PISAAI).
Locally available vaccines under the National Immunization Program have been used in the trial. These include Sinovac, Sputnik V, AstraZeneca, Pfizer and Moderna.
DOST Undersecretary for Research and Development Dr. Rowena Cristina L. Guevara said 332 participants got their first dose of Sinovac vaccines, while 86 participants were vaccinated with second dose of either Sinovac or Pfizer, Moderna, AstraZeneca, Sputnik V vaccines.
“As of January 5, 2022, the three sites in Marikina, Manila and Muntinlupa sites have already conducted their recruitment activities with a total of 332 vaccinated with first dose of Sinovac and 86 participants who have received their second dose of either a homologous (Sinovac) or heterologous (Pfizer, Moderna, AstraZeneca, Sputnik V) vaccines,” she said in an interview with the Manila Bulletin.
Guevara disclosed that in addition to Marikina, Manila and Muntinlupa trial sites, there were two other sites being coordinated with their respective local government units (LGUs) for study approval or endorsement prior to the conduct of the trial.
Around 3,000 adult volunteers aged 18 and above were targeted to participate in the study.
The MnM study has been given a total budget of P204.19 million under the DOST-Grants-in-Aid (GIA) program. It secured FDA’s approval on Nov. 16.
The study is aimed at determining the safety and immunogenicity of completing the vaccination series with available COVID-19 vaccines in the Philippines in those given Sinovac as the first dose.
The trial likewise seeks to analyze whether those who already completed the dosing regimen for Sinovac will have a better immune response after the immunization of a booster dose from a different vaccine platform or brand.
https://www.google.com/amp/s/mb.com.ph/2022/01/07/332-participants-of-ph-mix-and-match-trial-get-first-dose-of-sinovac-vaccine/%3famp
Moderna shares jumped about more than 6% after the company’s CEO said Monday that it’s working on a booster that targets the omicron variant of Covid-19 “with public health leaders around the world,” targeting a fall rollout. The booster will enter clinical trials soon, he added. The original two-dose vaccines from Moderna and Pfizer, on the other hand, are only about 10% effective at preventing symptomatic infection 20 weeks after the second dose, according to the study. He said Moderna had between 50 million and 100 million doses waiting for shipment to low-income countries on any given day in November.
The main challenge now is distribution, or actually getting those shots into people’s arms.
“There’s been a lot of issues on the distribution [cold chain requirement] and deployment of those vaccines,” Bancel said.
The Moderna CEO said the African Union decided to turn down 60 million doses the company reserved for the continent for the second quarter.
With a rather conservative positivity rate of 5%, the 3840 fully dosed SVT patients would reach the 75 infected cases for each Vax group even if the 3840 includes both vaxes. Besides, unlike mRNA vaxes which caused myocarditis and pericarditis, unlike AZN/Oxford, JNJ which caused blood clot, no cold chain requirement, great CD4+/CD8+ T-Cell, B-cell response, length of immunity, duration of protection, 4800 has two good shots (WHO’s SVT, INNOVATE) on goal of getting the WHO’s EUL, will be procured by COVAX, China ????, Brazil ????, Colombia ????, Mexico ????, Philippines ????, Thailand ????, India ????, Mali ????, USA ????, Rwanda ????, Tunisia ????, and the rest of the world.
INNOVATE 4800 P3 Update: As of 10/29/21 all 3 Brazil ????, 7 Philippines ????, 5 Colombia ???? sites have finished recruiting. Only 3 Mexico ???? sites were recruiting which would be done by now 1/7/22. Many ppl would have received 2nd dose. 4800 only needs 75 COVID-19 cases, 2 wks after 2nd dose (50% of 150) to issue an interim result, likely in 1Q22 with rampant Omicron.
https://clinicaltrials.gov/ct2/history/NCT04642638?A=9&B=10&C=merged#StudyPageTop
5,901 participants of WHO Solidarity Trial already received first dose of COVID-19 vaccines — DOST
NationalNews
Charissa Luci-Atienza January 7, 2022
The Department of Science and Technology (DOST) said Friday, Jan. 7, that more than 5,900 participants of the World Health Organization’s (WHO) Solidarity Trial for Vaccines (STV) in the country have already received their first dose of vaccines against coronavirus disease (COVID-19).
