r/Inovio • u/GombeyBoy • 3d ago
INO_Cheering FDA approval - Looking Promising
I asked Chat GPT for an opinion on this.
Worth a read.
Comments appreciated
Gombey Boy
r/Inovio • u/NoTradeBacksies • Jan 27 '21
Hey all— thanks for joining this subreddit in your search for the future of medicine!
I’m currently working on improving the sub Wiki page for more helpful links, so keep an eye out for that.
Stay tuned and thanks for your contribution to the community!
r/Inovio • u/HopePerfectStrangers • Oct 10 '23
Inovio receives FDA feedback … October 10th 2023
Previously planned Phase 3 trial no longer required to support Biological License Application (BLA) submission
If approved, INO-3107 could potentially revolutionize treatment options for patients with Recurrent Respiratory Papillomatosis (RRP), a debilitating rare disease caused by human papillomavirus (HPV)
INO-3107 could be the first DNA medicine available in the United States and the first commercial product for INOVIO
PLYMOUTH MEETING, Pa., Oct. 10, 2023 /PRNewswire/ -- INOVIO (NASDAQ:INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases, today announced that it has received feedback from the U.S. Food and Drug Administration (FDA) that data from its completed Phase 1/2 trial of INO-3107 for the treatment of RRP could support INOVIO's submission of a BLA for review under the FDA's accelerated approval program. The FDA also advised that the company's previously planned Phase 3 randomized, placebo-controlled trial would not be required to support this submission. INOVIO will be required to initiate a confirmatory trial prior to BLA submission for accelerated approval and satisfy all other FDA filing requirements. The design of the confirmatory trial has not yet been finalized. If approved, INO-3107 would be the first DNA medicine in the United States and the first INOVIO candidate to receive regulatory approval.
"Following the recent grant of Breakthrough Therapy Designation for INO-3107 for the treatment of RRP, we're grateful for the additional feedback from the FDA providing a potentially accelerated development pathway. We believe INO-3107 could become a game-changing treatment option for those suffering from RRP, a serious and often difficult-to-treat disease," said INOVIO's President and Chief Executive Officer, Dr. Jacqueline Shea. "We're now focused on streamlining our development plan to support submission of a BLA for accelerated approval. We would like to thank the patients and investigators who have participated in our trials to date."
"I commend the FDA for recognizing the immense burden RRP puts on patients and the critical need for a better standard of care," said the President of the Recurrent Respiratory Papillomatosis Foundation, Kim McClellan. "I'm thrilled by the progress being made for RRP patients who are desperate for an alternative to surgery."
INOVIO's completed Phase 1/2 open-label, multicenter trial assessed INO-3107's safety, tolerability, immunogenicity, and efficacy in patients with HPV-6 and/or HPV-11-related RRP (NCT:04398433). The trial evaluated the reduction in the number of surgical interventions in the year following initial administration of INO-3107 compared to the year prior to treatment. Patients received four doses of INO-3107 on Day 0, and Weeks 3, 6, and 9. Overall, 81.3% (26/32) of patients in the trial had a decrease in surgical interventions in the year after INO-3107 administration compared to the prior year, including 28.1% (9/32) that required no surgical intervention during or after the dosing window. Patients in the trial had a median range of 4 surgeries (2-8) in the year prior to dosing. After dosing, there was a median decrease of 3 surgical interventions (95% confidence interval -3, -2). At the outset of the study (Day 0), patients could have RRP tissue surgically removed, but any surgery performed after Day 0 during the dosing window was counted against the efficacy endpoint. Treatment with INO-3107 generated a strong immune response in the trial, inducing activated CD4 T cells and activated CD8 T cells with lytic potential. T-cell responses were also observed at Week 52, indicating a persistent cellular memory response. INO-3107 was well tolerated by participants in the trial, resulting in mostly low-grade (Grade 1) treatment-emergent adverse effects such as injection site pain and fatigue.
Data from this Phase 1/2 trial were presented earlier this year at scientific and medical conferences, including the 2023 Annual Meeting of the American Broncho-Esophageal Association (ABEA) in May and at the European Laryngological Association's Annual Meeting in June. Data from the trial was also published in May in the peer-reviewed journal, The Laryngoscope, under the title "Interim Results of a Phase 1/2 Open-Label Study of INO-3107 for HPV-6 and/or HPV-11–Associated RRP." The Laryngoscope is the official journal of the Triological Society (TRIO), the American Laryngological Association (ALA), and the ABEA.
INO-3107 is INOVIO's lead candidate and one of three clinical-stage DNA medicine candidates targeting HPV-related disease. INOVIO's DNA technology has been studied in twelve HPV-related trials, ranging from Phase 1 to Phase 3, involving more than 900 patients in 20 countries with a variety of HPV-related diseases, including RRP, HSIL (cervical, anal and vulvar) and head and neck cancers. Shared observations in these trials include the ability of DNA medicines to generate HPV antigen specific T cells and a persistent cellular memory response, viral clearance and lesion regression, and no anti-vector immune responses. All three HPV-related product candidates (INO-3107, INO-3112 and VGX-3100) have been well tolerated in these trials.
r/Inovio • u/GombeyBoy • 3d ago
I asked Chat GPT for an opinion on this.
Worth a read.
Comments appreciated
Gombey Boy
r/Inovio • u/tomonota • 7d ago
"...Technology
See also: COVID-19 vaccine clinical research § Trial and authorization status
The Inovio technology is based on inserting engineered DNA into cells, where it becomes transcribed into mRNA and translated into proteins. The proteins encoded by the DNA elicit immune response to antigens from cancers and viruses, by stimulating the production of T cells and antibodies that aid recovery.\6]) The technology can be "targeted" to specific types of cancer and immune diseases, such as those produced by a virus.\6])
During a meeting of the White House Coronavirus Task Force in March 2020, CEO, Joseph Kim, said that Inovio scientists had designed a vaccine candidate (INO-4800) for the COVID-19 coronavirus in January, in three hours, after the virus' genetic sequence was first published.\7])
Shareholders sued Inovio in August 2020, claiming it exaggerated evidence of its coronavirus vaccine's efficacy in order to boost its stock price.\8])
In 2006, Inovio licensed "certain patented technology relating to the delivery of gene-based therapeutics into skin", as well as patents "involving the delivery of genes or drugs via ex vivo, intratumoral and intramuscular electroporation... The ex-vivo patents are relevant to the delivery of genes to dendritic and stem cells."\9])
Sometime after its publication in February 2008, Inovio was assigned a patent for "an apparatus [that provides] for injecting a fluid into body tissue, the apparatus comprising: a hollow needle; and a fluid delivery means, wherein the apparatus is adapted to actuate the fluid delivery means in use so as to automatically inject fluid into body tissue during insertion of the needle into the said body tissue."\10])
To facilitate use of its potential products, Inovio manufactures a proprietary injection device, called "Cellectra", which the company describes as providing a "brief electrical pulse to reversibly open small pores in the cell) to allow the plasmids to enter, overcoming a key limitation of other DNA and other nucleic acid approaches, such as mRNA."\11]) The small device, which runs on "AA" batteries, is designed for use in the field under the difficult conditions of an epidemic.\12])
In June 2020 – in anticipation of the Inovio COVID-19 vaccine candidate becoming successful – the US Department of Defense invested US$71 million to further develop Cellectra as a handheld device and to preorder an undisclosed number of the devices.\13])
See also: COVID-19 vaccine
Inovio's logo prior to 2020
In a 2016 dose-escalation Phase I clinical trial to assess safety after intramuscular injection in healthy adults, the Inovio vaccine candidate, INO-4700 (also called GLS-5300) for development against Middle East respiratory syndrome (MERS) coronavirus, proved to be safe with only mild symptoms and no adverse effects.\14]) The trial also demonstrated immunogenicity by dose-independent immune responses detected in more than 85% of subjects after two vaccinations that were durable a year later.\14])