(MANILA BULLETIN FILE)
DOST Undersecretary for Research and Development Dr. Rowena Cristina L. Guevara said as of Jan. 3, a total of 5,901 participants have been inoculated with the first dose of COVID-19 vaccine, while 3,840 participants have completed their two-dose regimen.
“As of January 3, 2022, eight hospitals and two community-based sites have already conducted the recruitment activities with a total of 5,901 have already been vaccinated with first dose and 3,840 participants have already completed the two-dose schedule of the first study vaccine,” she told the Manila Bulletin in an interview.
The lead investigators of the trial are Dr. Jodor A. Lim and Dr. Marissa M. Alejandria of the University of the Philippines (UP) Manila-Philippine General Hospital (PGH).
Guevara explained that the WHO-coordinated global study “Solidarity Trial Vaccines” is implemented locally through the project “Solidarity Vaccine Trial in the Philippines: Randomized Trial of Candidate Vaccines for COVID-19”.
She said recruitment of participants are ongoing on the following sites:
Philippine General Hospital (PGH)
Lung Center of the Philippines (LCP)
Makati Medical Center (MMC)
Quirino Memorial Medical Center (QMMC)
St. Luke’s Medical Center (SLCM)
Medical Center Manila (MCM)
Baguio General Hospital
San Juan De Dios Hospital (SJDH)
Sampaloc, Manila (community-based)
Crame, Quezon City (community-based)
The project team is eyeing to enroll 15,000 to 20,000 Filipinos aged 16 and above [40K worldwide in Mali, Colombia] to participate in the trial.
The enrolment of participants for the WHO STV started on Sept. 30, 2021.
Guevara said the study “will continue to run until the second quarter of 2022.”
https://mb.com.ph/2022/01/07/5901-participants-of-who-solidarity-trial-already-received-first-dose-of-covid-19-vaccines-dost/
The Department of Science and Technology (DOST) said Friday, Jan. 7, that more than 5,900 participants of the World Health Organization’s (WHO) Solidarity Trial for Vaccines (STV) in the country have already received their first dose of vaccines against coronavirus disease (COVID-19).
DOST Undersecretary for Research and Development Dr. Rowena Cristina L. Guevara said as of Jan. 3, a total of 5,901 participants have been inoculated with the first dose of COVID-19 vaccine, while 3,840 participants have completed their two-dose regimen.
“As of 1/3/2022, eight hospitals and 2 community-based sites have already conducted the recruitment activities with a total of 5,901 have already been vaccinated with first dose and 3,840 participants have already completed the two-dose schedule of the first study vaccine,” she told the Manila Bulletin in an interview.
These are a spike adjuvanted vaccines developed by Medigen, and a DNA vaccine encoding the spike protein developed by Inovio.
When is 4Q21 Earning release date?
The online Investor Presentation is still dated Nov 2021. When can you update it?