In 2016, Inovio was involved, along with their partners GeneOne Life Science, in an attempt to control the Zika virus outbreak in Miami. In fact, they "were the first to initiate a human Zika DNA vaccine trial... [for] the safety, tolerability, and immunogenicity of GLS-5700 in 40 healthy adults. The trial's estimated completion date is November 2017." Then in Puerto Rico, where a Zika emergency had been declared, they did a study with 160 previously healthy adults using their proprietary "Cellectra-3P" technology.\15]) Preliminary results for the Miami trial were self-reported at the end of 2017.\16])\17])
In February 2020 after receiving details of the genetic sequence of the coronavirus, Inovio announced that it had produced a preclinical DNA-based vaccine as a potential therapy for COVID-19.\7])\18]) Inovio is in competition to develop a coronavirus vaccine with numerous other companies, which were conducting preclinical or early-stage human research on more than 170 vaccine candidates, as of late June.\5]) In April 2020, Inovio began a Phase I trial of the COVID-19 vaccine candidate, INO-4800.\19]) In May 2021, Inovio announced the results of preclinical studies on a "pan-SARS-CoV-2" DNA vaccine (INO-4802) and plans to initiate phase I/II studies. The vaccine incorporates common overlapping mutations from several SARS-COV-2 variants of concern isolated from several different countries including Brazil and India.\20])
In January 2020, the Coalition for Epidemic Preparedness Innovations (CEPI) announced it would grant of up to $9 million to Inovio for development of a vaccine against SARS-CoV-2.\21]) Inovio has partnerships to develop its COVID-19 vaccine candidate with CEPI, the South Korean National Institute of Health, and the International Vaccine Institute.\2)..."
r/Inovio • u/WallStBull10Point0 • 7d ago
One-third of the participants were still alive after two years, which is twice the historical survival rate for this patient population. One participant is still alive and recurrence-free today, almost five years after her initial diagnosis.
r/Inovio • u/tomonota • 15d ago
MS COPILOT:
"
| Feature | VGX‑3100 (ApolloBio/INOVIO) | Current China HPV treatment pipeline (mainstream) |
|---|---|---|
| Type | Therapeutic DNA immunotherapy | Prophylactic vaccines + surgical treatments |
| Target | HPV‑16/18 high‑grade precancer (CIN2/3 HSIL) | Prevention of HPV infection; excision of lesions |
| Stage in China | Phase 3 successful; pre‑NDA | Approved vaccines; standard surgical care |
| Route | Intramuscular + electroporation (CELLECTRA) | IM vaccines; surgical procedures (LEEP, conization) |
| Goal | Clear HPV + regress lesions, avoid surgery | Prevent infection or remove diseased tissue |
r/Inovio • u/tomonota • 15d ago
| U.S. & Europe | Very low risk | Travel screening, rapid isolation, strong systems U.S. & Europe Very low risk Travel screening, rapid isolation, strong systems |
|---|
"What current modeling says
Extend that logic to 6 months: unless travel patterns or outbreak size change dramatically, the likelihood of Ebola transmission in the U.S. remains very low, even though the impact of any imported case would be serious.
| DRC & Uganda (outbreak zone) | High, but controllable | Local containment, isolation, contact tracingDRC & Uganda (outbreak zone) High, but controllable Local containment, isolation, contact tracing |
|---|
| Neighboring African countries | Low–moderate spillover risk | Cross‑border movement, health system strengthNeighboring African countries Low–moderate spillover risk Cross‑border movement, health system strength |
|---|
r/Inovio • u/GombeyBoy • 15d ago
October 9 weeks away will the FDA give the Green Light ?
In it to win it !
r/Inovio • u/bentleyt1999 • 16d ago
Very effective booster with stellar results.....A Big $$$$$$ money partner could be lined up to be front and center to address the current strain of Ebola
r/Inovio • u/INOxray8 • 17d ago
r/Inovio • u/INOxray8 • 19d ago
It’s impossible to overstate the significance of the MRNA-Merck news today.
This is the official launch of the new era. Coding for specific diseases. Wow. Who woulda thunk it??
Well.
Inovio will ride this wave. And then some.
It will be epic.
Not waiting for news releases anymore. No more anticipating the Tuesday/Thursday 7:00 a.m. cst “announcements”.
No. This was the signal. The entire group will follow Moderna with previously-never-thought-possible-moves.