”We are in the process of updating our IR deck. We will also announce our earnings release date shortly.” 7/7/2022
OS30 data at 3rd GBM Drug Development Summit. Boston, 1/20/2022, 8:40A EST
A Deep Dive into DNA Damage Repair for GBM
Jeffrey Skolnik
VP Clinical Development Inovio
Inovio’s DNA Medicine for the Treatment of Glioblastoma:
• Using novel DNA-encoded medicines to treat human cancers such as GBM
• Generating robust, specific anti-tumor T cells against GBM antigens
• Combining DNA medicine with immune checkpoint inhibitors to build clinical responses
https://s23.q4cdn.com/479936946/files/doc_presentations/INOVIO-Investor-Deck-Presentation_Nov2021.pdf
GBM 5401 Overall Survival at 24 Months
MGMT Unmethylated (Cohort A)
MGMT Methylated (Cohort B)
Combined
n Alive/N Total
7/32
11/20*
18/52
OS24% (95% CI)
21.9 (9.3 - 40)
55 (31.5 – 76.9)
34.6 (23.1 – 49.1)
Of the estimated 17,000 primary brain tumors diagnosed in the US each year, approximately 60% are gliomas.1,2 Glioblastoma (GB), or grade IV astrocytoma, is the most aggressive of primary tumors of the brain for which no cure is available.1,3 Management remains palliative and includes surgery, radiotherapy, and chemotherapy. With optimal treatment, patients with GBs have a median survival of less than one year.1 About 2% of patients survive three years.4 Previously reported long-term survivors (LTSs) of GB may have been patients who actually harbored other low-grade gliomas.5 The overall prognosis for GB has changed little since the 1980s, despite major improvements in neuroimaging, neurosurgery, radiotherapy, and chemotherapy techniques.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3037140/#!po=46.0000
GBM 5401 Overall Survival at 24 Months
MGMT Unmethylated (Cohort A)
MGMT Methylated (Cohort B)
Combined
n Alive/N Total
7/32
11/20*
18/52
OS24% (95% CI)
21.9 (9.3 - 40)
55 (31.5 – 76.9)
34.6 (23.1 – 49.1)
https://s23.q4cdn.com/479936946/files/doc_presentations/INOVIO-Investor-Deck-Presentation_Nov2021.pdf
“results for GBM is on our website.
In terms of timing we are trying to be more conservative.”
4800 P3 interim result only needs 75 Covid-19 cases.
Previously, Dr Kim said INNOVATE Phase 3 interim data would be released in 1Q22, Now 1H22. Why?
“6 other country openings for our trial in last several weeks. But it really -- the clinical hold lift and authorization for Phase 3 in the U.S., it provides us additional validation, and it shows that we have met all of the concerns of the U.S. FDA satisfactorily. That being said, we're really pleased that -- to say that the dosing for INNOVATE Phase 3 trial has already begun and it's underway. And interim efficacy -- it's a case-driven study so magic number is around 150 lab-confirmed cases and of course, interim will be at the 50% of those cases. So faster re-enroll and the percent of attack rate in those countries or those regions will really impact when exactly where we will meet that 50% efficacy -- these are all blinded until we hit about 75 cases. So that's why we left that as a broadly first half 2022. So that's what we're looking for. And it's always been the same design from when we started the INNOVATE Phase 3 trial. “ JK 11/10/21
“6 other country openings for our trial in last several weeks. But it really -- the clinical hold lift and authorization for Phase 3 in the U.S., it provides us additional validation, and it shows that we have met all of the concerns of the U.S. FDA satisfactorily. That being said, we're really pleased that -- to say that the dosing for INNOVATE Phase 3 trial has already begun and it's underway. And interim efficacy -- it's a case-driven study so magic number is around 150 lab-confirmed cases and of course, interim will be at the 50% of those cases.
So faster re-enroll and the percent of attack rate in those countries or those regions will really impact when exactly where we will meet that 50% efficacy -- these are all blinded until we hit about 75 cases. So that's why we left that as a broadly first half 2022. So that's what we're looking for. And it's always been the same design from when we started the INNOVATE Phase 3 trial. “ JK 11/10/21
“So our team is working really hard to open these sites, get approvals in the country's open sites, and in all subjects. Separately, the Solidarity trial is operating independently, and we're really grateful that the WHO has selected, or their independent panel has selected INO-4800 as one of 2 initial vaccines.
And I think there's 2 more being added in the future, but out of 20 or so candidates of second wave COVID-19 vaccines out there, so we're highly grateful for that selection. Obviously, we think we are the leader of the second wave of COVID-19 vaccines, and we have the opportunity to demonstrate our efficacy and safety. I have no qualms about our safety, but we still have to get to that efficacy data. And we have two shots on the goal with our INNOVATE Phase 3 trial that we're conducting with our partner vaccine, as well as WHO's Solidarity trials. We couldn't be any happier. We're excited in our opportunities here and our team is working really hard to achieve that.”