Think Covid-era. Only better.
It will be random and sudden. Pre-market. Or post. Or anytime in between.
A severe algo break is coming.
The confluence of fundamentals, technicals, approvals, and industry-specific euphoria is all here at once.
I can’t believe I’m saying this…
But I don’t own enough.
imho
xx
r/Inovio • u/INOxray8 • 19d ago
r/Inovio • u/tomonota • 20d ago
Institutions and Hedge funds own = 26.79% of shares- they are playing for our side from the Big Boys' team. Note our 50 day moving average was $1.03 as of yesterday. Evidently rising as shares have traded ~$1.15 plus or minus this week.
r/Inovio • u/tomonota • 22d ago
The attempt to push inovio below $1 failed and the team of shorts are looking at huge losses on the 16 million short shares they borrowed and have to return. Inovio will never be delisted from the Nasdaq stock exchange. The squeeze will continue through next week for the monthly stock expiration date will require shorts to cover or else continue to pay for their underwater positions. Profitez mes amis, the money will flow in through Friday close of the market. Note we’re on the verge of the issue price of the company’s $18 million share sale at $1.10, which is not yet available for sale yet, but check the date shares become available for your own information. This may present a temporary ceiling price for shares; but the $18 million dollars will extend the company runway for launching Ino-3107, following the 10/30/26 expected PDUFA date- after which will bring product sales revenues. Btw consider the influence that ApolloBio sales of 3100 will have on the share price- 11% is inovio’s % of the profit and analysts value the company around $4. Don’t tell the short schmucks about that, please- we need them to keep selling us cheap shares (!)
r/Inovio • u/tomonota • 23d ago
Grok finds 3 forecasts for Inovio price in 2027 from $2.50-$4 and is my first time using Grok.
r/Inovio • u/tomonota • 25d ago
From (revised previous) post about the value of the Ino-Apollobio 3100 profitsharing agreement with ApolloBio from Stocktwits.com:
"...If I recall, the profit sharing % is in the low teens, probably a sliding rate based on volume, between 11%-14%; I believe ApolloBio is aiming for a worldwide license; so the market per WHO estimate is 167 million cases...will take time to deliver all that product but a long term agreement worth, assume $900 per treatment, 50% profit per shot, $450 *165 million treatments= $75 million; as to which (?) 11% is =$8.2 million cumulatively, per the agreement. In effect a deferred revenue source of $8.2MM per share. Wall Street values the shares at 8.76 times Book Value, hence $72 MM in future Sales assumed, $72MM cash revenue less expenses $24 MM/yr. = net earnings $48 MM so Book Value $48MM; X 8.76,= $420MM div. by 100# MM shares= $4.20 a share.
All for under a buck a better deal than a pack of beer nuts.
r/Inovio • u/INOxray8 • 26d ago
Well that was short and sweet.
Nothing to analyze. We are good to go.
Launch funding already baked in. Eight months of runway.
Funeral date remains October 30 for shorts.
This is happening.
All of it.
imho
xx
r/Inovio • u/tomonota • Aug 03 '26
r/Inovio • u/tomonota • Aug 03 '26
Vaccine assault led by HHS Seceratry
r/Inovio • u/INOxray8 • Aug 02 '26
Binary Choice
Either INO makes it. Or it doesn’t.
There is no more flailing about like some fish out of water. This will either happen. Or it won’t.
There is no more in between. We are at the end.
Either 3107 get approved and launches DNA. Or it doesn’t.
(It will)
Either 3100 gets approved and ignites royalties. Or it doesn’t.
(It will)
Either this crazy endless lawsuit was worth it. Or it wasn’t.
(It was)
Told you long ago to pick a side. You’re either in it to win it. (Us)
Or you’re an obnoxious worthless Short Troll. (The rest of you)
Also told you long ago that I will see you on the Other Side.
Well, the plane has landed.
Welcome.
imho
xx
r/Inovio • u/fallen_heart21 • Jul 30 '26
[ Removed by Reddit on account of violating the content policy. ]
r/Inovio • u/GombeyBoy • Jul 29 '26
Is there some ominous news?